Search Results for "Psoriasis"
David R. Adams MD PharmD, Tamy Buckel MD, Jennifer A. Sceppa MD| |
Minh-Ly N Gaylor PA, Madeleine Duvic MD| |
The Use of Methotrexate, Alone or in Combination With Other Therapies, for the Treatment of Palmoplantar Psoriasis
Jenna M. Wald MD,a Daniel M. Klufas BS,a and Bruce E. Strober MD PhDa,b| |
J Drugs Dermatol. 2015;14(8):888-892.
Iviensan F. Manalo BS,a Kathleen E. Gilbert BS,b and Jashin J. Wu MDc| |
Jennifer Ahdout BS, Hilary Mandel MD, Melvin Chiu MD| |
E. Ladoyanni MD, R. Nambi MD| |
Jashin J. Wu MD,a Kathleen E. Gilbert MD,b Michael Batech DrPH,c Iviensan F. Manalo MD,d William J. Towner MD,c,e Rui André Saraiva Raposo PhD,f,g Douglas F. Nixon MD,f,g and Wilson Liao MDh| |
BACKGROUND: HIV-associated psoriasis is well-documented. Genetic, cellular, and cytokine profiles have been used as evidence to suggest psoriasis activates antiviral pathways. There has been a lack of epidemiologic evidence investigating whether psoriasis patients have lower HIV viral counts compared to non-psoriasis patients.
OBJECTIVE: Compare the viral load set point of HIV positive patients with and without psoriasis.
METHODS: A retrospective matched cohort study of HIV positive patients with and without psoriasis using the Kaiser Permanente Southern California Health Plan database.
RESULTS: We identified 101 HIV-positive psoriasis cases; 19 met inclusion criteria and were matched with 3-5 control patients; 94 total patients were analyzed. The mean age was 41.4 (12.07) years and 83% were male. Overall, the median log of the viral load of cases was slightly higher than controls (4.3 vs 4.2; P less than 0.01).
CONCLUSIONS: The serum viral load set point of patients with HIV and psoriasis was slightly higher than the viral load set point of HIV patients without psoriasis.
J Drugs Dermatol. 2017;16(4):372-377.
Dornechia George MD, Ted Rosen MD| |
Francisco Kerdel MD,a,b Frank Don DOa| |
Jessica Price BS, Monali Bhosle MS, Steven R. Feldman MD PhD, Rajesh Balkrishnan PhD| |
Sara M. James BS,a Dane E. Hill MD,a and Steven R. Feldman MD PhDa,b,c| |
OBJECTIVE: To identify the most common and most costly (from the payer perspective) drugs used in the treatment of psoriasis.
METHODS: We analyzed patient data from a large claims-based database in order to identify the most common and most costly medications used in the treatment of psoriasis from 2010 to 2014.
RESULTS: The three most common psoriasis medications, accounting for 81.1% of all psoriasis medications, were topical corticosteroids. The three most costly drugs, accounting for only 9.6% of all psoriasis medications, were biologics, accounting for 86% of the cost of psoriasis medications.
CONCLUSIONS: Biologic agents are used far less commonly in the treatment of psoriasis than topical treatments. Despite the relatively small number of patients using biologic agents, biologics are responsible for a large proportion of the cost of psoriasis pharmacotherapy.
J Drugs Dermatol. 2016;15(3):305-308.
Tumor Necrosis Factor Inhibitor Therapy and Myocardial Infarction Risk in Patients With Psoriasis, Psoriatic Arthritis, or Both
Jashin J. Wu MDa and Kwun-Yee T. Poon MSb| |
DESIGN: Retrospective cohort study
SETTING: Between January 1, 2004 and November 30, 2010
PARTICIPANTS: At least 3 ICD9 codes for psoriasis (696.1) or psoriatic arthritis (696.0) (without antecedent MI.
MAIN OUTCOME MEASURE: Incident MI
RESULTS: When comparing to those not treated with TNF inhibitors (reference group), of those treated with TNF inhibitors: those with psoriasis only (N= 846) had a significant decrease in MI risk (hazard ratio (HR), 0.26; 95% CI, 0.12-0.56); those with psoriatic arthritis only (N= 112) had a non-significant decrease in MI risk (HR, 0.86; 95% CI, 0.28-2.70); those with both psoriasis and psoriatic arthritis (N= 715) had a non-significant decrease in MI risk (HR, 0.76; 95% CI, 0.47-1.24).
CONCLUSIONS: In the TNF inhibitor cohort, those with psoriasis only have the strongest association with MI risk reduction, followed by those with psoriatic arthritis only, and then followed by those with both psoriasis and psoriatic arthritis.
J Drugs Dermatol. 2014;13(8):932-934.
Alice B. Gottlieb MD PhD, Frank Dann MD, Alan Menter MD| |
Meghan O’Brien MS, John Koo MD| |
Ying Wu PhD, Douglas Mills MS, Mohan Bala PhD| |
Marzieh Thurber MD, Adrienne Feasel MD, John Stroehlein MD, and Sharon R Hymes MD| |
Fitza Singh, BA and Jeffrey M. Weinberg, MD| |
Adolfo C. Fernandez-Obregon MD| |
Infliximab-Induced Psoriasis in Treatment of Crohn's Disease-Associated Ankylosing Spondylitis: Case Report and Review of 142 Cases
Shannon Famenini BSa and Jashin J. Wu MDb| |
J Drugs Dermatol. 2013;12(8):939-943.
Kendra Gail Bergstrom MD| |
Nicholas Golda MD, Shahrad M. Benham MD, John Koo MD| |
Andrew A. Nelson BS, Daniel J. Pearce MD, Alan B. Fleischer Jr MD, Rajesh Balkrishnan PhD, Steven R. Feldman MD| |
Kircik, L.H. et al.| |
Laura McDermott BA,a Raman Madan MD,a Reena Rupani MD,b and Daniel Siegel MDa| |
METHODS: A PubMed search for the term “indigo naturalis” was performed, and literature from 2006 to the present relevant to indigo naturalis and treatment of psoriasis and nail psoriasis was reviewed.
RESULTS: Indigo naturalis shares several therapeutic mechanisms with current psoriasis treatments, such as regulation of keratinocyte proliferation and differentiation, restoration of epidermal barrier function, and reduction of inflammatory processes. Clinically, it is well tolerated.
CONCLUSION: Recent research of indigo naturalis suggests that it is a safe, inexpensive, and effective alternative topical treatment for skin and nail psoriasis.
J Drugs Dermatol. 2016;15(3):319-323.
Jashin J. Wu MDa and Young M. Choi BS| |
Jean-Paul Ortonne MD| |
David Rosmarin MA, Bruce E. Strober MD PhD| |
Fiona Larsen MBChB FRACP, Alan Menter MD, Clay J. Cockerell MD, Barry N. Wilcox MD| |
Approaching Psoriasis Differently: Patient-Physician Relationships, Patient Education and Choosing the Right Topical Vehicle
Steven R. Feldman MD PhD| |
Psoriasis and Psoriatic Arthritis in a Patient with HIV: Response to Mycophenolate Mofetil Treatment
Seth B. Forman MD, Robert Higginson PA-C, Algin B. Garrett MD| |
The National Psoriasis Foundation Psoriasis Score (NPF-PS) System versus the Psoriasis Area Severity Index (PASI) and Physicians's Global Assessment (PGA)
Alice B. Gottlieb, MD, PhD; Umesh Chaudhari; Daniel G. Baker, MD; Michelle Perate, MS and Lisa T. Dooley, DrPH| |
Our results indicated that NPF-PS was strongly correlated with PASI and PGA in this study, while better reflecting patient perception. This is the first report of a double-blind placebo-controlled study demonstrating this concordance.
Improvement of Nail and Scalp Psoriasis Using Apremilast in Patients With Chronic Psoriasis: Phase 2b and 3, 52-Week Randomized, Placebo-Controlled Trial Results
Catherine M. Nguyen BS,a Argentina Leon MD,b Melissa Danesh BS,c Kourosh Beroukhim BS,d Jashin J. Wu MD,e and John Koo MDb| |
METHODS: We reviewed the results of the phase IIb and phase III clinical trials for apremilast in treating nail and scalp psoriasis.
RESULTS: In ESTEEM 1, patients on apremilast showed a 22.5%, 43.6%, and 60.2% improvement in NAPSI at weeks 16, 32, and 52. 33.3%, 45.2%, and 63% of patients achieved NAPSI-50, respectively. In ESTEEM 2, patients on apremilast showed a 29%, 60%, and 59.7% improvement in NAPSI at weeks 16, 32, and 52, with 44.6%, 55.4%, and 68.6% of patients achieving NAPSI-50. In PSOR-005 at week 16, patients on a dose of 30 mg twice weekly had a 42.9% improvement in NAPSI with 45.5% reaching NAPSI-50. For scalp psoriasis, 46.5%, 37.4%, and 73% of patients achieved an Sc-PGA of 0 or 1 at weeks 16, 32, and 52 in ESTEEM 1. In ESTEEM 2, 40.9%, 32.4%, and 62.5% of patients achieved an Sc-PGA of 0 or 1 at weeks 16, 32, and 52.
CONCLUSION: With its limited safety profile of only diarrhea and headache and no additional lab requirements, apremilast may be a safer and more convenient alternative for patients with severe nail and scalp psoriasis.
J Drugs Dermatol. 2016;15(3):272-276.
Scott Fretzin MD, Jeffrey Crowley MD, Loretta Jones FNP-C, Melodie Young MSN RN ANP-C, Jeffrey Sobell MD| |
Ravi S. Krishnan, MD and Sylvia Hsu, MD| |
Leon H. Kircik MDa and Panagiotis Zografos MScb| |
J Drugs Dermatol. 2015;14(10):1113-1116.
Marie Rosalette Mortel BS and Jason Emer MD| |
David J. Cohen MD, Lubomira Scherschun MD| |
Leon H. Kircik MD| |
Increased understanding of psoriasis has led to a shift in treatments from non-specific immunosuppressants to targeted biologics. Studies in psoriasis have demonstrated minimal risk and substantial benefit. As a result, dermatologists and patients are more frequently choosing biologics as first-line treatments for moderate-to-severe disease as our biologics options have recently increased.
Scott F. Lindsey BS, Jonathan Weiss MD, Eric S. Lee MD, and Paolo Romanelli MD| |
J Drugs Dermatol. 2014;13(7):869-871.
Jeffrey Crowley, MD| |
Tacrolimus Ointment 0.1% Alone and in Combination with Medium-Dose UVA1 in the Treatment of Palmar or Plantar Psoriasis
Jennifer Rivard MD, Jennifer Janiga MD, Henry W. Lim MD| |
Emerging Oral Immunomodulators for the Treatment of Psoriasis: A Review of Phase III Clinical Trials for Apremilast and Tofacitinib
Rachel McAndrew MD,a,b Ethan Levin MD,b and John Koo MDb| |
METHODS: We reviewed phase III randomized, placebo-controlled clinical trial results for apremilast and tofacitinib for efficacy and safety in psoriasis.
RESULTS: Psoriasis Area and Severity Index (PASI) 75 after 16 weeks for apremilast was between 28.8% and 33.1%. PASI 75 was 39.5% after 12 weeks on tofacitinib 5 mg, and 63.6% after 12 weeks on tofacitinib 10 mg. Common side effects for both drugs included nasopharyngitis and upper respiratory tract infections. Gastrointestinal disturbance was common for apremilast. Dyslipidemia and infections were more common with tofacitinib than placebo.
CONCLUSION: Both new oral medications, apremilast and tofacitinib, appear to be effective in treating psoriasis.
J Drugs Dermatol. 2015;14(8):786-792.
Peter J. Aronson MD and Farah Malick MD| |
Anna H. Zivkovich and Steven R. Feldman MD, PhD| |
Andrew Blauvelt MD MBA,a April W. Armstrong MD MPH,b Gerald G. Krueger MDc| |
J Drugs Dermatol. 2015;14(8):805-812.
Erin Gilbert MD PhDa and Nicole L. Ward PhDb| |
Case reports and anecdotal evidence suggests that onabotulinumtoxinA may be useful for treating inverse psoriasis.1,2 We previously reported an improvement in skin phenotype in a preclinical mouse model following a single intradermal injection of abobotulinumtoxinA.3 Here we present a patient case report demonstrating efficacy of abobotulinumtoxinA in reversing plaque psoriasis.
J Drugs Dermatol. 2014;13(11):1407-1408.
Kenyatta Mireku BS,a Karen E. Huang MS,a Swetha Narahari MD,a Scott A. Davis MA,a and Steven R. Feldman MD PhDa,b,c| |
OBJECTIVE: To characterize psoriasis treatments by patients' types of payment in the US outpatient office setting.
METHODS: Using the National Ambulatory Medical Care Survey (NAMCS), a large survey that samples outpatient office visits to US non-federally funded physicians, visits linked with sole diagnoses for psoriasis (ICD-9-CM: 696.1) were identified. There were 545 unweighted records. The types and number of treatments prescribed at these visits were categorized by expected major payment type to be used for the visit.
RESULTS: Mainstay psoriasis therapies such as vitamin D analogs and clobetasol were prescribed regardless of payment type. Retinoids were also within the most frequently prescribed psoriasis medications for all payment types, however they were less frequently prescribed than vitamin D analogs. Payment type did not have a significant effect on the number of medications prescribed at psoriasis visits.
LIMITATIONS: Data on treatment adherence and filling of prescriptions are not included in the NAMCS database.
CONCLUSION: Prescribing patterns for psoriasis medications are similar across payment type. Additional factors appear to modulate therapy choice for patients with psoriasis.
J Drugs Dermatol. 2013;12(10):1095-1097.
Jennifer Rivard MD, Henry W. Lim MD| |
Shivani Reddy BSa and Jashin J. Wu MDb| |
Thomas G. Lewis MD, Chanisada Tuchinda MD, Henry W. Lim MD, Henry K. Wong MD PhD| |
Tiffani K. Hamilton MD| |
Eric Lee MD, Mina Zarei MD, Charlotte LaSenna BS, Gabriel Villada MD, and Paolo Romanelli MD| |
METHODS AND MATERIALS: A search of the University of Miami Dermatopathology database was performed to identify all available patient specimens within the various subtypes of psoriasis. IL-17A IHC staining was performed using 4 μm paraffin skin sections. 1:25 dilution of IL-17A antibody was used. Stained slides were analyzed using a semi-quantitative scoring method ranging from negative to three plus.
RESULTS: Palmoplantar and pustular psoriasis cases showed consistently strong IL-17A staining. Plaque psoriasis cases showed intermittent to strong IL-17A staining. The results in the scalp and guttate psoriasis cases showed variable results.
CONCLUSION: The results of our study suggests the significant role of the cytokine IL-17A in the development of palmoplantar and pustular psoriasis. However, scalp and guttate subtypes showed variable expression from negative to strongly positive, which demonstrates a case by case basis expression of IL-17A. Therefore, exploring the IHC characterization of subtypes of psoriasis will help dermatologists better understand the pathogenesis of each subtype and help clinicians optimize treatments.
J Drugs Dermatol. 2015;14(10):1133-1136.
Kenneth B. Gordon, MD and Richard Langley, MD| |
Transient Improvement in Chronic Psoriasis After Treatment of TNF-α Blocker Induced Disseminated M. Tuberculosis Infection
Philip R. Letada MD, Erin Hitchcock DO, Samuel L. Steele MD, Douglas Winstanley DO| |
J Drugs Dermatol. 2012;11(1):119-120.
Lucia Seminario-Vidal MD PhD, Wendy Cantrell DNP, and Boni E. Elewski MD| |
J Drugs Dermatol. 2015;14(8):901-902.
Next-generation Biologics in the Management of Plaque Psoriasis: A Literature Review of IL-17 Inhibition
Paul S. Yamauchi MD PhDa and Jerry Bagel MDb| |
J Drugs Dermatol. 2015;14(3):244-250.
Reproducible Novel Transcriptional Differences Between Psoriatic Lesional and Non-Lesional Skin Show Increased Inflammation and Metabolism
Daniel J. Aires MD JD,a Graham Rockwell PhD,b Alan Menter MD,c Colton Nielson,d Jo Wick PhD,e Stephanie Sedivy MD,f Ossamma Tawfik MD PhD,g Anne Bowcock PhD,h and Animesh A. Sinha MD PhDi| |
OBJECTIVE: To reproducibly assess single-gene transcriptional changes in psoriatic skin.
METHODS: We evaluated 210 top candidate genes from a first psoriasis study group (population 1), and then confirmed differential expression in a second independent psoriasis study group (population 2).
RESULTS: One hundred and thirty-eight differentially expressed genes were replicated in the 2 studies, of which 57 have not previously been reported as associated with psoriasis. This is significantly greater than the 10 expected false positives. Lesional skin vs uninvolved areas showed inflammatory and cell regulation changes.
CONCLUSION: Previously undescribed psoriasis-associated genes revealed in this study may provide potential future targets for development and assessment of novel therapeutic agents for psoriasis.
J Drugs Dermatol. 2015;14(8):794-800.
Ahmad A. Al Robaee MD MHPE| |
Dalia G. Aly MD,a Ihab Y. Abdallah MD,b Noha S. Hanafy MD,a Mohamed L. Elsaie MD,a,c and Neveen A. A. Hafizd| |
Aim: To evaluate the possible relationship between serum leptin in nonobese patients with psoriasis and other randomly selected skin diseases.
Subjects and methods: Eighty subjects (40 patients with psoriasis, 20 patients with other randomly selected skin diseases, and 20 healthy controls) were included in the study. Fasting serum leptin levels of the study groups were examined by sandwich enzyme-linked immunosorbent assay.
Results: Elevated serum leptin levels were detected in both nonobese patients with psoriasis (P=.004) and those with other randomly selected skin diseases (P=.05). Leptin levels failed to correlate to the Psoriasis Area and Severity Index score of psoriatic patients. Both sexes demonstrated comparable levels of serum leptin in psoriatic patients, while female patients suffering from other skin diseases showed higher levels of serum leptin than did males of the same group.
Conclusion: Leptin may play a role in the immunopathogenesis of psoriasis and other skin diseases, even in the absence of obesity as a cofactor.
J Drugs Dermatol. 2013;12(2):e25-e29.
Meagan-Helen Henderson Berg MDCMa and Daniel Carrasco MDb| |
Psoriasis is a chronic inflammatory cutaneous disease that affects 2-3% of the general population. Up to 30% of patients with psoriasis also develop psoriatic arthritis, a chronic inflammatory and progressive arthritis. Although their precise pathogeneses remain unclear, psoriasis and psoriatic arthritis involve altered expression of proinflammatory cytokines, including tumor necrosis factor-α, interleukin (IL)-12, IL-17, IL-22, and IL-23. The development of biologic agents that target these cytokines has greatly improved the treatment of psoriatic disease. Injection site reactions have been reported with many of these therapies. In this paper, we will present cases and review the literature on injection site reactions with the major biologic agents administered subcutaneously for the treatment of psoriasis and psoriatic arthritis.
J Drugs Dermatol. 2017;16(7):695-698.
Grace Sun MD, Carina A. Wasko MD, Sylvia Hsu MD| |
Induction of Lesional and Circulating Leukocyte Apoptosis by Infliximab in a Patient with Moderate to Severe Psoriasis
Rama Malaviya PhD, Yvonne Sun MD, Jennifer K. Tan BA, Melissa Magliocco MD, Alice B. Gottlieb MD PhD| |
Ethan C. Levin MD,a Maya Debbaneh BA,b John Koo MD,a and Wilson Liao MDa| |
OBJECTIVE: We sought to review the safety and efficacy of biologic medications in the treatment of these severe subtypes of psoriasis and to identify strategies to help clinicians optimally manage these patients.
METHODS: We searched Pubmed for English language literature that assessed the use of biologic medication to treat erythrodermic or generalized pustular psoriasis.
RESULTS: The primary literature included cases reports, cases series, and open-label, uncontrolled trials. There were no head-to-head studies or other controlled trials. In both erythrodermic and generalized pustular psoriasis, infliximab was used to treat over half of the reported cases. Other biologic medications that were successfully used included etanercept, ustekinumab, adalimumab, and anakinra. Most cases reported improvement with biologic therapy. Serious adverse events were reported in 10-12% of the patients.
CONCLUSION: Although the evidence is limited, biologic therapy appears to be effective in treating erythrodermic and generalized pustular psoriasis. In order to assess the comparative efficacy and safety of the biologic medications, larger controlled studies are needed.
J Drugs Dermatol. 2014;13(3):342-354.
Marco Ardigò MD, Alessia Giuliani, Catia de Felice MD, Antonio Mastroianni MD,Enzo Berardesca MD| |
Persistence and Failure Rates of Monotherapy Etanercept in Biologic-Naïve Psoriasis Patients: A Retrospective Study
Shivani P. Reddy BS,a Vidhi V. Shah BS,b Elaine J. Lin BS,c Alexander Egeberg MD PhD,d and Jashin J. Wu MDe| |
Clobetasol Propionate Shampoo 0.05%: A New Option to Treat Patients with Moderate to Severe Scalp Psoriasis
Michael Jarratt, MD, Debra Breneman, MD, Alice B Gottlieb, MD, Yves Poulin, MD, Yin Liu Y, PhD, Valerie Foley, Pharm D| |
This was a multicentre, randomized, vehicle-controlled, double-masked and parallel-group study. The aim was to evaluate the efficacy and safety of clobetasol propionate shampoo, 0.05% versus its corresponding vehicle in subjects aged 12 years and older with moderate to severe scalp psoriasis over a treatment period of 4 weeks. Recurrence of scalp psoriasis was assessed during a two week follow-up period.
A total of 142 subjects were treated. Results after 4 weeks demonstrated that clobetasol propionate shampoo, 0.05% was with a similar safety profile significantly more effective than its vehicle. The novel short contact shampoo formulation of clobetasol propionate is convenient and efficacious and minimizes systemic exposure while being efficient, safe and well-tolerated in the treatment of moderate to severe scalp psoriasis.
Jashin J. Wu MD FAADa and W.C. Valdecantos MDb| |
Psoriasis is a common, inflammatory disease that manifests itself as lesions on the skin, which greatly impacts the physical and psychological wellbeing of those affected. The current goal of treatment in psoriasis is to improve the signs and symptoms of disease, whilst minimizing the burden of disease on patient health-related quality of life. Psoriasis can also be associated with other comorbidities such as joint disease, cardiovascular disease, and depression, which can add to the complexity of treatment.
Adalimumab is a recombinant, fully human, monoclonal antibody against tumor necrosis factor alpha (TNF-α), which blocks the interaction of TNF with both of its cell-surface receptors, with high affinity and specificity. Adalimumab is well established for the treatment of moderate–severe chronic plaque psoriasis in adults, and has more recently been approved in the European Union for use in pediatric patients with severe chronic plaque psoriasis.
Here we provide a clinical guide for adalimumab and review existing data on the efficacy and safety of originator adalimumab in moderate–severe chronic plaque psoriasis in adult and pediatric patients. We discuss short- and long-term treatment with adalimumab, and efficacy in hard-to-treat psoriasis of the scalp, hands, feet, and nails, in addition to the impact on associated pain and pruritus. We also discuss treatment optimization with adalimumab in the context of relevant clinical scenarios, and treatment of complex patients with underlying comorbidities. Finally, we examine available real-world clinical data for adalimumab in psoriasis.
J Drugs Dermatol. 2017;16(8):779-790.
Amrollah Ahmadi MD, Babak Barikbin MD, Mohsen Naseri MD PhD, Mohammadali Mohagheghi MD| |
Methods: In a randomized, double-blind clinical trial, 28 patients (11 male, 17 female) with chronic plaque-type psoriasis were randomly assigned to treatment and placebo groups. Patients in treatment group received HESA-A tablet 25 mg/kg twice a day orally and control group received placebo with the same method for 6 months and were followed clinically during the study.
Results: At the end of study, in the treatment group psoriatic plaques were absent (no evidence of psoriasis or complete remission) in 9 cases (64.2%) and was very mild (controlled, but not entirely cleared) in 5 cases (35.8%). Disease relief was observed in 10 (71.4%) patients after 4 months, in 2 cases (14.3%) after 5 months and in 2 (14.3%) other patients after 6 months while none of the controls showed disease improvement.
Conclusion: This study showed rapid and good efficacy and safety of HESA-A in the treatment of plaque-type psoriasis.
Clobetasol Emulsion Foam and Calcipotriene 0.005% Foam Combination Therapy for the Maintenance of Treatment Response in Patients With Moderate Plaque Psoriasis
Neal Bhatia MDa and Leon Kircik MDb| |
J Drugs Dermatol. 2018;17(3):342-346.
Increased Prevalence of Psychiatric Disorders and Health Care-Associated Costs Among Patients With Moderate-to-Severe Psoriasis
Methods: In a retrospective, matched case-control study, data for services from nearly 75 health care plans in the United States (U.S.) were collected from PharMetrics Patient Centric Database using International Classification of Diseases, Ninth Revision Clinical Modification codes, identifying a total of 39,855 adults with moderate-to-severe psoriasis (n=7,971) and without (controls; n=31,884). Patients with psoriasis had at least one psoriasis health care claim and received at least one medical/prescription treatment claim within two consecutive years. Psychiatric comorbidities and treatments among patients and controls were determined by claims. Annual inpatient, outpatient, emergency room, and prescription costs for those with and without psoriasis and those with and without psychiatric disorders were compared.
Results: Patients had significantly higher prevalence of anxiety (6.9% versus 4.4%), depression (9.2% versus 5.3%), bipolar disorder (1.1% versus 0.5%), or delirium (0.3% versus 0.1%; P<0.05) than controls (others P<0.0001). Significantly higher proportions of patients with psoriasis received antidepressants (6.1% versus 0.9%), anxiolytics (5.0% versus 0.8%), or antipsychotics (5.9% versus 0.9%) compared with controls (each P<0.0001). Total health care costs for patients with psoriasis (US $11, 369.47) were significantly higher than for controls ($3,427.60; P<0.001). Psoriasis patients with psychiatric disorders had significantly higher health care costs ($17,637.66) than those without psychiatric disorders ($10,362.80; P<0.001).
Conclusion: The prevalence of psychiatric disorders is higher in patients with moderate-to-severe psoriasis than in controls. Annual health care costs are higher in psoriasis patients with psychiatric disorders than in those without psychiatric disorders.
J Drugs Dermatol. 2011;10(8):843-850.
Jerry Bagel MD MS| |
Exacerbation of Paranoid Schizophrenia in a Psoriatic Patient after Treatment with Cyclosporine A, but not with Etanercept
Sergio Di Nuzzo MD, Martina Zanni MD, Giuseppe De Panfilis MD| |
Reversible Posterior Leukoencephalopathy Syndrome (RPLS) in a Psoriasis Patient Treated With Ustekinumab
Lauren Dickson MD and Alan Menter MD| |
J Drugs Dermatol. 2017;16(2):177-179.
A Systematic Review of Light Emitting Diode (LED) Phototherapy for Treatment of Psoriasis: An Emerging Therapeutic Modality
Derek Ho BS,a,b Eugene Koo MS,a,b Andrew Mamalis MD MS,a,b and Jared Jagdeo MD MSa,b,c| |
Background: Psoriasis is a chronic, inflammatory skin condition. The economic burden of psoriasis is approximately $35.2 billion in the United States per year, and treatment costs are increasing at a higher rate than general inflation. Light emitting diode (LED) phototherapy may represent a cost-effective, efficacious, safe, and portable treatment modality for psoriasis.
Objective: The goal of our manuscript is to review the published literature and provide evidence-based recommendations on LED phototherapy for the treatment of psoriasis.
Methods & Materials: A search of the databases Pubmed, EMBASE, Web of Science, and CINAHL was performed on April 5, 2016. Key search terms were related to psoriasis and LED-based therapies.
Results: A total of 7,793 articles were generated from the initial search and 5 original articles met inclusion criteria for our review. Grade of recommendation: B for LED-blue light. Grade of recommendation: C for LED-ultraviolet B, LED-red light, and combination LED-near-infrared and LED-red light.
Conclusion: We envision further characterizing the effects of LED phototherapy to treat psoriasis in patients may increase adoption of LED-based modalities and provide clinicians and patients with new therapeutic options that balance safety, efficacy, and cost.
J Drugs Dermatol. 2017;16(5):482-488.
Zahida Khan Maskatia BS, John Koo MD| |
Biologic Therapy for Psoriasis: An Update on the Tumor Necrosis Factor Inhibitors Infliximab, Etanercept, and Adalimumab, and the T-Cell-Targeted Therapies Efalizumab and Alefacept
Jeffrey M. Weinberg MD, Clement J. Bottino BA, James Lindholm BA, Robin Buchholz MD| |
Christine Rønneberg Mehren MD,a Anders Clemmensen MD,a Anne Boe-Hansen Dall MD,a
Peter Philipsen PhD,a and Robert Gniadecki MDa,b
AIM: To assess the relative contribution of the different symptom domains on HRQoL in psoriasis.
METHODS: 165 psoriasis patients (41.2 % with psoriasis arthritis (PsA)) were enrolled in a single-center cohort-study. For the assessment of HRQoL, patients completed EuroQoL (EQ-5D), the Short Form 36-item Health Survey (SF-36), the Health Assessment Questionaire (HAQ), and Dermatological Life Quality Index (DLQI) questionnaires. Multiple regression analysis was applied to determine the contribution of the measured parameters to the EuroQoL score (used as a reference measure for overall HRQoL).
RESULTS: Psoriasis arthritis (PsA) patients showed a higher impairment in all HRQoL measures than the patients without PsA. PASI, number of affected joints (PsA-score), DLQI and HAQ were significant predictors of HRQoL (R2=0.57). HAQ was the dominant contributor to HRQoL, both in patients with PsA and without PsA (partial eta 0.23 and 0.28, respectively.) Final model with improved R2 (0.61) was obtained by backward regression analysis, and included 6 parameters: PASI, PsA-score, and three questions from HAQ and one question from DLQI questionnaire.
CONCLUSION: Musculoskeletal symptoms are an essential component of HRQoL in psoriasis, even in patients without active PsA. A model consisting of PASI, PsA-score, and 4 questions derived from DLQI and HAQ seems to reflect total HRQoL impairment in psoriasis. This finding may further optimize drug therapy in psoriasis.
J Drugs Dermatol. 2014;13(3):246-250.
William Sumner MD, Steven R. Feldman MD PhD| |
Kalindi Raval PharmD, Jennifer H. Lofland PharmD MPH PhD, Heidi C. Waters MS MBA, Catherine Tak Piech MBA| |
J Drugs Dermatol. 2011;10(2):189-196.
Laura F. Sandoval DO,a Karen E. Huang MS,a and Steven R. Feldman MD PhDa,b,c| |
PURPOSE: The purpose of this study is to determine adherence rates and reasons for nonadherence to ustekinumab in the treatment of psoriasis.
METHODS: This was a single center, retrospective study involving a chart review of patients with a diagnosis of psoriasis and administration of ustekinumab seen at one clinic between October 1, 2009 and June 1, 2013. We assessed the number of injections administered, the time between injections, and reasons for nonadherence.
RESULTS: 45 patients received ustekinumab for the treatment of psoriasis. The median time between doses of ustekinumab (n=164) was 13 weeks (91 days, interquartile range 89, 98). For patients that received at least 3 doses of ustekinumab, overall median adherence was 100% (IQR 66.7, 100). The median adherence to the 45 mg dose (n=26) was 100% (IQR 75, 100) and to the 90 mg dose (n=18) was 80% (IQR 60, 100; P=0.11).
LIMITATIONS: Only limited information was found on reasons for nonadherence. Conclusions: Adherence to ustekinumab in psoriasis patients appears to be higher than reported adherence rates to topical therapies and treatment with self-administered biologics. Many factors may contribute to the greater adherence.
J Drugs Dermatol. 2013;12(10):1090-1092.
Alefacept in Combination with Ultraviolet B Phototherapy for the Treatment of Chronic Plaque Psoriasis: Results from an Open-Label, Multicenter Study
John Y. M. Koo MD, Jerry Bagel MD, Marianne T. Sweetser MD PhD, Barry S. Ticho MD PhD| |
Long-Term Etanercept Use for Severe Generalized Psoriasis in an HIV-Infected Individual: A Case Study
J Drugs Dermatol. 2012;11(3):413-414.
Lisa H. Lam PharmDa and Jeffrey L. Sugarman MD PhDb| |
OBJECTIVE: The objective of this study was to investigate the real world effects of chronic TCS use and its effects on adrenal suppression in a chronic disease such as psoriasis.
MATERIALS: This retrospective study utilized data from screening visits of a psoriasis clinical trial in which subjects had been on chronic TCS.
RESULTS: In this study, subjects with moderate to severe psoriasis affecting 16-20% of total body surface area (BSA) and using high-potency TCS at screening had a lower post-cosyntropin cortisol level (18.83 mcg/dL) compared to those with moderate psoriasis involving 10-15% of total BSA and using lower potency TCS at screening (23.22 mcg/dL; P=0.03). Both subject groups had lower post-cosyntropin cortisol levels compared to normal, healthy adults (P<0.001 for both).
CONCLUSION: This suggests that real world chronic use of high potency TCS over a larger BSA may result in silent adrenal suppression.
J Drugs Dermatol. 2016;15(8):945-948.
Brooke E. Rothstein BA,a,b Brianna McQuade PharmD,a Jacqueline E. Greb BA,a,b Ari M. Goldminz MD,a
and Alice B. Gottlieb MD PhDa,b
J Drugs Dermatol. 2016;15(5):648-649.
The Static Physician’s Global Assessment of Genitalia: A Clinical Outcome Measure for the Severity of Genital Psoriasis
Joseph F. Merola MD MMSc,a Alison Potts Bleakman PhD,b Alice B. Gottlieb MD PhD,c Alan Menter MD,d April N. Naegeli PhD,b Robert Bissonnette MD MS FAAD FRCPC,e Lyn Guenther MD FRCPC,f John Sullivan MBBS MS,g Kim Meeuwis MD PhD,h Kyoungah See PhD,b and Kristina Callis Duffin MD MSi| |
Introduction: Genital psoriasis is a common but frequently overlooked manifestation of psoriasis with a considerable impact on patients’ quality of life. Currently no validated clinical trial outcome measures exist to assess genital psoriasis severity that meet regulatory agency requirements.
Methods: This study describes the development of the static Physician’s Global Assessment of Genitalia (sPGA-G) scale, a clinical outcome measure for the assessment of genital psoriasis severity that accounts for the erythematous clinical presentation of genital psoriasis. The reliability of the sPGA-G was evaluated using scores collected from clinician assessments of photographs of genital psoriasis cases. Scores were collected from 10 academic and clinical experts in genital psoriasis and 95 clinician assessors who participated in either in-person (n=28) or online (n=67) sPGA-G training modules.
Results: The sPGA-G had a high inter-rater reliability (IRR, measured by Kendall’s W) for expert raters (W=0.856, P less than 0.0001), in-person assessors (W=0.822, P less than 0.0001), and online assessors (W=0.678, P less than 0.0001). IRR was also high for all clinical assessors combined, (W=0.714, P less than 0.0001).
Discussion: This study demonstrates that the sPGA-G is an intuitive and reliable clinical outcome measure that specifically measures the severity of genital psoriasis.
J Drugs Dermatol. 2017;16(8):793-799.
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Shannon Famenini BSa and Jashin J. Wu MDb| |
J Drugs Dermatol. 2013;12(3):317-320.
Apremilast and Narrowband Ultraviolet-B Combination Therapy for Treating Moderate-to-Severe Plaque Psoriasis
Jerry Bagel MD MS, Elise Nelson LPN, Brian R. Keegan MD PhD| |
J Drugs Dermatol. 2017;16(10):957-962.
Tina Bhutani MD, Kristine B. Zitelli MD, John Koo MD| |
Psoriasis is a chronic disease that exists in two phases: (1) the acute, flaring phase when psoriasis is highly inflamed, erythematous and pruritic and (2) the chronic, indolent phase after the acute manifestations are brought under control. Ideal therapies for psoriasis must focus on both of these phases. Therefore, a rapid and effective agent must be utilized to treat the acute phase, followed by safe long-term therapy for maintenance. This article proposes a new, effective sequential topical therapy for psoriasis using ongoing treatment with clobetasol (Clobex®) spray for one month followed by calcitriol (Vectical®) ointment for the next month. This strategy provides a highly effective, reliable and safe treatment option with minimal local and systemic adverse risks.
J Drugs Dermatol. 2011;10(8):831-834.
