Long-term Safety and Effectiveness of Roflumilast Cream 0.3% in Adults with Chronic Plaque Psoriasis: A 52-week, Phase 2, Open-label Trial

Background: Efficacy and/or safety profiles limit topical psoriasis treatments.

Objective: Evaluate long-term effects of once-daily roflumilast cream 0.3% in patients with psoriasis.

Methods: In this open-label phase 2 trial, adult patients (N = 332) with psoriasis who completed the phase 2b parent trial or were newly enrolled applied roflumilast once-daily for 52 weeks. Safety and effectiveness were assessed.

Results: Overall, 244 patients (73.5%) completed the trial; 13 patients (3.9%) discontinued due to adverse events (AEs) and 3 (0.9%) due to lack of efficacy. Twelve patients (3.6%) reported treatment-related AEs; none were serious. ≥97% of patients had no irritation. No tachyphylaxis was observed with 44.8% of the patients achieving Investigator Global Assessment (IGA) Clear or Almost Clear at Week 52.

Limitations: Intertriginous-IGA and Psoriasis Area and Severity Index (PASI) were not evaluated in all patients.

Conclusions: In this long-term trial, once-daily roflumilast cream was well-tolerated and efficacious up to 64 weeks in patients in the earlier trial, suggesting it is suitable for chronic treatment, including the face and intertriginous areas.