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司库奇尤单抗治疗中度至重度斑块状银屑病的疗效和安全性:一项随机对照试验的荟萃分析

Efficacy and safety of secukinumab in the treatment of moderate to severe plaque psoriasis: a meta-analysis of randomized controlled trials.

作者信息

Xiong Hui-Zi, Gu Jun-Ying, He Zhi-Gang, Chen Wen-Juan, Zhang Xiao, Wang Jia-Yi, Shi Yu-Ling

机构信息

Department of Dermatology, Shanghai Tenth People's Hospital, Tongji University School of Medicine Shanghai 200072, China ; The First Affiliated Hospital of Soochow University Suzhou 215000, Jiangsu Province, China.

Department of Dermatology, Shanghai Tenth People's Hospital, Tongji University School of Medicine Shanghai 200072, China.

出版信息

Int J Clin Exp Med. 2015 Mar 15;8(3):3156-72. eCollection 2015.

Abstract

Psoriasis is a chronic inflammatory skin disease with high rate of recurrence. New anti-interleukin-17 (IL-17) and anti-IL17RA biologics are in Phase 3 clinical trials and may prove to be more effective than existing biologic drugs. Now we perform a meta-analysis on efficacy and safety of secukinumab in the treatment of moderate-to-severe plaque psoriasis. In this meta-analysis, data analysis was performed with the Cochrane Collaboration's RevMan 5.0 software. Eight randomized controlled trials (RCTs) with a total of 3,213 psoriasis cases were included in the meta-analysis. Co-primary endpoints (week 12) were ≥ 75%/90% improvement in psoriasis area and a score of 0 (clear) or 1 (almost clear) on a 5-point Investigator's Global Assessment scale (IGA mod 2011 0/1) versus placebo [1]. The overall efficacy in the meta-analysis was as follows: PASI 75: for secukinumab 150 mg versus placebo, fixed-effects OR = 49.25, 95% CI: 33.67-72.06, Z = 20.07, P < 0.00001; PASI 90: for secukinumab 150 mg versus placebo, fixed-effects OR = 44.92, 95% CI: 24.72-81.62, Z = 12.49, P < 0.00001; IGA mod 2011 0/1: for secukinumab 150 mg versus placebo, random-effects OR = 22.25, 95% CI: 7.63-64.84, Z = 5.68, P < 0.00001; Compared with placebo, there were no significant adverse effects in the secukinumab groups, demonstrating safety in the treatment of moderate to severe plaque psoriasis. The proportion of patients who achieved 75%, 90% and IGA mod 2011 0/1 reductions respectively was significant in the secukinumab groups, demonstrating a rapid clinical improvement accompanied by a favorable short-term safety profile.

摘要

银屑病是一种复发率很高的慢性炎症性皮肤病。新型抗白细胞介素-17(IL-17)和抗IL-17受体生物制剂正处于3期临床试验阶段,可能比现有的生物药物更有效。现在我们对司库奇尤单抗治疗中重度斑块状银屑病的疗效和安全性进行荟萃分析。在这项荟萃分析中,使用Cochrane协作网的RevMan 5.0软件进行数据分析。该荟萃分析纳入了8项随机对照试验(RCT),共3213例银屑病病例。共同主要终点(第12周)为银屑病面积改善≥75%/90%,以及在5分制研究者整体评估量表(IGA mod 2011 0/1)上得分为0(清除)或1(几乎清除),与安慰剂相比[1]。荟萃分析中的总体疗效如下:PASI 75:司库奇尤单抗150mg组与安慰剂组相比,固定效应OR = 49.25,95%CI:33.67 - 72.06,Z = 20.07,P < 0.00001;PASI 90:司库奇尤单抗150mg组与安慰剂组相比,固定效应OR = 44.92,95%CI:24.72 - 81.62,Z = 12.49,P < 0.00001;IGA mod 2011 0/1:司库奇尤单抗150mg组与安慰剂组相比,随机效应OR = 22.25,95%CI:7.63 - 64.84,Z = 5.68,P < 0.00001;与安慰剂相比,司库奇尤单抗组无显著不良反应,表明其在治疗中重度斑块状银屑病时具有安全性。司库奇尤单抗组分别实现75%、90%和IGA mod 2011 0/1降低的患者比例显著,表明临床改善迅速且短期安全性良好。

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