Christine S. Ahn BA,a Farah Awadalla MD,e Karen E. Huang MS,a Brad Yentzer MD,a
Tushar S. Dabade MD,a,d and Steven R. Feldman MD PhDa,b,c
OBJECTIVE: To determine the prescription patterns of topical corticosteroids and vitamin D analogs for the treatment of psoriasis in the United States and how their use has changed over time.
METHODS: Data from the National Ambulatory Medical Care Survey (NAMCS) from 1994 to 2010 were queried for visits linked with a psoriasis diagnosis. Prescriptions for topical corticosteroids and vitamin D analogs were described. Vitamin D analogs usage was compared across physician specialties. For each sampled visit reported in the NAMCS, visits meeting our inclusion criteria that also mentioned the following medications were identified: topical calcipotriene, topical calcipotriene/betamethasone or any topical corticosteroid indicated for the treatment of psoriasis.
RESULTS: There were an estimated 2.05 million psoriasis visits per year over the 1994-2010 interval. Dermatologists were responsible for 67% of these encounters followed by family practice (14%) and internal medicine (11%). Dermatologists prescribed a vitamin D product at 15% of psoriasis visits, followed by family physicians at 12%, and internists at 5%. Dermatologists prescribed calcipotriene, calcipotriene/betamethasone, and topical corticosteroids in 15%, 4% and 59% of psoriasis visits, respectively. Over time, there was no significant change in the use of topical steroids or vitamin D products by physicians.This study is limited by the inability to determine the severity of psoriasis from the data collected, and the lack of data on the length of treatment with different medications.
CONCLUSIONS: Despite their demonstrated efficacy and safer side effect profile, vitamin D analogs are used less often than topical corticosteroids for the treatment of psoriasis. These findings suggest that vitamin D products may not be utilized to their fullest potential as effective topical therapy or adjuncts to therapy for localized plaque psoriasis.
J Drugs Dermatol. 2013;12(8):906-910.
Jayashri V. Ghate MD and Carrie D. Alspaugh MD FAAD| |
Alan N. Elias, MD; Vandana S. Nanda, MD and Ronald J. Barr, MD| |
Drivers of Healthcare Costs Among the Costliest Patients With Psoriasis Over Three Years in a United States Health Plan
April W. Armstrong MD MPH,a Yang Zhao PhD,b Vivian Herrera PhD,b Yunfeng Li PhD,b Tim Bancroft PhD,e Michael Hull MS,c and Aylin Altan PhDd| |
OBJECTIVE: To compare patients with psoriasis by cost level over 3 years.
METHODS: Psoriasis patients in a large US health plan in 2011-2013 were identified. Four groups were created by healthcare costs excluding biologics: patients having top 10% of costs in all 3 years (Top), top 10% in 2 of 3 years (High), bottom 90% in 2 of 3 years (Medium), and bottom 90% in all 3 years (Bottom). Comorbidities, utilization, and costs between groups were compared.
RESULTS: The study included 18,653 patients: 514 (3%), 805 (4%), 2,443 (13%), and 14,891 (80%) patients in the Top, High, Medium, and Bottom groups, respectively. Significantly more patients in the Top vs Bottom group had diabetes (31.1% vs 9.4%), cardiovascular disease (26.5% vs 4.3%), psoriatic arthritis (25.7% vs 10.7%), depression (27.8% vs 6.9%), and anxiety (22.0% vs 7.9%) in 2011 (all P less than 0.05). Patients in the Top group had more unique 2011 prescriptions (17.7 vs 6.6; P less than 0.001) than the Bottom group, but similar biologic use (22.4% vs 21.6%). Patients in the Top, High, Medium, and Bottom groups had mean 2011 total costs of $68,913, $40,575, $24,292, and $8,815, and contributed to 14%, 13%, 23%, and 51% of the overall costs, respectively. Mean total costs increased 14-18% over time for all groups. Although mean 2011 total costs for patients in the Top group were 7.8 times of those in the Bottom group, psoriasis-related costs were less disparate ($8,716 vs $4,541). Compared with patients in the Bottom group, those in the Top group were more likely to have any 2011 hospitalization (36.8% vs 2.6%; psoriasis-related: 11.1% vs 0.7%) or emergency visit (50.8% vs 20.8%; psoriasis-related: 3.9% vs 1.0%).
CONCLUSION: The costliest patients with psoriasis had significantly higher prevalence of comorbidities, prescription fills, inpatient and emergency utilization, but not biologic medication use or biologic costs.
J Drugs Dermatol. 2017;16(7):651-658.
Comparison of Guidelines for the Use of Cyclosporine for Psoriasis: A Critical Appraisal and Comprehensive Review
Teo Soleymani MD,a Janna M. Vassantachart MS4,b and Jashin J. Wu MD FAADc| |
The purpose of this article is to review and compare the current evidence-based guideline recommendations for the use of cyclosporine in the treatment of psoriasis.
Although the various guidelines are similar in their initial treatment recommendations, significant differences exist in recommendations on maximal treatment duration (1 year versus 2 years), intermittent short-term versus continuous therapy, use in erythrodermic and palmoplantar psoriasis, as well as recommendations on managing cyclosporine-associated side effects. By following guideline recommendations, cyclosporine remains an excellent and indispensable tool for the dermatologist treating moderate-to-severe psoriasis.
J Drugs Dermatol. 2016;15(3):293-301.
Jackleen S. Marji MD PhD, Rebecca Marcus MD, Jessica Moennich MD, Julian Mackay-Wiggan MD MS| |
Charles A. Parrish MD, Jenny O. Sobera MD, Courtney M. Robbins MD, Wendy C. Cantrell CRNP, Renee A. Desmond DVM PhD, Boni E. Elewski MD| |
Lindsey Warino MS, Rajesh Balkrishnan PhD, Steven R. Feldman MD PhD| |
An Evidence-based Review of the Efficacy of Coal Tar Preparations in the Treatment of Psoriasis and Atopic Dermatitis
Jordan B. Slutsky MD, Richard A. F. Clark MD, Alexander A. Remedios MD, Peter A. Klein MD| |
Ixekizumab Is Effective in Subjects With Moderate to Severe Plaque Psoriasis With Significant Nail Involvement: Results From UNCOVER 3
Ellen B. Dennehy PhD,a Lu Zhang MS,a David Amato DO,a Orin Goldblum MD,a and Phoebe Rich MDb| |
MATERIALS AND METHODS: The design of UNCOVER-3, a Phase 3, multicenter, double-blind, placebo- and active-controlled trial that evaluated the efficacy and safety of ixekizumab for moderate to severe psoriasis, has been published previously. Patients were randomized to receive blinded placebo, etanercept (50 mg twice weekly) or 80 mg ixekizumab every 2 weeks (IXEQ2W) or every 4 weeks (IXEQ4W) for 12 weeks. At week 12, all patients were assigned to open-label ixekizumab 80 mg every 4 weeks through week 60. In this 60-week post hoc subset analysis, we evaluated only those patients with significant baseline nail involvement, defined as fingernail NAPSI ≥16 and at least 4 fingernails involved.
RESULTS: Ixekizumab Q2W or Q4W resulted in greater improvement in nail psoriasis than placebo or etanercept by week 12 of administration, as measured by percent NAPSI reduction (IXEQ2W 39% improvement, IXEQ4W 40%, etanercept 28%, placebo -4.7%). At week 24, significantly more patients receiving ixekizumab exhibited no signs of nail involvement (IXEQ2W/Q4W 34%, IXEQ4W/Q4W 30%). Similar gains were observed at 60 weeks in all treatment groups.
CONCLUSION: Ixekizumab led to improvement in fingernail psoriasis by week 12 compared with placebo. Continued improvement in fingernail psoriasis with ixekizumab was observed, with >50% of patients achieving complete fingernail psoriasis resolution (NAPSI=0) at week 60.
J Drugs Dermatol. 2016;15(8):958-961.
Samantha F. Smith BSa and Steven R. Feldman MD PhDa,b,c| |
The Koebner phenomenon refers to the development of lesions in response to injury of previously uninvolved skin. It occurs in psoriasis and a number of other inflammatory diseases. We present a patient who developed a Koebner reaction at the site of a tattoo. Treatment with ustekinumab resulted in striking clearance of the psoriasis changes at the tattoo site.
J Drugs Dermatol. 2011;10(10:1199-1200.
Combining Topical Psoriasis Treatment to Enhance Systemic and Phototherapy: A Review of the Literature
Jerry Bagel MD,a and Linda Stein Gold MDb| |
Psoriasis is a chronic inflammatory skin disease that affects millions of people in the United States as well as worldwide. While there is currently no cure for psoriasis, many treatment options are available. Topical therapies are the mainstay for the majority of patients who have limited or mild psoriasis. Among these medications, topical vitamin D analogs (eg, calcipotriene) and corticosteroids (eg, betamethasone), and these drugs in combination, are the most widely prescribed psoriasis drugs and are the cornerstone of topical therapies. For patients with more severe disease, phototherapy, conventional systemic agents, and biologics are often indicated. Currently, the goal of treatment is to control the clinical symptoms of the skin, reduce systemic disease potential, and improve the patient’s quality of life. Despite the availability of various therapeutic options for psoriasis, many patients go untreated, and even among those who are treated, many do not achieve complete resolution of the disease. The new consensus is to treat to a target of 1% or less of body surface area involvement. Innovative treatment strategies are needed to meet this goal and patients’ desire to achieve clear skin. Combination therapies are widely used by physicians, and adjunctive topical therapies used with other antipsoriatic regimens have been demonstrated to provide many clinical benefts. This article reviews the most recently published clinical evidence of adjunctive use of topical agents with biologics, conventional systemic agents, and phototherapy, to better establish the role of topical agents in combination therapy for the treatment of psoriasis.
J Drugs Dermatol. 2017;16(12):1209-1222.
Jennifer C. Sri BS, Charlotte L. Tsai MD, April Deng MD, Anthony A. Gaspari MD| |
Salicylic Acid 6% in an Ammonium Lactate Emollient Foam Vehicle in the Treatment of Mild-to-Moderate Scalp Psoriasis
Leon Kircik MD| |
J Drugs Dermatol. 2011;10(3):270-273.
Patient-Reported Satisfaction With the Fixed Combination Calcipotriene/Betamethasone Dipropionate Foam for Plaque Psoriasis
Joe Gorelick MSN FNP-BC,a Wendy Cantrell DNP CRNP,b Kristine Kucera PA-C MPAS DHS,c Karen A. Veverka PhD,d Kara Gooding MMS PA-Ce| |
Shedding Light on the “Hidden Psoriasis”: A Pilot Study of the Inverse Psoriasis Burden of Disease (IPBOD) Questionnaire
Jeffrey M. Cohen BA,1,* Kareem Halim AB,1,* Cara J. Joyce MS,2 Mital Patel MD,3 Abrar A. Qureshi MD MPH,4 and Joseph F. Merola MD MMSc3,5| |
J Drugs Dermatol. 2016;15(8):1011-1016.
Ustekinumab Treatment for Psoriasis in 119 Patients Maintained on Therapy for a Minimum of One Year: A Review
Elizabeth G. Wilder MD,a Mahir Patel MD,a Katherine Hebeler BA,b and Alan Menter MDa| |
J Drugs Dermatol. 2014;13(8):905-910.
Pedram Ghasri BS,a Brad A. Yentzer MD,a Tushar S. Dabade MD,a Steven R. Feldman MD, PhDa,b,c| |
Background: Combination therapy is a common and appropriate treatment strategy for moderate-to-severe psoriasis, as it provides for enhanced efficacy and decreased toxicity compared to the use of a single agent. Acitretin is an effective oral retinoid for psoriasis that seems to find its greatest value when complemented by other topical and systemic treatments.
Objective: The primary aim of this study is to assess the use of acitretin in combination with other treatments for psoriasis.
Methods: We assessed the use of acitretin for the treatment of psoriasis using nationally representative survey data from the National Ambulatory Medical Care Survey (NAMCS).
Results: Among visits where acitretin was listed in the NAMCS, other psoriasis medications were co-prescribed in 62 percent of visits. The co-prescribed medications included topical corticosteroids (51%), calcipotriene (31%), biologics (6%), cyclosporine (5%), methotrexate (5%) and tazarotene (2%).
Conclusion: The use of acitretin in combination with other psoriasis treatments, particularly topical corticosteroids and calcipotriene, is a common practice. Acitretin is co-prescribed with the biologics, likely because of the relative lack of overlapping effects on immune function. The immune-sparing method of action of acitretin makes combination treatment with the systemic agents an attractive treatment option, especially in patients where further immunosuppression is unwarranted.
J Drugs Dermatol. 2011;10(8):876-880.
Janna M. Vassantachart MD,a Teo Soleymani MD,b and Jashin J. Wu MD FAADc| |
J Drugs Dermatol. 2016;15(8):995-1000.
Psoriasis and Cardiometabolic Disease: A Brief, Focused, Educational Intervention on Cardiometabolic Risks
Courtney J. Burnett BS, Dennis P. West PhD, Alfred W. Rademaker PhD, and Roopal V. Kundu MD| |
J Drugs Dermatol. 2016;15(10):1176-1180.
Caren Garber BA,a,b Malcolm Creighton-Smith BA,a,b Eric P Sorensen BS,a Nicole Dumont,a
Alice B. Gottlieb MD PhDa,b
METHODS: In this case series, data were collected on patients ≤ 18 years old with moderate-to-severe psoriasis treated with systemic medications (traditional systemic drugs or biologics) from 2008 through 2014. Efficacy was measured using the validated simple measure for assessing psoriasis activity (S-MAPA), and the product of the body surface area and Physician Global Assessment.
RESULTS: Twenty-seven patients aged 5 to 18 years were eligible, and 56 treatment courses were analyzed. Methotrexate (MTX) was the most frequently prescribed systemic (70%), followed by etanercept (59%). Clearance rates were highest on biologic medications (67% for etanercept and adalimumab, 33% for ustekinumab). Phototherapy, cyclosporine, and MTX were less effective in clearing psoriasis, although they were successful in improving S-MAPA ≥ 50% from baseline 100%, 67%, and 36% of the time, respectively. The most common adverse events were sunburn for patients on narrowband ultraviolet B phototherapy (14%), gastrointestinal intolerance and minor infections for patients on MTX (16% each), and minor infections for patients on etanercept (25%) and adalimumab (33%). The most common reasons for discontinuation were secondary failure (38% for etanercept, 33% for adalimumab) or lack of response (37% for MTX, 33% for cyclosporine).
CONCLUSION: Although phototherapy, MTX, and cyclosporine are effective for controlling resistant pediatric psoriasis, concerns about long-term safety or inconvenience have led people to consider biologics in their place. However, there is a lack of literature on the use of biologics in pediatric psoriasis. These cases attest to the safety and efficacy of etanercept, adalimumab, and ustekinumab in pediatric psoriasis, expanding the treatment repertoire and guiding dermatologists in better managing recalcitrant pediatric psoriasis.
J Drugs Dermatol. 2015;14(8):881-886.
Scott A. Davis MAa and Steven R. Feldman MD PhDa-c| |
PURPOSE: To determine the frequency of prescribing calcipotriene and other psoriasis drugs in combination.
METHODS: Visits with a sole diagnosis of psoriasis were selected from 1990-2010 data from the National Ambulatory Medical Care Survey. The number of combination therapies used, the leading therapies in each class of medications, and the leading types used in combination were analyzed.
RESULTS: About 10.2 million of 20.3 million psoriasis visits used multiple treatments. The mean number of prescribed medications increased over time (P=.0003). The top 10 treatments included 6 topical steroids, calcipotriene, 2 other topicals, and methotrexate. The most common combinations were topical steroid plus other topical (15.0%), multiple topical steroids (11.5%), topical steroid plus vitamin D analogue (9.7%), and topical steroid plus systemic treatment (6.9%). Vitamin D analogues and systemic treatments were prescribed with increasing frequency over time, while fewer topical steroids were used, and use of other topicals did not change significantly.
LIMITATIONS: Visits with multiple diagnoses had to be excluded to ensure that the medications listed were for psoriasis.
CONCLUSIONS: Combination therapy is the most common way to treat psoriasis in the United States. The wide range of combination therapies prescribed may reflect increased attention to individualization of treatment to match patients’ diverse preferences.
J Drugs Dermatol. 2013;12(5):546-550.
José R. González-Chavez MD, Alma C. Berlingeri-Ramos MD, Mary Ann Sánchez Casiano MD| |
Jerry Bagel, MD| |
Background: Use of coal tar with narrowband (NB) ultraviolet B (UVB) light (the Goeckerman regimen) is an effective treatment for plaque psoriasis that has become impractical in outpatient care mainly due to the inconvenience and aesthetic concerns of coal tar.
Objective: This study evaluated the safety, efficacy, and convenience of adding a novel LCD (coal tar) solution to standard NB-UVB phototherapy in adults with chronic plaque psoriasis.
Methods: Patients applied LCD solution to half-body twice daily at home and received outpatient full-body NB-UVB light therapy 3 times a week for up to 12 weeks. A blinded investigator graded psoriasis severity of body halves and bilateral target lesions and monitored adverse reactions. Patients rated their psoriasis symptoms and LCD solution aesthetics.
Results: NB-UVB + LCD therapy reduced the median time to clearance or minimal disease in at least 50% of the population by 3 weeks (4 weeks with NB-UVB + LCD versus 7 weeks with NB-UVB alone). A statistically superior clinical response was observed by the end of week 4 with NB-UVB + LCD versus NB-UVB alone (P < 0.05) for: PGA, target lesions, ESI scores, and patient-reported symptoms.
Conclusion: Incorporating an at-home regimen with a novel LCD solution into outpatient NB-UVB light therapy is safe, convenient, effective, and can improve psoriasis more quickly than NB-UVB light therapy alone.
J Drugs Dermatol. 2012;11(2):160-167.
J Drugs Dermatol. 2012;11(11)e74-e75.
Meredith K. Shaw,a Scott A. Davis MA,a Steven R. Feldman MD PhD,a,b,c and Alan B. Fleischer Jr. MDa| |
OBJECTIVE: To determine and analyze what courses of treatment and in what frequency are being utilized to combat psoriasis in the United States.
METHODS: Analysis of data from the National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) of the National Center for Health Statistics. Data were analyzed to examine the prevalence of different therapy techniques to combat psoriasis from 1993 through 2010. The trends for phototherapy, methotrexate (MTX), retinoids, cyclosporine A (CSA), systemic steroids, and biologics were all analyzed over the entire 18-year period and independently before and after the introduction of biologics in 2002.
RESULTS: From 1993 to 2010, the trend for total systemic treatments has not significantly increased (P=0.5). Frequency of phototherapy treatments significantly decreased from 1993 to 2010 (P<0.001). Since the introduction of biologics in 2002, their frequency has significantly increased, becoming the most frequently used treatment from 2008-2010 (P<0.0001).
LIMITATIONS: Severity of psoriasis was not recorded in the NAMCS and NHAMCS.
CONCLUSIONS: The frequency of systemic treatments to treat psoriasis has not significantly increased from 1993 to 2010. Despite the introduction of biologics, it appears that little progress has been made in reducing under-treatment of moderate-to-severe psoriasis.
J Drugs Dermatol. 2014;13(8):917-920.
An Open-Label Study to Evaluate the Transition of Patients with Chronic Plaque Psoriasis from Cyclosporine to Alefacept
Melissa A. Magliocco MD, Ann Marie Lozano RN BSN CCRC, Claudia Van Saders RN CCRC, Kristine W. Schuler MS, Alice B. Gottlieb MD PhD| |
Treatment of Inverse/Intertriginous Psoriasis: Updated Guidelines from the Medical Board of the National Psoriasis Foundation
Hasan Khosravi MD,a Michael P. Siegel PhD,b Abby S. Van Voorhees MD,c and Joseph F. Merola MD MMSca,d| |
Inverse or intertriginous psoriasis commonly involves skin fold areas including the axillae, perianal skin, intergluteal cleft, inframammary, genital/inguinal, abdominal, and retroauricular folds. After reviewing the literature for new treatments, a task force was convened to update a consensus on inverse psoriasis therapy. Short-term treatment continues to be low-potency topical steroids. In order to avoid steroid-induced adverse effects, long-term therapy includes topical immunomodulators, calcitriol, and calcipotriene. Second and third-line therapies include antimicrobials, emollients, and tar-based products. Inverse psoriasis resistant to topical therapy has been shown to respond to botulinum toxin injections, excimer laser therapy, and certain systemic agents (such as anti-TNF and anti-IL12/IL23 therapy). Based on promising results from case reports and prior clinical experience, these systemic agents should be strongly considered in inverse psoriasis resistant to topical therapy. However, they need further evidence-based evaluation. The use of randomized trials and objective severity indices may allow for more robust therapeutic data.
J Drugs Dermatol. 2017;16(8):760-766.
Leon H. Kircik| |
Assessor-Blinded Study of the Metabolic Syndrome and Surrogate Markers of Increased Cardiovascular Risk in Children With Moderate-to-Severe Psoriasis Compared With Age-Matched Population of Children With Warts
Eva M. Volf MD,a Danielle E. Levine MD,a Melissa A. Michelon MD,a Shiu-Chung Au MD,b Eshan Patvardhan MD,b Nicole Dumont,b Daniel S. Loo MD,b Jeffrey Kuvin MD,a,b Alice B. Gottlieb MD PhDa,b| |
Adult patients with psoriasis have an increased prevalence of the metabolic syndrome (MetS) and cardiovascular disease (CVD) risk factors due to elevations of Tumor Necrosis Factor and other inflammatory cytokines.1,2 Recently, higher rates of hyperlipidemia, obesity, hypertension, and diabetes mellitus were seen in patients with juvenile psoriasis.3 Here, we report the interim results of an ongoing study of MetS and CVD risk factors in pediatric psoriasis patients.
J Drugs Dermatol. 2011;10(8):903-904.
Objective: Review the utility of JAK inhibitors in the treatment of psoriasis.
Methods: A review was performed using PubMed and Google to identify research relevant to the treatment of psoriasis using JAK inhibitors.
Results: In a CD18 mutant PL/J mouse model with T-cell dependent psoriasiform skin disease, the JAK inhibitor R348 reduced skin inflammation, with reductions in CD4+, CD8+, and CD25+ T-cell infiltration and systemic decreases of IL-17, IL-19, IL-22, IL-23 and TNF-α. Two JAK inhibitors, CP-690,550 (tasocitinib) and INCB018424 (ruxolitinib), were effective in psoriasis clinical trials. In a phase 1, randomized, double-blind, dose escalation trial for plaque psoriasis, CP-690,050 led to improvements in Psoriatic Lesion Severity Sum score at doses greater than 5 mg. A phase 2 trial showed CP-690,050 administered at 2, 5, and 15 mg twice daily resulted in a 75% reduction in Psoriasis Area and Severity Index (PASI) in 25%, 40.8%, and 66.7% of patients, respectively, for moderate to severe psoriasis. A phase 3 study of CP-690,550 for plaque psoriasis was begun in September 2010 (NCT01163253). INCB018424, another JAK inhibitor, was used topically at 3 doses (0.5%, 1%, 1.5%) in a phase 2B, double-blind, placebo-controlled trial, resulting in improved total lesion score, global assessment, and PASI for all doses.
Conclusion: Janus Kinase inhibitors are promising potential therapeutic options for psoriasis.
J Drugs Dermatol. 2012;11(8):913-918.
Anthony J. Chiaravalloti MDa and Bruce E. Strober MD PhDb,c| |
J Drugs Dermatol. 2014;13(8):929-931.
Kristin Noiles BSc, Ronald Vender MD FRCPC| |
Objective: The authors report a case of a female patient with psoriasis with severe cutaneous disease and extensive facial involvement successfully treated with adalimumab. This 50-year-old Caucasian female had a history of cutaneous psoriasis since 1990 and psoriatic arthritis since 2005. The patient had associated pruritus and a family history (maternal). Systematic treatment with mycophenolate mofetil and acitretin proved unsuccessful. The patient also lost efﬁcacy after months of ultraviolet light B and topical psoralen plus ultraviolet light A phototherapy.
Results: In 2007, the patient was screened and initiated therapy with a monoclonal humanized tumor necrosis factor alpha inhibitor, adalimumab. She had severe facial and body involvement with a body surface area of 25%, a Psoriasis Area and Severity Index of 20.4 (PASI), and a head and neck psoriasis area and severity index (HNPASI) of 3.6. Photographic documentation was carried out with improvement noted as soon as 4 weeks with continuing signiﬁcant response thereafter. No adverse effects were noted. The patient’s quality of life also improved.
Limitations: Although severe facial psoriasis is rare and associated with only the most extensive and severe psoriatic cases, it is likely the most psychologically disturbing and cosmetically disrupting to the patient because it cannot easily be covered or concealed. The authors hope this case can illustrate an excellent therapeutic option for these patients.
Conclusion: Although facial psoriasis is difﬁcult to treat, with newer systemic therapy now available in the form of biologics, patients now have a hope for this disease, especially devastating when associated with severe and extensive cutaneous involvement. The case gives promise in a serial photo-documented fashion of the success that can be achieved.
Treatment of Psoriasis and Long-term Maintenance Using 308 nm Excimer Laser, Clobetasol Spray, and Calcitriol Ointment: A Case Series
J Drugs Dermatol. 2012;11(8):994-996.
Topical Tacrolimus for the Treatment of Psoriasis on the Face, Genitalia, Intertriginous Areas and Corporal Plaques
G. Martín Ezquerra MD, M. Sánchez Regaña MD, E. Herrera Acosta MD, P. Umbert Millet MD| |
Valerate Foam (0.12%) for Plaque-type Psoriasis Sunil S. Dhawan MD, Marianna L. Blyumin MD, Daniel J. Pearce MD, Steven R. Feldman MD| |
To Treat or Not to Treat? Management of Guttate Psoriasis and Pityriasis Rosea inPatients With Evidence of Group A Streptococcal Infection
Karthik Krishnamurthy DO, Ashley Walker DO, Charles A. Gropper MD, Cindy Hoffman DO| |
Improvement in Extensive Moderate Plaque Psoriasis With a Novel Emollient Spray Formulation of Betamethasone Dipropionate 0.05%
Linda Stein Gold MD,a J. Mark Jackson MD,b Melissa L.F. Knuckles MD,c,d and Jonathan S. Weiss MDe| |
OBJECTIVE: To compare the efficacy and safety of DFD-01 to its vehicle for the treatment of moderate plaque psoriasis over 4 weeks.
METHODS: Two Phase 3 trials enrolled adults with moderate psoriasis (Investigator Global Assessment [IGA]=3; 10–20% body surface area [BSA]) and randomized them 2:1 to DFD-01 or Vehicle. Products were applied twice daily to affected areas for 28 days. Treatment success was defined as an IGA=0 or 1 and ≥2-grade improvement from baseline. Primary endpoint was the proportion of subjects achieving treatment success at day 15.
RESULTS: Moderate psoriasis subjects were enrolled in Study 1 (174 DFD-01; 87 Vehicle) and Study 2 (182 DFD-01; 95 Vehicle). Mean BSA was 13–14%. Treatment success was achieved in significantly more subjects using DFD-01 than Vehicle at day 15 in both Study 1 (P<0.001) and Study 2 (P=0.002), and at day 29 (both studies P<0.001). Treatment success with DFD-01 was significant at day 8 in Study 1 (P=0.003) but not in Study 2 (P=0.156). Erythema, scaling, and plaque elevation scores of target lesions were significantly reduced as early as day 4 with DFD-01. Adverse events were similar between groups, with no increase between 2 and 4 weeks.
CONCLUSION: These studies demonstrate DFD-01’s excellent efficacy and safety for the treatment of extensive psoriasis (10–20% BSA). DFD-01 achieved treatment success in significantly more subjects than Vehicle after 2 and 4 weeks of treatment, and showed early onset of action with improved signs of erythema, scaling and elevation of target lesions after 4 days of treatment. This medium potency formulation provides a safe and effective choice for topical steroid treatment of psoriasis.
J Drugs Dermatol. 2016;15(3):334-342.
Purpose: To characterize trends in older adult psoriasis health care practices of US ambulatory physician offices from 1993 to 2009.
Methods: We used data from the National Ambulatory Medical Care Survey to assess demographics, specialties seen, and treatment in visits by older adult patients, 55 years of age and older.
Results: There were approximately 14.1 million outpatient visits for psoriasis among the older adult population during the study period. Older adult psoriasis patients were 52.4% female and 47.6% male. The most frequent older adult age group seen for psoriasis was the 55 to 64 year age group. Dermatologists saw 69.3% of patients, internists saw 14.5%, and general and family practitioners saw 11.6%. Topical corticosteroids were the most frequently prescribed medications. Dermatologists preferred clobetasol whereas non-dermatologists more commonly prescribed betamethasone. For both the 18 to 54 year age group and the 55 and older group, the leading 7 out of 10 medications prescribed were topical corticosteroids and calcipotriene. However, etanercept, coal tar, and fluocinolone were among the leading medications in the younger group but not in the 55 and older group.
Conclusions: Treatment approach for older adult psoriasis patients showed some differences among medical specialties and among the younger and older age groups. Further research specific to older adult psoriasis patients is needed to determine optimal treatment strategies for this patient population.
J Drugs Dermatol. 2012;11(8):957-962.
A Rare Case of Non-Hodgkins B-cell Lymphoma in a Psoriatic Patient: A Case Report and Literature Review
Shilpa Gattu MD, Emily M. Becker MD, John Y. M. Koo MD| |
J Drugs Dermatol. 2012;11(8):939-942.
Scientific Proceedings From Select Sessions at the2010 Orlando Dermatology Aesthetic & Clinical (ODAC) Conference–Part II
Leon H. Kircik MD,Sandeep Kumar MD, Leon H. Kircik MD, Mercedes E. Gonzalez MD, Dee Anna Glaser MD, Utpal Patel MD PhD, Rebecca Fitzgerald MD| |
Ryan M. Trowbridgea and Mark R. Pittelkow MDb| |
J Drugs Dermatol. 2014;13(2):111-118.
Jacqueline E. Greb BA, Caren Garber BA, and Alice B. Gottlieb MD PhD| |
OBJECTIVE: We evaluate disease characteristics and treatment response variation in the moderate-to-severe psoriasis population based on PsA history.
METHODS: Simple-measure for assessing psoriasis activity (S-MAPA) was used to retrospectively analyze treatment responses.
RESULTS: 191 moderate-to-severe psoriatic patients, 58 with and 133 without rheumatologist-diagnosed PsA were analyzed. Regardless of PsA history, S-MAPA improvement was similar with biologic monotherapy (46.2 versus 44.1; P=0.74), traditional systemic monotherapy (62.29 versus 38.12; P=0.22), and combination treatments (64.62 versus 52.71; P=0.40) after 12 weeks. PsA patients on biologic monotherapy experienced a higher infection rate than patients without PsA (0.57% versus 0.19%; P=0.01). PsA patients experienced more adverse events (AEs) associated with traditional systemic monotherapy than biologic monotherapy (3.25 versus 1.04; P=.001).
LIMITATIONS: The relatively small PsA cohort was the primary limitation.
CONCLUSIONS: Patients with moderate-to-severe psoriasis responded similarly to all treatments independent of PsA history. PsA patients received more overall treatments and more biologic monotherapy prescriptions. PsA patients had a greater infection risk on biologic monotherapy compared to those without PsA, and greater adverse events risk on traditional systemic monotherapy compared to biologic monotherapy.
J Drugs Dermatol. 2016;15(8):917-922.
Hector Fernández-Llaca MD,a Pablo de la Cueva MD,b Jesús Luelmo MD,c Jose Carlos Armario-Hita MD,d
M Luz Samaniego,e and Carmen García-Calvo MDf [Representing the RECOR Study Group.],
METHODS: A cross-sectional, multicentre study was made of 477 patients, of whom 238 had moderate to severe psoriasis (cases) and 239 were diagnosed with another dermatological disease (controls).
RESULTS: The proportion of patients with intermediate to high 10-year cardiovascular risk using the Framingham equation was significantly higher among psoriasis patients (38.5%; 80/208) than among the controls with other dermatological diseases (23.4%; 50/214, P<.05). No significant differences were observed between the 2 groups with respect to cardiovascular risk using the SCORE risk charts (P=.591). The case group included a greater proportion of obese and morbidly obese patients, as well as patients with higher triglyceride and low density lipoprotein cholesterol levels (P<.05); while high density lipoprotein cholesterol levels were significantly more favorable in patients in the control group (P<.05).
CONCLUSIONS: Cardiovascular risk was greater in patients with moderate to severe psoriasis than in patients with other dermatological conditions, suggesting that early detection and tailored management of risk factors is essential to reducing cardiovascular morbidity in these patients.
J Drugs Dermatol. 2014;13(10):1240-1247.
The Successful Use of Etanercept in Combination Therapy for Treatment of Acrodermatitis Continua of Hallopeau
Kimberly Kazinski 2LT USA MC, Kathleen M. Joyce Capt USAF MC, Darryl Hodson MAJ USA MC| |
Kourosh Beroukhim BS,a Melissa J. Danesh BS,b Catherine Nguyen BS,c Annemieke Austin MD,b John Koo MD,b and Ethan Levin MDb| |
METHODS: We reviewed the results of the phase II clinical trials for the anti-IL-23 agents tildrakizumab and guselkumab, in order to assess the efficacy and safety profile of each agent.
RESULTS: By week 16, the proportion of patients achieving Physician Global Assessment (PGA) score of clear (0) or minimal (1) and Psoriasis Area and Severity Index (PASI 75) was above 70% among the most efficacious dosage of each agent (P< 0.001 compared to placebo for all agents). The safety profiles of the agents were similar, with the most frequently reported adverse events of nasopharyngitis, upper respiratory infections, cough, and headache.
CONCLUSION: The anti-IL-23 agents demonstrated a rapid clinical improvement and favorable short-term safety profile. The results of the phase II trials support IL-23 as an essential target in psoriasis treatment.
J Drugs Dermatol. 2015;14(10):1093-1096.
Infliximab is a chimeric monoclonal antibody, which acts by binding to both the soluble and membrane-bound tumor necrosis factor-a. In clinical practice, it is used as either monotherapy or in combination with other systemic therapies, particularly methotrexate. This study reviews clinical response and adverse events in 120 psoriasis patients with moderate-to-severe psoriasis who have received infliximab for a minimum of one year. The medical records of 120 infliximab-treated psoriasis patients at our referral psoriasis clinic in Dallas between 2002-2008 were reviewed for response rates, side effects and concomitant therapies. Of 120 charts reviewed, 112 (93%) patients had plaque type psoriasis, six (5%) had recalcitrant palmoplantar disease and two (1.6%) had severe acropustulosis of Hallopeau. Eighty-four (70%) patients had symptomatic psoriatic arthritis. The mean follow-up time was 2.2±1.1 years. One hundred and nine (91%) of the 120 patients had clearance of their psoriasis (response of more than 90% of initial BSA) at a median time of 12 weeks. Concomitant systemic treatments, primarily methotrexate, were given to 62 (52%) patients. Nineteen patients (16%) discontinued infliximab in the post-one-year treatment period for a variety of reasons, primarily failure to maintain adequate response. One hundred and four (87%) of patients required more than the standard dose of 5 mg/kg every eight weeks to maintain clearance. Infliximab either as monotherapy or in combination with traditional antipsoriatic agents is an effective and well-tolerated treatment option for patients with moderate to severe psoriasis and psoriatic arthritis on therapy for over one year and continuing for the long term.
J Drugs Dermatol. 2011;10(5):539-544.
Management of Moderate to Severe Plaque Psoriasis (Part I): Clinical Update on Antitumor Necrosis Factor Agents
Jeffrey M. Sobell MD, Robert E. Kalb MD, Jeffrey M. Weinberg MD| |
Bruce E. Strober, MD, PhD and Shari Clark, BA| |
Early and Explosive Development of Nodular Basal Cell Carcinoma and Multiple Keratoacanthomas in Psoriasis Patients Treated with Cyclosporine
Edward L Lain MDMBA, Ramsey F Markus MD| |
Adalimumab Plus Narrowband Ultraviolet B Light Phototherapy for the Treatment of Moderate to Severe Psoriasis
Jerry Bagel MDa,b| |
Background: Combining systemic agents with phototherapy is becoming a standard of care for patients with moderate to severe
psoriasis. The combination of adalimumab and phototherapy has not been previously explored.
Methods: In this 24-week single-arm open-label study, adults with moderate to severe psoriasis received adalimumab 40 mg every other week and narrowband (NB)-UVB phototherapy three times a week for 12 weeks and then were followed for 12 weeks without treatment. Response to therapy was determined using the Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA) affected and Physician’s Global Assessment (PGA) of psoriasis.
