Steven R. Feldman MD PhD
Psoriasis is a common, frustrating problem for dermatologists and patients. Long-held notions about the need to use thick, greasy
corticosteroid ointments for psoriasis contributed to frustration for many patients. Fortunately, the general approach to managing
psoriasis is changing. The purpose of this article is to describe key components of psoriasis management with a focus on the
changing paradigm for treating the disease. In addition to making the right diagnosis and prescribing the right treatment, key
elements of psoriasis management include establishing a strong physician-patient relationship, educating patients about the disease
and recognizing the importance of adherence to topical treatment. In light of the tendency toward poor adherence, use of a fastacting
agent in a vehicle that patients are willing to use is critically important for successful disease management.
The scalp is one of the regions of the body most commonly affected by psoriatic lesions. While the head represents only 10 percent
of the body’s surface area, the consequences of scalp psoriasis are disproportionate to the area, as it can be seriously debilitating and
presents social and emotional distress to the affected individual. Scalp lesions are often well-demarcated and may have thick gray
or white scale; patients with scalp psoriasis frequently complain of pruritus and shedding of scale. Current treatment modalities—
including phototherapy, topical corticosteroids, topical vitamin D analogues and conventional systemic therapies—have produced
unsatisfactory results for patients with moderate-to-severe scalp psoriasis due to difficulties in administration to the disease site,
poor compliance, toxicity and inadequate long-term efficacy. The emergence of biologic therapies as an effective modality for the
treatment of plaque psoriasis may provide another option for patients suffering from plaque psoriasis of the scalp.
Adaeze Egesi BS, Grace Sun MS, Amor Khachemoune MD , Rashid M. Rashid MD PhD
Statins, initially developed as antimicrobials, are primarily considered cholesterol-lowering agents. Recently, researchers discovered anti-inflammatory properties of statins. Studies on the effects of statins and the alterations noted include: bench work that supported a
Th1/Th2 skew to Th1, altered lymphocyte migration, inhibition of MHC-II induction and cytokine release on antigen-presenting cells, inhibition of mast cell degranulation and inhibition of Th17 cells and IL-17 production. In addition to the anti-inflammatory properties, statins have been found to induce apoptosis in melanoma models. The potential therapeutic value of statins is illustrated in the management of
alopecia areata, atopic dermatitis, psoriasis, systemic lupus erythematosus, cutaneous T-cell lymphomas, cutaneous melanoma, mastocytosis
and more. This manuscript presents a comprehensive review of statins and their potential dermatologic application.
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
Background: In two previous phase 3 studies, up to 60 weeks of etanercept therapy significantly improved the symptoms of psoriasis
and was well tolerated.
Objective: To evaluate the long-term safety of etanercept in an open-label extension study for up to 72 weeks in patients with
moderate-to-severe plaque psoriasis.
Methods: A total of 912 patients received 50 mg subcutaneous etanercept once weekly (QW) for the first 12 weeks of this extension
study. Thereafter, eligible patients could maintain the 50 mg QW dose (n=321) or escalate to 50 mg twice weekly (BIW; n=591)
anytime thereafter based on one of three predetermined criteria.
Results: Etanercept was well tolerated during 1056 patient-years of exposure; no difference was observed between the 50 mg QW
and 50 mg BIW dosages in rates of adverse events and infections. Improvement in skin disease was maintained throughout the
study. Patients who stopped and then restarted etanercept also showed improvement in psoriasis.
Conclusion: Psoriatic patients continued to benefit from open-label etanercept treatment, both continuous and interrupted therapy,
which was generally well tolerated after a combined 2.5 years of experience.
Marco daCosta DiBonaventura PhD, Samuel Wagner PhD RP, Heidi C. Waters MS, MBA, Chureen Carter PharmD, MS
Psoriasis is a chronic autoimmune condition that affects over 7 million Americans, approximately 1–3 percent of the population.
Although there are a number of treatment options currently available, little is known about the treatment patterns of patients. Using
data from 1,006 psoriasis sufferers, the aim of the present study was to analyze patients’ treatment timeline, as well as their
perceptions about these treatments. Most respondents were white, female and had health insurance. The results suggested that
over-the-counter (OTC) and prescription topicals were the most common initial treatments, but systemic orals and biologics were
the most common treatments for patients who required a third-line or fourth-line treatment (and for patients with greater severity).
Treatment dissatisfaction was relatively high, with very few positive attributes associated with the current treatment options. Overall,
this study suggests that treatment options vary (at a statistically significant level) as a function of severity, and many patients, despite
the choices in the number and quality of treatment options, are generally dissatisfied.
