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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.
CONCLUSIONS: Maintenance phase dropout rate (53.9%) was within the expected range but provides challenges in statistical analysis.
CONCLUSIONS: Long-term proactive management with Cal/BD foam demonstrated superior efficacy vs reactive management.
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.
CONCLUSIONS: Maintenance phase dropout rate (53.9%) was within the expected range but provides challenges in statistical analysis.
CONCLUSIONS: Long-term proactive management with Cal/BD foam demonstrated superior efficacy vs reactive management.
摘要：
背景：局部银屑病治疗依赖于反应性而非长期的主动治疗方法来治疗疾病复发。
目的：评估每周两次使用0.005%钙泊三烯/0.064%二丙酸倍他米松（Cal/BD）泡沫的前瞻性银屑病治疗的长期疗效和安全性。
方法：III期试验（NCT02899962）包括为期4周的开放标签导入期（Cal/BD泡沫每天一次）和为期52周，随机化，双盲,维护阶段。共有545名患者获得了治疗成功(医生的全球评估“clear”/“几乎清楚，“从基线开始≥2级改善）并随机接受主动管理（Cal/BD泡沫；n=272）或被动管理（车辆泡沫；n=273），每周两次，复发后每日一次Cal/BD泡沫抢救治疗，持续4周。主要终点是首次复发的时间（医生的全球评估“轻度”或更高）。
结果：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）和30天（反应）。在1年以上，与反应组相比，主动组的患者缓解时间增加了41天（P<.001）。每年暴露的复发次数为3.1（主动）和4.8（反应性）。Cal/BD泡沫具有良好的耐受性。
结论：维持期脱落率（53.9%）在预期范围内，但在统计分析方面存在挑战。
结论：Cal/BD泡沫的长期主动管理与反应性管理相比具有更好的疗效。
目的：评估每周两次使用0.005%钙泊三烯/0.064%二丙酸倍他米松（Cal/BD）泡沫的前瞻性银屑病治疗的长期疗效和安全性。
方法：III期试验（NCT02899962）包括为期4周的开放标签导入期（Cal/BD泡沫每天一次）和为期52周，随机化，双盲,维护阶段。共有545名患者获得了治疗成功(医生的全球评估“clear”/“几乎清楚，“从基线开始≥2级改善）并随机接受主动管理（Cal/BD泡沫；n=272）或被动管理（车辆泡沫；n=273），每周两次，复发后每日一次Cal/BD泡沫抢救治疗，持续4周。主要终点是首次复发的时间（医生的全球评估“轻度”或更高）。
结果：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）和30天（反应）。在1年以上，与反应组相比，主动组的患者缓解时间增加了41天（P<.001）。每年暴露的复发次数为3.1（主动）和4.8（反应性）。Cal/BD泡沫具有良好的耐受性。
结论：维持期脱落率（53.9%）在预期范围内，但在统计分析方面存在挑战。
结论：Cal/BD泡沫的长期主动管理与反应性管理相比具有更好的疗效。