Results: Twenty patients were enrolled with mean baseline scores of 17.0 for PASI, 21.2 for BSA and 3.5 for PGA. Half (10/20) of the patients achieved PASI 75 response by week 4. At the end of treatment at week 12, 19 (95%) patients achieved PASI-75, 15 (75%) patients achieved PASI-90 and 11 (55%) patients achieved PASI-100. Seventeen (85%) patients were clear or almost clear (PGA score ≤1). Mean baseline PASI, BSA and PGA scores improved by 95 percent, 93 percent and 80 percent, respectively. Disease improvement was observed through the end of follow up period at week 24. No serious adverse events were noted.
Conclusion: Concurrent use of adalimumab and NB-UVB phototherapy was clinically effective and well tolerated in patients with moderate to severe psoriasis. This combination regimen represents a new treatment option for clinical practice and warrants further investigation in controlled clinical trials.
J Drugs Dermatol. 2011;10(4):366--371.
Habibollah S. Alamdari BAa , Cheryl J. Gustafson MDa , Scott A. Davis MAa , William Huang MD MPHa , and Steven R. Feldman MD PhDa-c| |
Purpose: To determine how frequently psoriasis patients are screened for CV risk factors in the ambulatory care setting and to identify factors affecting screening rates.
Methods: Data from the 2005 to 2009 National Ambulatory Medical Care Survey (NAMCS) were analyzed to determine screening rates for blood pressure, glucose, cholesterol, and body mass index (BMI). The probability of a patient having at least 1 of the 4 risk factors screened was determined and was termed the "composite" score. Screening rates were assessed by physician specialty, patient demographics, and clinical practice characteristics.
Results: There were an estimated 11.4 million psoriasis patient visits from 2005 to 2009. Blood pressure, glucose, cholesterol, and BMI were evaluated at 32.2%, 5.9%, 9%, and 26% of psoriasis visits, respectively, with a composite score of 41.2%. Patients without psoriasis were screened for these CV risk factors at 59.0%, 6%, 8%, and 38.1% of outpatient visits, respectively, with a composite score of 66.3%. The results of a multivariate analysis accounting for patient age differences indicated psoriasis had a statistically significant effect on rates of blood pressure and BMI screening. In general, screening rates were higher if the patient was male, African American, or non-Hispanic, and screening rates were relatively equal across age groups. Higher screening rates were also associated with primary care specialties, faculty practice or community health clinics with contracted physicians, clinics that utilized electronic medical records, practices with a higher percentage of revenue from a Medicare/Medicaid payer, or offices with discounted fees and capitation payment structures.
Limitations: Data from NAMCS are cross-sectional, permitting assessment of screening rates based on visits but not on patients.
Conclusions: Screening for high blood pressure, diabetes, hypercholesterolemia, and obesity are not performed at most outpatient visits for psoriasis. Care should be taken to ensure that patients do receive appropriate screening for the comorbidities associated with psoriasis.
J Drugs Dermatol. 2013;12(1):e14-e19.
Debra Breneman MD, Pranav Sheth MD, Vivian Berger LPN, Vahid Naini PharmD, Victor Stevens PhD| |
The Use of a Reliable, Ubiquitous, Inexpensive, and User-Friendly Tablet-Based System to Track Target Lesion Improvements in Subjects With Plaque Psoriasis Treated With Clobetasol Propionate 0.05% Spray
Thomas H. Wiser PharmD, Matthew H. Meckfessel PhD, Warren Winkelman MD PhD MBA| |
J Drugs Dermatol. 2015;14(3):236-241.
Medication and Health Care Service Utilization Related to Depressive Symptoms in Older Adults with Psoriasis
Amit S Kulkarini MS, Rajesh Balkrishnan PhD, fabian T Camacho MS, Roger T Anderson PhD, Steven R Feldman MD PhD| |
Design: Prospective longitudinal cohort study over a 2-year post enrollment period in a population of older adults with psoriasis enrolled in managed care.
Setting: A Medicare Health Maintenance Organization (HMO) in southeastern United States with prescription benefits.
Participants: Sixty-three older adults with psoriasis using topical corticosteroids therapy and enrolled in a Medicare HMO for a 2- year continuous period.
Measurement: Upon enrollment, each enrollee was mailed a comprehensive health status assessment battery, which included the Center for Epidemiologic Studies Depression (CES-D) scale. Information on medication adherence (using medication possession ratio) and total health care utilization/costs following enrollment were retrieved from the Medicare HMO database.
Results: Nearly one-fifth of the patient population had depressive symptoms. Patients with psoriasis who had depressive symptoms at the time of enrollment were less likely to be adherent to topical corticosteroid medication (r= -0.29, p<0.01) and less likely to utilize health care resources as evidenced by lower health care costs (r= -0.27, p<0.05), after confounder adjustment.
Conclusions: The prevalence of depressive symptoms in older adults with psoriasis is commonplace, with strong, yet unexplained correlations between presence of depressive symptoms and lower rates of medication and health care service use among these patients.
Benjamin Farahnik BA,a Kourosh Beroukhim BS,b Mio Nakamura MD,c Michael Abrouk BS,d Tian Hao Zhu BA,e Rasnik Singh BS,b Kristina Lee BA,c Tina Bhutani MD,c and John Koo MDc| |
METHODS: We reviewed the results of the phase III clinical trials for the anti-IL-17 agents secukinumab, ixekizumab and brodalumab in order to assess the efficacy and safety profile of each agent.
RESULTS: By week 12, the proportion of patients reaching a 75% improvement from baseline Psoriasis Area and Severity Index (PASI 75) was comparable between the different agents (secukinumab 83%, ixekizumab 89%, and brodalumab 85%). The safety profiles of the agents were similar with the most frequently reported adverse events of nasopharyngitis, upper respiratory infections, headache, and injection site reaction.
CONCLUSION: The anti-IL-17 agents demonstrated a rapid and robust clinical improvement accompanied by a favorable short-term safety profile. The results of the phase III trials continue to reinforce the theory that the IL-17 pathway is an essential target in psoriasis treatment.
J Drugs Dermatol. 2016;15(3):311-316.
Kim A. Papp MD PhDa and Mark G. Lebwohl MDb| |
J Drugs Dermatol. 2018;17(3):247-250.
Central Serous Chorioretinopathy Associated With Topical Corticosteroids in a Patient With Psoriasis
Navid Ezra MD,a Mehran Taban MD,b Daniel Behroozan MDa,c,d| |
Background: Central serous chorioretinopathy (CSC), also known as central serous retinopathy (CSR), is a visual impairment, often temporary, usually in a single eye, which mostly affects males in the age group of 20 to 50 but may also affect women. CSC occurring after prolonged use of topical steroids in a patient with psoriasis is a novel complication in the English literature.
Observations: We describe a case of a 25-year-old male, with a 15-year history of corticoid ointment use for psoriasis, who presented with loss of vision secondary to CSR.
Conclusions: All topical steroid treatments were discontinued and the patient recovered his vision completely. Although topical corticosteroids are frequently utilized for psoriasis management with a low rate of complication, clinicians should be familiar with this rare yet distressing condition. Furthermore, patients with increased production of endogenous corticosteroids (e.g., those with Cushing's syndrome, hypertension, or obstructive sleep apnea) should be warned of the potential of chorioretinopathy following prolonged use of topical corticosteroids
J Drugs Dermatol. 2011;10(8):930-933.
Combination Use of Ustekinumab With Other Systemic Therapies: A Retrospective Study in a Tertiary Referral Center
Gillian M. Heinecke BS, Adam J. Luber BA, Jacob O. Levitt MD, and Mark G. Lebwohl MD| |
OBJECTIVE: To evaluate the prevalence, indications, and response to combination systemic therapy with ustekinumab for psoriasis in a tertiary referral center.
METHODS: This retrospective study comprised 102 psoriasis patients treated with ustekinumab at a single tertiary care center. Data was collected pertaining to history of psoriasis, past and current therapies including use of concomitant psoriasis agents, response to therapy, and side effects while on ustekinumab.
RESULTS: Twenty-two of 102 (22%) patients were identified as receiving combination systemic treatment involving ustekinumab and at least one additional agent. The most common indication for combination therapy was psoriatic arthritis (35%), followed by bridging therapy (26%), inadequate psoriasis control (13%), prevention of non-melanoma skin cancers (17%), and control of palmoplantar disease (9%). Methotrexate was the additional agent in 12 patients, cyclosporine in 7 patients, acitretin in 5 patients, and 1 patient received a second biologic agent, first etanercept and then adalimumab. Overall, the reduction in body surface area (BSA) was 80% for patients on combination therapy. For those patients on combination therapy for psoriatic arthritis, 75% had resolution or stabilization of their symptoms. Only one patient, receiving cyclosporine, discontinued combination therapy due to adverse side effects.
CONCLUSION: Combination systemic therapy with ustekinumab can be effective and well tolerated for patients who cannot be adequately treated with ustekinumab alone.
J Drugs Dermatol. 2013;12(10):1098-1102.
DFD-01, a Novel Medium Potency Betamethasone Dipropionate 0.05% Emollient Spray, Demonstrates Similar Efficacy to Augmented Betamethasone Dipropionate 0.05% Lotion for the Treatment of Moderate Plaque Psoriasis
Joseph F. Fowler Jr. MD,a Adelaide A. Hebert MD,b Jeffrey Sugarman MD PhDc| |
OBJECTIVE: To compare the efficacy and safety of medium potency DFD-01 with super potent augmented betamethasone dipropionate 0.05% lotion (Diprolene) for the topical treatment of moderate plaque psoriasis.
METHODS: Adults with moderate plaque psoriasis (Investigator Global Assessment [IGA]=3; 10–20% BSA) were randomized 2:1:1 to DFD-01, Diprolene, or Vehicle. Products were applied twice daily to affected areas for 14 days. Treatment success was defined as IGA=0 or 1 and ≥2-grade improvement from baseline. IGA and target lesion Total Sign Score (TSS; sum of erythema, scaling, and plaque elevation scores) were assessed at baseline and at days 4, 8, and 15. Adverse events (AEs) were recorded.
RESULTS: 351 subjects with moderate psoriasis were randomized to DFD-01 (n=174), Diprolene (n=90), or Vehicle (n=87). Mean BSA was 13–14%. Treatment success was achieved in 19.0% DFD-01, 18.9% Diprolene, and 2.3% Vehicle (P<0.001 DFD-01 vs Vehicle) at day 15. Treatment success at day 8 was 10% DFD-01, 6.7% Diprolene, and 1.2% Vehicle (P=0.003 DFD-01 vs Vehicle). TSS was significantly reduced with DFD-01 compared with Vehicle at days 4, 8, and 15 (P≤0.006) and compared with Diprolene at day 4 (P=0.010). DFD-01 relieved signs of erythema and scaling earlier than Diprolene or Vehicle, showing significant improvements on day 4 (P≤0.048). All products were well tolerated. Significantly more burning/stinging was reported with Diprolene than DFD-01 (13.6% vs 4.1%, P=0.006).
CONCLUSION: Medium potency DFD-01 was efficacious for the treatment of moderate psoriasis. DFD-01 demonstrated similar efficacy to super potent Diprolene lotion. Results at 4 and 8 days indicate that DFD-01 shows early improvement in some subjects. DFD-01 was well tolerated and had an excellent safety profile.
J Drugs Dermatol. 2016;15(2):154-162.
International Dermatology Outcome Measures (IDEOM) Group 2016 New York Meeting: Meeting Summary and Data from the Psoriasis Working Group
Lourdes M. Perez-Chada MD,a* Sanminder Singh BS,b* Kristina Callis-Duffin MD MS,c Amit Garg MD,d Alice B. Gottlieb MD PhD,e John Latella,f April W. Armstrong MD MPH,b† and Joseph F. Merola MD MMSca,g†| |
The International Dermatology Outcome Measures (IDEOM) Group was established to develop validated and standardized patient-centered outcome measures in dermatology that meet the needs of stakeholders and can be used in clinical practice as well as clinical research. At this meeting, we aimed to define the final core domain set to be assessed in psoriasis clinical research and to identify which of the current psoriasis assessment instruments appropriately address those domains. Specifically, we sought to ascertain stakeholder input on domain match and feasibility of multiple psoriasis instruments. We presented 19 physician-reported and 23 patient-reported outcome measures at the meeting. Stakeholders anonymously voted on the validity and feasibility of each instrument. Validity was rated as: green (good), amber (fair), red (poor), and white (not enough information). Feasibility was rated as: green (feasible), amber (concerns about some aspects of feasibility), red (not feasible), and white (not enough information). Eighteen physician-reported and 20 patient-reported instruments received a favorable green or amber rating for validity from the majority of voters. Seventeen physician-reported and 19 patient-reported instruments received a green or amber rating for feasibility from the majority of voters. A significant proportion of the psoriasis instruments received a good or fair vote for measuring their intended psoriasis domains in a feasible manner. We will continue to refine our voting methodology and incorporate patient input into our process of defining psoriasis domains and developing validated instruments.
J Drugs Dermatol. 2017;16(8):770-777.
Matthew E. Byran, MD; Kristen Lienart, BS; Bruce R. Smoller, MD and Sandra Marchese Johnson, MD| |
The Efficacy of Three Class I Topical Synthetic Corticosteroids, Fluocinonide 0.1% Cream, Clobetasol 0.05% Cream and Halobetasol 0.05% Cream: A Scholtz-Dumas Bioassay Comparison
Chai Sue Lee MD and John Koo MD| |
Background: This study compared the efficacy of a novel, topical class I synthetic, 0.10% fluocinonide corticosteroid with two other class I corticosteroids and placebo for the treatment of plaque psoriasis.
Methods: A 0.5 gram dose of fluocinonide 0.1% cream, clobetasol propionate 0.05% cream, halobetasol propionate 0.05% cream, and placebo ointment were applied to test sites on one psoriatic plaque per patient (n=5). Test sites were outlined according to the Scholtz-Dumas bioassay. Test sites were assessed by a blinded evaluator (1=psoriasis worsened to 5=psoriasis clear or almost clear), cleaned and medications were reapplied on days 3, 5, 7, 10 and 12.
Results & Conclusion: The three class I corticosteroid products were comparably effective, numerically and statistically, in clearing the psoriatic plaques. Upon completion of treatment, 60–80% of active-treated sites were clear or almost clear of psoriasis compared to zero with the placebo.
Halobetasol 0.01%/Tazarotene 0.045% Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: Maintenance of Therapeutic Effect After Cessation of Therapy
David M. Pariser MD,a Lawrence J. Green MD,b Linda Stein Gold MD,c Jeffrey L. Sugarman MD PhD,d Tina Lin PharmD,e Radhakrishnan Pillai PhDf| |
Evan Austin BS,a,b Jillian W. Millsop MD,a,b Haines Ely MD,a,b Jared Jagdeo MD MS,a,b,c and Joshua M. Schulman MDa,b| |
J Drugs Dermatol. 2018;17(4):471-473.
A Randomized, Double-Blinded Trial Evaluating the Efficacy and Tolerability of Vectical Ointment (Calcitriol 3 mcg/g Ointment) When Compared to Betamethasone Diproprionate Ointment (64 mg/g) in Patients With Nail Psoriasis
Lauren Kole MD, Wendy Cantrell DNP, and Boni Elewski MD| |
DESIGN: Single-center, double-blind study.
SETTING: One academic center.
PARTICIPANTS: 10 adult male and female subjects with psoriasis of the fingernails and/or toenails.
MEASUREMENTS: The primary efficacy evaluation was the absolute reduction of nail thickness (mm) of the target nail. A secondary endpoint was the improvement in the Physician Global Assessment score of disease severity.
RESULTS: Patients treated with either betamethasone diproprionate ointment or calcitriol ointment demonstrated a similar reduction of nail thickness of the selected target nail. The difference between the two groups was not statistically significant (P=0.42).
CONCLUSION: This small study illustrates that calcitriol ointment may be as effective as betamethasone diproprionate in the treatment of nail psoriasis, and its promise should be further investigated in a subsequent larger trial.
J Drugs Dermatol. 2014;13(8):912-915.
Brian Robert Keegan MD PhD| |
To qualify for inclusion, subjects were required to have a clinical diagnosis of stable plaque psoriasis involving ≥10% of the body surface area (BSA), a combined target lesion severity score (TLSS) of ≥7 for the target lesion, a plaque elevation score of ≥3 (moderate) for the target lesion, and a Physician Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.
At the baseline visit, the mean proportions of BSA affected by psoriasis were 17% (range 10% to 86%) in the desoximetasone 0.25% spray group and 16% (range 10% to 70%) in the vehicle spray group. Approximately 90% of the patients in each group had moderate to very severe scaling at baseline. Desoximetasone 0.25% spray was effective with significant improvements in overall severity and was well tolerated, with dryness, irritation, and pruritus at the application site being the only reported adverse events occurring in >1% of patients, each of which occurred in less than 3% of patients.
As a large proportion of psoriasis patients (94%) have reported being bothered by scaling, the relief of scaling was examined in these studies. At week 1, 69.7% of patients on desoximetasone 0.25% spray had scaling that was considered clear / almost clear / mild compared with 48.3% for those on vehicle spray (P= .0027). By week 4, the proportion of patients with clear / almost clear / mild scaling had risen to 83.9% in the desoximetasone 0.25% spray group (P < .0001). After four weeks of treatment, 66.4% of patients in the topical corticosteroid group had an overall improvement of at least two grades of disease severity. This demonstrates that desoximetasone 0.25% spray provided fast and effective relief of scaling in patients with plaque psoriasis affecting 10% to 86% of their BSA.
J Drugs Dermatol. 2015;14(8):835-840.
Michael Jude Welsch, MD| |
Comparing Clobetasol Propionate 0.05% Spray to Calcipotriene 0.005% Betamethasone Dipropionate 0.064% Ointment for the Treatment of Moderate to Severe Plaque Psoriasis
Alan Menter MD, William Abramovits MD, Luz E. Colón MS, Lori A. Johnson PhD, Ronald W. Gottschalk MD| |
Infectious Complications in Patients With Psoriasis and Rheumatoid Arthritis Treated With Antitumor Necrosis Factor Agents and Methotrexate
Kamruz Darabi MD, Rohit Jaiswal, Sarah Hostetler MD, Mark Bechtel MD, Matthew Zirwas MD| |
Treatment of patients with moderate-severe psoriasis and/or psoriatic arthritis includes systemic biologic, antimetabolite, and im- munosuppressive therapy. However, adverse events such as serious infectious complications must be considered before start- ing therapy and throughout treatment. The authors describe the case of a male on combination etanercept and methotrexate for psoriasis and psoriatic arthritis for years who developed a spontaneous epidural abscess with resulting quadriplegia. In addition, a review of the literature was performed looking at the risk of serious infectious complications with antitumor necrosis factor (anti-TNF) monotherapy or combination therapy with methotrexate fro the treatment of psoriasis and rheumatoid arthritis. Serious infectious risk does not appear to be increased with etanercept or other anti-TNF agents either alone or in combination with methotrexate. Nevertheless, clinicians are cautioned to carefully weigh the risks and beneﬁts of treating with anti-TNF agents in patients who are prone to infection.
Carlo Pincelli MD,a Peter H. Schafer PhD,b Lars E. French MD,c Matthias Augustin MD,d James G. Krueger MD PhDe| |
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Frank C. Victor, Alice B. Gottlieb| |
Secukinumab Improves Physical Function in Subjects With Plaque Psoriasis and Psoriatic Arthritis: Results from Two Randomized, Phase 3 Trials
Alice B. Gottlieb MD PhD,a Richard G. Langley MD,b Sandra Philipp MD PhD,c Bardur Sigurgeirsson MD PhD,d Andrew Blauvelt MD MBA,e Ruvie Martin PhD,f Charis Papavassilis MD PhD,g and Shephard Mpofu MDg| |
OBJECTIVE: To evaluate the efficacy of secukinumab in subjects with psoriasis and concomitant psoriatic arthritis (PsA) with respect to psoriasis symptoms and physical function, we conducted pre-specified subanalyses of the phase 3 FIXTURE and ERASURE trials.
METHODS: The 52-week FIXTURE and ERASURE trials randomized subjects with moderate-to-severe plaque psoriasis to subcutaneous secukinumab 300 or 150 mg (Baseline, weeks 1, 2, 3, every 4 weeks from week 4 until week 48), etanercept 50 mg (twice weekly through week 12, once weekly thereafter through week 51; FIXTURE only), or placebo. In this analysis, changes in Health Assessment Questionnaire–Disability Index (HAQ-DI) and PASI 75 responses were assessed in subpopulations with concomitant PsA (n=196, FIXTURE; n=171, ERASURE).
RESULTS: Physical functioning (mean change from Baseline in HAQ-DI) was greater with secukinumab 300 mg vs. placebo at week 12 in both trials (FIXTURE, -0.41 vs. 0.02/P=0.0001; ERASURE, -0.35 vs. -0.08/P=0.0003); corresponding values were -0.29 for etanercept and -0.19 for secukinumab 150 mg in FIXTURE and -0.18 for secukinumab 150 mg in ERASURE. Greater responses were seen in subjects with greater Baseline disability (HAQ-DI ≥05). Week 12 PASI 75 responses were higher with secukinumab 300 mg/150 mg vs. placebo in FIXTURE (72%/59% vs. 2%) and ERASURE (68%/70% vs. 4%; all P<0.0001) and with secukinumab 300 mg vs. etanercept (72% vs 39%; P=0.0084).
CONCLUSION: Secukinumab 300 mg produced significant improvement in psoriasis and physical functioning in subjects with concomitant PsA.
ClinicalTrials.gov numbers: NCT01358578 (FIXTURE); NCT01365455 (ERASURE)
J Drugs Dermatol. 2015;14(8):821-833.
Discordance Between Patient Reported Motivations to Seek Treatment for Psoriasis Compared to Television Advertisements
Nicole M. Golbari BA,a Martina L. Porter MD,b Alexa B. Kimball MD MPHc| |
Comparison of the Efficacy of Biologics Versus Conventional Systemic Therapies in the Treatment of Psoriasis at a Comprehensive Psoriasis Care Center
Shiu-chung Au MD,a Abdulaziz Madani MD,a Marwan Alhaddad MD,a Maha Alkofide MD,a and Alice B. Gottlieb MD PhDa,b| |
DESIGN: Retrospective, cross-sectional
METHODS: All patient visits with a code for psoriasis (ICD-9 696.1) in the clinical practice of two dermatologists with a high percentage (over 70% of chief complaints) of psoriasis patients from Jan 1, 2008 to Jan 4, 2012 inclusive were included in this retrospective data analysis. Patients were excluded if the baseline Physician's Global Assessment (PGA) at start of treatment was unknown, or less than 3 (moderate). The practice is a comprehensive psoriasis care center in the Northeastern United States serving a metropolitan population of over 4 million people. Patients were divided by treatment type (biologic, conventional systemic or both) and history of previous treatments. Patients were evaluated by Body Surface Area (BSA), PGA, Simple-Measure for Assessing Psoriasis Activity (S-MAPA, calculated by BSA multiplied by PGA). Patients were evaluated at baseline, 8, 12, 16, and 24 weeks after start of treatment. Patients must have completed at least 8 weeks on a single treatment in order to be included.
RESULTS: 46 courses of biologics, 12 courses of conventional systemic therapies, and 18 courses of both together were identified with PGA 3 or greater at baseline. Baseline S-MAPA for biologics was 74, for non-biologic systemics was 62.25. At week 24, S-MAPA improved 70.2% over baseline in patients treated with biologics, patients treated with non-biologic systemics improved by only 40.4% (P<0.05). The average number of prior treatments for patients on biologics was 1.87 versus 1.25 for patients on conventional systemic therapies (P=0.169).
CONCLUSION: Biologics show superior results to conventional systemic therapies (70% improvement versus 40% improvement) for the treatment of patients with moderate to severe psoriasis, as measured by decrease in S-MAPA (PGA multiplied by BSA) at week 24. These results were observed despite the fact that patients on biologics had a greater baseline severity and had a greater number of previous treatments.
J Drugs Dermatol. 2013;12(8):861-866.
Clobetasol Propionate 0.05% Spray for the Management of Moderate-to-Severe Plaque Psoriasis of the Scalp: Results From a Randomized Controlled Trial
Background: Clobetasol propionate 0.05% spray is available for treating moderate-to-severe plaque psoriasis; however, there is limited information with plaque psoriasis of the scalp.
Objective: Evaluate the efficacy, safety, and quality-of-life impact of clobetasol propionate 0.05% spray in patients with moderate to severe plaque psoriasis of the scalp.
Methods: Multicenter, randomized, double-blind, vehicle-controlled study involving 81 men and women with moderate-to-severe (Global Severity Score [GSS] = 3 or 4) plaque psoriasis of the scalp. Eligible patients were treated with clobetasol propionate 0.05% spray or vehicle spray, which was applied twice daily for up to four weeks. The primary efficacy end point was the GSS of psoriasis of the scalp after four weeks. Safety assessments included local tolerability, presence of Cushing's syndrome, and adverse events.
Results: At the end of treatment, 85 percent (35/41) of patients in the clobetasol propionate 0.05% spray group achieved success (GSS clear or almost clear), compared with 13 percent (5/40) in the vehicle spray group (P < .001). The proportion of patients treated with clobetasol propionate 0.05% spray who achieved a rating of clear (GSS = 0) after two weeks and at the end of treatment was 12 percent and 51 percent, respectively. Clobetasol propionate 0.05% spray was well tolerated, and there were no serious adverse events or reported cases of folliculitis or Cushing's syndrome.
Conclusion: Treatment with clobetasol propionate 0.05% spray for up to four weeks is effective and well tolerated for moderate-to-severe plaque psoriasis of the scalp.
J Drugs Dermatol. 2011;10(8):888-895.
Alice B. Gottlieb MD PhD, Wolf-Henning Boehncke MD, Mohamed Darif PhD| |
Rebecca G. Pomerantz, Elinor Mody MD, M. Elaine Husni MD MPH, and Abrar A. Qureshi MD MPH| |
Halobetasol and Tazarotene: Further Defining the Role of a Unique Fixed Combination Topical Lotion in Moderate-to-Severe Plaque Psoriasis
Linda Stein Gold MD,a Jerry Bagel MD,b Mark G. Lebwohl MD,c Tina Lin PharmD,d Gina Martin MOT,e Radhakrishnan Pillai PhD| |
A Retrospective Analysis of 72 Patients on Prior Efalizumab Subsequent to the Time of Voluntary Market Withdrawal in 2009
Elizabeth Farley Prater MD,a Antoinette Day BS,b Mahir Patel MD,c and Alan Menter MDc| |
OBJECTIVE: To review the baseline characteristics and psoriasis phenotypes of patients with prior excelled response to efalizumab, and to determine the response of these patients to prior as well as subsequent therapies. By defining this subgroup of patients, particularly relating to palmoplantar psoriasis, future therapeutic considerations could be improved.
DESIGN: A retrospective review of 72 patients who were on efalizumab at the time of market withdrawal was conducted. Data was obtained through chart review of patients at a specialty psoriasis clinic in Dallas, TX.
MAIN OUTCOMES AND MEASURES: Patient characteristics, details of efalizumab use, and efficacy of efalizumab compared with other psoriasis treatment modalities.
RESULTS: Of the 72 patients, 24 (33%) were found to have palmoplantar disease. As a group, these patients were older, more likely to be female, and less likely to have a family history of psoriasis. 48 patients (67%) were on one or more systemic and/or biologic medication prior to starting efalizumab. Their BSA improved from 5.45 to 0.8 as a group. Six patients were identified as having failed TNF alpha antagonist treatment prior to starting efalizumab. All responded well to the medication with an average BSA of 0.54. Five of these six patients had evidence of palmoplantar disease prior to starting efalizumab and five of these six patients were female. Eleven patients (15%) experienced neurologic side effects and 13 (18%) had infections while on efalizumab treatment.
LIMITATIONS: This was a retrospective review. Quality of life issues could not always be fully assessed from the data available.
CONCLUSIONS AND RELEVANCE: Efalizumab was effectively utilized in our clinical practice to treat patients with palmoplantar psoriasis, including six patients who had failed prior treatment with one or more TNF alpha antagonist agents.
J Drugs Dermatol. 2014;13(6):712-718.
Scott A. Elman AB,a Joseph F. Merola MD MMSc,a,b April W. Armstrong MD MPH,c Kristina Callis Duffin MD,d John Latella,e Amit Garg MD,f Alice B. Gottlieb MD PhDg| |
The International Dermatology Outcome Measures (IDEOM) group, comprising patients, physicians, health economists, industry partners, payers, and regulatory agencies, was established to develop unified and validated patient-centered outcome measures in dermatology in response to increasing demand to quantify effectiveness of treatments and performance outcomes among providers. IDEOM has chosen to start with psoriasis outcome measures, and then apply its methodology to other dermatologic diseases. In this paper, we review the background and progress to date of IDEOM, including an update of IDEOM activities as of our 2016 meeting in Washington DC, USA. Briefly, the progress-to-date of a Delphi process to create outcome measures for psoriasis was reviewed, including preliminary data from the first round of Delphi voting. Updates were also heard from industry partners including the National Psoriasis Foundation (NPF) and the US Food and Drug Administration (FDA). Furthermore, plans to establish outcome measures for hidradenitis suppurativa (HS) were discussed.
J Drugs Dermatol. 2017;16(2):119-124.
Extended Efalizumab Therapy Sustains Efficacy Without Increasing Toxicity in Patients with Moderate to Severe Chronic Plaque Psoriasis
Alice B Gottlieb MD PhD, Kenneth B Gordon MD, Mark G Lebwohl MD, Ivor Caro MD, Patricia A Walicke MD PhD, Nicole Li PhD,Craig L Leonardi MD, for the Efalizumab Study Group| |
Mycobacterium Fortuitum Infection Following Adalimumab Treatment for Psoriasis and Subsequent Complication-Free Treatment With Alternate TNF-α Blockers
Michael B. Chang BS, Jennifer C. Sri MD, Marcia Driscoll MD, Anthony A. Gaspari MD| |
J Drugs Dermatol. 2011;10(8):927-929.
Tazarotene Revisited: Safety and Efficacy in Plaque Psoriasis and Its Emerging Role in Treatment Strategy
Emil A. Tanghetti MD,a Mark G. Lebwohl MD,b Linda Stein Gold MDc| |
Craig Leonardi MD, Bruce Strober MD PhD, Alice B. Gottlieb MD PhD, Boni E. Elewski MD, Jean-Paul Ortonne MD, Peter van de Kerkhof MD, Chiun-Fang Chiou PhD, Meleana Dunn MA, Angelika Jahreis MD PhD| |
Real-World Clinical Experience With Apremilast in a Large US Retrospective Cohort Study of Patients With Moderate to Severe Plaque Psoriasis
April Armstrong MD MPH,a and Eugenia Levi PharmDb| |
OBJECTIVE: To examine real-world use and patient outcomes with apremilast, an oral PDE4 inhibitor, in the dermatology practice set-ting for treatment of patients with moderate to severe plaque psoriasis.
METHODS: This retrospective, multicenter, longitudinal, observational cohort study used Modernizing Medicine’s electronic medi-cal record (EMR) database of >5000 US dermatology providers. There were 7517 adults aged ≥18 years with a psoriasis diagnosis (ICD-9, ICD-10) who received apremilast therapy from October 1, 2015, to January 31, 2016, and were included in effcacy and safety analyses. Among patients who switched from non-apremilast to apremilast monotherapy, the majority (74.2%) switched from prior topical treatment.
RESULTS: At apremilast initiation, in systemic-naive and systemic-experienced patients, mean (SD) Physician Global Assessment (PGA) was 2.79 (0.13) and 2.48 (0.15); mean (SD) psoriasis-affected body surface area (BSA) was 17.85% (2.27) and 12.93% (2.59); and mean itch numeric rating scale (NRS; 0=no itch, 10=worst itch possible) score was 4.14 and 3.82, respectively. Within 6 months of apremilast initiation, PGA decreased (mean [SD]) in systemic-naive patients (−1.71 [0.19], P less than0.001) and systemic-experienced pa-tients (−1.02 [0.18], P less than 0.001); 26.8% (systemic-naive) and 25.5% (systemic-experienced) of patients achieved a PGA score of 0 or 1. Likewise, statistically signifcant reductions in BSA were noted in systemic-naive patients (~62% reduction from baseline; P less than 0.01) and systemic-experienced patients (~60% reduction from baseline; P=0.002). Mean itch NRS decreased to 2.38 in systemic-naive patients (P=0.139) and 0.0 in systemic-experienced patients (P=0.034). Of 160 patients with ≥1 assessment of patient-perceived overall treatment effectiveness, 138 (86.2%) strongly/somewhat agreed apremilast was effective in clearing their skin of psoriasis. For safety analyses, body weight was available in the EMR database and decreased in systemic-naive patients (−1.75 kg) and systemic-experienced patients (−1.09 kg).
Conclusions: Findings support the effectiveness of apremilast in patients with moderate to severe psoriasis in dermatology clinical practices. Patients perceived apremilast to be effective.
J Drugs Dermatol. 2017;16(12):1240-1245.
Fariba Iraji MD, Gita Faghihi MD, Amir Hossein Siadat MD, Shahla Enshaieh MD, Zabihlah Shahmoradi MD, Abolfazl Joia MD, Fatemeh Soleimani MD| |
Alan Menter MD, Mark Kosinski MA, Brian W Bresnahan PhD, Kim A Papp MD PHdd, John E Ware Jr PhD| |
1.0 mg/kg /wk or placebo were followed for 12 weeks. DRQL and psoriasis symptom severity were assessed at baseline (pre-treatment) and at the end of the first treatment phase (12 weeks). DRQL was measured using the Dermatology Life Quality Index (DLQI). Symptoms were measured using the Psoriasis Symptom Assessment (PSA) and an Itch scale. Disease burden was assessed at baseline by examining responses to individual questions of the DLQI, PSA, and Itch patient-reported outcome measures. The impact of treatment on disease burden was assessed over a 12-week double-blind study period by comparing changes in DLQI, PSA, and Itch scale scores between the active treatment and placebo groups. Patient-reported outcomes were also assessed during a 12-week extended treatment phase.
Prior to treatment, the responses to DLQI and PSA items revealed significant disease burden. Greater than 90% of patients reported being embarrassed or self conscious because of their skin, 53% reported that their skin prevented them from working or studying, and 98% reported that scaling and itching was bothersome. Compared to placebo-treated patients, efalizumab-treated patients showed significant improvement in patient-reported outcomes, reducing the limitations and burden associated with moderate to severe psoriasis within each of the three studies, as measured by DLQI (p<0.001), PSA-Severity (p<0.001), PSA-Frequency (p<0.001), and Itch (p<0.001) scores. Across all measures, the proportion of patients that improved on both statistical and clinical criteria for meaningful improvement was at least twofold greater among efalizumab- treated patients than in placebo-treated patients. The benefit of efalizumab was maintained over the course of an additional 12 weeks during an extended treatment phase.
In conclusion, patients with moderate to severe plaque psoriasis reported significant DRQL burden and symptom severity at baseline, but efalizumab significantly improved patient-reported DRQL and reduced the frequency and severity of psoriasis symptoms during 12-week double-blind and 12-week extended treatment periods.
J Drugs Dermatol. 2012;11(8):1000-1002.
David A. Sanchez BS,a,e Joshua D. Nosanchuk MD,b,c and Adam J. Friedman MDa,d,| |
J Drugs Dermatol. 2015;14(2):127-130.
Safety and Efficacy of a Once-Daily Halobetasol Propionate 0.01% Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: Results of Two Phase 3 Randomized Controlled Trials
Lawrence J. Green MD,a Francisco A. Kerdel MD,b Fran E. Cook-Bolden MD,c Jerry Bagel MD,d Tina Lin PharmD,e Gina Martin MOT,f Radhakrishnan Pillai PhD,f Robert Israel MD,g Tage Ramakrishna MDg| |
Scott A. Davis MA,a Brad A. Yentzer MD,a and Steven R. Feldman MD PhDa,b,c| |
PURPOSE: To determine the demographics of acitretin prescribing patterns as an assessment of acitretin use in women of child-bearing potential.
METHODS: We examined National Ambulatory Medical Care Survey (NAMCS) data from the years 1990-2009 to determine demographic data on patients who were prescribed etretinate or acitretin. We used age under 50 as a proxy for childbearing potential.
RESULTS: From 1996-2009, there were an estimated 29 million office visits for psoriasis. Females accounted for 14.3 million of these visits, and 6.5 million (45.6%) of them were under the age of 50. The NAMCS contained only one record of a female patient under the age of 50 being prescribed acitretin from 1996-2009, the years during which acitretin had been available in the United States. This corresponds to an estimated 2.3% of all psoriasis patients prescribed acitretin during this time (20,000 out of 890,000).
