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%.
DISCUSSION
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