EFFICACY AND SAFETY OF APREMILAST IN PATIENTS WITH MILD TO MODERATE PLAQUE PSORIASIS: RESULTS OF A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL.

Patients with mild-to-moderate psoriasis may have substantial quality-of-life impairment.
To evaluate apremilast 30 mg BID for mild-to-moderate psoriasis.
Phase 3, double-blind, placebo-controlled study in adults with mild-to-moderate psoriasis inadequately controlled or intolerant to ≥1 topical psoriasis therapy (NCT03721172). The primary endpoint was achievement of static Physician Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) and ≥2-point reduction at Week 16.
595 patients were randomized (apremilast: 297; placebo: 298). The primary endpoint was met, with significantly greater sPGA response rate observed at Week 16 in the apremilast group compared with the placebo group (21.6% vs. 4.1%; P<0.0001); all secondary endpoints were met (achievement of BSA-75 [33.0% vs. 7.4%], BSA ≤3% [61.0% vs. 22.9%], ≥4-point reduction in Whole Body Itch NRS [43.2% vs. 18.6%], Scalp PGA 0 or 1 and ≥2-point reduction [44.0% vs. 16.6%], and changes from baseline in BSA, PASI, and DLQI; all P<0.0001). The most commonly reported adverse events (≥5%) with apremilast were diarrhea, headache, nausea, nasopharyngitis, and upper respiratory tract infection, consistent with prior studies.
The study lacked an active comparator arm.
Apremilast demonstrated efficacy in mild-to-moderate psoriasis and safety consistent with the established safety profile of apremilast.

Copyright © 2021. Published by Elsevier Inc.