Efficacy and Safety of Apremilast in Patients With Moderate Plaque Psoriasis With Lower BSA: Week 16 Results from the UNVEIL Study.

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. .