Marie Rosalette Mortel BS and Jason Emer MD
Psoriasis and psoriatic arthritis are immune-mediated, chronic, inflammatory diseases that place a heavy burden on the lifestyle of
patients affected. Current understanding of the pathophysiology of these conditions has produced very encouraging new medical
developments, largely a consequence of research that has targeted precise elements of the immune cascade, expanding the repertoire
of therapeutic options available to dermatologists. Promising new treatments, such as antibodies to interleukin-12 and -23,
show superior efficacy and safety in treating psoriasis; the more sophisticated tumor necrosis factor antagonists significantly improve
symptoms of rheumatic and psoriatic arthritis and may also be effective in the treatment of plaque psoriasis. In this article, innovative,
new treatments for psoriasis and psoriatic arthritis are critically reviewed.
Fariba Iraji MD, Gita Faghihi MD, Amir Hossein Siadat MD, Shahla Enshaieh MD, Zabihlah Shahmoradi MD, Abolfazl Joia MD, Fatemeh Soleimani MD
Background: Psoriasis is a common disorder affecting 1–3 percent of the general global population. Many therapeutic modalities have
been suggested for treatment of this condition, but still there is no definite treatment for this disease. The objective in this study was to
evaluate the efficacy of topical azelaic acid gel versus placebo in the treatment of psoriasis vulgaris.
Patients, Materials and Methods: This study was a single-blinded randomized clinical trial. Overall, 31 patients were selected and the
left or right sided lesions of the patients were randomized to receive either 15% azelaic acid or gel twice daily for a one-month period.
Two symmetrical lesions with almost similar severity in every patient were selected and considered as index lesions to evaluate lesion
response to treatment. The severity of erythema, scaling, hyperkeratosis and pruritus of the index lesions were scored in range of 0–3
for each lesion by the investigator at the baseline and follow up visits. The percent of involvement of each side of body was also measured
using rule of nines. The collected data were analyzed using statistical tests including Mann-Whitney and ANOVA tests.
Results: There was no significant difference between the two groups before treatment (P>0.05). After treatment, however, except
pruritus, there was significant difference between the two groups (P<0.05). There was no significant difference regarding total
psoriasis score between the two groups before treatment (P>0.05). After treatment, however, there was significant difference
between the two groups (P<0.05) in favor of more efficacy for azelaic acid. There was no significant difference regarding percent of
body involvement between the two groups before treatment (P>0.05). After treatment, however, there was a significant difference
between the two groups (P<0.05) in favor of more efficacy on the part of azelaic acid gel.
Discussion: The results of our study showed that 15% azelaic acid gel was effective in reduction of purities, scaling and hyperkeratosis
of psoriasis plaques. This treatment was also effective in reduction of skin involvement with psoriasis. It is recommended that
a longer study be performed that can better evaluate the efficacy of this treatment against plaque-type psoriasis.
Colin Fleming MD, Cecilia Ganslandt MD, Graham P. Leese MB ChB
The two-compound ointment (Taclonex®/Daivobet®/Dovobet® ointment) combining calcipotriene 50 μg/g and betamethasone 0.5
mg/g (as dipropionate) is very effective in the treatment of psoriasis vulgaris. There is a possibility that hypothalamo-pituitaryaxis
(HPA) suppression may occur if the potent corticosteroid component is absorbed to a sufficient extent. The effect of the
two-compound ointment on HPA axis function was assessed in two studies. Study 1 was a four-week, double-blind study which
compared the effects of the two-compound ointment with betamethasone 0.5 mg/g (as dipropionate; Diprosone®) ointment in 24
patients with extensive psoriasis (involving 15–30% of the body surface area). No patients receiving the two-compound ointment
had HPA axis suppression. Study 2 assessed HPA axis function after four and 52 weeks in a subset of patients (n=19) participating
in a long-term safety study. Patients were treated with the two-compound ointment for the first four weeks followed by 48
weeks of treatment as needed with either 1) two-compound ointment; 2) two-compound ointment alternating with calcipotriene
four-weekly or 3) calcipotriene. No patients using the two-compound ointment for all 52 weeks or alternating four-weekly with
calcipotriene had HPA axis suppression.
Jackleen S. Marji MD PhD, Rebecca Marcus MD, Jessica Moennich MD, Julian Mackay-Wiggan MD MS
Psoriasis affects approximately 2 percent of the population. Approximately 30–45 percent of those affected first experience symptoms
during childhood or adolescence. Although biologics have proven to be a relatively safe and effective treatment option for adults
with psoriasis, limited information is available regarding the use of biologic agents in pediatric patients with psoriasis. The authors
attempt to assess and summarize the available data on the use of biologic agents in patients under the age of 18, regardless of the
indication, as well as to examine the limited available data on the use of biologics for psoriasis in the pediatric population. In doing so,
the authors aim to provide guidance on the safety and efficacy of biologic therapies in pediatric patients with psoriasis.
