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Twice-weekly topical calcipotriene/betamethasone dipropionate foam as proactive management of plaque psoriasis increases time in remission and is well tolerated over 52 weeks (PSO-LONG trial)
Journal of the American Academy of Dermatology ( IF 13.8 ) Pub Date : 2020-09-18 , DOI: 10.1016/j.jaad.2020.09.037
Mark Lebwohl 1 , Leon Kircik 1 , Jean-Philippe Lacour 2 , Monika Liljedahl 3 , Charles Lynde 4 , Marie Holst Mørch 3 , Kim A Papp 5 , Jean-Luc Perrot 6 , Linda Stein Gold 7 , Amrit Takhar 8 , Diamant Thaçi 9 , Richard B Warren 10 , Andreas Wollenberg 11
Affiliation  

Topical psoriasis treatment relies on a reactive rather than a long-term proactive approach to disease relapse. Assess long-term efficacy and safety of proactive psoriasis management with twice-weekly calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam. Phase III trial () 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). 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 ( < .001). Number of relapses per year of exposure was 3.1 (proactive) and 4.8 (reactive). Cal/BD foam was well tolerated. Maintenance phase dropout rate (53.9%) was within the expected range but provides challenges in statistical analysis. Long-term proactive management with Cal/BD foam demonstrated superior efficacy vs reactive management.

中文翻译:

每周两次局部使用卡泊三烯/二丙酸倍他米松泡沫作为斑块状银屑病的主动治疗可延长缓解时间,并且在 52 周内具有良好的耐受性(PSO-LONG 试验)

局部牛皮癣治疗依赖于对疾病复发的反应性而非长期主动方法。评估每周两次使用 0.005% 卡泊三烯/0.064% 二丙酸倍他米松 (Cal/BD) 泡沫进行银屑病主动治疗的长期疗效和安全性。 III 期试验 () 包括为期 4 周的开放标签导入阶段(Cal/BD 泡沫每天一次)和为期 52 周的随机、双盲维持阶段。共有 545 名患者取得了治疗成功(医生的总体评估为“清除”/“几乎清除”,较基线改善 ≥2 级),并被随机分配至主动治疗组(Cal/BD 泡沫;n = 272)或反应性治疗组(车辆泡沫;n = 273)每周两次,复发后每日一次使用 Cal/BD 泡沫进行救援治疗,持续 4 周。主要终点是首次复发的时间(医生的总体评估为“轻度”或更高)。共有 251 名随机患者 (46.1%) 完成了试验。首次复发的中位时间为 56 天(主动型)和 30 天(反应型)。与反应组患者相比,主动组患者的缓解时间多了 41 天 (< .001)。每年暴露的复发次数为 3.1 次(主动性)和 4.8 次(反应性)。 Cal/BD 泡沫具有良好的耐受性。维持阶段脱落率(53.9%)在预期范围内,但给统计分析带来了挑战。使用 Cal/BD 泡沫进行的长期主动管理比被动管理表现出卓越的功效。
更新日期:2020-09-18
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