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Journal of the American Academy of Dermatology


BACKGROUND: Topical psoriasis treatment relies on a reactive, rather than 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 52-week, randomized, double-blind, maintenance phase. 545 patients achieved treatment success PGA '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: time to first relapse (PGA ≥'mild').

RESULTS: 251 (46.1%) randomized patients completed the trial. Median time to first relapse: 56 days (proactive), 30 days (reactive). Patients in the proactive group had an additional 41 days in remission compared with the reactive group over 1 year (P < 0.001). Number of relapses per year of exposure: 3.1 (proactive), 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 versus reactive management.

PubMed ID



ePub ahead of print