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.
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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