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.
Most common AEs (≥5% patients, either group) included diarrhea, headache, nausea, upper respiratory tract infection, decreased appetite, and vomiting (Table 3). Among patients reporting an AE of diarrhea, with follow-up questioning, protocol-defined diarrhea (≥2 loose watery stools in 1 day) was confirmed in 10/73 patients (13.7%) receiving placebo and 28/147 patients (19.0%) receiving apremilast (P=0.1704); 1 patient receiving placebo and 1 receiving apremilast withdrew due to diarrhea. Significant abnormalities in clinical laboratory parameters were infrequent and comparable between groups. At week 16, mean change from baseline in body weight was +0.42 kg (mean percentage change: +0.58%) in placebo patients and −0.65 kg (mean percentage change: −0.68%) in apremilast patients (P=NS), >5% weight loss from baseline occurred in 13/147 apremilast patients (8.8%), and 3/73 placebo patients (4.1%). No patient had weight loss >10%.
UNVEIL is the first prospective, randomized, controlled trial to evaluate the clinical efficacy and safety of a systemic treatment, oral apremilast, in patients with moderate plaque psoriasis with BSA involvement of 5% to 10% who were naive to conventional