LIMITATIONS: The NAMCS estimates national trends based on a large nationwide database. While the use of acitretin in women under 50 is low, the precision of the estimate is limited by the small sample size provided by this database.
CONCLUSIONS: There are now many alternative treatments besides acitretin for women of childbearing potential with moderate to severe psoriasis. Acitretin is used at most infrequently in this population. In females of reproductive potential, acitretin should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments.
J Drugs Dermatol. 2013;12(7):799-802.
G. Martín-Ezquerra MD, M. Sánchez-Regaña MD, P. Umbert-Millet MD| |
A Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Calcipotriene Foam, 0.005%, vs Vehicle Foam in the Treatment of Plaque-type Psoriasis of the Scalp
Steven R. Feldman MD PhD,a William J. Eastman MD,b Thomas Brundage MS,b and Mary Mills BSb| |
OBJECTIVES: To evaluate the efficacy and safety of calcipotriene foam, 0.005%, for plaque-type psoriasis of the scalp.
METHODS: Subjects (n=363) were randomized into an 8-week, multicenter, double-blind, vehicle-controlled, parallel-group, phase 3b study of calcipotriene foam, 0.005% (NCT01139580). Primary end point was the proportion of subjects with an Investigator's Static Global Assessment (ISGA) score of 0 (clear) or 1 (almost clear) at week 8 for scalp involvement. Body involvement, target lesion score, and improvement for erythema, scaling, and plaque thickness were also assessed.
RESULTS: At week 8, more subjects in the calcipotriene foam, 0.005% group (40.9%) met the primary end point vs the vehicle foam group (24.2%; intent-to-treat [ITT] population; P<.001); a significant difference between groups was also observed at weeks 2 (P=.041) and 4 (P<.001). No significant difference was observed between treatment groups for ISGA of body psoriasis (ITT population; P=.544). In the per-protocol population, but not the ITT population, more subjects in the calcipotriene foam, 0.005%, group than the vehicle foam group met the secondary end points for scaling (P=.019) and plaque thickness (P=.027). Incidence of adverse events in both treatment groups was low; calcipotriene foam, 0.005%, was associated with erythema. Limitations: An 8-week study provides limited safety and efficacy data.
CONCLUSION: Calcipotriene foam, 0.005%, was more effective than vehicle foam for improving scalp psoriasis over an 8-week period, with improvements evident from week 2, and had a similar safety profile to vehicle foam.
J Drugs Dermatol. 2013;12(3):300-306.
Impact of Clobetasol Propionate 0.05% Spray on Health-Related Quality of Life in Patients With Plaque Psoriasis
J Drugs Dermatol. 2012;11(11):1348-1354.
Safety and Effectiveness of Ustekinumab for Treatment of Moderate to Severe Psoriasis: A Prospective Study in a Clinical Setting
Alejandro Molina-Leyva MD, Husein Husein-Elahmed MD, Ramon Naranjo-Sintes PhD,
and Jose Carlos Ruiz-Carrascosa MD
OBJECTIVE: To assess the utility of ustekinumab in a psoriasis unit.
METHODS: Analysis of the prospective data gathered during the follow-up of 30 consecutive psoriasis patients treated with ustekinumab at a single referral centre. Three effectiveness endpoints were defined 12 weeks, 28 and “long-term treatment”. The main outcome measure was improvement from baseline PASI at week 28 and at a point of adjustment of prolonged treatment signed as “long-term treatment”.
RESULTS: Overall 82.1% and 42.8% patients achieved respectively PASI75 and PASI90 response rates at week 28. Long-term treatment maintained efficacy outcomes 81.5% and 40.7% PASI75 and PASI90, respectively were observed. At week 28, patients naïve to TNFα- blockers agents and patients with a baseline PASI >10 had better PASI75 and PASI90 response rates than previously treated patients.
CONCLUSIONS: In clinical practice, the efficacy and patient adherence to ustekinumab are excellent and even better to the data obtained in clinical trials. Clinical indicators of psoriasis severity: previous treatments with tumor necrosis factor α blockers agents and active treatment beside small increases in PASI determine a delayed maximal response.
J Drugs Dermatol. 2014;13(8):971-974.
Evaluation of the Physician Global Assessment and Body Surface Area Composite Tool for Assessing Psoriasis Response to Apremilast Therapy: Results from ESTEEM 1 and ESTEEM 2
Kristina C. Duffin MD MS,a Kim A. Papp MD PhD,b Jerry Bagel MD,c Eugenia Levi PharmD BCPS,d Rongdean Chen PhD,d and Alice B. Gottlieb MD PhDe| |
J Drugs Dermatol. 2017;16(2):147-153.
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Xi Tan PharmD,a Steven R. Feldman MD PhD,b and Rajesh Balkrishnan PhDa| |
J Drugs Dermatol. 2013;12(3):e41-e45.
Treatment Patterns and Perceptions of Treatment Attributes, Satisfaction and Effectiveness Among Patients With Psoriasis
Marco daCosta DiBonaventura PhD, Samuel Wagner PhD RP, Heidi C. Waters MS, MBA, Chureen Carter PharmD, MS| |
Excimer Laser for Psoriasis: A Review of Theories Regarding Enhanced Efficacy Over Traditional UVB Phototherapy
Karine Zakarian MD, Alain Nguyen MD, Julie Letsinger MD, John Koo MD| |
Comparative Evaluation of Topical Calcipotriol Versus Coal Tar and Salicylic Acid Ointment in Chronic Plaque Psoriasis
Preeti Singh MD,a Surabhi Gupta MD,a Afroz Abidi MD,a and Arvind Krishna MDb| |
AIMS: To evaluate and compare the differences in terms of efficacy, safety and relapse with Calcipotriol 0.005% (50 mcg/gm) and 6% coal tar and 3% salicylic ointment in patients with Plaque psoriasis.
SETTING and DESIGNS: Study conducted on 60 patients of plaque psoriasis, who attended the skin OPD in our hospital.
METHODS: The patients with mild to moderate plaque psoriasis were selected. 60 patients were enrolled for the study after obtaining informed consent. Subjects were asked to apply Calcipotriol 0.005% (50 mcg/gm) (Heximar Win care) twice a day on the right side plaques and on left side plaques, Petroleum jelly (Vaseline) in the morning and 6% coal tar and 3% salicylic ointment (Protar® Percos) at nighttime. PASI score was used to assess the reponse to therapy at 2nd, 4th, 6th and 8th week. After treatment subjects were observed for 6 weeks for any relapse.
STATISTICAL ANALYSIS: It was done by paired t-test and independent sample t-test.
CONCLUSIONS: The results showed that statistically significant difference was seen in the mean percentage reduction of PASI score between both the groups, at all the assessment visits, 2, 4, 6, and 8 weeks, the mean percentage reduction at 2 weeks for calcipotriol being 21±12.06 and for coal tar being 13.44±11.19 (P=0.000), at 4 weeks for calcipotriol was 40±16.71 and for coal tar 25±99 (P=0.000), at 6 weeks for calcipotriol was 53.99+-22.43 and for coal tar 41±21.23 (P=0.002), at 8 weeks for calcipotriol was 62.73±24.04 and for coal tar was 51.53±23.27 (P=0.11). Relapse was seen in 5/60 (8.3%) of patients on calcipotriol treated side and 9/60 (15%) of patients with coal tar treated side. Thus it can be concluded that calcipotriol cream is more efficacious when compared with coal tar and does have a quick response. It is well tolerated and acceptable cosmetically.
J Drugs Dermatol. 2013;12(8):868-873.
Lower Socioeconomic Status is Associated With Decreased Therapeutic Response to the Biologic Agents in Psoriasis Patients
Eric P. Sorensen BS,ab Haitham Algzlan MD,a Shiu-chung Au MD,a Caren Garber BA,ac Kristina Fanucci BS,ac Michelle Bichchau Nguyen MD MPH,ac and Alice B. Gottlieb MD PhDac| |
OBJECTIVE: To examine the impact of individual socioeconomic status on systemic therapeutic outcomes amongst psoriasis patients.
METHODS: The study analyzed 156 psoriasis patients treated at the Tufts Medical Center Department of Dermatology from 2008-2014. Individual socioeconomic status was inferred from neighborhood income, defined as the percentage of households with income below the federal poverty line (% below FPL) in the patient’s census tract. The following outcomes were compared between socioeconomic groups: improvement in simple measure for assessing psoriasis activity (S-MAPA) score at 12 weeks, primary and secondary drug failure rates, and incidence of documented medication non-adherence.
RESULTS: Those patients living in relatively poorer neighborhoods (% below FPL ≤10%) experienced a significantly decreased improvement in S-MAPA score at 12 weeks of biologic treatment when compared to those in relatively richer neighborhoods (% below FPL >10%), 23.2% vs. 45.5%, P=0.021. Patients living in poorer neighborhoods also had a significantly higher rate of primary drug failure when treated with biologics (34.7% vs. 18.4%, P=0.039) and were significantly more likely to have ≥1 documented instance of medication non-adherence when treated with biologics (45.5% vs. 8.8%, P<0.001).
LIMITATIONS: Retrospective design, small sample size
CONCLUSIONS: Our study offers preliminary data that suggests lower socioeconomic status may be associated with decreased clinical response to the biologic agents, presumably through decreased medication adherence.
J Drugs Dermatol. 2016;15(2):147-153.
Tumor Necrosis Factor Inhibitor Primary Failure Predicts Decreased Ustekinumab Efficacy in Psoriasis Patients
Eric P. Sorensen BS,ab Kristina A. Fanucci BS,ac Ami Saraiya MD,a Eva Volf MD,a Shiu-chung Au MD,a Yahya Argobi MD,a Ryan Mansfield AS,a and Alice B. Gottlieb MD PhDa,c| |
OBJECTIVE: To examine the predictive effect of TNFi primary failure and the number of TNFi exposures on the efficacy of ustekinumab in psoriasis treatment.
METHODS: This retrospective study examined 44 psoriasis patients treated at the Tufts Medical Center Department of Dermatology between January 2008 and July 2014. Patients were selected if they were treated with ustekinumab and had ≥ 1 previous TNFi exposure. The following subgroups were compared: patients with vs without a previous TNFi primary failure, and patients with one vs multiple previous TNFi exposures. The efficacy measure used was the previously validated Simple Measure for Assessing Psoriasis Activity (S-MAPA), which is calculated by the product of the body surface area and physician global assessment. The primary outcome was the percentage improvement S-MAPA from course baseline at week 12 of ustekinumab treatment. Secondary outcomes were the psoriasis clearance, primary failure, and secondary failure rates with ustekinumab treatment.
RESULTS: Patients with a previous TNFi primary failure had a significantly lower percentage improvement in S-MAPA score at week 12 of ustekinumab treatment compared with patients without TNFi primary failure (36.2% vs 61.1%, P=.027). Multivariate analysis demonstrated that this relationship was independent of patient demographics and medical comorbidities. Patients with multiple TNFi exposures had a non-statistically significant lower percentage S-MAPA improvement at week 12 (40.5% vs 52.9%, P=.294) of ustekinumab treatment compared with patients with a single TNFi exposure.
CONCLUSIONS: Among psoriasis patients previously exposed to TNFi, a history of a previous TNFi primary failure predicts a decreased response to ustekinumab independent of patient demographics and medical comorbidities.
J Drugs Dermatol. 2015;14(8):893-898.
Calcipotriene Plus Betamethasone Dipropionate Topical Suspension for the Treatment of Mild to Moderate Psoriasis Vulgaris on the Body: A Randomized, Double-Blind, Vehicle-Controlled Trial
Alan Menter MD,a Linda Stein Gold MD,b Michael Bukhalo MD,c Steven Grekin DO,d Steven Kempers MD,e Brent M. Boyce MD,f Cecilia Ganslandt MD, gJohn Villumsen MSc,h and Mark Lebwohl MDi| |
Methods: This was a randomized, double-blind, vehicle-controlled, 4-arm trial in 1,152 subjects. The co-primary efficacy end points were the proportion of subjects achieving controlled disease based on the Investigators' Global Assessment of disease severity at weeks 4 and 8. Adverse events, vital signs, and clinical laboratory measurements were also assessed.
Results: At week 4, a greater proportion of subjects in the calcipotriene plus betamethasone group achieved controlled disease compared with subjects in the calcipotriene-only and vehicle-only treatment groups. At week 8, a statistically significantly (P<.01) greater proportion of subjects in the calcipotriene plus betamethasone group achieved controlled disease compared with subjects in the 3 other treatment groups. Adverse events and other safety assessments were similar between the groups.
Conclusion: The topical suspension containing calcipotriene plus betamethasone dipropionate traditionally used for scalp psoriasis is also a safe and effective once-daily treatment for psoriasis vulgaris on the body.
J Drugs Dermatol. 2013;12(1):92-98.
Richard G. Langley MD, Kenneth B. Gordon MD| |
Utilization of Narrow-Band Ultraviolet Light B Therapy and Etanercept for the Treatment of Psoriasis(UNITE): Efficacy, Safety, and Patient-Reported Outcomes
Leon Kircik MD, Jerry Bagel MD, Neil Korman MD PhD, Alan Menter MD, Craig A. Elmets MD,John Koo MD, Yu-Ching Yang PhD, Chiun-Fang Chiou PhD, Frank Dann MD, Seth R. Stevens MD| |
Objective: To evaluate the effectiveness, tolerability, and patient-reported outcomes of combination etanercept plus NB-UVB phototherapy in moderate to severe plaque psoriasis.
Methods: This 12-week, single-arm, open-label study evaluated the combination of etanercept 50 mg twice weekly and NB-UVB thrice weekly in 86 patients. The primary outcome measure was ≥75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75). Other measures included PASI 90, PASI 100, and the Dermatology Life Quality Index (DLQI).
Results: At week 12, 26.0% achieved PASI 100, 58.1% achieved PASI 90, and 84.9% of patients achieved PASI 75. Mean improvement from baseline in DLQI was 84.4%. No unexpected, untoward adverse events were noted.
Conclusions: A 12-week course of etanercept plus NB-UVB phototherapy was well tolerated and produced clinically meaningful improvements in signs and symptoms of moderate to severe plaque psoriasis and in patient-reported outcomes. Further investigation of the safety and efficacy of the use of such combination for this indication in controlled clinical trials would be of interest.
Two Multicenter, Randomized, Double-Blind, Parallel Group Comparison Studies of a Novel Enhanced Lotion Formulation of Halobetasol Propionate, 0.05% Versus Its Vehicle in Adult Subjects With Plaque Psoriasis
David Pariser MD,a Michael Bukhalo MD,b Scott Guenthner MD,c Steven Kempers MD,d Stephen Shideler MD,e Linda Stein Gold MD,f Eduardo Tschen MD MBA,g Jim Berg,h Mary Beth Ferdon PhD,h and Syd Dromgoole PhDh| |
BACKGROUND: A novel lotion formulation of halobetasol propionate, 0.05% (HBP Lotion) with enhanced vehicle characteristics of a cream while preserving the ease of use and cosmetic elegance of a lotion has been developed to treat plaque psoriasis. OBJECTIVE: Determine the safety and effectiveness of HBP Lotion in patients with plaque psoriasis. METHODS: Two prospective, randomized, vehicle-controlled clinical studies were conducted in 443 adult subjects with moderate-severe plaque psoriasis. Subjects applied the test article to psoriatic plaques within the treatment area twice daily for 14 days. Efficacy data are based upon treatment “success” defined as those subjects that achieved scores of 0=clear or 1=almost clear with at least a two-grade improvement relative to baseline for an Investigator’s Global Assessment (IGA) and clinical signs (plaque elevation, erythema, scaling). Safety data are presented as adverse events and local skin reactions. RESULTS: After two weeks of treatment with HBP Lotion, 44.5% of the HBP Lotion treated subjects in each study achieved (a) treatment “success” (ie, an IGA score of 0=clear or 1=almost clear and >2 grade improvement compared to baseline) and (b) a notable reduction in plaque elevation, erythema, scaling, and pruritus. In contrast, only 6.3% and 7.1% of VEH subjects in Studies 1 and 2, respectively, achieved treatment success and the reduction of disease related signs was materially lower. Statistically, at day 15 in both Phase 3 studies, treatment success with HBP Lotion was superior to VEH (P less than 0.001). From a safety perspective the outcomes were in general unremarkable with similar findings in the HBP Lotion and VEH treatment groups. CONCLUSIONS: The results demonstrate the safety and effectiveness of HBP Lotion in the treatment of plaque psoriasis. Furthermore, this novel HBP lotion formulation is also distinguished by its moisturization qualities and ease of use.
J Drugs Dermatol. 2017;16(3):234-240.
Subacute Annular Generalized Pustular Psoriasis Treated with Etanercept and Cyclosporine Combination
Francisco A. Kerdel BSc MBBS| |
A Double-Blind, Randomized Clinical Trial of 20% Alpha/Poly Hydroxy Acid Cream to Reduce Scaling of Lesions Associated With Moderate, Chronic Plaque Psoriasis
Kristie L. Akamine MD,a Cheryl J. Gustafson MD,a Brad A. Yentzer MD,a Brenda L. Edison BA,d Barbara A. Green RPh MS,d Scott A. Davis MA,a and Steven R. Feldman MD PhDa,b,c| |
PURPOSE: To evaluate the therapeutic efficacy of topical 20% alpha-hydroxy/polyhydroxy acid versus standard salicylic acid to reduce scaling in patients with moderate, chronic psoriasis.
METHODS: Twenty-five subjects with moderate, chronic psoriasis were enrolled in a 2-week, double-blind, left-right, randomized, bilateral comparison clinical trial to compare the efficacy of 20% alpha-hydroxy/polyhydroxy acid emollient versus 6% salicylic acid cream and 24 were randomized/completed. Clinical evaluations to assess the severity of psoriasis and scaling were performed using a 6-point scale prior to treatment, as well as following 1 and 2 weeks of therapy.
RESULTS: Twenty-four participants completed the study. Both 20% alpha-hydroxy/polyhydroxy acid emollient and 6% salicylic acid cream were efficacious in reducing scale of psoriatic lesions. The topical 20% alpha-hydroxy/polyhydroxyacid reduced scaling at a faster rate; however, following 2 weeks of treatment the efficacy of both products were relatively the same.
CONCLUSION: 20% alpha-hydroxy/polyhydroxyacid is as efficacious as salicylic acid in regards to the de-scaling of psoriatic plaques. Additionally, 20% alpha-hydroxy/polyhydroxyacid cream may yield quicker results and less toxicity than salicylic acid.
J Drugs Dermatol. 2013;12(8):855-859.
Treatment of Moderate to Severe Plaque Psoriasis With Concomitant Efalizumab and Narrow-Band Ultraviolet B Phototherapy
Leon H. Kircik MD, Clive Liu MD, Bernard S. Goffe MD| |
Methods: This study investigated the efﬁ cacy and safety of efalizumab (1 mg/kg/wk) combined with NB-UVB 3 times a week for 12 weeks, followed by efalizumab monotherapy for 12 additional weeks.
Results: Twenty patients were enrolled with mean Psoriasis Area and Severity Index (PASI) of 12.8±7.4, mean physician’s global assessment (PGA) of 5±1, and mean body surface area (BSA) affected of 18.2%±15.3% at baseline. At week 12, 65% of patients (n=13) achieved PASI 75; mean PGA was 2±1, corresponding to a 60% reduction; and mean BSA was 4.7%±4.1%, corresponding to a 74% reduction. The improvements seen at week 12 were maintained during the ensuing efalizumab monotherapy.
Conclusion: Combination of efalizumab and NB-UVB followed by efalizumab monotherapy was effective and well tolerated, this warranting further investigation.
Satya Bommakanti MD, Amol Patil MD, Camellia Eshoa MD, Christopher R. Chitambar MD| |
Evidence Based or Theoretical Concern? The Alleged Acitretin Side Effects of Pseudotumor Cerebri and Depression
John Starling III BA, John Koo MD| |
Paola Machado Gomes Esteves MD, Marcella Gramigna Magalhaes Barbalho MD, Julia Gomes Cortes MD, Tullia Cuzzi MD PhD, Celso Tavares Sodré MD, and Marcia Ramos-e-Silva MD PhD| |
J Drugs Dermatol. 2015;14(10):1152-1154.
Leon H. Kircik MD, Neh Onumah MD, Joshua A. Zeichner MD, Elena Sotiriou MD PhD, Christina Goussi MD, Aimilios Lallas MD, Eleni Chovarda MD, Zoe Apalla MD, Elisabeth Lazaridou MD PhD, Demetris Ioannides MD PhD| |
Efficacy and Safety of Toreforant, a Selective Histamine H4 Receptor Antagonist, for the Treatment of Moderate-to-Severe Plaque Psoriasis: Results from a Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Ellen Frankel MD,a Michael Song MD,b Shu Li PhD,b Jingzhi Jiang MS,b Robin L. Thurmond PhD,c Bruce Randazzo MD PhDc,d| |
Tejaswi Mudigonda BS, Tushar S. Dabade MD, Steven R. Feldman MD PhD| |
Background: 308 nm excimer laser phototherapy is efficacious in the treatment of localized psoriasis. Different approaches regarding
dose fluency, number of treatments, and maintenance have been utilized, and there is yet to be a consensus on standard protocol.
Objective: To characterize treatment parameters for 308 nm excimer laser phototherapy.
Methods: We performed a PubMed search for studies describing excimer laser treatment protocol with particular attention to dosage determination, dose adjustment, dose fluency, number of treatments, and maintenance.
Results: Seven prospective studies were found describing the excimer efficacy for psoriasis. All studies determined the initial treatment dose using either the minimal erythema dose (MED) or induration. Fluency ranged from 0.5 MED (low) to 16 MED (high); one study demon- strated that medium to high fluencies yielded better improvement in fewer number of treatments. Fluency adjustments during the course of treatment were important to minimize phototherapy-associated side effects. The use of higher fluencies was reported to result in higher occurrences of blistering. One study implemented a maintenance tapering of dose-frequency phase to better manage psoriasis flare-ups.
Conclusion: The 308 nm excimer laser is an effective therapy for psoriasis regardless of the method used to determine initial dosage, dose fluency, or number of treatments. As its usage as a targeted monotherapy increases, future trials should consider evaluating and modifying these parameters to determine the most optimal management of localized psoriasis. Based on our reviewed studies, there is no consensus for a single excimer laser therapy protocol and as a result, patient preferences should continue to be an important consid- eration for phototherapy regimen planning.
J Drugs Dermatol. 2012;11(1):92-97.
Avnee Shah BS, Jenna ONeill MD, Steven R. Feldman MD PhD| |
Efficacy and Safety of Apremilast in Systemic- and Biologic-Naive Patients With Moderate Plaque Psoriasis: 52-Week Results of UNVEIL
Linda Stein Gold MD,a Jerry Bagel MD,b Mark Lebwohl MD,c J. Mark Jackson MD,d Rongdean Chen PhD,e Joana Goncalves MD,e Eugenia Levi PharmD,e Kristina Callis Duffin MD MSf| |
BACKGROUND: Many patients with moderate plaque psoriasis are undertreated despite broadening treatment options. In the phase IV UNVEIL study, oral apremilast demonstrated efficacy and safety in systemic-naive patients with chronic moderate plaque psoriasis with lower psoriasis-involved body surface area (BSA; 5%–10%) during the 16-week, double-blind, placebo-controlled phase. We describe efficacy and safety of apremilast in this population through week 52 in UNVEIL.
METHODS: Patients with moderate plaque psoriasis (BSA 5%–10%; static Physician’s Global Assessment [sPGA] score of 3 [moderate]) and naive to systemic therapies for psoriasis were randomized (2:1) to receive apremilast 30 mg twice daily or placebo for 16 weeks. At week 16, patients continued on apremilast (apremilast/apremilast) or were switched from placebo to apremilast (placebo/apremilast) through week 52 (open-label apremilast treatment phase). Efficacy assessments included the product of sPGA and BSA (PGAxBSA) (mean percentage change from baseline; ≥75% reduction from baseline [PGAxBSA-75]), sPGA response (achievement of score of 0 [clear] or 1 [almost clear]), and the Dermatology Life Quality Index (DLQI; mean change from baseline).
RESULTS: A total of 136 patients completed the 52-week analysis period (placebo/apremilast, n=50/64; apremilast/apremilast, n=86/121). At week 52, improvements in all efficacy end points observed at week 16 were maintained in the apremilast/apremilast group (mean percentage change from baseline in PGAxBSA: −55.5%; PGAxBSA-75: 42.1%; sPGA response: 33.1%; mean change from baseline in DLQI score: −4.4); similar improvements emerged in the placebo/apremilast group after switching to apremilast. The most common adverse events (≥5% of patients) through week 52 were diarrhea (28.0%), nausea (19.0%), headache (15.2%), nasopharyngitis (10.4%), upper respiratory tract infection (7.1%), vomiting (5.7%), and decreased appetite (5.2%).
CONCLUSIONS: Apremilast was effective in systemic-naive patients with moderate plaque psoriasis with BSA 5%–10%; efficacy was sustained through week 52. No new safety signals emerged with continued apremilast exposure.
J Drugs Dermatol. 2018;17(2):221-228.
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Lilia M. Correa-Selm MD,a Mahin Alamgir MD,b Babar K. Rao MDc| |
Over a decade ago, the FDA approved biologics for psoriasis, which changed how the disease is treated and, in most cases, has a significant positive impact on the lives of patients. Side effects primarily identified during the investigational and research phase led to the development of specific guidelines for treatment. The treatment guidelines have been amended to incorporate better understandings of side-effects over the years that the disease has been treated. In this study, we focused on a chart review that included assessing the current guidelines and their alignment with modern patient management and the recent side effects presented. This life-cycle evaluation included over 100 patients, management of their treatment, laboratory abnormalities, criteria for choosing or changing to a different biologic, and the effects of the treatments management throughout the years. The review identified some recommended changes in the application and treatment of psoriasis with biologics. To further evidence our findings, we hope to expand this study to a larger scale with more patients.
J Drugs Dermatol. 2017;16(3):215-217.
Joanna L. Chan MD, Michael S. Graves BS, Clay J. Cockerell MD, Amit G. Pandya MD| |
Peter W. Hashim MD MHS,a Tinley Chen BA,a Mark G. Lebwohl MD,a Lauren B. Marangell MD,d Leon H. Kircik MDa,b,c| |
Efficacy of Tofacitinib, an Oral Janus Kinase Inhibitor, on Clinical Signs of Moderate-to-Severe Plaque Psoriasis in Different Body Regions
Alan Menter MD,a Kim A. Papp MD PhD FRCPC,b Huaming Tan PhD,c Steve Tyring MD PhD,dRobert Wolk MD PhD DSc,c and Marjorie Buonanno MSN RNc| |
METHODS: This exploratory analysis of a Phase IIb, 12-week, dose-ranging study (clinicaltrials.gov identifier: NCT00678210) evaluated tofacitinib efficacy in four body regions of patients with moderate-to-severe chronic plaque psoriasis. Patients (n=197) were randomized to tofacitinib 2, 5, or 15 mg, or placebo, twice daily (BID). Psoriasis Area and Severity Index (PASI) score, body surface area values and change from baseline to week 12 were measured according to body region (head/neck, upper limbs, trunk and lower limbs). Change in Target Plaque Severity Score (TPSS) from baseline to week 12 was measured according to typically responsive as well as non-responsive treatment areas.
RESULTS: At week 12, mean improvements in PASI and body surface area values were significantly greater with tofacitinib doses vs placebo across all four body regions measured (P<0.0001). TPSS in responsive areas decreased (improved) with tofacitinib 2, 5, and 15 mg BID vs placebo: -4.35, -4.79 and -6.32, vs -2.06, respectively (P<0.0001). In non-responsive areas, TPSS decreased with tofacitinib 2, 5, and 15 mg BID vs placebo: -3.74, -4.60 and -6.15, vs -2.23, respectively (P<0.01).
CONCLUSION: Short-term (12-week) treatment with oral tofacitinib produced clinical improvement across all body regions assessed in patients with moderate-to-severe plaque psoriasis, including areas typically non-responsive to treatment.
J Drugs Dermatol. 2014;13(3):252-256.
Understanding the Relationship Between Pruritus Severity and Work Productivity in Patients With Moderate-to-Severe Psoriasis: Sleep Problems Are a Mediating Factor
A.B. Kimball MD MPH,a E. Edson-Heredia MPH,b B. Zhu PHD,b J. Guo MS,b T. Maeda-Chubachi MD PHD,b W. Shen PHD,b and M.T. Bianchi MD PHDa| |
OBJECTIVE: This study evaluated associations between pruritus and work productivity, and the role of sleep problems as a possible mediator of the relationship between the two.
METHODS AND MATERIALS: Data from a pruritus visual analog scale (Itch VAS), the Medical Outcomes Study Sleep Scale (MOS-SS), and the Work Productivity and Activity Impairment Questionnaire (WPAI) were collected in a phase 2 clinical trial in patients with psoriasis treated with ixekizumab or placebo. Mediating effects of sleep were tested in multiple regressions with pruritus severity (independent variable) and work productivity (dependent variable). Sobel tests evaluated the significance of sleep’s effect.
RESULTS: Several MOS-SS domains were significantly associated with the WPAI presenteeism, work productivity, and activity impairment scores, and decreased the effect of pruritus. Sobel tests indicated that the Sleep Problems Index I had a significant effect (P<.05) in mediating the relationship between pruritus and presenteeism, work productivity, and activity impairment.
CONCLUSION: Sleep may mediate the role of pruritus on work productivity, but both factors appear to have independent negative effects on work.
J Drugs Dermatol. 2016;15(2):183-188.
The Biological Rationale for Use of Vitamin D Analogs in Combination With Corticosteroids for the Topical Treatment of Plaque Psoriasis
Siegfried Segaert MD PhDa and Mads Røpke PhDb| |
J Drugs Dermatol. 2013;12(8):e129-e137.
Steven R. Feldman MD PhD| |
Mingliang Zhang PhD,a Chureen Carter PharmD MS,a William H. Olson PhD,b Michael P. Johnson MS,c Susan K. Brenneman PT PhD,c Seina Lee PharmD MS,d Kamyar Farahi PhDe| |
J Drugs Dermatol. 2017;16(3):220-226.
Evaluation of Risk of Major Adverse Cardiovascular Events With Biologic Therapy in Patients With Psoriasis
Robert Bissonnette MD,a Francisco Kerdel MD,b Luigi Naldi MD,c Kim Papp MD,d Claudia Galindo MD,e Wayne Langholff PhD,f K. L. Tang PhD,f Philippe Szapary MD MSCE,f Steven Fakharzadeh MD PhD,e Bhaskar Srivastava MD PhD,e Kavitha Goyal MD,e and Alice B. Gottlieb MD PhDg| |
J Drugs Dermatol. 2017;16 (10):1002-1013.
Safety and Efficacy of a Fixed Combination Halobetasol and Tazarotene Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: A Pooled Analysis of Two Phase 3 Studies
Jeffrey L. Sugarman MD PhD,a Jonathan Weiss MD,b Emil A. Tanghetti MD,c Jerry Bagel MD,d Paul S. Yamauchi MD,e Linda Stein Gold MD,f Tina Lin, PharmD,g Gina Martin MOT,h Radhakrishnan Pillai PhD,h Robert Israel MDi| |
Leon H. Kircik MD and James Q. Del Rosso DO| |
Introduction: Psoriasis is one of several systemic diseases that presents chiefly with cutaneous symptoms and has the potential to negatively impact patients' overall health and quality of life. Physicians who treat patients with psoriasis must be cognizant of the chronic, lifelong character of the disease and of the potential for multisystem pathology. According to the National Institutes of Health (NIH), between 5.8 and 7.5 million persons in the U.S.-approximately 2.2% of the population-have psoriasis; worldwide, it affects an estimated 125 million people. The annual cost of treating psoriasis may exceed $3 billion annually. Immunologic mechanisms are now accepted as the pathophysiologic basis for the development of psoriatic disease. Treatment strategies-which include topical treatment, phototherapy, methtrexate, cyclosporine and acitretin-also encompass several biologic agents that target immune mediators associated with the condition.
Discussion: Patients with mild disease may obtain symptomatic relief with topical agents and targeted phototherapy. Patients with moderate-to-severe disease are likely to benefit from systemic therapy. Shortcomings of the traditional agents, particularly their adverse event profiles, have motivated research and development of biologic agents. Currently three anti-TNF agents - etanercept, infliximab and adalimumab - are FDA-approved for treatment of psoriasis. Differences exist among study designs and, therefore, in interpretation of data; however, the improvements observed in the psoriasis study populations participating in clinical trials are dramatic. Long-term clinical data continue to accumulate and demonstrate sustained benefits with anti-TNF agents. Safety data also continue to be collected over the long-term; key safety considerations are infection, cytopenia, demyelinating disease, lupus-like syndromes, congestive heart failure and malignancies. Combination therapy should also be considered when managing psoriasis for such reasons as augmenting an inadequate response to monotherapy or improving tolerability. Combination therapy with an anti-TNF agent and phototherapy has shown considerably higher rates of response compared with either intervention alone.
Objective: The objective of this paper is to critically examine the anti-TNF studies to assess the efficacy and safety of the agents in patients with psoriasis and determine applicability of the data in clinical practice. In light of the chronic nature of this disease, the emphasis will be on the longest-term data available.
Conclusion: The treatment of plaque psoriasis with TNF-α antagonists is still a relatively recent addition to the pharmacologic armamentarium available to clinicians. The collection of long-term data is, therefore, small but growing as results from newer studies emerge. From the data reviewed here, the clinician can attempt to arrive at a satisfactory assessment of the benefits and risks of treatment with these agents.
A Comparative Study to Evaluate Epidermal Barrier Integrity of Psoriasis Patients Treated With Calcipotriene/Betamethasone Topical Suspension Versus Betamethasone Dipropionate 0.05% Lotion
Peter W. Hashim MD MHS,a John K. Nia MD,a David Terrano MD,a Gary Goldenberg MD,a and Leon H. Kircik MDa,b,c| |
BACKGROUND: Topical corticosteroids are known to impair the epidermal barrier, even after short-term use, whereas topical vitamin D analogues can have a reparative effect. Combination products using corticosteroids and vitamin D analogues have gained popularity in recent years and may provide a means to minimize skin atrophy in patients treated with topical corticosteroids.
OBJECTIVE: To compare epidermal barrier function and cutaneous atrophy after 4 weeks of calcipotriene 0.005% and betamethasone dipropionate 0.064% topical suspension (Taclonex® TS) versus betamethasone dipropionate 0.05% lotion (Diprosone®).
METHODS: Ten subjects with moderate plaque psoriasis were enrolled. Patients were randomized to apply calcipotriene 0.005%/betamethasone dipropionate 0.064% once daily to psoriasis plaques on one side of the body and betamethasone dipropionate 0.05% lotion twice daily to plaques on the other side. Biopsies were performed at baseline and after four weeks of treatment to evaluate for epidermal and dermal changes.
RESULTS: Treatment with betamethasone lotion resulted in significant decreases in epidermal thickness and dermal thickness. In contrast, treatment with calcipotriene/betamethasone did not lead to significant decreases in epidermal thickness or dermal thickness. Comparing betamethasone and calcipotriene/betamethasone, there was a significantly greater reduction in epidermal thickness with betamethasone lotion versus calcipotriene/betamethasone (P less than .0001). Relative differences in dermal thickness and transepidermal water loss (TEWL) did not reach statistical significance.
CONCLUSION: This study is the first to demonstrate that treatment of plaque psoriasis with a combination topical corticosteriod and calcipotriene product results in greater preservation of the skin layers relative to topical corticosteroid use alone. These results hold important ramifications for minimizing cutaneous atrophy in patients receiving treatment with topical corticosteroids.
J Drugs Dermatol. 2017;16(8):747-752.
Association Between the Type and Length of Tumor Necrosis Factor Inhibitor Therapy and Myocardial Infarction Risk in Patients With Psoriasis
Jashin J. Wu MD,a Kwun-Yee T. Poon MS,b and Judith D. Bebchuk ScDb| |
DESIGN: Retrospective cohort study
SETTING: Between January 1, 2004 and November 30, 2010
PARTICIPANTS: At least 3 ICD9 codes for psoriasis (696.1) or psoriatic arthritis (696.0) (without antecedent MI).
