Department of Dermatology, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan.
Department of Pharmacy, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan.
J Dtsch Dermatol Ges. 2022 Sep;20(9):1201-1209. doi: 10.1111/ddg.14832. Epub 2022 Aug 26.
To compare the efficacy and safety of biologic treatments for moderate-to-severe pediatric psoriasis approved by the US Food and Drug Administration and European Medicines Agency.
MEDLINE, Embase, and Cochrane Central Register of Controlled Trials for relevant randomized controlled trials (RCTs) were searched for the identification of eligible RCTs until May 7, 2021. Fixed-effect frequentist network meta-analysis (NMA) was performed with the surface under the cumulative ranking curve (SUCRA) calculated for ranking. Our primary outcomes included ≥ 90 % improvement of Psoriasis Area and Severity Index score (PASI 90) at 12-16 weeks and discontinuation owing to adverse events (DAE) through the first 12-16 weeks.
Five RCTs involving 798 pediatric psoriasis patients were included. Compared to placebo, all biologic regimens exhibited a significantly higher PASI 90 response but did not differ in the risk for DAE. Based on the SUCRA, secukinumab-low dose (SEC-L) ranked first in the achieved PASI 90 response (84.7 %), followed by ixekizumab (70.8 %).
Among all biologic treatments, SEC-L showed the best PASI 90 response without increasing the risk for DAE. More long-term studies are warranted.
比较美国食品药品监督管理局和欧洲药品管理局批准的用于中重度儿童银屑病的生物治疗药物的疗效和安全性。
检索 MEDLINE、Embase 和 Cochrane 对照试验中心注册库,以确定符合条件的随机对照试验(RCT),检索时间截至 2021 年 5 月 7 日。采用固定效应频率网络荟萃分析(NMA)进行分析,并计算排序的累积排序曲线下面积(SUCRA)。我们的主要结局包括在 12-16 周时 PASI 90 评分(PASI 90)≥90%的改善率和在 12-16 周内因不良反应(DAE)而停药的发生率。
纳入了 5 项涉及 798 例儿童银屑病患者的 RCT。与安慰剂相比,所有生物制剂方案的 PASI 90 应答率均显著提高,但 DAE 风险无差异。根据 SUCRA,低剂量司库奇尤单抗(SEC-L)在达到 PASI 90 应答方面排名第一(84.7%),其次是依奇珠单抗(70.8%)。
在所有生物治疗中,SEC-L 显示出最佳的 PASI 90 应答,且不增加 DAE 的风险。需要更多的长期研究。