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 © 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.

Abstract

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.

ClinicalTrials.gov: NCT02425826

J Drugs Dermatol. 2017;16(8):801-808.

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INTRODUCTION

Treatment of moderate to severe plaque psoriasis has improved substantially with the introduction of treatments that have demonstrated the ability to reduce disease severity and improve quality of life (QOL).1,2 Despite these advances, management of moderate psoriasis (≥3% to <10% body surface area [BSA] involvement)3 remains a significant challenge. Patients with moderate psoriasis often do not achieve satisfactory skin clearance with conventional systemic therapy due to under-treatment and/or toxicity concerns.4-6 In the Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) survey of patient and physician perceptions of satisfaction with current psoriasis therapies, >80% of psoriasis patients with 4 to 10 handprints BSA involvement reported receiving no treatment or topical treatment only.6 Of psoriasis patients receiving conventional oral medication (cyclosporine, methotrexate, acitretin, fumaric acid esters), 57% reported discontinuing therapy, most often for safety or tolerability reasons and lack/loss of efficacy.6 Although newer biologics can provide substantially higher clearance rates, their use in more moderate disease has not been studied, and high cost without evidence of clear benefit in this population might be a limiting factor.7 Clinical studies of biologics typically require patients to have BSA involvement ≥10%, a population that is very different from patients with more moderate disease.8,9 Apremilast, an oral, small-molecule phosphodiesterase 4 inhibitor, works intracellularly to regulate inflammatory mediators, including

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