MAIN OUTCOME MEASURE: Incident MI
RESULTS: In the 3 subgroups of TNF inhibitors, 976 received etanercept; 217 received monoclonal antibody; and 480 received etanercept or monoclonal antibody, in addition, 5075 received topical therapy and 2097 received oral therapy. In the Cox proportional hazards analysis, etanercept (HR, 0.53; 95% CI, 0.31-0.92) was associated with a significant reduction of MI risk, compared to topical agents and, monoclonal antibody only (HR, 0.25; 95% CI, 0.06-1.03), and etanercept or monoclonal antibody (HR, 0.53; 95% CI, 0.27-1.06) were associated with a non-significant reduction of MI risk compared to topical agents. Using year 1 as reference, those who received TNF inhibitor therapy at year 2 (HR, 1.15; 95% CI, 0.30-4.44), at year 3 (HR, 1.89; 95% CI, 0.64-5.58), and at year 4 and above (HR, 1.16; 95% CI, 0.46-2.94) had a non-significant increase of MI risk.
CONCLUSIONS: Treatment with etanercept, compared to treatment with topical agents, was associated with a significant decreased risk of MI in psoriasis patients. Treatment with monoclonal antibody and etanercept or monoclonal antibody, compared to treatment with topical agents, was associated with a non-significant decreased risk of MI risk in psoriasis patients. There were no statistically significant changes in risk of MI associated with length of TNF inhibitor treatment.
J Drugs Dermatol. 2013;12(8):899-903.
Effect of Calcipotriene Plus Betamethasone Dipropionate Topical Suspension on the Hypothalamic-Pituitary-Adrenal Axis and Calcium Homeostasis in Subjects With Extensive Psoriasis Vulgaris: An Open, Non-Controlled, 8-week Trial
Shane Silver MD,a Raj Tuppal MD,b Aditya K Gupta MD,c Fabrice Clonier MSc,d
Martin Olesen MD,e Randy Leeder PhD,e and Victoria Taraska MDf
OBJECTIVE: To evaluate the systemic effects of once-daily use of two-compound topical suspension/gel on the hypothalamic-pituitary-adrenal (HPA) axis and calcium homeostasis in subjects with extensive psoriasis vulgaris.
METHODS: An open-label, single-group, 8-week trial in 43 subjects with extensive psoriasis covering 15–30% of the body surface area. Blood and 24-hour urine samples were collected and a standard-dose adrenocorticotropic hormone (ACTH) stimulation test was performed at baseline, weeks 4 and 8. Primary endpoints were serum cortisol 30 minutes after ACTH injection (HPA axis response abnormal at serum cortisol ≤18 μg/dL) and changes from baseline in albumin-corrected serum calcium (sCa), 24-hour urinary calcium excretion (24hCa) and urine calcium:creatinine ratio (Ca:Crea).
RESULTS: Two (4.7%) subjects showed signs of adrenal suppression based on the ACTH stimulation test results at week 4; both were withdrawn from treatment and had normal serum cortisol 30-minute values at follow-up 4 weeks later. None of the subjects who continued treatment to week 8 showed signs of adrenal suppression. There were no clinically relevant mean changes from baseline to weeks 4 and 8 in sCa, 24hCa or Ca:Crea and no subject had sCa above the reference range.
CONCLUSION: The two-compound topical suspension/gel containing calcipotriene plus betamethasone dipropionate may be applied once daily to extensive psoriasis vulgaris without generally causing adrenal suppression or disturbance of calcium homeostasis, consistent with previous findings. In a small number of patients with extensive psoriasis treated with large volumes of topical suspension, adrenal suppression may be observed. In the real-world setting, it is anticipated that systemic side-effects would occur in only a few cases within the general psoriasis patient population.
J Drugs Dermatol. 2013;12(8):882-887.
ClinicalTrials.gov Identifier: NCT 01229098
Short-Term Safety Assessment of Clobetasol Propionate 0.05% Shampoo: Hypothalamic–Pituitary–Adrenal Axis Suppression, Atrophogenicity, and Ocular Safety in Subjects with Scalp Psoriasis
Philippe Andres MD, Michel Poncet MS, Farzaneh Sidou MS, Pascale Soto Pharm D| |
A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of a Halobetasol/Tazarotene Fixed Combination in the Treatment of Plaque Psoriasis
Jeffrey L. Sugarman MD PhD,a Linda Stein Gold MD,b Mark G. Lebwohl MD,c David M. Pariser MD,d Binu J. Alexander MD,e and Radhakrishnan Pillai PhDf| |
BACKGROUND: Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression. Treatment options focus on relieving symptoms, reducing inflammation, induration, and scaling, and controlling the extent of the disease. Topical corticosteroids are the mainstay of treatment, however long-term safety remains a concern, particularly with the more potent formulations. Combination therapy with a corticosteroid and tazarotene may improve psoriasis signs at a lower corticosteroid concentration providing a superior safety profile. OBJECTIVE: To investigate the efficacy and safety of a once-daily application of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) lotion in comparison with its monads and vehicle in subjects with moderate-to-severe plaque psoriasis. METHODS: Multicenter, randomized, double-blind, vehicle-controlled Phase 2 study in moderate or severe psoriasis (N=212). Subjects randomized (2:2:2:1 ratio) to receive HP/TAZ, individual monads, or vehicle, once-daily for 8 weeks. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline in the IGA score and a score of ‘Clear’ or 'Almost Clear'), and impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at the target lesion. Safety and treatment emergent adverse events (TEAEs) were evaluated throughout. RESULTS: HP/TAZ lotion demonstrated statistically significant superiority over vehicle as early as 2 weeks. At week 8, 52.5% of subjects had treatment success compared with 33.3%, 18.6%, and 9.7% in the HP (P=0.033), TAZ (P less than 0.001), and vehicle (P less than 0.001) groups, respectively. HP/TAZ lotion was superior to its monads and vehicle in reducing the psoriasis signs of erythema, plaque elevation, and scaling at the target lesion. At week 8, a 2-grade improvement in IGA was achieved by 54.2% of subjects for erythema, 67.8% for plaque elevation, and 64.4% for scaling. Most frequently reported TEAEs were application site reactions, and were more likely associated with the tazarotene component. Side effects such as skin atrophy were rare. CONCLUSIONS: HP/TAZ lotion was consistently more effective than its monads or vehicle in achieving treatment success and reducing psoriasis signs of erythema, plaque elevation, and scaling at the target lesion. Safety data were consistent with the known safety profile of halobetasol propionate and tazarotene, and did not reveal any new safety concerns with the combination product.
J Drugs Dermatol. 2017;16(3):197-204.
Efficacy and Safety of Apremilast in Patients With Moderate Plaque Psoriasis With Lower BSA: Week 16 Results from the UNVEIL Study
Bruce Strober MD PhD,a Jerry Bagel MD,b Mark Lebwohl MD,c Linda Stein Gold MD,d J. Mark Jackson MD,e Rongdean Chen PhD,f* Joana Goncalves MD,f Eugenia Levi PharmD,f and Kristina Callis Duffin MD MSg| |
INTRODUCTION: Many options are available for patients with moderate to severe plaque psoriasis. Patients with moderate disease, however, are often undertreated and do not achieve satisfactory clearance. UNVEIL (NCT02425826) assessed efficacy and safety of apremilast in patients with chronic moderate plaque psoriasis.
METHODS: Patients with psoriasis body surface area (BSA) 5% to 10% and static Physician’s Global Assessment (sPGA) score of 3 (moderate) without prior exposure to systemics were randomized (2:1) to apremilast 30 mg twice daily or placebo for 16 weeks. The primary efficacy endpoint was mean percentage change in the product of sPGA and BSA scores (PGAxBSA).
RESULTS: Of 221 patients (placebo, n=73; apremilast, n=148), >80% had received prior topical therapy. At week 16, apremilast yielded a significantly greater percentage change from baseline in PGAxBSA (−48.1%) vs placebo (−10.2^; P less than 0.0001). Dermatology Life Quality Index scores were significantly improved with apremilast (−4.8) vs placebo (−2.4; P=0.0008). Mean improvements in the Treatment Satisfaction Questionnaire for Medication, version II, were greater with apremilast vs placebo for global satisfaction (63.2 vs 48.7; P less than 0.0001) and treatment effectiveness (57.3 vs 38.8; P less than 0.0001). Most adverse events were mild or moderate; most common were diarrhea, headache, nausea, upper respiratory tract infection, decreased appetite, and vomiting.
CONCLUSION: Apremilast was effective and well tolerated, significantly improved quality of life, and was associated with high patient satisfaction in systemic-naive, post-topical patients with moderate plaque psoriasis.
J Drugs Dermatol. 2017;16(8):801-808.
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Steven R. Feldman MD PhD| |
Shailendra Kapoor MD| |
Mona Sadeghpour MD, Kristen LoSicco MD, Laura K. Ferris MD PhD| |
Calcitriol 3µg/g Ointment in the Management of Mild to Moderate Plaque Type Psoriasis: Results from 2 Placebo-Controlled, Multicenter, Randomized Double-Blind, Clinical Studies
Mark Lebwohl MD, Alan Menter MD, Jonathan Weiss MD, Scott D. Clark MD, Javier Flores MD, Jerold Powers MD, Arthur K. Balin MD, Steven Kempers MD, Robert J. Glinert MD, Thomas Fleming MD, Yin Liu PhD, Michael Graeber MD, David M. Pariser MD| |
Safety Surveillance for Ustekinumab and Other Psoriasis Treatments From the Psoriasis Longitudinal Assessment and Registry (PSOLAR)
Kim Papp MD PhD,a Alice B. Gottlieb MD PhD,b Luigi Naldi MD,c David Pariser MD,d Vincent Ho MD,
e Kavitha Goyal MD,f Steven Fakharzadeh MD PhD,f Marc Chevrier MD PhD,g Stephen Calabro MS,f
Wayne Langholff PhD,g and Gerald Krueger MDh
OBJECTIVE: To assess the risk of adverse events of special interest (AEoSIs) with ustekinumab and other psoriasis treatments in a real-world setting using 2014 Psoriasis Longitudinal Assessment and Registry (PSOLAR) data. AEoSIs included malignancy (excluding nonmelanoma skin cancer), major adverse cardiovascular events (MACE), serious infection, and all-cause mortality.
METHODS: Cumulative rates of AEoSIs/100 patient-years (PY) are reported for ustekinumab, infliximab, other biologics (mostly adalimumab/etanercept), and non-biologics based on pre-specified analyses using attribution rules biased against ustekinumab. Risk factors for AEoSIs, including treatments, were determined using multivariate statistical analysis.
RESULTS: A total of 12,093 patients (40,388 PY) were enrolled in PSOLAR. Overall incidence rates were 0.68/100PY for malignancy, 0.33/100PY for MACE, 1.60/100PY for serious infection, and 0.46/100PY for mortality. Unadjusted rates of serious infection for infliximab (2.91/100PY) and other biologics (1.91/100PY) were numerically higher compared with ustekinumab (0.93/100PY). Exposure to the combined group of biologics other than ustekinumab was significantly associated with serious infection (hazard ratio=1.96, P<.001). None of the biologics was associated with increased risk of malignancy, MACE, or mortality.
LIMITATIONS: Observational data have inherent biases.
CONCLUSION: Analysis of 2014 PSOLAR data identified no increased risk of malignancy, MACE, serious infection, or mortality with ustekinumab.
J Drugs Dermatol. 2015;14(7):706-714.
Biologic and Conventional Systemic Therapies Show Similar Safety and Efficacy in Elderly and Adult Patients With Moderate to Severe Psoriasis
Caren Garber BA,a,b Natalia Plotnikova MD,a Shiu-chung Au MD,a Eric P Sorensen BS,a Alice Gottlieb MD PhDa,b| |
METHODS: All patient visits coded for psoriasis or psoriatic arthritis (ICD-9 696.1 or 696.0) at the Tufts Medical Center General Dermatology Clinic from January 1, 2008, to March 1, 2015 were included in this retrospective cohort study. The outcome measure used was the validated simple-measure for assessing psoriasis activity (S-MAPA), the product of the physician’s global assessment and the body surface area.
RESULTS: 194 patients who underwent 278 treatment courses were included in the study. 48 patients were included in the elderly cohort (≥ 65 years old) and 146 in the adult cohort (18-64 years old). There was no significant difference in S-MAPA improvement at 12 weeks between the two cohorts when treated with biologics (42.92% improvement in adults, 48.77% in elderly; P=0.498) or conventional systemics (43.96% and 51.82%, respectively; P=0.448). Within the elderly cohort, there was no significant difference in efficacy of biologics versus conventional systemics at any time point. Topical prescription rates were significantly higher in the elderly cohort (P=0.004) while biologic prescription rates were significantly lower (P=0.014) despite the same baseline S-MAPA in both age groups. For both biologics and conventional systemics, there was no statistically significant intergroup difference in the rate of adverse events (P=0.322 for biologics; P=0.581 for conventional systemics) or infection (P=0.753 for biologics; P=0.828 for conventional systemics). Within the elderly cohort, there was a higher rate of adverse events with conventional systemic treatment than with biologic treatment (P=0.033).
CONCLUSIONS: This study provides preliminary evidence to suggest that biologic and conventional systemic therapies are similarly safe and effective in the elderly and nonelderly cohorts. Within the elderly population, biologics may be a safer option than conventional systemic agents.
J Drugs Dermatol. 2015;14(8):846-852.
Daniel Opel MA,a Afrodite Economidi MD,b Daphne Chan PhD,c Yasmine Wasfi MD PhD,cSameer Mistry BSc MB ChB MRCS,d Theognosia Vergou MD,b Christina Antoniou MD PhD,band Howard Sofen MDe
aLoyola University Chicago Stritch School of Medicine, Chicago, IL bPsoriasis Clinic, Department of Dermatology, University of Athens, A. Sygros Hospital, Athens, Greece cDepartment of Immunology, Janssen Research & Development, LLC, Spring House, PA dDepartment of Medical A7airs, Janssen-Cilag Ltd, Buckinghamshire, UK eDermatology Research Associates, Los Angeles, CA
Objective: To report the first known cases of acute HBV infection in 2 ustekinumab-treated patients with psoriasis from a phase 3 (PHOENIX 1) and a phase 4 (TRANSIT) study.
Results: Both ustekinumab-treated patients generated an immune response toward HBV and experienced typical courses of infection, without progression to chronic HBV infection.
Conclusion: Continued monitoring of liver-related adverse events in clinical trials, registries, and spontaneous reporting from the postmarketing setting will further contribute to understanding the role of ustekinumab in viral hepatitis.
J Drugs Dermatol. 2012;11(12):1498-1501.
Efficacy of Adalimumab Compared With Methotrexate or Placebo Stratified by Baseline BMI in a Randomized Placebo-Controlled Trial in Patients With Psoriasis
Ronald Prussick MD,a Kristina Unnebrink PhD,b Wendell C. Valdecantos MDc| |
METHODS: PASI responses and Dermatology Life Quality Index (DLQI) scores through 16 weeks of treatment were examined by baseline BMI category (<25 kg/m2 [normal], 25 to <30 kg/m2 [overweight], and ≥30 kg/m2 [obese]) in patients with psoriasis with a baseline PASI total score ≥12. Treatment differences between the adalimumab and the methotrexate or placebo groups were compared using Fisher’s exact test for PASI responses and 1-way analysis of variance for DLQI scores.
RESULTS: In all BMI categories, adalimumab treatment led to significantly greater rates of PASI75/90 responses at weeks 12 and 16 compared with methotrexate or placebo (P<0.05 for all). In normal weight, overweight, and obese patients at week 16, the respective PASI75 response rates were 85.0%, 85.7%, and 61.3% with adalimumab; 43.3%, 29.3%, and 26.1% with methotrexate; and 28.6%, 16.7%, and 0% with placebo. PASI90 response rates were 70.0%, 53.6%, and 35.5% with adalimumab; 26.7%, 7.3%, and 8.7% with methotrexate; and 9.5%, 16.7%, and 0% with placebo. Across all BMI subgroups, the greatest decreases in DLQI scores from baseline occurred in the adalimumab group.
CONCLUSION: Significantly higher PASI75/90 response rates and more pronounced improvements in DLQI scores at week 16 were identified in patients treated with adalimumab, compared with methotrexate or placebo, regardless of baseline BMI category.
J Drugs Dermatol. 2015;14(8):864-868.
Aerosol Foam Formulation of Fixed Combination Calcipotriene Plus Betamethasone Dipropionate is Highly Efficacious in Patients With Psoriasis Vulgaris: Pooled Data From Three Randomized Controlled Studies
Linda Stein Gold MD,a Mark Lebwohl MD,b Alan Menter MD,c John Villumsen MSc,d Monika Rosen PhD,d and John Koo MDe| |
METHODS: Patients aged ≥18 years with mild–severe psoriasis were enrolled into three Phase II/III studies (nCT01536886, nCT01536938, nCT01866163); each study evaluated Cal/BD aerosol foam versus different comparators. Endpoints included: proportion of patients clear/almost clear with ≥2-step improvement in physician's global assessment of disease severity (‘treatment success’); modified (excluding head) psoriasis area and severity index (mPASI); proportion of patients with ≥75% reduction in mPASI (PASI75); change in itch (according to visual analog scale [VAS]).
RESULTS: 1104 patients were included in the pooled analysis: Cal/BD aerosol foam (n=564), Cal/BD ointment (n=135), BD aerosol foam (n=101), Cal aerosol foam (n=101), aerosol foam vehicle (n=152), ointment vehicle (n=51). At week 4, 51% of Cal/BD aerosol foam patients achieved treatment success, a higher proportion than in all other groups (Cal/BD ointment, 43%; BD aerosol foam, 31%; Cal aerosol foam, 15%; aerosol foam vehicle, 5%; ointment vehicle, 8%). Greater percentage mean decrease in mPASI with Cal/BD aerosol foam was noted versus other treatments at week 4 (72% vs 63%, 53%, 43%, 32%, and 33%, respectively); week 4 PASI75 rate was also greater (51% vs 41%, 34%, 18%, 7%, and 10%, respectively). Cal/BD aerosol foam was efficacious irrespective of baseline disease severity and on all body areas assessed (arms, legs, trunk). Cal/BD aerosol foam alleviated itch as early as week 1 (change in itch VAS: –30 mm), maintained to week 4 (change in itch VAS: –41 mm).
CONCLUSIONS: Cal/BD aerosol foam was significantly more effective than Cal/BD ointment and the individual active ingredients for treating psoriasis vulgaris, resulting in greater and faster reduction in disease severity and rapid, effective relief of itch.
J Drugs Dermatol. 2016;15(8):951-957.
Steven R. Feldman MD PhD| |
Shari R. Lipner MD PhD| |
Rapid Onset of Action in Patients With Moderate-to-Severe Plaque Psoriasis With Halobetasol 0.01%/Tazarotene 0.045% Fixed Combination
Linda Stein Gold MD,a Leon H. Kircik MD,b David Pariser MD,c Jeffrey L. Sugarman MD PhD,d Tina Lin PharmD,e Robert Kang MS,f Radhakrishnan Pillai PhDg| |
Richard A. Krathen MD, Cindy N. Berthelot MD, Sylvia Hsu MD| |
Federico Bardazzi MD,a Camilla Loi MD,a Francesca Prignano MD,b Federica Ricceri MD,b Ferdinando Giordano PhD,c Annalisa Patrizi MD,a and Michela Magnano MDa| |
Ronald B. Vender MD FRCPC| |
OBJECTIVE: All clinical trials have an ending by study design. In the past, trials ended abruptly but it is more common now for transitioning to the approved or another biologic to be offered. Sometimes, study subjects leave clinical trials suddenly for reasons of lack of efficacy, safety, withdrawing consent, being lost to follow-up, or personal reasons. Presenting early experience in transitioning is important for clinicians.
METHODS: A retrospective case series of 11 patients who were exposed to brodalumab from clinical trials that ended abruptly and transitioned to secukinumab is presented.
RESULTS: This is an early descriptive experience of transitioning between two IL-17 antagonists.
LIMITATIONS: A small number of patients were available and a short follow up limited the data presented.
CONCLUSION: Transitioning between two IL-17 antagonists is an option for those patients requiring such a change.
J Drugs Dermatol. 2016;15(8):941-943.
Efficacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis Vulgaris – a Randomized Phase III Study (PSO-FAST)
Craig Leonardi MD,a Jerry Bagel MD,b Paul Yamauchi MD,c David Pariser MD,d Zhenyi Xu MD,e Martin Olesen MD,e* Marie Louise østerdal MSc,e and Linda Stein Gold MDf| |
OBJECTIVE: To compare the efficacy and safety of Cal/BD aerosol foam with aerosol foam vehicle in patients with psoriasis.
DESIGN: Phase III, double-blind, randomized PSO-FAST (Cal/BD foam in PSOriasis vulgaris, a Four-week, vehicle-controlled, efficacy And Safety Trial) study recruited patients with ≥ mild severity psoriasis of the trunk and/or limbs from 27 US outpatient sites (NCT01866163). Patients were randomized (3:1) to Cal/BD foam or vehicle once-daily for 4 weeks. Primary outcome: proportion of patients at week 4 who achieved treatment success according to physician’s global assessment. Secondary outcomes: modified (excluding head) psoriasis area and severity index (mPASI) and patient's assessment of itch (visual analog scale). Safety was monitored by adverse events/calcium homeostasis.
RESULTS: 426 patients enrolled between June and October 2013 (Cal/BD foam, n=323; vehicle, n=103). At week 4, significantly more patients using Cal/BD foam achieved treatment success versus vehicle (53.3 versus 4.8%; OR 30.3, 95% CI 9.7,94.3; P < .001) and mean mPASI score was significantly lower for patients using Cal/BD foam than vehicle (2.0 versus 5.5; adjusted difference –3.3, P <.001). Significantly greater itch relief was observed for patients using Cal/BD foam than vehicle (P = .010 at day 3, P < .001 from day 5). Adverse drug reactions were reported in 10 Cal/BD foam patients (3.1%) and two vehicle patients (1.9%); events occurred in one patient each except application site pain (Cal/BD foam, two patients; vehicle, one patient). There were no clinically significant changes in calcium homeostasis.
CONCLUSIONS: Cal/BD foam was efficacious, achieved rapid itch relief and was well tolerated in patients with body psoriasis. This innovative aerosol foam formulation is expected to become a valuable treatment option.
J Drugs Dermatol. 2015;14(12):1468-1477.
An Open-Label, Prospective Cohort Pilot Study to Evaluate the Efficacy and Safety of Etanercept in the Treatment of Moderate to Severe Plaque Psoriasis in Patients Who Have Not Had an Adequate Response to Adalimumab
Ronald Vender MD FRCPC| |
Background: The past several years have seen the approval of five different biologic agents for the treatment of moderate to severe
plaque psoriasis in the United States and Canada. Psoriasis has proven to be a difficult disease to treat and treatment failures, even
with newer biologic therapies, are not uncommon. The vast majority of clinical data for these medications is derived from treatment
of biologic-naïve patients, or patients who have not responded to, or lost response to, or not tolerated systemic therapy for psoriasis.
There is currently little data available on therapeutic response of a second biologic therapy after loss of response, or no response,
to the first biologic therapy initiated. It has become common clinical practice to switch medications that are structurally distinct but
therapeutically similar in order to achieve an improved clinical outcome. Therapeutic interchange now is being applied to the biologic
agents used to treat psoriasis.
Objectives: Using a proof of concept study, describe the response of etanercept after adalimumab has failed to produce a satisfactory response in moderate to severe plaque psoriasis.
Methods: A total of 10 biologically naïve patients with moderate to severe psoriasis who were initiated on adalimumab for at least 12 weeks but had a Physician’s Global Assessment (PGA) of mild or worse were transitioned to commercial etanercept 50 mg twice weekly (BIW) for 12 weeks followed by a dose reduction to 50 mg once weekly (OW) for an additional 12 weeks. Ethics approval was obtained and the study registered with ClinicalTrials.gov (NCT00833729). The primary outcome measured was the mean change in Physician’s Global Assessment (PGA) score (range 0-5) from baseline (when the first etanercept injection is given) to 12 weeks of etanercept therapy. The secondary outcomes measures included the mean change in Dermatology Quality of Life Index (DLQI), mean change in body surface area (BSA) covered in psoriasis, Subject’s Global Assessment of disease (SGA), proportion of patients achieving an improvement in PGA score from baseline to 12 weeks and again at 24 weeks and safety.
Results: Overall, there were significant favorable changes in all outcomes measured (PGA, SGA, BSA and DLQI) with respect to etanercept’s efficacy after an inadequate response to at least 12 weeks of adalimumab therapy. There were no significant safety issues noted especially during the transition period from adalimumab to etanercept. ClinicalTrials.gov identifier: NCT00833729.
J Drugs Dermatol. 2011;10(4):396-402.
Efficacy and Safety of Ustekinumab in Chinese Patients With Moderate to Severe Plaque-type Psoriasis: Results From a Phase 3 Clinical Trial (LOTUS)
Xuejun Zhu MD,a Min Zheng MD PhD,b Michael Song MD,c Yaung-Kaung Shen PhD,dDaphne Chan PhD MHEcon,c Philippe O. Szapary MD MSCE,c and Baoxi Wang MDe on behalf of LOTUS investigators*| |
Objectives: The LOTUS study is a phase 3, double-blind, placebo-controlled study that evaluated the efficacy and safety of ustekinu-mab in Chinese patients with moderate to severe plaque-type psoriasis.
Patients and Methods: Patients (n=322) were randomized to receive ustekinumab 45 mg or placebo at weeks 0 and 4, with placebo crossover to ustekinumab at week 12; all patients were followed up to week 36. The primary end point was the proportion of patients achieving at least a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) at week 12. Other end points at week 12 included the proportion of patients with a Physician's Global Assessment (PGA) score of 0 or 1 and the change in Dermatology Life Quality Index (DLQI) score from baseline.
Results: At week 12, 82.5% of ustekinumab-treated patients achieved PASI 75 responses compared with 11.1% of placebo-treated patients (P<.001). Clinical responses were maintained through week 28, with maximum responses observed at week 24. Significant improvements in PGA and DLQI were observed at week 12 and were generally maintained through week 28. At week 12, adverse events rates were similar between groups (45 mg: 42.5% vs placebo: 38.5%), and serious adverse events were reported in 0.6% of patients in each group. Through week 36, no cases of active tuberculosis, serious infections, malignancies, or major adverse cardiovascular events were reported.
Conclusions: Consistent with results previously reported in global phase 3 studies, ustekinumab was highly effective and generally well tolerated in Chinese patients with moderate to severe psoriasis through 36 weeks.
J Drugs Dermatol. 2013;12(2):166-174.
Catherine D. Buzney MA,a Caitlin Peterman BS,a Ami Saraiya MD,b Shiu-chung Au MD,b
Nicole Dumont,b Ryan Mansfield AS,b and Alice B. Gottlieb MD PhDa,b
METHODS: 258 subjects were included from a database of psoriasis patients seen at Tufts Medical Center (Boston, MA) during 2008-2014. Insurance was classified as primarily private or public (Medicare or MassHealth/Medicaid). Patients required a minimum of two consecutive visits per treatment and at least 8 weeks within one of four treatment categories: biologics, oral systemics/ phototherapy, combined biologics and oral systemics/phototherapy, or topicals only. Primary endpoint was the Simple-Measure for Assessing Psoriasis Activity (S-MAPA) calculated by multiplying Physician Global Assessment by Body Surface Area. S-MAPA<3 constituted absolute clearance. Insurance type was evaluated as a predictor of prescribed treatment categories, maximum S-MAPA
improvement from baseline, and total drugs used per treatment course (“drug-switching”).
RESULTS: 80.2% (n=207) and 19.8% (n=51) had primarily private and public insurance, respectively. 69.6% with private insurance were prescribed biologics versus 66.7% (public insurance) (P=0.689). 54% (private) versus 49% (public) achieved clearance (P=0.514). However, S-MAPA decreased 78.35% from baseline in those with private insurance compared to 61.48% (public) (P=0.036). On average, privately insured patients used at least twice as many same-category treatments, most commonly biologics, than publicly insured individuals (P=0.003). Drug-switching was significantly associated with clearance (P=0.024). Multivariate analysis demonstrated no significant differences in prescribed treatment categories, drug efficacy, clearance, S-MAPA, or drugswitching with respect to patient age.
CONCLUSIONS: Treatment categories were comparably prescribed between insurance subgroups. However, privately insured patients achieved significantly greater degrees of clearance and switched between more medications within biologic and systemic categories, potentially explaining their overall improved therapeutic response. Further studies including cost-analysis could clarify any difference in the effectiveness of prescribed therapy for these two patient populations.
J Drugs Dermatol. 2015;14(2):119-125.
Open Label Study to Evaluate the Efficacy of Re-Treatment With Etanercept in Patients With Psoriasis
Objective: To evaluate the efficacy of the re-treatment with etanercept in patients with a history of etanercept use with good response and secondary loss of efficacy.
Methods: This is an open label prospective study involving 20 patients with moderate to severe plaque psoriasis, who had been initially treated with etanercept and were re-treated after a variable interval with 50 mg BIW for 12 weeks.
Results: At week 12 of etanercept re-treatment, 13 of 20 patients (65%) achieved a PGA score of 2 or less and 40% (8 of 20), achieved a PGA score of 0 to 1. Etanercept was well tolerated and no serious adverse events were reported.
Limitations: Our study involved a small number of patients. Failure of etanercept was establish by patient's history. However we were able to correlate such failure from our medical records in 17 patients.
Conclusions: Re-treatment with etanercept, after secondary loss of efficacy should be considered in patients with psoriasis if satisfactory therapy cannot be achieved with other therapeutic regimens.
J Drugs Dermatol. 2012;11(8):950-954.
Predicting Improvement in Signs and Symptoms of Plaque Psoriasis After 1 Week of Treatment With Clobetasol Propionate 0.05% Spray
Steven R. Feldman MD PhD,a Warren Winkelman MD PhD,b Eric Baum MD,c Norman Preston PhDb| |
J Drugs Dermatol. 2013;12(12):1456-1460.
Evren Odyakmaz Demirsoy MD,a Rebiay Kıran MD,a Selma Salman MD,a Çiğdem Çağlayan MD,b
Aysun Şikar Aktürk MD,a Dilek Bayramgurler MD,a and Nilgün Bilen MDa
AIM: We aimed to evaluate the effect of systemic antipsoriatic agents on nail findings.
METHODS: Eighty-seven psoriatis patients with fingernail involvement who required systemic treatment but had not used any systemic treatment in the previous 12 weeks were included in this study. Different systemic treatment agents were given to patients, considering factors such as age, sex, and joint involvement, but not nail involvement. The control group was recruited from psoriatis patients with nail involvement who were not receiving any systemic treatment. Baseline and week 16 Nail Psoriasis Severity Index (NAPSI) and PASI were detected in all groups. At the end of the study, effects of the agents on both PASI and NAPSI were compared statistically.
RESULTS: Patients were divided into 5 groups to receive either: 1) methotrexate, 2) narrow-band ultraviolet B phototherapy, 3) biological agents, 4) acitretin, or 5) no treatment (control group). None of the conventional treatment agents caused any significant difference on NAPSI at the end of week 16 compared with control group, although PASI decreased significantly. Rate of NAPSI changes were more prominent in the biological treatment group, and a statistically significant difference was detected when compared with the control group.
J Drugs Dermatol. 2013;12(9):1039-1043.
Peter W. Hashim MD MHS,a Mark G. Lebwohl MD,a Leon H. Kircik MDa,b,c| |
Secukinumab Self-Administration by Prefilled Syringe Maintains Reduction of Plaque Psoriasis Severity Over 52 Weeks: Results of the FEATURE Trial
Alice B. Gottlieb MD PhD,a Andrew Blauvelt MD MBA,b Jörg C. Prinz MD,c Philemon Papanastasiou PhD,d Rashidkhan Pathan MS,e Judit Nyirady MD MBA,f Todd Fox PharmD ACPR,d Charis Papavassilis MD PhDd| |
J Drugs Dermatol. 2016;15(10):1226-1234.
Maggie Chow MD PhD,a Kevin Lai MS,b Richard Ahn PhD,b Rashmi Gupta PhD,b Sarah Arron MD PhD,b and Wilson Liao MDb| |
METHODS: Thirty adult subjects with > 10% body surface area of chronic plaque psoriasis were recruited for the study. Lesional skin and peripheral blood mononuclear cell samples prior to and one month following treatment with adalimumab were collected. The skin samples were analyzed using genome-wide RNAseq, and the blood samples were analyzed using genome-wide Affymetrix microarrays. Data preprocessing and analysis were conducted using the EdgeR and Affy packages in R/Bioconductor.
RESULTS: In the skin, paired analysis before and after treatment revealed changes in pathways important to epidermal development and keratinocyte differentiation. Such important genes as keratin 6A and 6B, tubulin B6, desmocollin, and desmoglein 3 were among the top differentially expressed genes. In peripheral blood, pathways involved in hematopoetic cell lineage and immune response were found to be differentially expressed, including genes such as the Fc receptor-like A and 5, as well as immunoglobulin heavy chains. Using a principal components approach, we show that expression of genes in post-treatment skin more closely resembles that of healthy controls.
CONCLUSION: Treatment of psoriasis with adalimumab appears to be associated with modulation of keratinocyte and epidermal proliferation in the skin and with immunologic changes in the blood. We discuss the ramifications of these findings for the treatment for psoriasis.
J Drugs Dermatol. 2016;15(8):988-994.
J Drugs Dermatol. 2012;11(8):907-910.
Improvement in Signs and Symptoms of Plaque Psoriasis After 1 Week of Treatment With Clobetasol Propionate 0.05% Spray
Robert Brodell MDa,b and Norman Preston PhDc
aDivision of Dermatology, University of Mississippi Medical Center, Jackson, MS bDepartment of Dermatology, University of Rochester School of Medicine and Dentistry, Rochester, NY cGalderma Laboratories, L.P., Fort Worth, TX| |
J Drugs Dermatol. 2012;11(12):1455-1459.
A Multi-center, Open-label Study to Evaluatethe Safety and Efficacy of a Sequential TreatmentRegimen of Clobetasol Propionate 0.05% SprayFollowed by Calcitriol 3 mg/g Ointment in theManagement of Plaque Psoriasis
Robert T. Brodell MD, Suzanne Bruce MD, Charles P. Hudson MD, Jonathan S. Weiss MD,Luz E. Colon MS, Lori A. Johnson PhD, Ronald W. Gottschalk MD FRCPC| |
Aims: Our aim is to evaluate caregiver opinions regarding the clinical presentations and treatment of psoriasis in African-Americans compared to Caucasians.
Patients/Methods: A survey was sent to 29 dermatologists who are opinion leaders in the field of psoriasis. The survey included a number of questions regarding the characteristics of the patients seen in their practice.
Results: A total of 29 surveys were completed and returned. All of the dermatologists use the extent of disease as a criterion to determine the severity of the disease. Other criteria include scale, thickness, erythema, associated general symptoms, and dyspigmentation. About 66% of the respondents reported the different manifestations of disease, such as more dyspigmentation, thicker plaques, and less erythema in African-Americans. The most common first-line treatments for mild to moderate disease were highpotency topical steroids (68%) followed by topical vitamin D analogues (41%). For moderate to severe disease, the most commonly used first-line treatments were high-potency topical steroids (54%) and phototherapy (46%).
Conclusions: The clinical manifestations of psoriasis in African-Americans are not exactly the same as in Caucasians. Physicians should be aware of the difference in clinical manifestations in African-Americans. Further research and large-scale studies are necessary to elucidate the differences in the clinical presentation, natural course of the disease, and the criteria used for the evaluation of severity among ethnic groups.
J Drugs Dermatol. 2012;11(4):478-482.
Introduction: Acitretin is a systemic retinoid drug used in the treatment of severe psoriasis. It has also been used for a spectrum of
other difficult-to-treat dermatoses, including hyperkeratotic and inflammatory dermatoses and non-melanoma skin cancers. Here we
review the available data regarding both FDA-approved and off-label uses of acitretin, clinically relevant adverse events, precautions
Methods: A PubMed literature search was conducted utilizing the search term "acitretin," which yielded 714 hits. Results were further limited to English language clinical trials in human subjects. Of 78 articles evaluated for relevance, 60 were included for review.
Results: Acitretin is effective as monotherapy and in multidrug therapeutic regimens for the treatment of psoriasis and other hyperkeratotic and inflammatory disorders, as well as for malignancy chemoprevention. Its use is limited by its teratogenic potential and other adverse effects, including mucocutaneous effects and hepatotoxicity. Potential adverse effects may be reduced or avoided by using lower doses of acitretin or in combination with other therapies.
Limitations: The reviewed studies include many small trials and case reports of the use of acitretin for psoriasis. Studies of acitretin therapy for the treatment of other cutaneous disorders are limited.
Conclusion: Acitretin is a beneficial treatment for psoriasis, and should be considered when not contraindicated. Particularly when used in combination with ultraviolet (UV) phototherapy, is a safe and cost effective therapeutic strategy.
