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

Background: Roflumilast cream 0.3%, a highly potent phosphodiesterase 4 inhibitor, was recently approved for treatment of psoriasis. We describe pooled results from two Phase 3 clinical trials evaluating efficacy and safety of once-daily topical roflumilast in patients (2:2 years) with psoriasis involving 2-20% BSA. Patients were randomized 2:1 to roflumilast or vehicle cream for 8 weeks. The primary efficacy endpoint was Investigator Global Assessment (IGA) Success (score of Clear or Almost Clear plus 2:2-grade improvement from baseline) at Week 8. The Psoriasis Area and Severity Index (PASI) and a modified version that allows higher discrimination (PASI-HD) in which area scores for <10% of an anatomical region are 0.1-0.9 rather than default to 1 were evaluated. Overall, significantly more roflumilast- than vehicle-treated patients achieved IGA success at Week 8 (39.9% vs. 6.5%; P<0.001).