Background: Topical psoriasis treatment relies on a reactive rather than a long-term proactive approach to disease relapse.
Objective: Assess long-term efficacy and safety of proactive psoriasis management with twice-weekly calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam.
Methods: Phase III trial (NCT02899962) included a 4-week open-label lead-in phase (Cal/BD foam once daily) and a 52-week, randomized, double-blind, maintenance phase. A total of 545 patients achieved treatment success (physician's global assessment "clear"/"almost clear," ≥2-grade improvement from baseline) and were randomized to proactive management (Cal/BD foam; n = 272) or reactive management (vehicle foam; n = 273) twice-weekly, with rescue treatment of Cal/BD foam once daily for 4 weeks upon relapse. Primary endpoint was time to first relapse (physician's global assessment "mild" or higher).
Results: A total of 251 randomized patients (46.1%) completed the trial. Median time to first relapse was 56 days (proactive) and 30 days (reactive). Patients in the proactive group had an additional 41 days in remission compared with the reactive group over 1 year (P < .001). Number of relapses per year of exposure was 3.1 (proactive) and 4.8 (reactive). Cal/BD foam was well tolerated.
Limitations: Maintenance phase dropout rate (53.9%) was within the expected range but provides challenges in statistical analysis.
Conclusion: Long-term proactive management with Cal/BD foam demonstrated superior efficacy vs reactive management.
Keywords: Enstilar; betamethasone dipropionate; calcipotriene; fixed-dose; foam; long-term; maintenance; proactive; psoriasis vulgaris; relapse; topical preparation.
Copyright © 2020 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.