J Drugs Dermatol.2011;10(7):772-782.
A Comparison of Psoriasis Drug Failure Rates and Reasons for Discontinuation in Biologics vs Conventional Systemic Therapies
Adriane A. Levin BA,a,b Alice B. Gottlieb MD PhD,b,c and Shiu-chung Au MDb| |
DESIGN: Retrospective, cross-sectional.
METHODS: All patient visits coded for psoriasis (ICD-0 696.1) in the clinical practice of 2 dermatologists from January 1 2008 through January 4 2012 were included in this retrospective data analysis. The practice is a comprehensive psoriasis care center in the northeastern United States serving a metropolitan population of over 4 million people. Patients were divided by treatment type: biologic or traditional systemic. Treatment failure was defined as discontinuation of treatment course for any reason. Patient time to failure for each therapy was calculated, as were previous treatments and reasons for treatment discontinuation.
RESULTS: One hundred and fifty-nine patients who underwent 284 courses of treatment were studied. Forty-eight percent of biologics failed in an average of 242 days, compared with 75% of traditional systemics (P<.0001), which failed in an average of 143 days (P<.0001). Infliximab had the longest survival time (292 days), and ustekinumab had the smallest failure rate (39%). Reasons for discontinuation differed significantly between biologics and systemics, with biologics being discontinued more often due to loss of efficacy (P=.0014), and systemics failing significantly more frequently due to adverse events (P<.001). Adverse events were observed most frequently with methotrexate and infliximab, while golimumab had the highest rates of both loss and lack of efficacy.
CONCLUSION: Biologics had longer survival times and lower failure rates than traditional systemics in the treatment of psoriasis. Biologics were more likely to be discontinued due to loss of efficacy, and systemics were more likely to fail due to adverse events.
J Drugs Dermatol. 2014;13(7):848-853.
Leon Kircik MD,a,b,c Mark G. Lebwohl MD,c James Q. Del Rosso DO,d
Jerry Bagel MD,eLinda Stein Gold MD,f Jonathan S. Weiss MDg
In both Phase 3 studies, a statistically significantly greater percentage of subjects in the desoximetasone spray 0.25% compared to vehicle group achieved both Clinical Success and Treatment Success at Day 28. These results, which were the primary efficacy variables, demonstrated superior efficacy in the active study group for both overall improvement of plaque psoriasis (by PGA) and in the individual psoriasis lesion (by TLSS) designated at baseline as the most severely involved plaque (target lesion). Assessment of secondary efficacy variables in both Phase 3 studies showed that subjects receiving desoximetasone Spray 0.25% twice daily exhibited statistically significantly mean changes from Baseline to Day 28 in PGA, TLSS, and % BSA affected when compared to subjects receiving vehicle spray twice daily.
Tolerability and safety were assessed at all study visits. No statistically significant differences were observed between study arms and no major safety signals related to AEs were noted. No stinging and burning were reported with the spray formulation. This Class I topical corticosteroid has shown to be safe and efficacious in moderate to severe plaque psoriasis.
J Drugs Dermatol. 2013;12(12):1404-1410.
Factors Affecting Prescription of Ultra-High Potency Topical Corticosteroids in Skin Disease: An Analysis of US National Practice Data
Rajesh Balkrishnan PhD, Fabian T. Camacho MS, Daniel J. Pearce MD, Amit S. Kulkarni MS, Lori Spencer PhD, Alan B. Fleischer Jr. MD, Steven R. Feldman MD PhD| |
Open-Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed Therapy With Apremilast
Jerry Bagel MD MS,a Ahmed S. Samad MD,b Bradley S. Stolshek PharmD,b Girish A. Aras PhD,b James B. Chung MD PhD,b Gregory Kricorian MD,b Leon H. Kircik MDc| |
James Q. Del Rosso DO| |
Tumor Necrosis Factor-α Inhibitor Use in Psoriasis Patients With a First-degree Relative With Multiple Sclerosis
Bobbak Mansouri MD, Mary E. Horner MD, Alan Menter MD| |
J Drugs Dermatol. 2015;14(8):876-878
Short- and Long-term Safety Assessment of a Two-compound Ointment Containing Calcipotriene/Betamethasone Dipropionate (Taclonex®/Daivobet®/Dovobet® Ointment): Hypothalamic-Pituitary-Adrenal Axis Function in Patients with Psoriasis Vulgaris
Colin Fleming MD, Cecilia Ganslandt MD, Graham P. Leese MB ChB| |
J Drugs Dermatol. 2012;11(8):979-987.
Kircik, L.H. et al.| |
Mark Lebwohl MD, Kathryn Martin PharmD| |
Effect of Infliximab on Health-Related Quality of Life and Disease Activity by Body Region in Patients With Moderate-to-Severe Psoriasis and Inadequate Response to Etanercept: Results from the PSUNRISE Trial
Robert E. Kalb MD,a Andrew Blauvelt MD,b Howard L. Sofen MD,c Marc Chevrier MD,d David Amato DO,d
Stephen Calabro MS,d Jim Wang PhD,e Brad Schenkel MS,f and Alice B. Gottlieb MD PhDg
METHODS: PSUNRISE is a multicenter, open-label, prospective study evaluating the efficacy and safety of switching from etanercept to infliximab in psoriasis patients with an inadequate response to etanercept. Patients received intravenous infusions of infliximab 5 mg/ kg at weeks 0, 2, 6, 14, and 22. HRQoL was assessed using the Dermatology Life Quality Index (DLQI), the 36-item Short-Form Health Survey (SF-36), and the EuroQoL (EQ-5D) index and EQ-5D visual analog scale (VAS; 0-100 cm) among patients receiving at least one infliximab infusion. Subgroup analyses (t- test) were performed to compare mean DLQI improvement between patients who achieved and did not achieve clinical response (Physician’s Global Assessment [PGA] 0/1 and at least a 75% improvement in the Psoriasis Area and Severity Index [PASI 75]) at weeks 10 and 26.
RESULTS: A total of 215 patients received at least one infliximab infusion. A DLQI score of 0 or 1 (no negative effect on HRQoL) was achieved by 3.7%, 44.2%, and 41.4% of patients at weeks 0, 10 and 26, respectively. Mean changes in SF-36 Physical Component Summary scores were 1.8 (week 10) and 2.4 (week 26); corresponding changes in Mental Component Summary scores were 4.5 and 5.0. The mean change in EQ-5D index score was 0.08 at week 10 and 0.09 at week 26; respective mean changes in EQ-5D VAS score were 7.73 and 9.49. Mean improvements in DLQI were significantly higher for patients achieving versus those not achieving PGA 0/1 (P=0.0193 [week 10] and P=0.0010 [week 26]) and PASI 75 response (P<0.0001 [week 10]; P=0.0012 [week 26]).
CONCLUSION: Psoriasis patients with prior inadequate response to etanercept demonstrated sustained improvements in HRQoL after switching to infliximab, and HRQoL improvements were associated with clinical responses.
J Drugs Dermatol. 2013;12(8):874-880.
PSOLAR: Design, Utility, and Preliminary Results of a Prospective, International, Disease-Based Registry of Patients With Psoriasis Who are Receiving, or are Candidates for, Conventional Systemic Treatments or Biologic Agents
Objective: To describe the on-going Psoriasis Longitudinal Assessment and Registry (PSOLAR) study.
Methods: PSOLAR is a large, international, long-term, prospective, disease-based registry enrolling patients with psoriasis who are receiving, or are candidates for, treatment with systemic therapies. The registry fulfills postmarketing regulatory commitments and charges a global Steering Committee to manage epidemiological research on psoriasis and its therapies. Key demographics, disease characteristics, and medication history are collected at enrollment. Adverse events and efficacy data are collected longitudinally.
Results: The August 2011 annual database extract includes 9,495 patients enrolled at 266 global centers. At entry, mean percent of body surface area affected by psoriasis was 12.3% (peak, 29.5%). Approximately 80% of patients were overweight/obese, more than one-third had cardiovascular disease (38.8%) or psoriatic arthritis as captured by the treatment center (37.1%), and over half had received one or two biologic agents (58.8%) or phototherapy (54.8%). Mean duration of participation is 1.3 years, and annual withdrawal rates are less than 6.5%. Of 9,495 patients, 7,476 have been exposed to at least one biologic agent. Serious infections, malignancies, all-cause mortality, and major adverse cardiovascular events (ie, myocardial infarction, stroke, cardiovascular death) occurred at rates of 1.40, 0.61, 0.37, and 0.36 per 100 patient-years of follow-up, respectively.
Limitations: PSOLAR may be subject to limitations common to observational studies (eg, participation bias and potential confounders).
Conclusion: PSOLAR is a disease-based registry designed to assess therapeutic risk and benefit in the general psoriasis population.
J Drugs Dermatol. 2012;11(10):1210-1217.
Amy S. Paller MD,a Rakesh Singh PhD,b Martin Cloutier MSc,c Marjolaine Gauthier-Loiselle PhD,c Bruno Emond MSc,c Annie Guérin MSc,c and Arijit Ganguli MBA PhDb| |
Scott A. Davis MA,a Hsien-Chang Lin PhD,b Cheng-Han Yu MA,c
Rajesh Balkrishnan PhD,d and Steven R. Feldman MD PhDa,e,f
PURPOSE: To characterize the timing of first follow-up visits in US dermatologic practice.
Methods: Patients with a diagnosis of psoriasis, acne, or atopic dermatitis were identified in the 2003-2007 MarketScan Medicaid database. Factors affecting the length of time before first follow-up were assessed using a Cox proportional hazards model.
RESULTS: Mean length of time to the first follow-up visit was 153 days for adults and 142 days for children with psoriasis; 151 days for adults and 218 days for children with acne; and 161 days for adults and 209 days for children with atopic dermatitis. Black and those other than white patients were less likely than whites to receive early follow-up in psoriasis and acne, but more likely in atopic dermatitis. Dermatologists were more likely to schedule early follow-up visits than nondermatologists.
LIMITATIONS: The database includes only Medicaid patients. The rate of non-attendance at scheduled visits could not be determined.
CONCLUSIONS: Most physicians are missing the opportunity to maximize patient adherence by scheduling early follow-up visits. Contact by email or phone may be beneficial for physicians who cannot schedule early follow-up.
J Drugs Dermatol. 2014;13(7):833-836.
Reduction in C-Reactive-Protein Levels With Adalimumab Therapy in Patients With Moderate-to-Severe Hand and/or Foot Psoriasis
Craig L. Leonardi MD,a Kristina Unnebrink PhD,b and Wendell C. Valdecantos MDc| |
METHODS: REACH was a phase 4, multicenter, randomized, double-blind trial, evaluating adalimumab treatment for patients with psoriasis of the hands and/or feet. Adults were randomized 2:1 to adalimumab 40 mg every other week (following 80 mg at week 0) or matching placebo from weeks 1 to 16, followed by a 12-week, open-label extension. In this post hoc analysis, changes in hs-CRP were reported as observed from baseline to week 16.
RESULTS: Of the 72 patients (23 placebo, 49 adalimumab) who participated in REACH, 63 (19 placebo, 44 adalimumab) with hs-CRP measurements at baseline and at week 16 were included in this analysis. Baseline median hs-CRP values were 1.6 mg/L (placebo) and 2.2 mg/L (adalimumab), and were 3 times higher for patients with, as compared with those without, psoriatic arthritis (5.45 vs 1.8 mg/L). At week 16, the adalimumab group showed greater improvements (median reduction) from baseline than the placebo group in hs-CRP overall (−0.55 vs +0.10 mg/L), regardless of achievement of PGA of the hands and/or feet (hfPGA) 0 or 1 at week 16 (−0.80 vs 0 mg/L for patients who achieved hfPGA 0/1; −0.40 vs +0.30 mg/L, patients who did not achieve hfPGA 0/1), baseline psoriatic arthritis history (−2.35 mg/L with history [adalimumab group; no history for placebo group]; −0.40 vs +0.10 mg/L without history), and body mass index (BMI) category (defined by median BMI) (−0.80 vs +0.20 mg/L for BMI <30.28 kg/m2; −0.40 vs 0 mg/L for BMI ≥30.28 kg/m2).
CONCLUSION: Treatment with adalimumab 40 mg every other week resulted in greater overall reductions in hs-CRP levels among patients in this post hoc analysis, compared with placebo at 16 weeks regardless of baseline characteristics.
ClinicalTrials.gov Registry for REACH: NCT00735787
J Drugs Dermatol. 2016;15(5):562-566.
Cost Per Additional Responder Associated With Ixekizumab and Etanercept in the Treatment of Moderate-to-Severe Psoriasis
Steven R. Feldman MD PhD,a Shonda A. Foster PharmD MS,b Baojin Zhu PhD,b Russel Burge PhD,b,c Sarah Al Sawah PhD,b and Orin M. Goldblum MDb| |
BACKGROUND: Newer psoriasis treatments can achieve greater levels of effcacy than older systemic therapies; however, current pso-riasis costs are substantial. We sought to estimate costs per additional responder associated with ixekizumab and etanercept, versus placebo, using effcacy data from phase 3 clinical trials (UNCOVER-2 and UNCOVER-3).
METHODS: In UNCOVER-2/UNCOVER-3, patients received subcutaneous placebo, etanercept 50 mg twice weekly (BIW), or ixekizumab one 80 mg injection every 2 weeks (Q2W) after a 160-mg starting dose. Twelve-week induction-phase Psoriasis Area and Severity Index (PASI) 75, PASI 90, and PASI 100 response rates for ixekizumab, etanercept, and placebo were obtained from pooled data from the overall and United States (US) subgroup intention-to-treat (ITT) populations, and used to calculate numbers needed to treat (NNTs) to achieve one additional PASI 75, PASI 90, or PASI 100 response for ixekizumab Q2W and etanercept BIW versus placebo. Twelve-week drug costs per patient were calculated based on the UNCOVER-2/UNCOVER-3 dosing schedule and wholesale acquisition costs. Mean costs per additional responder for PASI 75, PASI 90, and PASI 100 for each treatment versus placebo were calculated for pooled UN-COVER-2/UNCOVER-3 overall and US subgroup ITT populations.
RESULTS: Pooled overall ITT population: costs per additional PASI 75, PASI 90, or PASI 100 responder were US $37,540, US $46,299, or US $80,710 for ixekizumab Q2W and US $57,533, US $120,720, or US $404,695 for etanercept BIW, respectively. US subgroup ITT population: costs per additional PASI 75, PASI 90, or PASI 100 responder were US $38,165, US $49,740, or US $93,536 for ixekizumab Q2W and US $69,580, US $140,881, or US $631,875 for etanercept BIW, respectively.
CONCLUSIONS: Twelve-week costs per additional responder were lower for ixekizumab Q2W than for etanercept BIW across all levels of clearance (PASI 75, PASI 90, and PASI 100) in the pooled UNCOVER-2/UNCOVER-3 overall and US subgroup ITT populations.
J Drugs Dermatol. 2017;16(12):1246-1252.
An Intra-Individual Randomized Safety and Efficacy Comparison of Clobetasol Propionate 0.05% Spray and its Vehicle in the Treatment of Plaque Psoriasis
Karl Beutner MD PhD, Arun Chakrabarty MD, Shawna Lemke PhD, Karen Yu PhD| |
Objectives: To evaluate the efficacy and safety of CP 0.05% spray compared to its vehicle in the treatment of moderate to severe plaque psoriasis.
Methods: A 4-week, single-center, randomized, double-blind, vehicle-controlled, intra-individual study in subjects with plaque psoriasis. Each of 2 target lesions per subject were randomized to receive either CP 0.05% spray or its vehicle twice daily over 4 weeks. Efficacy parameters included overall target plaque severity score, scaling, erythema, and plaque elevation at all visits. Adverse events were reported throughout the study.
Results: A total of 27 subjects were enrolled in the study. At all visits there was a significant intra-individual treatment effect for the overall target plaque severity (P<.001) in favor of CP spray. Throughout the study, results for scaling, erythema, and plaque elevation were significantly (P<.001) in favor of CP spray. After 4 weeks of treatment, all intra-individual response measures, with the exception of erythema, showed an average difference in severity scores of more than 4 points (based on a 9-point scale) between the lesions treated with CP 0.05% spray and the lesions treated with vehicle. No serious adverse event occurred during the course of the study. One local adverse event at the application site (5%) was considered probably related to study medication.
Conclusion: CP 0.05% spray was effective and safe in reducing overall plaque severity, scaling, erythema, and plaque elevation from the first week of treatment continuing throughout the trial.
The Aerosol Foam Formulation of the Fixed Combination Calcipotriene Plus Betamethasone Dipropionate Improves the Health-Related Quality of Life in Patients With Psoriasis Vulgaris: Results from the Randomized PSO-FAST Study
Craig Leonardi MD,a Jerry Bagel MD,b Paul Yamauchi MD,c David Pariser MD,d Zhenyi Xu MD,e Anders Møller MSc,e Marie Louise Østerdal MSc,e and Linda Stein Gold MDf| |
OBJECTIVE: To compare the impact on HRQoL of Cal/BD foam vs vehicle in patients with mild-to-severe psoriasis.
METHOD: HRQoL was assessed by dermatology life-quality index (DLQI; baseline, weeks 1, 2, 4) and EQ-5D-5L (EQ-5D; baseline, week 4) questionnaires. A DLQI score of 0 (range, 0–30) indicates no effect on the patient’s life; an EQ-5D utility score of 1 (range, 0–1) and an EQ-5D visual analog scale (VAS) score of 100 (range, 1–100) indicate perfect health.
RESULTS: 426 patients were randomized (Cal/BD foam, n=323; vehicle, n=103). Baseline mean DLQI scores were 9.9 (Cal/BD foam) and 10.3 (vehicle). The impact of psoriasis on HRQoL (EQ-5D utility score) at baseline was primarily driven by pain/discomfort (Cal/BD foam: 69.9%; vehicle: 65.0%) and anxiety/depression (Cal/BD foam: 45.3%; vehicle 44.7%). There was a greater improvement from baseline in DLQI score for Cal/BD foam vs vehicle at week 4 (–7.0 vs –4.4; P<.001); increased improvement was also seen in EQ-5D scores. At week 4, 48.1% of patients using Cal/BD foam reported no effect of psoriasis on their lives (DLQI = 0/1), and of patients using Cal/BD foam with baseline DLQI scores ≥5, 81.2% achieved a ≥5-point improvement.
CONCLUSION: Cal/BD aerosol foam improved HRQoL after 4 weeks, with most patients experiencing a clinically meaningful improvement and almost 50% reporting no impairment.
J Drugs Dermatol. 2016;15(8):981-987.
Leon Kircik MD| |
Methods for Imputing Missing Efficacy Data in Clinical Trials of Biologic Psoriasis Therapies: Implications for Interpretations of Trial Results
Richard G.B. Langley MD FRCPC,a Kristian Reich MD PhD,b Charis Papavassilis MD PhD,c Todd Fox PharmD ACPR,c Yankun Gong PhD,d and Achim Güttner PhDc| |
BACKGROUND: An issue in long-term clinical trials of biologics in psoriasis is how to handle missing efficacy data. This methodological challenge may not be understood by clinicians, yet can have a significant effect on the interpretation of clinical trials.
OBJECTIVE Evaluate the effects of different data imputation methods on apparent secukinumab response rates.
METHODS: Post hoc analyses were conducted on efficacy data from 2 phase III, multicenter, randomized, double-blind trials (FIXTURE and ERASURE) of secukinumab in moderate to severe plaque psoriasis. Per study protocols, missing data were imputed using strict non-response imputation (NRI), a highly conservative method that assumes non-response for all missing data. Alternative imputation methods (observed data, last observation carried forward [LOCF], modified NRI, and multiple imputation [MI]) were applied in this analysis and the resultant response rates compared.
RESULTS: Response rates obtained with each imputation method diverged increasingly over 52-weeks of follow-up. Strict NRI response estimates were consistently lower than those using the other methods. At week 52, Psoriasis Area and Severity Index (PASI) 90 rates for secukinumab 300 mg based on strict NRI were 9.2% (FIXTURE) and 8.7% (ERASURE) lower than estimates obtained using the least conservative method (observed data). Estimates obtained through LOCF and modified NRI were closest to those produced by MI, currently regarded as the most methodologically sophisticated approach available.
CONCLUSION: Awareness of differences in assumptions and limitations among imputation methods is necessary for well-informed interpretation of trial data.
J Drugs Dermatol. 2017;16(8):734-742.
Cost-Effectiveness Analysis of Ixekizumab vs Etanercept and Their Manufacturer-Recommended Dosing Regimens in Moderate to Severe Plaque Psoriasis
Jeremy Udkoff MA MAS and Lawrence F. Eichenfield MD| |
J Drugs Dermatol. 2017;16(10):964-970.
Topical Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Maintains Efficacy of Etanercept After Step-Down Dose in Patients With Moderate-to-Severe Plaque Psoriasis: Results of an Open Label Trial
Trial Design: In this single-center, open-label study, subjects (n=20) underwent 12 weeks treatment with etanercept 100 mg/week (50 mg, 2x week; weeks –12 to -1), followed by etanercept 50 mg/week maintenance therapy for 40 weeks (weeks 0 to 40). Subjects were followed at four-week intervals. Starting at week 4, subjects who demonstrated an increase from baseline (week 0) body surface area (BSA) of >2% initiated therapy with calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment for four weeks. The study is limited by its small sample size, open-label nature, and lack of blinding.
Findings: Mean BSA involvement decreased significantly from week –12 to 0 with etanercept 50 mg twice a week. At week 4, on the etanercept 50 mg/week dose, mean BSA increased to 9.42±9.39 compared to week 0. With introduction of calcipotriene 0.005%/betamethasone dipropionate 0.064% ointment at week 4, mean BSA decreased to 4.62±8.19 by week 24 and was relatively stable for the remainder of the study period. Similarly, mean PASI (Psoriasis Area and Severity Index) scores improved from week -12 to week 0, increased at week 4, then decreased significantly by week 24 with adjunctive topical treatment.
Conclusion: Topical calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment is a safe and effective adjunct to etanercept 50 mg/week maintenance therapy.
J Drugs Dermatol. 2011;10(8):881-885.
Diffuse Large B-cell Lymphoma Associated Withthe Use of Biologic and Other InvestigationalAgents: The Importance of Long-term PostmarketingSafety Surveillance
Allison Goddard MD, Judy H. Borovicka MD, Dennis P. West PhD,Andrew M. Evens DO MS, Anne Laumann MBChB MRCP| |
Genevieve Egnatios MD, Molly Mae Warthan MD, Robert Pariser MD, Antoinette F. Hood MD| |
Noah Scheinfeld MD JD| |
A Prospective, Open-Label Study Evaluating Adjunctive Calcipotriene 0.005%/Betamethasone Dipropionate 0.064% Foam in Psoriasis Patients With Inadequate Response to Biologic Therapy
Jerry Bagel MD MS, James Zapata, and Elise Nelson LPN CCRC| |
Immune Response to Pneumococcus and Tetanus Toxoid in Patients With Moderate-to-Severe Psoriasis Following Long-Term Ustekinumab Use
Carrie Brodmerkel PhD,a Eric Wadman BA,a Richard G. Langley MD,b Kim A. Papp MD,c Marc Bourcier
MD,d Yves Poulin MD,e Vincent Ho MD,f Lyn Guenther MD,g Rod Kunynetz MD,h Simon Nigen MD,i
Ronald Vender MD,j Norman Wasel MD,k Ming-Chun Hsu PhD,a and Philippe Szapary MD MSCEa
OBJECTIVES: Assess the impact of continuous maintenance ustekinumab treatment on patients' ability to mount immune responses to pneumococcal (T-cell-independent) and tetanus toxoid (T-cell-dependent) vaccines.
PATIENTS and METHODS: Ustekinumab-treated patients with moderate-to-severe psoriasis treated in the long-term extension of the Phase 3 PHOENIX 2 trial (n=60) were compared with control psoriasis patients not receiving systemic therapy (n=56). Patients were vaccinated with both 23-valent pneumococcal and tetanus toxoid vaccines. Serum samples collected pre-vaccination and 4 weeks post-vaccination were assessed for antibody responses.
RESULTS: No differences in the ability of ustekinumab-treated patients to respond to pneumococcal or tetanus toxoid vaccinations were observed compared with controls. A ≥2-fold increase in antibody levels in ≥7 of 14 serotypes of the pneumococcal vaccine was observed in ustekinumab-treated (96.6%) and untreated control (92.6%) patients following vaccination. Ustekinumab-treated patients achieved a ≥4-fold increase (84.7%) in anti-tetanus antibody vs. 77.8% in the control group. No differences were detected in ex-vivo responses to anti-CD3/CD28 or tetanus toxoid between ustekinumab-treated and control groups.
CONCLUSION: Long-term treatment (≥3 years) with ustekinumab does not compromise the immune response to T-cell-dependent/-independent vaccines in patients with moderate-to-severe psoriasis.
J Drugs Dermatol. 2013;12(10):1122-1129.
Punctate Palmoplantar Keratoderma (Buschke-Fischer-Brauer Disease) with Psoriasis: A Rare Association Showing Excellent Response to Acitretin
Nawaf Al-Mutairi MD FRCP(C), Arun Joshi MD, Osama Nour-Eldin MSc| |
J Drugs Dermatol. 2012;11(10):1240-1241.
A Review of the Chemopreventive and Chemotherapeutic Effects of Topical and Oral Retinoids for both Cutaneous and Internal Neoplasms
Pooja Khera MD, John Y. Koo MD| |
New-onset Psoriasis and Psoriatic Arthritis in a Patient Treated with Bacillus Calmette-Guerin (BCG)Immunotherapy
Jacob Dudelzak MD, Ashley R. Curtis MS IV, Daniel J. Sheehan MD, Jack L. Lesher Jr MD| |
Efficacy, Tolerability, and Pharmacodynamics of Apremilast in Recalcitrant Plaque Psoriasis: A Phase II Open-Label Study
Alice B. Gottlieb MD PhD,a Robert T. Matheson MD,b Alan Menter MD,c Craig L. Leonardi MD,d Robert M. Day PhD,e ChiaChi Hu EdM,e Peter H. Schafer PhD,e and James G. Krueger MD PhDf| |
METHODS: This multicenter, open-label study comprised four phases: pre-treatment (≤35 days), treatment (12 weeks), extension (12 weeks), and observational follow-up (4 weeks). Patients with recalcitrant plaque psoriasis received apremilast 20 mg BID for 12 weeks. Responders (≥75% improvement in Psoriasis Area and Severity Index [PASI-75]) continued treatment and non-responders (< PASI-75) were titrated to apremilast 30 mg BID through week 24. Efficacy assessments included change in static Physician's Global Assessment, PASI, and body surface area, and proportion of patients achieving PASI-50, PASI-75, and PASI-90. Other assessments included adverse events, lesional skin biopsies to assess changes in epidermal thickness, and immunohistochemistry to assess changes in peripheral blood subsets.
RESULTS: A total of 30 patients were enrolled. At week 12, 67% of patients had a ≥1-point improvement in static Physician’s Global Assessment, meeting treatment effect criterion. Mean percent decreases (improvements) from baseline were –59% for PASI score and –53% for body surface area. Most adverse events were mild. Median reduction in epidermal thickness was 34% at week 12 (P=0.083); five patients showed absence of keratin 16. Significant reductions in CD11c, CD3, and CD56 indicate that apremilast reduced myeloid dendritic cell, T-cell, and NK-cell or NK–T-cell infiltration into the epidermis and dermis. Reduced inflammatory leukocytes, with a pattern of broad, partial inhibition, suggested reduced IL-23/Th17 and Th22 response pathways.
CONCLUSIONS: These results confirm apremilast's biological and clinical activity and support ongoing studies in psoriasis. Clinicaltrials.gov Identifier: NCT00521339.
J Drugs Dermatol. 2013;12(8):888-897.
The Current State of Dermatologists’ Familiarity and Perspectives of Biosimilars for the Treatment of Psoriasis: A Global Cross-Sectional Survey
Iviensan F. Manalo MD,a Kathleen E. Gilbert MD,b and Jashin J. Wu MDc| |
BACKGROUND: Biologic patent expiration, accelerated approval pathways, and business interests of third party payers and the biopharmaceutical industry are driving the development of biosimilars to treat immune-mediated disorders like psoriasis. No studies have investigated dermatologists’ familiarity and perspectives of biosimilars.
OBJECTIVES: To assess: (1) dermatologists’ familiarity with biosimilars and interchangeability and (2) their perspectives toward biosimilar properties, including interchangeability, indication extrapolation, and immunogenicity risk.
METHODS: For this prospective survey study, we distributed electronic and paper questionnaires to dermatologists from selected societies and attendees at the 73rd annual American Academy of Dermatology meeting between March 20, 2015 and May 30, 2015. Primary outcome was dermatologists’ familiarity with biosimilars. Secondary aims included dermatologists’ confidence in biosimilar efficacy and safety, familiarity concerning the concept of interchangeability and perspectives regarding indication extrapolation, interchangeability, and immunogenicity risk.
RESULTS: Of the 116 total dermatologists who completed the questionnaire, 73 (62.9%) were slightly to very unfamiliar with biosimilars. On a 5-point Likert scale, dermatologists were somewhat to very concerned with the practice of interchangeability (3.4±1.1) and slightly uncomfortable to fairly comfortable in prescribing biosimilars for an extrapolated indication (3.3±1.0).
CONCLSUIONS: Our survey identified that the majority of dermatologists were unfamiliar with biosimilars. Dermatologists were consistently concerned regarding safety issues surrounding the practice of interchangeability without provider knowledge.
J Drugs Dermatol. 2017;16(4):336-343.
Possible Drug-Drug Interaction Between Adalimumab and Duloxetine and/or Pregabalin in a Psoriasis Patient
Rishu Gupta BS,a,b Jashin J. Wu MD,c Ethan C. Levin MD,b John Y.M. Koo MD,b and Wilson Liao MDb| |
Tina Bhutani MD and John Koo MD| |
J Drugs Dermatol. 2011;10(11):1292-1298.
Adaeze Egesi BS, Grace Sun MS, Amor Khachemoune MD , Rashid M. Rashid MD PhD| |
Treatment of Plaque-Type Psoriasis With Oral CF101: Data from a Phase II/III Multicenter, Randomized, Controlled Trial
Michael David MD,a Dimitar Konstantinov Gospodinov MD,b Nicola Gheorghe MD,c Grisha Stefanov Mateev MD,d Mariyana Venelinova Rusinova MD,e Evgeniya Hristakieva MD,f Laura Gheuca Solovastru MD,g Rita.V. Patel MD,h Calin Giurcaneanu MD,i Mariela Chepileva Hitova MD,j Anca Ioana Purcaru MD,j Beti Horia MD,k Iliya Iliev Tsingov MD,l Rumyana Kaloferova Yankova MD,m Miroslava Ilieva Kadurina MD,n Michal Ramon MD,o Maria Rotaru MD,p Olga Simionescu MD,q Vasile Benea MD,r Zdravka Velichkova Demerdjieva MD,s Maria Rodica Cosgarea MD,t Horia Silviu Morariu MD,u Ziv Michael MD,v Patricia Cristodor MD,w Carmen Nica MD,x Michael H. Silverman MD,y David R. Bristol PhD,y Zivit Harpaz MSc,y Motti Farbstein BSc,y Shira Cohen MSc,y and Pnina Fishman PhDy| |
OBJECTIVE: To evaluate the safety and efficacy of CF101 treatment in a Phase 2/3 study in patients with moderate to severe plaque-type psoriasis.
METHODS: This multicenter, double-blind, 2-segment, placebo-controlled study randomized subjects with moderate to severe plaque psoriasis to CF101 1 or 2 mg, or placebo twice daily. At either week 12 (Segment 1) or 16 (Segment 2), the placebo group crossed over to CF101 BID through week 32 in an open-label fashion. At week 12, following an interim analysis, the CF101 1mg group was discontinued due to futility. The primary endpoint was proportion of patients achieving ≥75% improvement in Psoriasis Area Severity Index (PASI 75). Efficacy testing was performed using the Cochran-Mantel Haenszel test, the primary analysis of PASI 75 was performed at the 0.035 significance level.
RESULTS: CF101 had an excellent safety profile at all tested dosages with a profile similar to the placebo group. The most common adverse events were infections and gastrointestinal events, and there was no cumulative intolerance over the 32-week dosing period. The study did not meet the primary endpoint of PASI 75 at week 12 (2 mg: 8.5% vs. placebo: 6.9%, P=0.621). However, at week 32, PASI mean percent improvement with CF101 2 mg was 57% (P<0.001) compared to baseline, with linear improvement in PASI 50 (63.5%), 75 (35.5%), 90 (24.7%), and 100 (10.6%).
CONCLUSIONS: Oral CF101 was found to be safe and very well tolerated, demonstrating evidence of efficacy in patients with moderate to severe plaque psoriasis through 32 weeks of treatment.
J Drugs Dermatol. 2016;15(8):931-938.
Long-Term Efficacy of Guselkumab for the Treatment of Moderate-to-Severe Psoriasis: Results from the Phase 3 VOYAGE 1 Trial Through Two Years
Christopher E.M. Griffiths MD,a Kim A. Papp MD,b Alexa B. Kimball MD,c Bruce Randazzo MD,d Michael Song MD,d Shu Li PhD,d Yaung-Kaung Shen PhD,d Andrew Blauvelt MDe| |
Palmoplantar Pustulosis With Fulminant Dystrophic 20-Nail Psoriasis in a Patient Receiving Adalimumab Therapy
Vineet Mishra MDa, Ralph C. Daniel MDb, Craig A. Elmets MDa, Anna Levin MDc, and Boni E. Elewski MDa| |
Real-Life Treatment Profile of Calcipotriene and Betamethasone Dipropionate Topical Suspension in Patients With Psoriasis Vulgaris
Jerry Bagel MD FAAD,1 Eugenia Levi, PharmD BCPS,2 Stephen Tyring MD PhD FAAD,3
and Melissa L.F. Knuckles MD FAAD4
AIM: To document experiences with CBD topical suspension in a US clinical dermatology setting using patient-reported outcomes (PROs).
METHODS: In total, 147 patients were enrolled in this 8-week, prospective, noninterventional, multicenter, one-arm study. Data were collected at baseline and week 8 at the office, and at one time at home (week 2). PROs were assessed using the Dermatology Life Quality Index (DLQI), Patient’s Global Assessment of disease severity (PtGA) using a 5-point Likert scale, patient-reported level of itching using a 0–100 graduated visual analog scale, and Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9). Treatment adherence and adverse events (AEs) were assessed at week 8.
RESULTS: After 8 weeks of treatment, DLQI score significantly improved compared with baseline (–5.5 ± 5.93; P<.0001), starting as early as week 2 (–4.2 ± 5.28; P<.0001). The level of itching was significantly reduced from baseline to week 2 (–19% ± 25.94%; P<.0001) and week 8 (–28.6% ± 29.14%; P<.0001). The percentage of patients with “controlled disease” (PtGA score of “clear” or “very mild”) was 34.1% at week 2 and 60.2% at week 8. At the end of treatment, mean TSQM-9 scores for effectiveness, convenience, and satisfaction domains ranged from 68 to 74. Patients reported the need to use CBD topical suspension for an average of 53.62 ± 8.05 days. Treatment-emergent AEs occurred in 3 patients.
CONCLUSION: The results of this noninterventional study are consistent with previously reported data from interventional trials and suggest that treatment with CBD topical suspension is efficacious and well tolerated and improves quality of life in patients with psoriasis vulgaris.
J Drugs Dermatol. 2014;13(11):1374-1379.
Topical Corticosteroid Treatment Choice: A Clinical and Practical Discussion of Clocortolone Pivalate Cream
Resident Rounds. Part III A. Serendipitous Improvement in Moderate to Severe Acne in Psoriasis Patients Treated With Ustekinumab: A Two-Case Series
J. Daniel Jensen MD,a Thy Huynh BS,a Jennifer Cafardi MD,b and Naveed Sami MDa| |
Efficacy of Tofacitinib for the Treatment of Moderate-to-Severe Chronic Plaque Psoriasis in Patient Subgroups from Two Randomised Phase 3 Trials
M. Alan Menter MD,a Kim A. Papp MD,b Jennifer Cather MD,c Craig Leonardi MD,d David M. Pariser MD,e
James G. Krueger MDM,f Johannes Wohlrab MD,g Mario Amaya-Guerra MD,h Andrzej Kaszuba MD,i
Oleg Nadashkevich MD,j Tsen-Fang Tsai MD,k Pankaj Gupta PhD,l Huaming Tan PhD,l
Hernan Valdez MD,m Lotus Mallbris MD,n and Svitlana Tatulych MDl
OBJECTIVES: To assess consistency of treatment effects of tofacitinib versus placebo in subgroups defined by baseline characteristics, and to ascertain whether baseline characteristics are of value in optimizing tofacitinib use.
