Gold LS, Bagel J, Del Rosso J, Green LJ, Lebwohl M, Kircik LH, Feng A, Snyder S, Higham RC, Burnett P, and Berk DR. 33463 Pooled efficacy and safety results from the DERMIS-1 and DERMIS-2 phase 3 trials of once-daily roflumilast cream 0.3% by baseline body surface area. J Am Acad Dermatol 2022; 87(3):AB192.
J Am Acad Dermatol
Roflumilast cream 0.3% is a selective and potent phosphodiesterase-4 inhibitor under investigation as a 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) analyzed by baseline body surface area (BSA) affected ( 10%). Patients (≥2 years) with psoriasis involving 2-20% BSA were randomized to roflumilast (n = 576) or vehicle (n = 305) for 8 weeks. Overall, significantly more roflumilast- vs. vehicle-treated patients achieved the primary efficacy endpoint of Investigator Global Assessment (IGA) Success (Clear or Almost Clear IGA status plus ≥2-grade improvement from baseline) at Week 8 (39.9% vs. 6.5%; P <.0001). More roflumilast-treated patients achieved IGA Success at Week 8 with generally consistent rates (36.5%-46.7% with roflumilast vs. 1.8%-8.5% with vehicle) across all BSA categories (P <.0001 for all). Differences favoring roflumilast were also observed for percentages achieving 75% reduction in Psoriasis Area Severity Index (38.1%-47.8% with roflumilast vs. 1.8%-9.4% with vehicle) across all BSA categories. Percentages with baseline Worst Itch-Numeric Rating Scale ≥4 achieving a 4-point reduction favored roflumilast (P ≤.0001 for all BSA subgroups). Overall incidence of treatment-emergent adverse events (TEAE), serious adverse events, and TEAEs leading to discontinuation were low with similar rates between roflumilast and vehicle. Local tolerability was highly favorable on patient and investigator assessments. Once-daily roflumilast cream 0.3% provided superior improvement across multiple efficacy endpoints and favorable safety and tolerability in patients with psoriasis in 2 phase 3 trials regardless of BSA affected.