Results from the phase 3 DERMIS-1 and DERMIS-2 trials were presented at the 2023 American Academy of Dermatology Annual Meeting.
Roflumilast (Zoryve, Acrutis) treatment for chronic plaque psoriasis successfully achieved its primary endpoint, according to new data resented at the American Academy of Dermatology (AAD) 2023 Annual Meeting in New Orleans, LA.1
The clinical trials of topical roflumilast, DERMIS-1 (NCT04211363) and DERMIS-2 (NCT04211389), included 2 groups: the roflumilast active treatment group and the vehicle group. The primary endpoint was an Investigator Global Assessment (IGA) score of almost clear with at least a 2-grade improvement at week 8.
The 52-week phase 2 safety trial was conducted at 30 testing centers in the US and Canada and was supported by Arcutis Biotherapeutics, Inc. DERMIS-1 and DERMIS-2 were 2 identical, phase 3, randomized, double-blind, vehicle-controlled, 8-week studies of once-daily roflumilast cream 0.3% in patients (≥2 years of age) with psoriasis involving 2-20% body surface area (BSA). Patients were randomized 2:1 to roflumilast or vehicle cream.
Study authors evaluated the Psoriasis Area and Severity Index (PASI)and a modified higher discrimination (PASI-HD) in which area scores for <10% of an anatomical region are 0.1-0.9 rather than default to 1. The results show overall, significantly more roflumilast- than vehicle-treated patients achieved IGA success at Week 8 (39.9% vs. 6.5%; P<0.001).
Statistically, significant differences favoring roflumilast were observed at Week 8 for percentages of patients achieving 50% reduction in PASI and PASI-HD (72.1% vs 25.5% and 79.4% vs 33.1%, respectively; P<0.0001), 75% reduction (40.3% vs 6.5% and 59.9% vs 17.9%, respectively; P<0.0001), 90% reduction (19.7% vs 2.3% and 39.9% vs 9.1%, respectively; P<0.0001), and 100% reduction (12.3% vs 0.8% for both; P<0.001). There were no serious treatment-related adverse events reported. Several common adverse events included diarrhea, headaches, nausea, and urinary tract infection.
The US Food and Drug Administration approved the treatment for the treatment of plaque psoriasis in adolescents and adults in July 2022.
1. Papp K, Lebwohl M, Chih-ho Hong, H, et al. Efficacy and safety of roflumilast cream 0.3% in patients with chronic plaque psoriasis: pooled PASI and PASI-HD results from the DERMIS-1 and DERMIS-2 Phase 3 Trials. Presented at the 2023 American Academy of Dermatology Annual Meeting. March 17-21, 2023; New Orleans, Louisiana.