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利纳西珠单抗治疗中重度银屑病的疗效和安全性:系统评价和荟萃分析。

Efficacy and safety of Risankizumab in moderate to severe psoriasis: A systematic review and meta-analysis.

机构信息

Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, India.

Department of Dermatology, Venereology and Leprology, All India Institute of Medical Sciences, Jodhpur, India.

出版信息

Dermatol Ther. 2021 Jan;34(1):e14487. doi: 10.1111/dth.14487. Epub 2020 Nov 14.

Abstract

Monoclonal antibodies are explored for their therapeutic potential in Psoriasis. To evaluate Risankizumab in the moderate to severe psoriasis with regard to efficacy, tolerability, and safety PubMed, Cochrane Central Register of Controlled Trials (CENTRAL) and clinicaltrials.gov, databases were searched for relevant RCTs. The reference lists of relevant publications were also scanned manually to identify any further studies not indexed in the searched databases. Only RCT aiming to evaluate the role of Risankizumab in the treatment of moderate to severe psoriasis were considered eligible for this systematic review. Intervention group was patients taking Risankizumab and placebo or other monoclonal antibody was considered as control group. Cochrane review manager 5 (RevMan) version 5.3 was used for data synthesis and meta-analysis. Quality assessment of included randomized controlled trials was done with Cochrane Collaboration risk of bias assessment tool, version 2.0 (ROB-2). Overall Grading of evidence for study objectives was performed with GRADE Pro GDT software. A total of seven studies were included in analysis with total of 1533 and 710 patients in Risankizumab and standard care groups, respectively. Statistically significant increase in percentage of individual achieving PASI90 (OR = 11.01 (95% CI = 8.67-13.99), DLQI-01 (OR = 6.95 (95% CI = 5.53-8.75), sPGA-01 (OR = 14.22 (95% CI = 11.10-18.22); sPGA-0 (OR = 6.39 (95% CI = 4.79-8.54) in risankizumab group as compared with control, with high quality of evidence. Increased risk of infections with risankizumab as compared with placebo (OR = 1.44 [95% CI = 1.13-1.83], high quality evidence), while no difference in SAE among two groups. Analysis of all outcome data from RCTs. In the light of evidence from systematic review on effectiveness of Risankizumab, we propose treatment with risankizumab for psoriasis patients not responding to available treatment.

摘要

单克隆抗体在银屑病的治疗潜力方面正在被探索。为了评估 risankizumab 在中度至重度银屑病中的疗效、耐受性和安全性,我们在 PubMed、Cochrane 中心对照试验注册库(CENTRAL)和 clinicaltrials.gov 数据库中搜索了相关的 RCT。还手动扫描了相关出版物的参考文献列表,以确定未在搜索数据库中索引的任何其他研究。只有旨在评估 risankizumab 在治疗中度至重度银屑病中的作用的 RCT 才被认为符合本系统评价的纳入标准。干预组为接受 risankizumab 的患者,安慰剂或其他单克隆抗体组为对照组。Cochrane 评论经理 5(RevMan)版本 5.3 用于数据综合和荟萃分析。使用 Cochrane 协作风险偏倚评估工具,版本 2.0(ROB-2)对纳入的随机对照试验进行质量评估。使用 GRADE Pro GDT 软件对研究目标的总体证据进行分级。共有 7 项研究纳入分析,risankizumab 组和标准治疗组分别有 1533 名和 710 名患者。与对照组相比,risankizumab 组在达到 PASI90(OR = 11.01(95%CI = 8.67-13.99)、DLQI-01(OR = 6.95(95%CI = 5.53-8.75)、sPGA-01(OR = 14.22(95%CI = 11.10-18.22)和 sPGA-0(OR = 6.39(95%CI = 4.79-8.54)的个体百分比方面有统计学意义的增加,证据质量高。与安慰剂相比,risankizumab 组感染风险增加(OR = 1.44(95%CI = 1.13-1.83),高质量证据),但两组间 SAE 无差异。对 RCT 的所有结局数据进行分析。根据系统评价中关于 risankizumab 有效性的证据,我们建议对未对现有治疗产生反应的银屑病患者进行 risankizumab 治疗。

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