Mark Lebwohl1, Leon Kircik2, Jean-Philippe Lacour3, Monika Liljedahl4, Charles Lynde5, Marie Holst Mørch4, Kim A Papp6, Jean-Luc Perrot7, Linda Stein Gold8, Amrit Takhar9, Diamant Thaçi10, Richard B Warren11, Andreas Wollenberg12. 1. Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: lebwohl@aol.com. 2. Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York. 3. Department of Dermatology, University Hospital of Nice, Nice, France. 4. LEO Pharma Ballerup, Ballerup, Denmark. 5. Lynde Dermatology, Probity Medical Research, Markham, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada. 6. K. Papp Clinical Research, Waterloo, Ontario, Canada. 7. Department of Dermatology, University Hospital of St-Etienne, St-Etienne, France. 8. Department of Dermatology, Henry Ford Hospital, Detroit, Michigan. 9. Wansford and Kings Cliffe Practice, Wansford, Cambridgeshire, United Kingdom. 10. Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany. 11. Dermatology Centre, Salford Royal National Health Service Foundation Trust, Manchester National Institute for Health Research Biomedical Research Centre, University of Manchester, Manchester, United Kingdom. 12. Department of Dermatology and Allergology, Ludwig Maximilian University Munich, Munich, Germany.
Abstract
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.
RCT Entities:
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.
Authors: Julie J Hong; Megan L Mosca; Edward K Hadeler; Nicholas D Brownstone; Tina Bhutani; Wilson J Liao Journal: Dermatol Ther (Heidelb) Date: 2021-04-29
Authors: Marta Kasprowicz-Furmańczyk; Joanna Czerwińska; Waldemar Placek; Agnieszka Owczarczyk-Saczonek Journal: Int J Environ Res Public Health Date: 2022-07-08 Impact factor: 4.614