METHODS: Pooled data from the two trials were used to evaluate ≥75% reduction in PASI from baseline (PASI75 response) in subgroups defined by age, age at psoriasis onset, gender, race, geographical region, weight, body mass index, diabetes, metabolic syndrome, tobacco/alcohol use, psoriatic arthritis, disease activity, and prior therapy.
RESULTS: Week 16 PASI75 response rates (N=1843) were 43%, 59% and 9% with tofacitinib 5 and 10mg twice daily (BID) and placebo, respectively (each P<0.0001 versus placebo). Tofacitinib 5 and 10mg BID were effective regardless of baseline characteristics. Across subgroups, tofacitinib generally produced greater response rates with the 10 versus 5mg BID dosage. Lower absolute response rates were seen in heavier patients and patients with prior biologic experience.
CONCLUSIONS: Both tofacitinib dosages demonstrated consistent efficacy versus placebo across subgroups. Lower response rates were seen in heavier patients and those with prior biologic experience. Tofacitinib 10mg BID resulted in a substantial proportion of responders regardless of baseline characteristics.
J Drugs Dermatol. 2016;15(5):568-580.
Safety Observations in 12095 Patients With Psoriasis Enrolled in an International Registry (PSOLAR): Experience With Infliximab and Other Systemic and Biologic Therapies
Alice B. Gottlieb MD PhD,1 Robert E. Kalb MD,2 Richard G. Langley MD,3 Gerald G. Krueger MD,4
Elke M.G.J. de Jong MD PhD,5 Lynn Guenther MD,6 Kavitha Goyal MD,7 Steven Fakharzadeh MD PhD,7
Marc Chevrier MD PhD,7 Stephen Calabro MS,7 Wayne Langholff PhD,8 Alan Menter MD9
OBJECTIVE: To evaluate the incidence of adverse events of interest (AEIs), including all-cause mortality, major adverse cardiovascular events (MACE), malignancy (excluding nonmelanoma skin cancer), and serious infections (SI), in patients treated for psoriasis in clinical practice settings.
METHODS: PSOLAR is a large, ongoing, observational study of patients receiving, or eligible to receive, biologic or systemic therapy for psoriasis. Cumulative incidence rates of AEIs per 100 patient-years (PY) are reported across treatment cohorts: (1) infliximab, (2) ustekinumab, (3) other biologics (eg, adalimumab and etanercept), and (4) non-biologic agents. Significant predictors of each AEI were identified using Cox proportional hazards regression methodology.
RESULTS: PSOLAR is now fully enrolled at 12095 patients followed for 31818PY. The cumulative rate was 0.46/100PY for death, 0.36/100PY for MACE, 0.68/100PY for malignancy, and 1.50/100PY for SI. Increasing age was a significant predictor of all AEIs. A history of cardiovascular disease, malignancy, and significant infection was associated with a higher risk of developing MACE, malignancy, and SI, respectively. Exposure to infliximab (Hazard Ratio [HR]=3.101, P<0.001) and exposure to other biologics (HR=1.736, P<0.001) were significant predictors of SI. Use of immunomodulators (HR=1.954, P=0.005) was a significant predictor of MACE. Compared with non-biologic therapy, the use of biologic agents was not a significant predictor of death, MACE, or malignancy.
CONCLUSIONS: Based on PSOLAR data through 2013, no new safety concerns were observed with infliximab for all-cause mortality, MACE, or malignancy; the data suggest that infliximab was associated with serious infections.
J Drugs Dermatol. 2014;13(12):1441-1448.
Ustekinumab Improves Health-Related Quality of Life in Korean and Taiwanese Patients With Moderate to Severe Psoriasis: Results from the PEARL Trial
Objectives: To evaluate the effect of ustekinumab on HRQoL in Korean/Taiwanese patients with moderate to severe psoriasis enrolled in the phase III, randomized, double-blind, placebo-controlled PEARL study.
Methods: In the PEARL study, 121 patients were randomized to receive ustekinumab 45 mg at weeks 0, 4, and 16 (n=61) or placebo at weeks 0 and 4 with crossover to ustekinumab at weeks 12 and 16 (n=60). A major secondary endpoint was the change in Dermatology Life Quality Index (DLQI) from baseline at week 12. Other endpoints included the change in individual DLQI domains, proportion of patients achieving DLQI ≤ 1 (no negative effect), and proportion of patients achieving ≥ 5-point reduction in DLQI (clinically meaningful improvement) at week 12.
Results: At baseline, psoriasis had a very large effect on HRQoL (average DLQI, 15.7). At week 12, patients treated with ustekinumab 45 mg had significantly greater improvement from baseline in DLQI scores compared with placebo (mean decrease, 11.2 vs 0.5 (P<0.001). Likewise, 32.2% and 1.7% of patients receiving ustekinumab 45 mg and placebo, respectively, achieved a DLQI ≤ 1, and 81.4% and 18.3% achieved ≥5-point reduction (both P<0.001 vs placebo). Individual DLQI domains in the ustekinumab group were significantly improved compared with placebo (P<0.001). For ustekinumab-randomized patients, HRQoL improvements were sustained through week 28. Placebo patients who crossed over to ustekinumab experienced similar improvements compared with those randomized to ustekinumab.
Conclusions: Ustekinumab significantly improves HRQoL in Korean/Taiwanese patients with moderate to severe psoriasis.
J Drugs Dermatol. 2012;11(8):943-949.
Randomized Pilot Clinical Trial of Tofacitinib Solution for Plaque Psoriasis: Challenges of the Intra-Subject Study Design
William C. Ports DVM,a Steven R. Feldman MD PhD,b Pankaj Gupta PhD,a Huaming Tan PhD,a Theodore R. Johnson PhD,c and Robert Bissonnette MDd| |
J Drugs Dermatol. 2015;14(8):777-784.
Meng Chen MD, Michael J. Holland MD, Mohsin R. Mir MD, Michael G.Wong BA, Brian P. Kelley MD, Kelli D. Grim MD, Sunaina S. Bhuchar MD, Sylvia Hsu MD| |
J Drugs Dermatol. 2011;10(3):280-284.
Jamie Surovik MD, Catherine Riddel MD, Susan Y. Chon MD| |
Atypical Presentation of Histoplasmosis in a Patient With Psoriasisand Psoriatic Arthritis on Infliximab Therapy
Qurat ul Ain Kamili MD and Alan Menter MD| |
Manal Salah MD, Nevien Sami PhD, Maha Fadel PhD| |
An Update on the Long-Term Safety Experience of Ustekinumab: Results From the Psoriasis Clinical Development Program With up to Four Years of Follow-Up
Objective: To evaluate the safety of ustekinumab in patients with moderate to severe psoriasis treated for up to four years.
Methods: Safety data were pooled across four Phase II/III randomized controlled trials. Rates over time and cumulative rates of adverse events (AEs), AEs leading to treatment discontinuation, serious adverse events (SAEs), serious infections, malignancies, and major adverse cardiovascular events (MACE) (i.e., cardiovascular death, myocardial infarction [MI], or stroke as adjudicated by an independent panel of academic cardiologists) were evaluated. Observed rates of AEs of interest were compared with those expected in the general (malignancies, MI, and stroke) and psoriasis (serious infections, MI, and stroke) populations.
Results: Overall, 3,117 patients were followed for up to four years (6,791 patient-years). Rates of AEs, AEs leading to treatment discontinuation, and SAEs remained stable over time, whereas cumulative rates were generally comparable between patients who received 45 mg and 90 mg of ustekinumab. The rates of AEs of interest also remained stable over time, and cumulative rates per 100 patient-years were 0.80 and 1.32 (serious infections), 0.70 and 0.53 (nonmelanoma skin cancer), 0.63 and 0.61 (other malignancies), and 0.56 and 0.46 (MACE) in patients treated with 45 mg and 90 mg, respectively. Rates of AEs of interest were consistent with those in the general and psoriasis populations.
Conclusion: The safety profile of long-term ustekinumab treatment with up to four years of continuous use remains consistent with previous reports, with no evidence of cumulative toxicity.
J Drugs Dermatol. 2012;11(3):300-312
A Retrospective Study to Investigate Racial and Ethnic Variations in the Treatment of Psoriasis With Etanercept
Objectives: Psoriasis is a chronic inflammatory condition that occurs worldwide; however, few studies have examined this condition in non-Caucasian populations. The purpose of this study was to investigate racial/ethnic differences in demographics, psoriasis severity,
efficacy, safety, and health-related quality of life in patients treated with etanercept using data from the Etanercept Assessment of Safety and Effectiveness (EASE) in Psoriasis trial.
Patients and Methods: This is an investigator-initiated evaluation of data from the EASE study.
Results:The study included 2511 patients (Caucasian n=2164; Hispanic/Latino n=173; African American n=98; Asian n=76). Although baseline Physicians' Global Assessment (PGA) scores were similar, we found significant baseline differences in patient characteristics, prior therapy, percentage of body surface area (%BSA) affected and Dermatology Life Quality Index (DLQI) scores between the groups. At baseline, the Caucasian group had the longest disease duration (19 years), but the lowest percentage of BSA involvement (28%). The Asian group had the highest percentage of BSA involvement (41%). Baseline DLQI score was lowest for Caucasians (12.0) and highest for Hispanic/Latinos (14.6).
At week 12, response to therapy was similar in all ethnic/racial groups. The BSA involvement was reduced by more than 50 percent for all groups, but remained significantly higher for the Asian group (17%) than for the Caucasian (13%; P=0.0105) and African American groups (13%; P=0.0461).
At week 12, the mean Asian DLQI score of 5.2 was significantly higher (worse) than scores for the Caucasian (3.5; P=0.0001) and Hispanic/Latino groups (3.8; P=0.028). For both percentage of BSA and DLQI, differences among racial/ethnic groups in the percentage improvement from baseline were not statistically significant. Adverse event rates were similar for the groups.
Conclusions:Patient characteristics at enrollment differed among ethnic groups, but no significant racial/ethnic differences were found in safety or efficacy of etanercept. However, racial/ethnic differences in the impact of psoriasis on quality of life were observed.
J Drugs Dermatol. 2011;10(8):862-868.
Joseph Gadzia MD and James Turner MD PhD| |
J Drugs Dermatol. 2012;11(2):247-249.
Skin Microbiome in Patients With Psoriasis Before and After Balneotherapy at the Thermal Care Center of La Roche-Posay
Richard Martin MSc,a Jessica B. Henley PhD,b Patrick Sarrazin MD,c and Sophie Seité PhDd| |
METHODS: This open label study was conducted between July and September 2012. Microbial communities of patients with psoriasis vulgaris were characterized prior and post a 3-week selenium-rich water balneotherapy treatment at the thermal care center La Roche-Posay (La Roche-Posay, France). Balneotherapy consisted of high-pressure filiform showers, baths, facial, and body spray treatments as well as La Roche-Posay thermal spring water (LRP-TSW) consumption. Swabs were taken from affected and proximal unaffected skin and the 16S rRNA bacterial gene was used to analyze the composition of bacterial communities. Using the same 16S rRNA gene tool, we tried to describe the LRP-TSW bacterial landscape.
RESULTS: This study included 54 patients diagnosed with moderate to severe forms of psoriasis vulgaris. After eliminating individuals lacking paired samples from both visits, 29 individuals were analyzed for their microbiome profile. Shannon Diversity Index and global bacterial landscape indicate similar microbial communities on both unaffected and adjacent affected skin. PASI values decreased post-balneotherapy implying improvement of disease severity. No significant change in the Shannon Diversity Index was noticed at the end of the third week. The average taxonomic composition of skin microbial communities associated with unaffected and affected skin of psoriatic patients post-balneotherapy shows that treatment with LRP-TSW significantly increased the level of Xanthomonas genus and, to a lesser extent, Corynebacterium genus. The Xanthomonas genus belongs to the main Xanthomonadaceae family found in LRP-TSW and also on healthy skin.
CONCLUSIONS: In psoriatic patients, a poor bacterial biodiversity was noticed and the bacterial communities were similar on unaffected and affected adjacent skin. Family analysis identified, for the first time, Xanthomonadaceae belonging to Proteobacteria phylum and known to be keratolytic, associated with the clinical improvement observed after a 3-week balneotherapy treatment. This data supports the interest of selenium-rich thermal spring water in the treatment of psoriasis vulgaris.
J Drugs Dermatol. 2015;14(12):1400-1405.
Jacqueline E. Greb BA MS4,a Joseph Merola MD MMSC,b Amit Garg MD,c John Latella, Leah Howard JD,d Nayan Acharya MBBS MRCP MFPM, and Alice B. Gottlieb MD PhDa| |
J Drugs Dermatol. 2016;15(5):641-644.
Photodynamic Therapy Induces Less Pain in Patients Treated with Methyl Aminolevulinate Compared to Aminolevulinate Acid
A. Kasche MD, S. Luderschmidt MD, J. Ring MD, R. Hein MD| |
Calcitriol Ointment: A Comprehensive Review of a New Vitamin D3 for the Long Term Management of Psoriasis
Leon Kircik, MD| |
A Randomized, Prospective, Sham-Controlled Study of Localized Narrow-Band UVB Phototherapy in the Treatment of Plaque Psoriasis
Adriane A. Levin BA,a,b Saud Aleissa MD,a Nicole Dumont,a Francisca Martinez,a Courtney Donovan RN,a
Shiu-chung Au MD,a Afnan Hasanain MD,a and Alice B. Gottlieb MD PhDa,c
OBJECTIVE: We aimed to evaluate the efficacy of the Levia® localized NB-UVB phototherapy machine in the treatment of patients with symmetrical psoriatic lesions.
DESIGN: We performed a prospective, double-blinded, sham-treatment controlled study of this device beginning March 2012 through April 2014.
SETTING: a comprehensive dermatology clinic in the northeastern United States.
PARTICIPANTS: 21 subjects with chronic plaque psoriasis.
INTERVENTIONS: Each patient had one lesion randomized to receive the Levia treatment and one lesion (the control) treated with visible light. Treatment was administered three times a week for twelve weeks. Target lesion score (TLS), a rating of 0-4 each of erythema, scaling, and thickness, was measured biweekly by a blinded assessor, and visual analogue scale of pruritus was recorded by subjects.
MAIN OUTCOMES AND MEASURES: The primary outcome, formulated prior to study initiation, was the percentage of lesions achieving clear or almost clear TLS after 12 weeks of treatment. Secondary endpoints included changes in target lesion pruritus VAS, percentage improvement in TLS, and the percentage of subjects achieving 50% improvement in TLS (TLS-50).
RESULTS: The primary endpoint, TLS of three or less, was not achieved (P=0.118), but the secondary endpoints of percentage improvement in TLS (P=0.043) and TLS-50 (P=0.0195) were significantly superior in treated compared to sham-treated lesions. Percentage improvement in pruritus VAS was not significant (P=0.0565).
CONCLUSIONS AND RELEVANCE: This device was found to be efficacious, though not necessarily to the point of clearance, in the treatment of psoriasis over a 12-week period.
TRIAL REGISTRATION: www.clinicaltrials.gov, identifier: NCT02107482, http://clinicaltrials.gov/show/NCT02107482
J Drugs Dermatol. 2014;13(8):922-926.
Analysis of Body Regions and Components of PASI Scores During Adalimumab or Methotrexate Treatment for Patients With Moderate-to-Severe Psoriasis
Alexander A. Navarini MD,a Yves Poulin MD,b Alan Menter MD,c Yihua Gu MS,d and Henrique D. Teixeira PhDd| |
OBJECTIVE: Highlight treatment response patterns potentially hidden by PASI score's compounded weighted-average calculation.
METHODS: Patients with moderate-to-severe psoriasis enrolled in the phase-3, 16-week, randomized CHAMPION study, and received adalimumab, methotrexate, or placebo. PASI scores were assessed post hoc for improvement, by body region and component.
RESULTS: At Week 16, a significantly greater percentage of adalimumab-treated patients vs methotrexate- and placebo-treated patients, achieved PASI 75, PASI 90 and PASI 100 response in each body region and component. 55.7% of adalimumab-treated patients reached PASI 100 response in the head and neck region vs 16.7% overall. Two key components of PASI, induration and desquamation, were affected by treatment more than erythema, the third component. Adalimumab was particularly effective in complete resolution of induration (44.9% of patients) vs methotrexate (10.9%). For all PASI body regions and components, mean percent improvement in score at Weeks 2, 4, 8, 12, and 16 was significantly greater (P<0.05) for adalimumab treatment vs methotrexate or placebo.
CONCLUSION: Adalimumab therapy resulted in complete resolution of individual body regions in at least 30.6% up to 55.7% of patients in CHAMPION. This was more than twice that of methotrexate and placebo. PASI improvement by body region is a novel and an important patient-relevant outcome worthy of reporting in future studies.
J Drugs Dermatol. 2014;13(5):554-562.
Review of Cyclosporine Immunosuppressive Safety Data in Dermatology Patients after two Decades of Use
Shahrad M. Behnam BS, Shahdad E. Behnam MD, John Y. Koo MD| |
Paul Devakar Yesudian MRCP,a Joyce Leman FRCP,b Periasamy Balasubramaniam MRCP,a
Andy W. Macfarlane FRCP,a Firas Al-Niaimi MRCP,c Christopher E. M. Griffiths FRCP MD FMedSci,c
Arthur David Burden MD,b and Richard B. Warren FRCP PhDc
METHODS: We retrospectively reviewed case notes of 85 patients prescribed SC MTX for psoriasis in three dermatology centres in the UK (Betsi Cadwaladr University Health Board, Western Infirmary, Glasgow, and Salford Royal NHS Foundation Trust). Audit department approval was sought and granted.
RESULTS: A total of 85 patients (44 male; 41 female; age range 14 – 78 years, mean 44 years; 79 Caucasian, 6 Asian) with CPP were identified. The average duration of psoriasis was 19 years [range 3 - 60 years]. Co-morbidities included depression, diabetes mellitus, hypertension, epilepsy, obesity, ischaemic heart disease, and hyperlipidaemia; 29 patients had no associated co-morbidities. Psoriatic arthritis was noted in 18 patients.
Previous treatments included phototherapy (both narrow band ultraviolet B [TLO1] and psoralen and ultraviolet A [PUVA])(n=60), oral MTX (n=82), ciclosporin (n=37), acitretin (n=19), fumaric acid esters (n=20), hydroxycarbamide (n=6), mycophenolate mofetil (n=2), and repeated in-patient admissions (n=2). Oral MTX was stopped due to nausea (n=43), ineffectiveness (n=13) or partial response (n=11), headache (n=3), increased liver enzymes (n=2), and lethargy (n=2). The median number of systemic agents used prior to SC MTX was 3 (mean 2.65, range 1 to 6 agents). The weekly dose of SC MTX varied between 7.5mg to 30mg (mean 18.5mg, median 20mg) and had been used for 2 months to 67 months (mean 14 months; median 9 months). Folic acid supplementation was used in every patient. The patients were reviewed between 6 weeks to 3 months once treatment was fully established. Using a pre-determined “adjective list” (where specific adjectives were used to denote those who responded or did not respond to treatment), patients were classified as “responders” (n=59) or “non-responders” (n=26).
CONCLUSION: This study suggests that SC MTX is an effective option in patients with CPP who have failed oral MTX and could be a worthwhile consideration prior to commencement of a biologic agent. Furthermore, the SC route may be a viable first choice of MTX administration. A randomised controlled trial comparing oral and SC MTX is required to validate these findings.
J Drugs Dermatol. 2016;15(3):345-349.
Arielle R. Nagler| |
A Randomized Controlled Study of Combination Therapy With Alefacept and Narrow Band UVB Phototherapy (UVB) for Moderate to Severe Psoriasis: Efficacy, Onset, and Duration of Response
Objective: To assess the efficacy of alefacept in combination with nbUVB phototherapy compared to alefacept alone in subjects with moderate to severe psoriasis.
Methods: Ninety-eight adults with moderate to severe psoriasis were randomized to treatment with alefacept 15 mg intramuscularly (IM) once weekly for 12 weeks alone or in combination with three times weekly nbUVB treatments in this prospective, open-label, assessor-blinded, randomized, multicenter, parallel-group, 36-week study.
Results: A statistically significantly greater proportion of subjects in the alefacept plus nbUVB arm achieved the primary endpoint of PASI 75 at week 16 compared to subjects in the alefacept alone arm (44.9% vs 22.5%, P=0.032). Secondary outcomes were also in favor of the alefacept plus nbUVB group, including the proportion of subjects achieving a Physician Global Assessment (PGA) score of clear or almost clear at any time during the study (59.2% vs 34.7%, P=0.026) and reduction in percent body surface area (BSA) involved with psoriasis at week 16 (13.4% vs 8.0%, P<0.001). The onset of clinical response was significantly faster in the combination therapy group compared to monotherapy (mean time to PASI 75: 82 vs 107 days, P=0.007). Both treatments were generally well tolerated.
Limitations: Open-label, assessor-blinded study without a phototherapy-only treatment arm.
Conclusion: The addition of nbUVB to treatment with alefacept significantly enhanced and accelerated the clinical benefits of alefacept therapy and was generally safe and well-tolerated.
J Drugs Dermatol. 2012;11(8):929-937.
Leon H. Kircik, MD and Jeffrey M. Weinberg, MD| |
Adverse Medical Conditions Across Treatment Options in Patients With Psoriasis: A Claims-Based Analysis
Jashin J. Wu MD,a April Armstrong MD MPH,b Rakesh Singh PhD,c Martin Cloutier MSc,d Marjolaine Gauthier-Loiselle PhD,d Patrick Gagnon-Sanschagrin MSc,d Dilek Arikan MD,c Alan Fleischer MD,e Annie Guérin MSc,d Arijit Ganguli PhDc| |
No Association Between TNF Inhibitor and Methotrexate Therapy Versus Methotrexate in Changes in Hemoglobin A1C and Fasting Glucose Among Psoriasis, Psoriatic Arthritis, and Rheumatoid Arthritis Patients
Jashin J. Wu MD,a Christopher G. Rowan PhD,b Judith D. Bebchuk ScD,c and Mary S. Anthony PhDd| |
OBJECTIVE: To compare changes in hemoglobin A1C and fasting glucose for patients exposed to TNFi.
METHODS: In this retrospective cohort study, patients with at least 3 recorded diagnosis codes for psoriasis, psoriatic arthritis, or rheumatoid arthritis between January 1, 2004 and July 31, 2011. Patients were Kaiser Permanente Southern California members for at least 1 year prior to the index date.
RESULTS: For hemoglobin A1C, there were 344 patients in the MTX cohort, and 118 patients in the TNFi+MTX cohort. In the covariate adjusted main effects ANCOVA model, the TNFi+MTX cohort had a lower mean change in hemoglobin A1C of -0.18mg/dL (95% CI: -0.35, -0.01) compared to the MTX cohort, although the difference is small and this model was not complete as there were significant interactions. For fasting glucose, there were 524 patients in the MTX cohort, and 121 patients in the TNFi+MTX cohort. In the covariate adjusted main effects ANCOVA model, change in fasting glucose was not significantly different between groups: -0.58 mg/dL (95% CI: -5.05, 3.88) for the TNFi+MTX cohort compared to the MTX cohort, although this model was not complete as there was a significant interaction.
CONCLUSIONS: The use of TNF inhibitors with MTX was not associated with a significant difference in the change of hemoglobin A1C or fasting glucose compared to MTX alone.
J Drugs Dermatol. 2015;14(2):159-166.
Noah Scheinfeld, MD| |
Noah Scheinfeld, MD,JD| |
Nicole D. Cresce BS,a Scott A. Davis MA,a William W. Huang MD MPH,a Steven R. Feldman MD PhDa,b,c| |
PURPOSE: We review available literature to assess the HRQL impact of acne and rosacea and compare them with major medical conditions.
METHODS: A PubMed search identified studies that utilized the Short Form 36 (SF-36), the Dermatology Life Quality Index (DLQI), and the willingness-to-pay (WTP) metric to assess the HRQL impact of acne and rosacea. These data were compared to HRQL values for other diseases.
RESULTS: The HRQL impact of acne is similar to asthma, epilepsy, diabetes, back pain, arthritis, and coronary heart disease using SF-36 data. DLQI scores for acne ranged from 2 to 17.7 and for rosacea ranged from 4.3 to 17.3; the DLQI scores for psoriasis ranged from 1.7 to 18.2. WTP data identified ranged widely for both acne and rosacea.
LIMITATIONS: There was limited broadly generalizable data for acne and rosacea.
CONCLUSIONS: Acne and rosacea impact HRQL to a similar degree as other major medical conditions by indirect comparison to psoriasis, a skin condition causing significant disability, and by direct comparison for acne. In the setting of limited health care resources, allocation should be grounded in the evidence that acne and rosacea are not trivial in their effects.
J Drugs Dermatol. 2014;13(6):692-697.
Adverse Drug Events in Inﬂiximab-treated Patients Compared With the General and Psoriasis Populations
Alan Menter MD, Kristian Reich MD, Alice B. Gottlieb MD PhD, Mohan Bala PhD, Shu Li MS, Ming-Chun Hsu PhD, Cynthia Guzzo MD, Joris Diels MSc, Joel M. Gelfand MD MSCE| |
Methods: Integrated data (n=1373 patients) were compared with external databases.
Results: The analyses reported here are based on 1106 patient years and 116 patient years of follow-up in the inﬂiximab group and the placebo group, respectively. The standardized mortality ratio in inﬂiximab-treated patients (0.17 [95% conﬁdence interval [CI]: 0.00-0.92], 1 patient died) was lower than that of the general PsO population. No death occurred in the placebo group. Comparing with the psoriasis population, the standardized incidence ratios (SIRs) for hospitalization were 1.16 (95%CI: 0.92-1.43) in inﬂiximab-treated patients and 1.07 (95%CI: 0.46-2.11) in placebo-treated patients. For serious infection, the SIRs were 1.28 (95%CI: 0.78-1.97) in inﬂiximab-treated patients and 1.47 (95% CI: 0.18-5.32) in placebo patients. The incidence of tuberculosis (TB) among inﬂiximab-treated patients was 0.18 per 100 pa- tient-years (95% CI: 0.02-0.65). No TB occurred in the placebo group. Standardized incidence ratio for malignancy (excluding nonmelanoma skin cancers) was 0.39 (95% CI: 0.05-1.42; 2 malignancies) in inﬂiximab-treated patients. No malignancy occurred in the placebo group.
Limitations: Exclusion criteria in clinical studies may bias selection of subjects who are healthier than the general population. Additionally, the limited number of patients followed over a maximum of 1 year can limit the ability to detect infrequent events or those events that require prolonged follow-up to detect. Nonmelanoma skin cancers were excluded from the analysis. Finally, populations and adverse event deﬁnitions may have differed in external databases and studies.
Conclusion: Based on the data from external databases, mortality, hospitalization, and serious infection rates in inﬂiximab-treated patients were generally comparable to or less than that of the PsO population. Internal malignancy rates were similar to that expected in the general US population. However, the limitations of these data must be considered when compared with the totality of the safety proﬁle of inﬂix- imab generated across all indications.
Increased Prevalence of Cancer in Adult Patients With Psoriasis in the United States: A Claims Based Analysis
Alexandra B. Kimball MD MPH,a Murali Sundaram PhD,b Martin Cloutier MSc,c Marjolaine Gauthier-Loiselle PhD,c Patrick Gagnon-Sanschagrin, MSc,c Annie Guérin MSc,c and Arijit Ganguli PhDd| |
Andrea Chiricozzi MD,a Francesca Specchio MD,b Annunziata Dattola MD,b Monika Fida MD,c
Luca Bianchi MD,b and Sergio Chimenti MD,b
and Rosita Saraceno MDb
OBJECTIVE: The aim of this study is to detect electrophoretic abnormalities in psoriatic patients undergoing treatment with infliximab.
RESEARCH DESIGN AND METHODS: A retrospective study evaluating all charts from the clinic database of all patients treated with infliximab. The evaluation of serum protein profile is routinely performed in the clinical setting during biologic therapies. We reported the occurrence MGUS in infliximab-treated patients.
RESULTS: The study analysis included 141 charts. Overall, 23 patients showed a MGUS in their electrophoretic profile, though in 6 cases MGUS was detected at the baseline. Thereby, 17 cases (12.06% of the study population) developed MGUS during infliximab therapy.
CONCLUSIONS: Serum protein electrophoresis test represents a useful tool to detect and monitor any potentially harmful condition that could occur during treatment with a biologic agent. Particularly, it could be crucial for the detection of MGUS, which does not affect clinical response, and it does not represent a criteria to withdraw the treatment.
J Drugs Dermatol. 2016;15(2):134-138.
Effects of Ustekinumab Administration on Primate/Human Antigen-recall and Humoral Immune Response Functions
Carrie Brodmerkel PhD, Yaowei Zhu PhD, Qun Jiao MS, Joel Cornacoff PhD DVM,George Treacy MS, Mary Ann Mascelli PhD, Alice B. Gottlieb MD PhD| |
Jeffrey M. Weinberg, MD; Ritu Saini, BA and William D. Tutrone, BS| |
Jeffrey M. Weinberg, MD, FAAD| |
Topical Desoximetasone 0.25% Spray and Its Vehicle Have Little Potential for Irritation or Sensitization
Anish Nadkarni BS, Mohammed D. Saleem MD, and Steven R. Feldman MD PhD| |
BACKGROUND: Topical corticosteroids are the most common dermatologic medications and are available in numerous different vehicles. Adherence is limited by traditional vehicles because they are messy and time consuming to apply. The preferred spray formulations have the advantage of being applied with ease, resulting in improved adherence and subsequently improved psoriasis. One limitation of topical treatments, especially spray vehicles, is the potential for irritation and sensitization.
OBJECTIVE: To evaluate the irritation and sensitization potential of topical desoximetasone spray formulation.
METHODS: A multicenter, double-blinded, randomized, controlled study assessed the irritancy and sensitization of 0.25% and 0.05% topical desoximetasone spray. Controls included vehicle, a positive control (0.1% sodium lauryl sulfate), negative control (0.9% saline), and an active comparator control (clobetasol spray). The primary outcome of the study was to evaluate the difference in mean cumulative irritation and potential sensitization response of desoximetasone 0.25% and 0.05% topical sprays.
RESULTS: Of the 297 enrolled, 269 completed the study per protocol for the irritation phase and 250 completed the protocol for the sensitization phase. At 22 days, desoximetasone 0.25 and 0.5% spray were less irritating than clobetasol 0.05% spray; mean irritation score difference of -0.46 and -0.57, respectively. Median total irritation score over the 22 days was 0 for all products. No subjects demonstrated any sensitization reaction to any of the six products. No serious adverse reactions were reported.
LIMITATIONS: Selection bias, use of a healthy population, limits the external validity. In addition, the duration of the study was short lived, unlike numerous inflammatory skin diseases. Conclusions: Desoximetasone spray has little potential for irritation or sensitization. The availability of another spray option for patients desiring less messy treatment may facilitate better adherence and treatment outcomes.
J Drugs Dermatol. 2017;16(8):755-758.
Josephine A. Taverna MD, Arash Radfar MD, Alice Pentland MD, George Poggioli MD, Marie-France Demierre MD FRCPC| |
Brian Berman MD PhD,a,b Charles Ellis MD,c and Craig Elmets MDd,*| |
J Drugs Dermatol. 2016;15(2):224-228.
Kristin Noiles BSc and Ronald Vender MD FRCPC| |
Methods: An in-depth literature review was conducted using PubMed and MEDLINE. Randomized, controlled trials utilizing biologic agents as monotherapy for the treatment of psoriasis were analyzed for patient numbers over time. Studies which provided data on patient retention for at least 24 weeks were selected, graphed, and compared. Reasons for discontinuation were noted.
Results: Nineteen trials were selected, graphed and charted to compare attrition rates of the various biologic therapies. Due to differences in sample size, study design, dosing regimens, study duration and limited data with regards to patient numbers, it is difficult to reach a definitive conclusion as to which biologic agent is associated with the lowest rate of discontinuation. However, given the data available, etanercept appears to be the most successful therapy in terms of patient retention in studies both greater than and less than 30 weeks. For the studies using various dosing regimens, intrastudy attrition rates are also compared.
Conclusion: While the data available thus far on patient retention for the biologic therapies are very limited, preliminary conclusions can be drawn. Among the available biologic agents, etanercept appears to be associated with the lowest rate of discontinuation. This may be due to greater superior effiacy and to a decreased likelihood of experiencing adverse events.
Gastrointestinal Signs and Symptoms Related to Inflammatory Bowel Disease in Patients With Moderate-to-Severe Psoriasis
Steven R. Feldman MD PhD,a Bhaskar Srivastava MD PhD,bJill Abell MPH PhD,b Timothy Hoops MD,b Steve Fakharzadeh MD,c Soumya D. Chakravarty MD PhD,b,d Erik Muser PharmD MPH,b Danielle Dungee BA,b Sean T. Quinn BSc,b Megan Leone-Perkins PhD,e Michael D. Kappelman MD MPHf| |
Valrubicin Activates PKCα in Keratinocytes: A Conceivable Mode of Action in Treating Hyper-Proliferative Skin Diseases
Ina Groenkjaer Laugesen MD,a Eva Hauge,a Stine Maria Andersen MD,a Karin Stenderup PhD,a
Elisabeth de Darkó MD,b Tomas Norman Dam MD PhD,c and Cecilia Rosada PhDa
OBJECTIVE: The aim of the present study was to investigate valrubicin’s mode of action in keratinocytes by studying its possible effect on PKCα activation.
METHODS: PKCα's characteristic to translocate from the cytoplasm to the cellular membrane when activated was assessed by measuring the amount of PKCα in the soluble and membrane-bound protein fractions isolated from valrubicin stimulated keratinocytes and by visualizing PKCα in stimulated cells over time. Downstream signaling was investigated by measuring the amount of phosphorylated Myristoylated Alanine-rich C-kinase substrate (MARCKS) and extracellular signal-regulated kinases (ERK) 1/2 of valrubicin-stimulated keratinocytes. To investigate whether there was a direct interaction between valrubicin and PKCα, an activity assay employing purified PKCα protein was used.
RESULTS: Valrubicin activates PKCα in vitro as shown by PKCα's translocation and phosphorylation of downstream signaling molecules.
CONCLUSION: Valrubicin stimulates PKCα activity and downstream signaling which may contribute to its beneficial effect in psoriasis and NMSC.
J Drugs Dermatol. 2013;12(10):1156-1162.
Michael J. Fellner MD FAADa and Nicholas Yohe BSb| |
J Drugs Dermatol. 2013;12(10):1168-1169.
Collin M. Costello MD,a Melody Maarouf MHS,b Vivian Y. Shi MDb| |
Danah M. Holman, Amer N. Kalaaji MD| |
Danielle Tartar PhD,a Tina Bhutani MD,b Monica Huynh BA,c Timothy Berger MD,b and John Koo MDb| |
J Drugs Dermatol. 2014;13(5):564-568.
Melvin Lee, John Koo MD| |
Background: Some dermatologic disorders are known to be much more common in patients of color, but the leading dermatologic
disorders in patients of color have not yet been described on the basis of nationally representative data.
Purpose: To determine the leading dermatologic disorders for each major racial and ethnic group in the United States.
Methods: We queried the National Ambulatory Medical Care Survey (NAMCS) for the leading diagnoses in patient visits to U.S. dermatologists from 1993 to 2009. The leading diagnoses were tabulated for each racial and ethnic group, and the top conditions were compared between groups. In a separate analysis, visits for skin conditions regardless of physician specialty were analyzed for leading diagnoses in each racial and ethnic group.
Results: The top five diagnoses for African-American patients in dermatology clinics were acne, unspecified dermatitis or eczema, seborrheic dermatitis, atopic dermatitis, and dyschromia. For Asian or Pacific Islander patients, the top five were acne, unspecified dermatitis or eczema, benign neoplasm of skin, psoriasis, and seborrheic keratosis. By contrast, in Caucasian patients, the top five were actinic keratosis, acne, benign neoplasm of skin, unspecified dermatitis or eczema, and nonmelanoma skin cancer. In Hispanic patients of any race, the leading diagnoses were acne, unspecified dermatitis or eczema, psoriasis, benign neoplasm of skin, and viral warts. When the leading dermatologic diagnoses across all physician specialties were assessed, the top diagnoses for African-Americans were unspecified dermatitis or eczema, acne, dermatophytosis of scalp and beard, sebaceous cyst, and cellulitis or abscess; for Asians or Pacific Islanders were unspecified dermatitis or eczema, acne, atopic dermatitis, urticaria, and psoriasis; and for Caucasians were acne, unspecified dermatitis or eczema, actinic keratosis, viral warts, and sebaceous cyst. For Hispanics of any race, they were unspecified dermatitis or eczema, acne, sebaceous cyst, viral warts, and cellulitis or abscess. For a sole diagnosis of a dermatologic condition, only 28.5% of African-Americans' visits and 23.9% of Hispanics' visits were to dermatologists, as compared to 36.7% for Asians and Pacific Islanders and 43.2% for Caucasians.
