Efficacy and Safety of Apremilast in Patients With Moderate Plaque Psoriasis With Lower BSA: Week 16 Results from the UNVEIL Study
August 2017 | Volume 16 | Issue 8 | Original Article | 801 | Copyright © August 2017
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
aUniversity of Connecticut, Farm ington, CT, and Probity Medical Research, Waterloo, Ontario, Canada bPsoriasis Treatment Center of Central New Jersey, East Windsor, NJ cIcahn School of Medicine at Mount Sinai, New York, NY dHenry Ford Health System, West Bloomfield, MI eUniversity of Louisville, Forefront Dermatology, Louisville, KY fCelgene Corporation, Summit, NJ gUniversity of Utah, Salt Lake City, UT *Employed by Celgene Corporation at the time of study conduct.
Joana Goncalves MD, Eugenia Levi PharmD, and Rongdean Chen PhD are employees of Celgene Corporation. Kristina Callis Duffin MD MS has been a consultant, steering committee member, and/or advisory board member for, and/ or has received grants and/or honoraria from AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene Corporation, Centocor/Janssen, Eli Lilly, Novartis, Pfizer, Regeneron, Stiefel, and XenoPort.
The authors acknowledge nancial support for this study from Celgene Corporation. The authors received editorial assistance from Peloton Advantage, LLC, sponsored by Celgene Corporation.
- Biologics for Psoriasis and Psoriatic Arthritis (Adalimumab, Etanercept, Golimumab, In iximab, Ustekinumab). VA Pharmacy Bene ts Management Services. Available at: http://www.pbm.va.gov/PBM/clinicalguidance/drugmonographs/BiologicsinPsoriasisandPsoriaticArthritisMonographandLiteratureReview.pdf. Accessed May 10, 2017.
- Takeshita J, Gelfand JM, Li P, et al. Psoriasis in the US Medicare Population: Prevalence, Treatment, and Factors Associated with Biologic Use. J Invest Dermatol. 2015;135(12):2955-2963.
- Van Voorhees AS, Feldman SR, Koo JYM, et al. The Psoriasis and Psoriatic Arthritis Pocket Guide: Treatment Algorithms and Management Options. 4th ed. Alexandria, VA: National Psoriasis Foundation; 2016.
- Al-Suwaidan SN, Feldman SR. Clearance is not a realistic expectation of psoriasis treatment. J Am Acad Dermatol. 2000;42(5 Pt 1):796-802.
- Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment, treatment trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the United States: findings from the National Psoriasis Foundation surveys, 2003-2011. JAMA Dermatol. 2013;149(10):1180-1185.
- Lebwohl MG, Bachelez H, Barker J, et al. Patient perspectives in the management of psoriasis: results from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis Survey. J Am Acad Dermatol. 2014;70(5):871-881.
- van de Kerkhof PCM, Reich K, Kavanaugh A, et al. Physician perspectives in the managment of psoriasis and psoriatic arthritis: results from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis survey. J Eur Acad Dermatol Venereol. 2015;29(10):2002-2010.
- Sterry W, Ortonne JP, Kirkham B, et al. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial. BMJ. 2010;340:c147.
- Reich K, Nestle FO, Papp K, et al. In iximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet. 2005;366(9494):1367-1374.
- Schafer PH, Parton A, Capone L, et al. Apremilast is a selective PDE4 inhibitor with regulatory effects on innate immunity. Cell Signal. 2014;26(9):2016-2029.
- Papp K, Reich K, Leonardi CL, et al. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM 1]). J Am Acad Dermatol. 2015;73(1):37-49.
- Paul C, Cather J, Gooderham M, et al. Efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate to severe plaque psoriasis over 52 weeks: a phase III, randomized, controlled trial (ESTEEM 2). Br J Dermatol. 2015;173(6):1387-1399.
- Walsh JA, McFadden M, Woodcock J, et al. Product of the Physician Global Assessment and body surface area: a simple static measure of psoriasis severity in a longitudinal cohort. J Am Acad Dermatol. 2013;69(6):931-937.
- Chiesa Fuxench ZC, Duf n KC, Siegel M, Van Voorhees AS, Gelfand JM. Validity of the Simple-Measure for Assessing Psoriasis Activity (S-MAPA) for objectively evaluating disease severity in patients with plaque psoriasis. J Am Acad Dermatol. 2015;73(5):868-870.
- Duffin KC, Papp KA, Bagel J, Levi E, Chen R, Gottlieb AB. 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. J Drugs Dermatol. 2017;16(2):147-153.
- Atkinson MJ, Sinha A, Hass SL, et al. Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health Quality Life Outcomes. 2004;2:12.
- Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. Longterm (52-week) results of a phase III randomized, controlled trial of apremilast in patients with psoriatic arthritis. J Rheumatol. 2015;42(3):479-488.
- Edwards CJ, Blanco FJ, Crowley J, et al. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis and current skin involvement: a phase III, randomised, controlled trial (PALACE 3). Ann Rheum Dis. 2016;75(6):1065-1073.
- Cutolo M, Myerson GE, Fleischmann R, et al. A phase III, randomized, controlled trial of apremilast in patients with psoriatic arthritis: results of the PALACE 2 trial. J Rheumatol. 2016;43(9):1724-1734.
Bruce Strober MD PhD E-mail:................................................... [email protected]