The authors’ findings suggest that biologic agents should be considered for use solely in children with psoriasis that is refractory to
conventional therapies, including children currently with severe, widespread, refractory pustular, plaque or psoriatic arthritis. Of all the
currently available biologics, etanercept appears to have resulted in fewer and less severe side effects compared to infliximab in the
juvenile rheumatoid arthritis population. In addition, while biologics are generally safe and effective in the pediatric population, serious
adverse events (including infection), have been reported in the literature and should be taken into account before beginning treatment
with any biologic agent. The physician and parents of the patient must carefully consider the risk-benefit ratio when deciding whether
to use these medications. Additional randomized, controlled trials are needed to adequately assess the safety and efficacy of biologic
medications for childhood psoriasis.
Ahmad A. Al Robaee MD MHPE
Objective: To assess the efficacy and safety of narrowband ultraviolet B (UVB) phototherapy in dark-skinned Saudi patients with
chronic plaque psoriasis.
Patients and Methods: This prospective study was performed on 63 patients of chronic plaque psoriasis attending Qassim University clinics from May 2004 through June 2009. Narrowband UVB irradiation was done three times per week using the 311±2 nm wavelength.
Results: Approximately 79 percent of patients achieved disease clearance (i.e., 90% or more reduction in PASI scores). The response
to treatment was significantly better in females compared to males. No serious side effects were observed.
Conclusion: The narrowband UVB phototherapy was found to be safe and effective in darker-skinned Saudi patients with chronic plaque psoriasis, especially among females. A longer period of treatment (minimum of six months) is recommended for complete clearance of psoriasis.
Deirdre Cocks Eschler MD and Peter A. Klein MD
Objective: To critically review the body of clinical trials refuting or supporting the efficacy of topical antihistamines in the relief of pruritus.
Design: Review of PubMed from January 1950 through September 2009 and the Cochrane Database of Systematic Reviews to
identify therapeutic trials of topical antihistamines in the relief of pruritus.
Main Outcome Measures: All randomized controlled trials or clinical trials of topical antihistaminic compounds used in the treatment
of pruritus. The authors found 19 trials throughout the literature. The quality of each trial was ranked by applying a modified
version of Sackett’s criteria for clinical evidence. Grade A trials are large, randomized, double-blind, placebo-controlled studies with
low false-positive (α) and low false-negative (β) errors. Grade B studies are also randomized, double-blind, placebo-controlled studies,
but include a small number of patients. Grade C trials lack one or more of the following criteria: randomization, placebo control
Results: Only four large, randomized, double-blind, placebo-controlled clinical trials with definitive conclusions (grade A) support the
use of topical antihistaminic agents, specifically topical doxepin, for relief of pruritus. Of seven grade B trials, four supported the efficacy
of topical antihistamines while three refute their use in relieving pruritus. One grade B trial was inconclusive. All remaining trials
(grade C) lacked placebo controls or randomization, or contained fewer than 20 patients in each treatment group.
Conclusion: While topical antihistamines are widely prescribed for the treatment of pruritus, the evidence to support their use is
mixed. Topical doxepin has been demonstrated to reduce pruritus. Evidence is lacking, however, for other topical antihistamines,
including diphenhydramine (Benadryl®), that are widely used and available without a prescription.
James J. Leyden MD, Marge Nighland BS, Ana Beatris Rossi MD, Ratna Ramaswamy PhD
This single-center, investigator-blinded, randomized, split-face, phase 4 study compared the irritation potential of tretinoin gel microsphere (TGM) 0.04% in a pump dispenser with adapalene 0.1% plus benzoyl peroxide 2.5% gel (ADA-BPO 0.1%/2.5%) in a panel of 170 subjects. Participants were treated with TGM 0.04% pump on a randomly assigned side of the face and ADA-BPO 0.1%/2.5% gel on the other side of the face daily for three consecutive weeks. Expert grader assessments of erythema and dryness and subject self-assessments of burning/stinging and itching were conducted daily, except on weekends. TGM 0.04% pump was associated with better facial tolerance as demonstrated by significantly less cumulative erythema (P<0.0001), dryness (P<0.0001), burning/stinging
(P<0.0001) and itching (P<0.0001) compared with ADA-BPO 0.1%/2.5% gel. While both agents were well tolerated by most patients, TGM 0.04% pump demonstrated significantly better tolerance than ADA-BPO 0.1%/2.5% gel in both neurosensory parameters and signs of contact irritation.
Daven N. Doshi MD and Adam J. Friedman MD
The New Melanoma Staging System: What the Clinician Should Know
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatological 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.
Clinical Trial Review is a JDD department designed to provide physicians with information on drugs undergoing clinical testing. It is our goal to inform the reader of the status of select drug trials 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.