J Drugs Dermatol. 2021 Apr 1;20(4):436-441. doi: 10.36849/JDD.2021.5728.
Psoriasis is a chronic disease requiring long-term treatment strategies. Optimal strategies should include initial rapid relief of symptoms followed by long-term management to maintain remission. This 4-week open-label phase of a long-term proactive management phase 3 trial aimed to select responders to once daily, fixed-dose combination calcipotriene 0.005% and betamethasone dipropionate 0.064% (Cal/BD) foam in adults with psoriasis and assess patient-reported outcomes.
This phase 3 trial in adults with psoriasis included a 4-week open-label lead-in phase to determine treatment success prior to entering the randomized maintenance phase. Success was defined as Physician Global Assessment (PGA) score ‘clear’/‘almost clear’ (PGA <2) with ≥2-grade improvement from baseline. Those achieving treatment success at week 4 entered the maintenance phase; non-responders were withdrawn from the trial.
650 patients enrolled in the open-label phase, and 623 were treated with Cal/BD foam for 4 weeks; 521 (80%) patients achieved treatment success and were included in the maintenance phase. In those patients achieving success (responders), 21.1% and 78.9% achieved a PGA score of ‘clear’ and ‘almost clear’, respectively. Mean change from baseline in modified Psoriasis Area and Severity Index (± standard deviation [SD]) and body surface area (± SD) in responders at week 4 was −82.1% (16.4%) and −56.6% (38.3%), respectively. Mean Dermatology Life Quality Index score reduced by 6.0 from baseline to week 4 (n=521). 17.7% of patients experienced AEs; with only one severe AE reported.
Cal/BD foam was highly efficacious and well tolerated during the 4-week lead-in phase of PSO-LONG. J Drugs Dermatol. 2021;20(4):436-441, doi:10.36849/JDD.5728.
银屑病是一种需要长期治疗策略的慢性疾病。最佳策略应包括初始症状迅速缓解，然后进行长期管理以维持缓解。这项为期 4 周的开放性标签试验是长期主动管理 3 期试验的一部分，旨在选择每日一次固定剂量复方钙泊三醇 0.005%和倍他米松二丙酸酯 0.064%（Cal/BD）泡沫治疗银屑病成人患者的应答者，并评估患者报告的结局。
这项 3 期临床试验纳入了银屑病成人患者，包括 4 周的开放性标签导入期，以确定进入随机维持期之前的治疗成功情况。成功定义为医生总体评估（PGA）评分 ‘清除’/‘几乎清除’（PGA <2），与基线相比改善 ≥2 级。第 4 周达到治疗成功的患者进入维持期；未应答者退出试验。
650 例患者进入开放性标签期，623 例患者接受 Cal/BD 泡沫治疗 4 周；521 例（80%）患者达到治疗成功并进入维持期。在达到成功的患者（应答者）中，分别有 21.1%和 78.9%达到 PGA 评分 ‘清除’和 ‘几乎清除’。第 4 周时，应答者的改良银屑病面积和严重程度指数（±标准差 [SD]）和体表面积（±SD）自基线的平均变化分别为−82.1%（16.4%）和−56.6%（38.3%）。从基线到第 4 周，平均皮肤病生活质量指数评分降低了 6.0 分（n=521）。17.7%的患者发生了不良事件；仅报告了 1 例严重不良事件。
Cal/BD 泡沫在 PSO-LONG 的 4 周导入期具有高度疗效和良好的耐受性。皮肤病药物杂志。2021;20(4):436-441,doi:10.36849/JDD.5728.
