31865 Pooled efficacy and safety results from the DERMIS-1 and DERMIS-2 phase 3 trials of once-daily roflumilast cream 0.3% for treatment of chronic plaque psoriasis

Abstract

Roflumilast cream 0.3% is a selective, highly potent phosphodiesterase-4 inhibitor being investigated as a nonsteroidal, once-daily treatment for psoriasis. Here we describe pooled efficacy and safety results from 2 identical Phase 3 randomized controlled trials of roflumilast cream (DERMIS-1: NCT04211363 and DERMIS-2: NCT04211389). Patients with psoriasis involving 2-20% of body surface area (aged ≥2 years) were randomized to roflumilast (n = 576) or vehicle (n = 305) for 8 weeks. Significantly greater percentages of roflumilast-treated versus vehicle-treated patients achieved the primary efficacy endpoint, Investigator Global Assessment (IGA) Success (Clear or Almost Clear IGA plus ≥2-grade improvement from baseline) at Week 8 (39.9% vs.