J Drugs Dermatol. 2020 Sep 1;19(9):874-880. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5020.
To demonstrate the efficacy and safety of adding fixed-dose combination calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam to oral apremilast in treating moderate plaque psoriasis.
A 16-week, investigator-blinded study in patients with moderate psoriasis (Physician’s Global Assessment [PGA] score of 3). Patients were randomized 1:1 to Cal/BD foam plus apremilast or vehicle foam plus apremilast for 4 weeks, followed by 8 weeks of apremilast monotherapy, and then 4 weeks of combination therapy as in the original randomization schedule. Efficacy assessments – Psoriasis Area and Severity Index (PASI), PGA, body surface area (BSA), visual analog scale (VAS) for pruritus, and quality of life (QoL) – and safety were evaluated at weeks 1, 2, 3, 4, 12, and 16.
28 subjects were enrolled (mean age, 64 years; 67.9% males). Cal/BD foam plus apremilast group achieved statistically significantly greater improvement than vehicle foam plus apremilast in PASI75 (50% vs 7%; P=.003), PGA score of “clear” or “almost clear” (43% vs 7%; P=.001), and VAS score (2 vs 5; P=.0079) at week 4. BSA and QoL improvements were also observed. Most efficacy assessments worsened after withdrawing Cal/BD foam for 8 weeks but recovered after reinitiating Cal/BD foam from week 12 to week 16. Cal/BD foam plus apremilast appeared to be safe and well tolerated.
In the treatment of moderate plaque psoriasis, Cal/BD foam plus apremilast provided more benefits than with apremilast alone. These improvements appeared to be lost when Cal/BD foam was withdrawn but recovered when Cal/BD foam was reinitiated. J Drugs Dermatol. 2020;19(9):874-880. doi:10.36849/JDD.2020.5020.
展示固定剂量复方卡泊三醇 0.005%加倍他米松二丙酸酯 0.064%（Cal/BD）泡沫剂联合口服阿普米司特治疗中度斑块型银屑病的疗效和安全性。
一项为期 16 周、研究者设盲的研究，纳入中度银屑病患者（医生整体评估[PGA]评分 3）。患者以 1:1 的比例随机分配至 Cal/BD 泡沫剂联合阿普米司特或载体泡沫剂联合阿普米司特治疗 4 周，随后接受 8 周的阿普米司特单药治疗，然后再按原始随机分组方案接受 4 周的联合治疗。在第 1、2、3、4、12 和 16 周评估疗效评估（银屑病面积和严重程度指数[PASI]、PGA、体表面积[BSA]、瘙痒视觉模拟量表[VAS]和生活质量[QoL]）和安全性。
共纳入 28 例受试者（平均年龄 64 岁，67.9%为男性）。与载体泡沫剂联合阿普米司特组相比，Cal/BD 泡沫剂联合阿普米司特组在第 4 周时 PASI75（50%比 7%；P=.003）、PGA 评分“清除”或“几乎清除”（43%比 7%；P=.001）和 VAS 评分（2 比 5；P=.0079）的改善更为显著。BSA 和 QoL 也有改善。停用 Cal/BD 泡沫剂 8 周后，大多数疗效评估指标恶化，但从第 12 周开始重新使用 Cal/BD 泡沫剂至第 16 周后恢复。Cal/BD 泡沫剂联合阿普米司特似乎安全且耐受良好。
在治疗中度斑块型银屑病时，Cal/BD 泡沫剂联合阿普米司特比单独使用阿普米司特能带来更多获益。当停用 Cal/BD 泡沫剂时，这些改善似乎消失，但当重新开始使用 Cal/BD 泡沫剂时，改善又恢复。J 皮肤病学杂志。2020;19(9):874-880. doi:10.36849/JDD.2020.5020.