Limitations: The data are based on numbers of ambulatory care visits rather than numbers of patients. Data on race or ethnicity were not collected for some patients.
Conclusions: Several dermatologic disorders are much more commonly seen in patients of color. Acne and unspecified dermatitis or eczema are in the top five for all major U.S. racial and ethnic groups. There may be an opportunity to improve the care of patients of color by ensuring they have equal access to dermatologists.
J Drugs Dermatol. 2012;11(4):466-473.
Safety and Tolerability of Ixekizumab: Integrated Analysis of Injection-Site Reactions from 11 Clinical Trials
Neil H. Shear MD FRCPC,a Carle Paul MD PhD,b Andrew Blauvelt MD MBA,c Melinda Gooderham MD MSc FRCPC,d Craig Leonardi MD,e Kristian Reich MD PhD,f Mamitaro Ohtsuki MD PhD,g Beth Pangallo RN,h Wen Xu PhD,h Susan Ball PhD,h Terri Ridenour MBA BSN,h Hitoe Torisu-Itakura MD PhD,i Noah Agada, MD MPH,h and Lotus Mallbris MD PhDh| |
BACKGROUND: Injection-site reactions (ISRs) are reported with biologic therapies. The objective of this study was to comprehensively characterize ISRs among moderate-to-severe psoriasis patients treated with ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin (IL)-17A.
METHODS: ISRs are presented from UNCOVER-1, UNCOVER-2, and UNCOVER-3 (12 weeks) and all ixekizumab-exposed patients in 11 controlled and uncontrolled trials (156 weeks).
RESULTS: At week 12, reported ISR frequency with 80 mg ixekizumab every 2 weeks (IXE Q2W, 16.8%) was comparable with etanercept twice weekly (16.4%); both were significantly higher than placebo (3.3%). With IXE Q2W, ISRs were mild (12.3%), moderate (3.9%), or severe (0.7%), typically reported in the first 2 weeks (median onset, 6.6 days), and most commonly characterized as nonspecified, erythema, and pain. Generally, erythema onset was delayed, whereas pain occurred around drug administration. Discontinuation from ixekizumab due to ISRs (0.4%) occurred in the first 12 weeks. After 2 weeks, ISR frequency decreased and remained stable (≤4.2%) through week 156. No ISR-related serious adverse events were reported in ixekizumab-treated patients. ISR data were solicited if patients reported injection-associated events. Since nonspecified ISR was the most commonly reported term, specific types might be underreported.
CONCLUSIONS: ISRs have been reported with ixekizumab during clinical trials. These reactions are typically tolerable, manageable, and decrease over time.
Clinicaltrials.gov: NCT01474512 (UNCOVER-1); NCT01597245 (UNCOVER-2); NCT01646177 (UNCOVER-3); NCT01777191 (UNCOVER-A); NCT01624233 (UNCOVER-J); NCT01107457 (I1F-MC-RHAJ); NCT02561806 (I1F-MC-RHBS); NCT02387801 (I1F-US-RHBO);NCT02513550 (I1F-MC-RHBP); NCT02634801 (I1F-EW-RHBZ)
J Drugs Dermatol. 2018;17(2):200-206.
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Raghavendra L. Girijala BS,a Imaad Siddiqi MD,B Young Kwak MD,c David Wright MD,c Dhruti B. Patel MD,d Leonard H. Goldberg MDc| |
Over the last 4 decades, topical retinoids have become standard therapy for the treatment of acne vulgaris. Although the market currently encompasses multiple formulations of next-generation topical retinoids, Tazorac is unique among them due to its dual role as a treatment option for both acne vulgaris and psoriasis vulgaris. Tazorac has also demonstrated that it is highly effective for the treatment of acne vulgaris as a monotherapy or in combination with other agents. Recent studies show that Tazorac can be combined effectively with dapsone 5% gel or with a benzoyl-peroxide - containing formulation to augment efficacy. Additionally, Tazorac does not have a generic substitution, so physicians can be assured that their patients will receive exactly what they have been prescribed.
Jennie T. Clarke MD, Harper Price MD, Shari Clarke MD, Rosalyn George MD, Jeffrey J. Miller MD| |
Fiona P. Blanco MD, Richard K. Scher MD FACP| |
Varun Kalhana and Neil Sadick MDb| |
Biologic drugs, a novel class of agents engineered to target specifc mediators of infammation, and small-molecule inhibitors that pen-etrate the cell membrane to interact with targets inside a cell represent the cutting-edge of pharmacological biomedical therapeutics. Clinical studies have already demonstrated the effectiveness of this new generation of drugs in treating a variety of medical illnesses and conditions that were refractory to traditional treatments. This review aims to describe the latest available or currently in-develop-ment drugs, biologic agents, and small molecule inhibitors for treatment of psoriasis, rosacea, alopecia areata, and atopic dermatitis.
J Drugs Dermatol. 2017;16(12):1224-1228
Miriam Bettencourt MD| |
J Drugs Dermatol. 2016;15(8):1026-1028.
Samreen Z. Choudhry MD,a Neal Bhatia MD,b Roger Ceilley MD,c Firas Hougeir MD,d
Robert Lieberman MD,e Iltefat Hamzavi MD,a and Henry W. Lim MDa
J Drugs Dermatol. 2014;13(2):148-153.
Pseudoepitheliomatous Hyperplasia and Transepidermal Elimination in Lepromatous Leprosy: Does T-cell Plasticity Play a Role?
Observation: A 71-year-old man presented with an infiltrative dermopathy characteristic of LL, as well as several hyperkeratotic plaques. Microscopic examination of the hyperkeratotic lesions demonstrated PEH with loss of the grenz zone and transepidermal elimination of acid-fast bacilli, whereas classic histopathologic features of LL were present at other sites.
Hypotheses: We hypothesize that: Th17 and Th22 T-cell subsets act locally to induce T-cell plasticity in LL lesions, manifesting PEH; miR-181a is normal or increased in LL lesions with PEH compared to its expressional loss in classic LL lesions; miR-21 and STAT3 are increased in LL lesions with PEH, given their association with epithelial hyperproliferation; and Cbl-b is diminished in LL lesions with PEH compared to classic LL lesions.
Conclusion: By understanding the factors that regulate T-cell and cytokine responses in leprosy, it should be possible to recognize these dynamic immunologic processes clinically and histopathologically and devise specific immunologic interventions.
J Drugs Dermatol. 2012;11(10):1233-1235.
Aanand N. Geria MD, Christina N. Lawson MD, Rebat M. Halder MD| |
J Drugs Dermatol. 2011;10(5):483-489.
Management of Moderate to Severe PlaquePsoriasis (Part II)- Clinical Update on T-CellModulators and Investigational Agents
Jeffrey M. Sobell MD, Robert E. Kalb MD,Jeffrey M. Weinberg MD| |
Maira E. Herz Ruelas MD, Minerva Gómez MD, Oliverio Welsh MD DrSc, Horacio Decanini Arcaute MD, Jorge Ocampo-Candiani MD| |
Ann R. Tucker BA,a Ashley N. Emerson MD,a Julie P. Wyatt MD,b Robert T. Brodell MDc| |
Elephantiasis nostras verrucosa is a rare disorder characterized by dermal fibrosis, hyperkeratotic, verrucous, and papillomatous le- sions that result from both chronic filarial and nonfilarial lymphedema. Various treatment options have been reported for this disease. We present a 64-year-old man with erythrodermic psoriasis and elephantiasis nostras verrucosa in whom the lesions were resolved almost completely after acitretin treatment.
J Drugs Dermatol. 2012;11(3):402-405.
Isabel Hernandez Garcia MD| |
Vicky Kwan Wong, BA; Christine Della Croce, MA; Sara Schonfeld; Anthony M. Mastrangelo, PhD and Mark Lebwohl, MD| |
Joanna L. Chan, AB; Linda Davis-Reed, MD and Alexa Boer Kimball, MD, MPH| |
Danielle Levine MD, Stephen A. Switlyk MD, Alice Gottlieb MD PhD| |
Reductions in Healthcare Resource Utilization in Psoriatic Arthritis Patients Receiving Etanercept Therapy: Results from the EDUCATE Trial
Alexa Boer Kimball MD MPH, J. Mark Jackson MD, Jeffrey M. Sobell MD, Erin E. Boh MD PhD, Steven Grekin MD, Elaine B. Yu PharmD MS, J. Michael Woolley PhD, H. Amy Xia PhD, Chiun-Fang Chiou PhD, Seth R. Stevens MD| |
The Use of an Over-the-Counter Hand Cream With Sweet Almond Oil for the Treatment of Hand Dermatitis
Joshua A. Zeichner MD,a Diane Berson MD,b Kavita Mariwalla MD,c and Angela Donald ND MScd| |
J Drugs Dermatol. 2018;17(1):78-82.
The Treatment of Inflammatory Facial Dermatoses With Topical Corticosteroids:Focus on Clocortolone Pivalate 0.1% Cream
Methods: Clocortolone pivalate 0.01% cream was applied to affected facial skin in subjects presenting with seborrheic dermatitis, contact dermatitis, atopic dermatitis, or psoriasis. Application was completed three times daily for 21 days. Assessments of erythema, edema, transudation, lichenification, scaling, pruritus and/or pain were completed at baseline and Days 4, 7, 14, and 21. Overall therapeutic response was assessed at all follow-up visits. Forty-nine subjects were entered, ranging in age from 1 month to 88 years of age. Thirty-eight subjects completed the studies, with 11 subjects lost to follow-up after the first visit. Individuals between the ages of 13 and 19 years were pre-emptively excluded to avoid potential application of a corticosteroid to acne-affected or acne-prone skin.
Results: Treatment with clocortolone pivalate 0.1% cream resulted in decreases in erythema, edema, transudation, lichenification, scaling, and pruritus/pain in 76% of treated study subjects. The overall therapeutic response in approximately two-thirds of the subjects (68%) was rated as good to excellent. There were 7 adverse events noted over the course of the study that were judged to be related to treatment, all of which were cutaneous and localized to the site of application (acneiform eruptions, burning, and folliculitis).
Conclusion: Clocortolone pivalate 0.1% cream was effective in relieving the signs and symptoms of corticosteroid-responsive inflammatory dermatoses involving facial skin, including seborrheic dermatitis, contact dermatitis, atopic dermatitis, and psoriasis. Overall, the safety profile was favorable and devoid of any treatment-related serious adverse events.
J Drugs Dermatol. 2012;11(10):1194-1198.
Joseph F. Fowler Jr. MD, Heather Woolery-Lloyd MD, Heidi Waldorf MD, Ritu Saini MD| |
Rino Cerio MD, Magdalene Dohil MD, Jeanine Downie MD FAAD, Sofia Magina MD, Emmanuel Mahé MD, Alexander J. Stratigos MD| |
Magdalene Dohil MD, Leslie Baumann MD, Hema Sundaram MD, Jason Emer MD| |
Providing optimal patient outcomes continues to be a challenge in the treatment and management of dermatologic conditions. Most physicians and patients are interested in doing everything possible to optimize the treatment of their skin disease. This is especially important in treating patients with chronic disorders such as eczema, acne, psoriasis, rosacea, photodamage and the negative effects of aging. Physicians and patients often explore the therapeutic benefits of natural ingredients as alternative or complementary treatments to conventional methods. It is important that dermatologists remain up-to-date on the research and new advances in skin care products with natural ingredients.
This is a CME supplement; visit the JDD Medical Education Library to participate in this activity and earn 1 category 1 CME Credit.
Salman Bin Dayel MDa and Khalid AlGhamdi MDb| |
Objective: To evaluate the safety and efficacy of alefacept in the treatment of vitiligo.
Methods: After providing informed written consent, 4 adult patients with widespread vitiligo (covering a body surface area ≥5%) were treated with weekly intramuscular injections of 15 mg alefacept for 12 weeks. All patients were monitored clinically, by laboratory investigation, and by digital image analysis. All patients were followed up with for 24 weeks.
Results: All patients tolerated alefacept well, without any adverse events. None of the patients showed any repigmentation. However, 1 patient developed new depigmented patches during treatment with alefacept.
Limitations: A pilot study with a small number of patients.
Conclusion: Alefacept as a monotherapy for vitiligo treatment did not result in any patient improvement, and further evaluation in larger studies may be required.
J Drugs Dermatol. 2013;12(2):159-161.
The Role of IL-17 in the Human Immune System and Its Blockage as a Treatment of Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis
Juan J. Jaller Char MD,a Jose A. Jaller MD,b Juan J. Jaller Raad MD,c Jill S. Waibel MD,b Dhaval G. Bhanusali MD,d and Neha Bhanusali MDa| |
Yamini V. Saripalli MD, Anthony A. Gaspari MD| |
Though TNF-α immunomodulation seems to be a very effective, promising treatment in several TNF-α mediated disease processes, long-term studies need to be performed to assess the risk-benefit ratio of using these drugs over an extended period of time.
Alexandra Barsell MD, Monica Rengifo-Pardo MD, and Alison Ehrlich MD MHS| |
BACKGROUND: Biologics have transformed the treatment of psoriasis and psoriatic arthritis, but at a significant cost to payers and patients. The introduction of biosimilars into the US market could reduce costs while increasing access to biologic medications.
OBJECTIVE: We sought to identify gaps in biosimilar knowledge and perception among US dermatologists.
METHODS: An online survey was sent to dermatologists from January to April 2015.
RESULTS: Ninety-seven US dermatologists responded, of which 84% state they prescribe biologics in their practice. Only 37% of dermatologists were aware that a biosimilar is highly similar to a US-licensed reference biological product, 26% incorrectly described a biosimilar as a “generic” of a known biologic, and 10% of dermatologists stated they did not know the definition. Most dermatologists (88%) believe that substitutions from biologics to biosimilars will be made by pharmacists without consulting the physician. A total of 37% of dermatologists believed that a biosimilar with the same name as a biologic suggested they are “structurally identical.” Only 25% said they would likely prescribe biosimilars to their patients, while 38% stated they would try using them on a very select, small group of patients before trying it on a majority of their patients.
LIMITATIONS: Limitations include small sample size and non-responder bias.
CONCLUSION: A biosimilars knowledge gap exists amongst dermatologists, suggesting the need for more educational initiatives.
J Drugs Dermatol. 2017;16(6):612-615.
David S. Lee MD,a* Nicholas Gulati BA,b* Frank Martiniuk PhD,c William R. Levis MDd| |
J Drugs Dermatol. 2011;10(10):1192-1194.
Joshua Zeichner MDa and Sophie Seite PhDb| |
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Elizabeth S. Robinson MD,a Emily C. Murphy BS,a,b and Adam J. Friedman MDa| |
Imatinib Mesylate and Dermatology Part 2: A Review of the Cutaneous Side Effects of Imatinib Mesylate
Noah Scheinfeld MD| |
Laura F. Sandoval DO,a Scott A. Davis MA,a and Steven R. Feldman MD PhDa,b,c| |
PURPOSE: The primary aim of this study is to determine how dermatologists classify particular topical corticosteroids according to potency, and which products they prefer in cases when allergenicity is a concern.
METHODS: The data were collected and analyzed from 105 US-based dermatologists surveyed at the 2011 Summer American Academy of Dermatology meeting.
RESULTS: The majority of dermatologists were in agreement on the potency ranking of many commonly prescribed topical corticosteroids. Two thirds of the surveyed dermatologists expressed concern about allergy to topical corticosteroids. In cases of a suspected allergy, desoximetasone was the leading product dermatologists would choose to prescribe.
LIMITATIONS: The survey was limited to attendees of an educational conference, possibly leading to an overestimation of dermatologist knowledge of topical steroids.
CONCLUSIONS: This study shows that dermatologists are generally knowledgeable about group classifications of corticosteroids in terms of potency and that they can appropriately select a topical product with low potential for allergy.
J Drugs Dermatol. 2013;12(7):786-789.
Simon Nigen, MD, FRCPC; Sandra R. Knowles, BScPhm; and Neil H. Shear, MD, FRCPC| |
Shivani S. Patel BS,a Karen E. Huang MS,a Alan B. Fleischer Jr. MD,a and Steven R. Feldman MD PhDa,b,c| |
METHODS: We conducted a query of ClinicalTrials.gov for dermatologic clinical trials from 2009 to 2013 for 6 common skin conditions: acne, psoriasis, rosacea, eczema and atopic dermatitis, actinic keratosis, and skin cancer. Results were sorted by condition and number of study subjects. This study did not involve any participants apart from the researchers.
RESULTS: Although there is an increasing trend in the number of trials performed annually, the results were not significant (P=.08). The average number of patients per study has not significantly changed (P=.12), but there was a significant increase in the number of large studies (201+ subjects) conducted over time (P=.002). Although there was significant variation based on dermatologic condition studied (global statistic P=.01), only skin cancer demonstrated a significant change in the number of studies registered annually (β=10.6 studies/year, P=.04).
CONCLUSIONS AND RELEVANCE: The sky does not appear to be falling, at least not yet, with regard to continued development of treatments for patients with skin disease.
J Drugs Dermatol. 2015;14(5):497-500.
Jennifer Hayes BAa and John Koo MDb| |
The potential relationship between systemic retinoids used in dermatology and affective disorders is controversial. Acitretin, which is widely used in the treatment of psoriasis is part of this controversy secondary to its chemical relation to isotretinoin, a drug which has been associated with a large number of anecdotal case reports of depression and suicidal ideation. Moreover, an FDA package insert precaution regarding acitretin's association with depression and suicide has elevated the level of concern for patient safety. The objective of this article is to review the evidence in the literature regarding acitretin's association with affective disorders. After 12 years of worldwide use only two cases involving acitretin have been reported in the literature. In addition, despite many anecdotal cases involving isotretinoin, there have been no clinical studies that have proven a causal relationship between isotretinoin and depression or suicidal ideation. For acitretin there have been no systematic clinical studies that examine such a relationship. Moreover, it is notable that the FDA precaution regarding depression and suicide on the package insert of acitretin predates the publication of the aforementioned two cases. This suggests that a relationship between acitretin and affective disorders is a class labeling rather than a scientifically proven association.
J Drugs Dermatol. 2011;10(4):409-412.
James Q. Del Rosso DO FAOCDa and Emil Tanghetti MDb| |
J Drugs Dermatol.2013;12(3 suppl 2):s53-s58.
R. Bissonnette MD FRCPC, Y. Poulin MD FRCPC, C. Bolduc MD FRCPC, C. Maari MD FRCPC, N. Provost MD FRCPC, J. Syrotuik MA, M. Poulin-Costello MSc PStat, S. Nigen MD FRCPC| |
Methods: Fifteen subjects with PPP were randomized (2:1) to receive subcutaneous injections of either etanercept 50 mg or a place- bo twice a week for 3 months. All subjects then received the etanercept 50 mg injections twice a week for an additional 3 months.
Results: Etanercept was well tolerated by subjects with PPP. The decrease in median Palmoplantar Pustulosis Area and Sever- ity Index (PPPASI) score from baseline to 24 weeks was statistically significant for subjects treated with etanercept for 24 weeks (P = 0.038, n = 10) but not for subjects in the placebo/etanercept cross-over group (P = 0.125, n = 5). Comparison of changes in PPPASI from baseline to week 12 was not statistically significant for subjects assigned to etanercept or to placebo. Some subjects treated with etanercept presented good clinical improvements in PPP severity whereas others showed an increase in PPP severity
Conclusion: This study showed that etanercept was well tolerated in subjects with PPP and suggests that some PPP subjects might benefit from etanercept therapy. Larger studies are needed to assess PPP response to etanercept including the influence of smoking and the presence or absence of psoriasis outside palms and soles.
Apremilast for Discoid Lupus Erythematosus: Results of a Phase 2, Open-Label, Single-Arm, Pilot Study
Observations: Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) showed a significant (P<0.05) decrease after 85 days of treatment with apremilast 20 mg twice daily in 8 patients with active discoid lupus. The adverse events related to the drug were mild and transient.
Conclusions: This is the first open label study to use apremilast as a treatment modality for discoid lupus. Our observations indicate that apremilast may constitute a safe and effective therapeutic option for DLE.
J Drugs Dermatol. 2012;11(10):1224-1226.
Katerina Yale BA,a Olabola Awosika MD MS,b Monica Rengifo-Pardo MD,a,b and Alison Ehrlich MD MHSa,b| |
J Drugs Dermatol. 2017;16(10):995-1000.
Aikaterini I. Liakou MD,a Michael J. Theodorakis MD,b Bodo C. Melnik MD PhD,c
Apostolos Pappas PhD,d and Christos C. Zouboulis MD PhDa
METHODS: Nutritional clinical studies in dermatology have been reviewed using the MedLine literature source and the terms "diet" or "nutrition" and "skin".
RESULTS & CONCLUSIONS: The data on the relationship between nutrition and skin are until now controversial and much more work is needed to be done to clarify possible etiological correlations.
J Drugs Dermatol. 2013;12(10):1104-1109.
Adam J. Friedman MD FAAD,a Erika C. von Grote PhD,b Matthew H. Meckfessel PhDb| |
J Drugs Dermatol. 2016;15(5):633-639.
Progressive Multifocal Leukoencephalopathy and Reversible Progressive Leukoencephalopathy Syndrome in Dermatologic Therapy
Barry Ladizinski MD,a Misha M. Heller BA,b Tina Bhutani MD,c Kristine B. Zitelli MD,c and John Y. M. Koo MDc| |
J Drugs Dermatol. 2013;12(2):e20-e24.
A.F. Nikkels MD PhD, P. Gillard MD, G.E. Pierard MD PhD| |
Case Report: A 65-year-old woman suffered from an overlapping form of pityriasis lichenoides (OPL) for 5 years. Several initial acute episodes were controlled by successive courses of oral antibiotics, topical corticosteroids, and/or psoralen ultraviolet light-A (PUVA) therapy. The disease progressively evolved to a more chronic form. Topical immune response modifiers and corticosteroids, as well as PUVA, ultraviolet light-B (UVB), methotrexate, dapsone, and cyclosporine were introduced, but all proved ineffective. Due to the therapy multiresistance, 2 weekly injections of etanercept were administered. After 2 months, a marked improvement was observed in regards to the patient’s pruritus and inflammation. No treatment-related adverse effects were observed. Therapy was continued for 4 months without any new lesion development. However, 1 month after stopping treatment new OPL lesions recurred.
Conclusion: At the time of publication, this is the first report of the effectiveness of etanercept in OPL. This drug might be consid- ered as a therapeutic alternative for treatment multiresistant OPL.
Kircik, L.H. et al.| |
Clinical Trial Safety and Mortality Analyses in Patients Receiving EtanerceptAcross Approved Indications
Alice B. Gottlieb MD PhD,a Kenneth Gordon MD,b Edward H. Giannini MSc DrPH,c Philip Mease MD,d Juan Li PhD,e Yun Chon PhD,e Judy Maddox DO,e Haoling H. Weng MD MHS,e Joseph Wajdula PhD,f Shao-Lee Lin MD PhD,e Scott W. Baumgartner MDe| |
Patients and Methods: Forty-nine U.S. and non-U.S. trials of etanercept, involving up to 13,977 patients for approved indications, with final trial reports as of May 2006, were selected from the Amgen Inc. clinical trials database. Exposure-adjusted rates of serious infections, opportunistic infections, malignancies and deaths were reported by trial, indication and dosage.
Results: Rates of serious infections were generally similar between etanercept and controls. Overall rates of opportunistic infections and tuberculosis were low. The standardized incidence ratio (SIR) (95% CI) for malignancy was 1.00 (0.83–1.19) for all etanercept patients across all indications. The SIR for lymphoma for patients with rheumatoid arthritis was 3.45 (1.83-5.89); all other indications reported SIRs similar to those observed in the general population. The SIRs for cutaneous squamous cell carcinoma in patients with psoriasis relative to the general population with high or low sun exposure were 2.09 (1.27-3.22) and 4.96 (3.03-7.66), respectively. SIRs were less than 1.0 for all other indications regardless of sun exposure. Rates of melanoma and basal cell carcinoma were not significantly different from those in the general population. There was no increase in mortality associated with etanercept use relative to control populations.
Conclusion: These data support the overall tolerability of etanercept across approved indications.
J Drugs Dermatol. 2011;10(3):289-300.
A Novel Multifactorial Approach to Developing Mild Laundry Detergents and Assessing Their Relative Mildness
Joseph F. Fowler Jr. MD,a Matthew J. Zirwas MD,b Lisa Napolitano BS,c Meghan Russell BS,c and Janet Coope-Epstein PhDc| |
INTRODUCTION: Dermatologists are becoming more aware of the irritant and allergic potential of laundry detergents that incorporate harsh surfactants and potentially sensitizing ingredients. It is difficult however for the physician to distinguish one laundry detergent from another because the only distinguishing feature advertised tends to be the lack of dyes and fragrances.
DESIGN: A new objective method was developed for measuring the harshness of laundry detergents using a three-pronged laboratory testing approach consisting of zein, corneosurfametry, and cytokine testing. Combing these methods, a Detergent Mildness Index was created which conveniently provides a single value by which products can be compared.
Results: A new mild laundry detergent was formulated with ingredients carefully selected by dermatologists who are experts in con-tact dermatitis. The irritancy potential of the formula was measured using the Detergent mildness index score. Compared to 11 other commercial laundry detergents marketed for sensitive skin, the new formula is measurably the mildest formula.
Discussion: The Detergent Mildness Index provides dermatologists with an objective method to compare commercial laundry deter-gents. Currently the only method available is patch testing, this new test is able to more finely differentiate between products and thus enables more informed recommendations on laundry detergent choices for their patients with sensitive skin.
J Drugs Dermatol. 2017;16(12):1235-1239.
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A Randomized, Double-Blind, Placebo-Controlled Study of the Vasoconstrictor Potency of Topical 0.25% Desoximetasone Spray: A High to Super High Range of Potency (Class I to Class II) Corticosteroid Formulation
Elias Oussedik BS,a Mohammed D. Saleem MD,a Steven R. Feldman MD PhDa,b,c| |
J Drugs Dermatol. 2017;16(10):972-975.
Vitamin A and Its Derivatives in Experimental Photocarcinogenesis: Preventive Effects and Relevance to Humans
Stanley S. Shapiro PhD,a Miri Seiberg PhD,b and Curtis A. Cole PhDc| |
J Drugs Dermatol. 2013;12(4):458-463.
Inflammatory Mediators are Inhibited by a Taurine Metabolite in CpG Oligodeoxynucleotide and IFN-r Activated Macrophage Cell Line
Bo Sook Kim DVM PhD,a Daryl S. Spinner PhD,b Richard J. Kascsak PhD,b Seung Yong Park DVM PhD,c In Soo Cho DVM PhD,d Georgia Schuller-Levis PhD,e and Eunkyue Park PhDe| |
J Drugs Dermatol. 2013;12(5):551-557.
The Clinical Relevance and Therapeutic Benefit of Established Active Ingredients Incorporated into Advanced Foam Vehicles: Vehicle Characteristics Can Influence and Improve Patient Outcomes
James Q. Del Rosso DO,Ma Leon Kircik MD,b Joshua Zeichner MD,c Linda Stein Gold MDd| |
A Phase 2, Open-Label, Investigator-Initiated Study to Evaluate the Safety and Efficacy of Apremilast in Subjects With Recalcitrant Allergic Contact or Atopic Dermatitis
Research design and methods: This was a proof-of-concept, phase 2, open-label, single institution trial that evaluated the efficacy and safety of apremilast, 20 mg twice daily, for twelve weeks, in ten subjects with either AD and/or ACD. The primary endpoint was a ≥2 point improvement in Investigator Global Assessment (IGA) score after 12 weeks of treatment. Secondary endpoints included a 75% reduction in the Eczema Assessment Severity Index (EASI-75), EASI-50, and the maximum EASI response.
Results: The primary endpoint of improvement in IGA by two or more points was met by 20% of subjects. Ten percent of subjects achieved EASI-75 and another 10% reached EASI-50. All subjects tolerated apremilast well with no serious adverse events or withdrawal due to side effects. Common adverse events associated with apremilast included headache, nausea, and soft stool.
Limitations: This study was limited by its small sample size and lack of a comparison group to serve as a control.
Conclusions: Apremilast was well tolerated in all subjects. Apremilast was minimally effective in AD and ACD and results were inferior to previous trials of apremilast in psoriasis.
J Drugs Dermatol. 2012;11(3):341-346.
An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of Naftifine HCl Gel 2% in Pediatric Subjects With Tinea Pedis
Amit Verma DrPH MPH, Babajide Olayinka MSc, Alan B. Fleischer Jr. MD| |
OBJECTIVE: To assess trends in efficacy, tolerability, safety, and to quantify the pharmacokinetics (PK) of topical naftifine hydrochloride gel 2% in pediatric subjects with tinea pedis.
METHODS: Twenty-eight subjects (22 pediatric and 6 adult controls) were enrolled and treated in the study. Approximately 2 grams of naftifine hydrochloride gel 2% was applied to each foot (4 grams total) for subjects with tinea pedis. Pharmacokinetic blood and urine samples were collected at various time points throughout the study. Efficacy was assessed based on potassium hydroxide, dermatophyte culture, and signs and symptom results at days 7, 14, and 28. Adverse event information was collected routinely.
RESULTS: The rate and extent of systemic exposure among the pediatric and adult control subjects was low. Adverse events were minimal and were not related to treatment. Positive results were observed as early as day 7; however the proportion of subjects achieving success generally increased over time through day 28 in both treatment groups.
CONCLUSIONS: Naftifine hydrochloride gel 2% was found to be well tolerated and safe. Trends in clinical benefit were observed throughout the treatment period; however, continued improvement in efficacy rates were observed during the post-treatment period.
J Drugs Dermatol. 2015;14(7):686-691.
Objective: We describe one patient who developed sarcoidosis while being treated for psoriasis with etanercept. We sought to review to previously reported cases and further characterize the nature of this reaction.
Methods: A literature search was performed with the key words "sarcoidosis, sarcoid, etanercept, infliximab, adalimumab, granulomatous, and drug reaction." All relevant cases in the English language were included and evaluated for demographic data, duration of therapy prior to developing sarcoid, duration of sarcoid signs/symptoms, treatments used and time to resolution after discontinuation of the drug.
Results: Including the present case, there are 34 cases of sarcoidosis developing during anti-tumor necrosis factor therapy. All previously reported cases were patients with a primarily rheumatologic diagnosis. In all but one case, discontinuation of the drug resulted in complete resolution of symptoms. The lung and surrounding lymph nodes were the areas most commonly affected. The average amount of time between initiation of therapy and onset of symptoms was 22 months. The average time to resolution of symptoms after discontinuation of the drug was 5.2 months.
Limitations: This is a retrospective case review.
Conclusions: These data indicated that sarcoid is a possible adverse effect of tumor necrosis factor inhibitor therapy that should be noted by dermatologists using these drugs. While it has been reported in the rheumatology literature, it may be under-recognized by dermatologists.
J Drugs Dermatol. 2012;11(5):609-612.
Comparative Study of Professional vs Mass Market Topical Products for Treatment of Facial Photodamage
Hilary Reich MD,a,b Irmina Wallander BA,a Lacie Schulte MS BA,a Molly Goodier BS,a and Brian Zelickson MDa| |
OBJECTIVE: This split face study compares a mass market skincare regimen with a prescription skin care regimen for improvement in photo damaged skin.
METHODS: Twenty-seven subjects with moderate photo damaged facial skin were enrolled. Each subject was consented and assigned with the mass market anti-aging system (Treatment A) to one side of the face and the prescription anti-aging system (Treatment B or Treatment C) to the other side of the face. Treatment B contained 13 subjects whom did not use 0.025% Retinol cream. Treatment C contained 14 subjects who used a 0.025% Retinol Cream. Subjects had 4 visits over 12 weeks for digital photography and surveys. Photographs were evaluated by blinded physicians.
RESULTS: Physician objective analysis showed all three systems to have a statistically significant clinical improvement in photoaged skin seen in as little as 4 weeks of use. Participant’s surveys rated the mass market system higher than both of the professional systems for visible skin changes, ease of use, and likelihood to recommend to a friend. Twelve of twenty-seven subjects preferred the mass market system for overall improvement while twelve thought each system gave the same improvement.
CONCLUSION: This study demonstrates that a mass marketed skin care system can give similar clinical improvements in photo-aged skin as a professionally dispensed prescription system and the majority of participants preferred the mass-marketed system.
J Drugs Dermatol. 2016;15(1):37-44.
Comparison of Skin Concentrations Following Topical Versus Oral Corticosteroid Treatment: Reconsidering the Treatment of Common Inflammatory Dermatoses
Richard W. McClain BS, Brad A. Yentzer MD, Steven R. Feldman MD PhD| |
Purpose: To analyze the assumption that oral corticosteroid therapy should be more potent than topical therapy by comparing relative corticosteroid concentrations in the skin expected with topical versus systemic administration.
Methods: The estimated skin concentration of prednisone following oral dosing was calculated based on data showing 70–100% bioavailability and an even tissue distribution. Data on the concentration of corticosteroids found in skin after topical application were obtained from the literature. The relative potencies of corticosteroid molecules were then used to compare skin concentrations of corticosteroid following topical versus oral treatment.
Results: Data derived from the existing literature demonstrated that hydrocortisone 2.5% ointment, triamcinolone 0.1% ointment, and clobetasol 0.05% foam achieved effective skin concentrations greater than the effective concentration achieved by oral prednisone. Betamethasone 0.1% cream achieved effective concentrations in skin within the range created by oral prednisone.
Limitations: This analysis was limited by the paucity of data regarding cutaneous concentrations of corticosteroids after topical application, and by the differing experimental designs utilized in the available studies.
Conclusion: Most topical corticosteroids have the potential to achieve greater effective drug levels in the superficial layers of skin than those achieved with standard doses of oral prednisone. The apparently greater efficacy of oral corticosteroid therapy may be attributable, in part, to poor patient compliance with topical therapy. Systemic alterations in immune function following oral, but not topical, corticosteroid use may also play a role.
Objective: To evaluate the efficacy and safety of treating vitiligo patients with anti-TNF-α agents.
Methods: A total of 6 patients were recruited. All patients had widespread non-segmental vitiligo. Biologics, including infliximab, etanercept, and adalimumab, were given according to treatment regimens used for psoriasis. Photographs were taken at the initial visit, every two months during the therapy and then six months after therapy completion.
Results: All patients completed the treatment; two patients were treated with infliximab, two with etanercept, and two with adalimumab. All of the biologics were well tolerated throughout the treatment period, and none of the patients reported any significant adverse events. Digital images were compared before, during and after treatment. Repigmentation of the vitiliginous areas was not observed in any of the patients. Vitiligo worsened in one patient who was treated with infliximab and developed a psoriasiform rash. However, the remaining patients did not develop any new depigmented patches during treatment or at the six-month follow-up; vitiligo was considered stable in these five patients.
Conclusions: Although the anti-TNF-α agents were well tolerated in all six vitiligo patients, efficacy was not observed. Further evaluation with larger studies may be required.
J Drugs Dermatol. 2012;11(4):534-539.
Hashim et al.| |
Steven R. Feldman MD| |
Winning Poster: A Phase 2, Open-Label, Investigator-Initiated Study to Evaluate the Safety and Efficacy of Apremilast in Subjects with Recalcitrant Contact or Atopic Dermatitis
Eva Volf MD| |
Turna İlknur MD,a Sevgi Akarsu MD,a
Saim Çarşanbalı MD,a Banu Lebe MD,b
and Emel Fetil MDa
Christopher S. Hale MDa and William R. Levis MDb| |
Resident Rounds: Part I - Program Spotlight: Department of Dermatology, University Hospitals Case Medical Center
Jeffrey F. Scott MD, Ashley Feneran DO, and Kevin D. Cooper MD| |
Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.
Laura Diluvio MDa, Elena Campione PhDa, Cristina Mordenti MDa, Valentina Bagnolo MDb, Caterina Cerminara MDb, Sergio Chimenti MDa, and Luca Bianchi MDa| |
Thomas Lee MD, Julia Schwartz MD| |
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval. We trust you will find this information beneficial to your practice and research.
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.