Department of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, India.
Am J Clin Dermatol. 2021 May;22(3):415-423. doi: 10.1007/s40257-021-00596-6. Epub 2021 Mar 12.
Placebo-controlled studies have reported the efficacy of apremilast in the management of palmoplantar psoriasis but studies comparing efficacy with a conventional agent are lacking.
The objective of this article was to compare the efficacy and safety of apremilast and methotrexate in patients with palmoplantar psoriasis.
In this prospective, randomized, active-controlled, observer-blinded clinical trial, conducted at a psoriasis clinic of a tertiary care institute in India from 1 July, 2019 to 1 June, 2020, 84 patients with palmoplantar psoriasis were randomized (1:1) to receive either methotrexate (0.4 mg/kg/week orally) or apremilast (30 mg twice daily). The treatment protocol was continued for 16 weeks or until achieving a ≥ 75% improvement in the Modified Palmoplantar Psoriasis Area and Severity Index (m-PPPASI 75), whichever was earlier. Changes in m-PPPASI and Dermatology Life Quality Index scores from baseline, the proportion of patients achieving m-PPPASI 75, and adverse events were assessed.
Eighty-four patients were included (76 palmoplantar psoriasis and 8 palmoplantar pustulosis). The mean age (standard deviation) was 44.5 (12.9) years and 53 (63%) were women. The m-PPPASI score [median (interquartile range)] after 16 weeks of treatment showed a significant improvement from baseline in both apremilast [- 6.3 (10.9), p < 0.001] and methotrexate groups [- 8.5 (9.9), p < 0.001]. The estimated median difference between the groups was - 1.2 (p = 0.39, 95% confidence interval - 4.2 to 2.1). At 16 weeks, m-PPPASI 75 was achieved by 14/42 (33%) and 17/42 (41%) patients in the apremilast and methotrexate groups, respectively (p = 0.49). A significant reduction in the Dermatology Life Quality Index score [median (interquartile range)] was observed in both groups [apremilast: - 3.0 (6.0), p < 0.001; methotrexate: - 3.0 (6.3), p < 0.001] with an estimated median difference of 0.0 (p = 0.99, 95% confidence interval - 1.0 to 2.0). The proportion of patients experiencing adverse events was comparable (p = 0.49).
Apremilast showed a comparable efficacy and safety profile to methotrexate in the management of palmoplantar psoriasis.
CTRI/2019/06/019830, date of registration: 24 June, 2019; trial registered prospectively.
安慰剂对照研究已经报道了阿普米司特在掌跖银屑病治疗中的疗效，但缺乏与传统药物进行疗效比较的研究。
本文旨在比较阿普米司特和甲氨蝶呤治疗掌跖银屑病患者的疗效和安全性。
这是一项前瞻性、随机、活性对照、观察者盲法临床试验，于 2019 年 7 月 1 日至 2020 年 6 月 1 日在印度一家三级医疗机构的银屑病诊所进行，84 例掌跖银屑病患者被随机（1:1）分为接受甲氨蝶呤（0.4mg/kg/周口服）或阿普米司特（30mg，每日 2 次）治疗。治疗方案持续 16 周或直至达到改良掌跖银屑病面积和严重程度指数（m-PPPASI）改善≥75%，以先达到者为准。评估 m-PPPASI 和皮肤病生活质量指数评分从基线的变化、达到 m-PPPASI 75 的患者比例以及不良事件。
共纳入 84 例患者（76 例掌跖银屑病和 8 例掌跖脓疱病）。平均年龄（标准差）为 44.5（12.9）岁，53 例（63%）为女性。治疗 16 周后，阿普米司特组[-6.3（10.9），p＜0.001]和甲氨蝶呤组[-8.5（9.9），p＜0.001]的 m-PPPASI 评分均较基线显著改善。两组间估计的中位数差值为-1.2（p=0.39，95%置信区间-4.2 至 2.1）。治疗 16 周时，阿普米司特组和甲氨蝶呤组分别有 14/42（33%）和 17/42（41%）患者达到 m-PPPASI 75（p=0.49）。两组患者的皮肤病生活质量指数评分[中位数（四分位数间距）]均显著降低[阿普米司特：-3.0（6.0），p＜0.001；甲氨蝶呤：-3.0（6.3），p＜0.001]，估计的中位数差值为 0.0（p=0.99，95%置信区间-1.0 至 2.0）。发生不良事件的患者比例相当（p=0.49）。
阿普米司特在掌跖银屑病的治疗中显示出与甲氨蝶呤相当的疗效和安全性。
CTRI/2019/06/019830，注册日期：2019 年 6 月 24 日；试验前瞻性注册。
