Abstract:
The effect and safety of monoclonal antibodies (mAbs) targeting the interleukin-23 (IL-23) p19 subunit for treatment of psoriasis has not previously been systematically evaluated. To perform a systematic review and meta-analysis of randomized clinical trials (RCTs) (including Phase I-III trials) to evaluate the efficacy and safety of these mAbs for treatment of psoriasis. The databases of PubMed, Baidu Scholar, and Cochrane Library of Clinical Trials were searched from inception of the databases to January 1st, 2018. A systematic review and meta-analysis was conducted using Review Manager Software version 5.3 (RevMan 5.3). Nine RCTs with a total of 2,478 subjects met our inclusion criteria. A significant increase in PASI 75 (RR: 11.65; 95% CI: 9.01-15.06), PASI 90 (RR: 21.74; 95% CI: 14.28-33.10), PASI 100 (RR: 31.56; 95% CI: 14.66-67.96), PGA 0/1 (OR: 23.21; 95% CI: 14.61-36.89), and DLQI 0/1 (RR: 10.29; 95% CI: 7.52-14.09) was identified for anti-IL-23p19 mAb vs. placebo, and PASI 75 (RR: 1.25; 95% CI: 1.18-1.32), PASI 90 (OR: 2.56; 95% CI: 2.13-3.09), PASI 100 (OR: 2.38, 95% CI: 1.89-2.99), and DLQI 0/1 (RR: 1.33; 95% CI: 1.20-1.47) vs. tumour necrosis factor (TNF) antagonists for the treatment of psoriasis. Furthermore, there was no significant difference in adverse events between placebo and TNF antagonists. Anti-IL-23p19 mAbs are effective with acceptable safety as therapy for psoriasis, and may be superior to TNF antagonists. More RCTs with a larger sample size are required to verify the current findings.
摘要:
以前尚未系统地评估靶向白介素-23(IL-23)p19亚基的单克隆抗体(mAb)治疗牛皮癣的效果和安全性。对随机临床试验(RCT)(包括I-III期试验)进行系统评价和荟萃分析,以评估这些单克隆抗体治疗银屑病的疗效和安全性。PubMed的数据库,百度学者,从数据库开始到1月1日搜索Cochrane临床试验库,2018.使用ReviewManagerSoftware5.3版(RevMan5.3)进行系统评价和荟萃分析。9项RCT共2,478名受试者符合我们的纳入标准。PASI75显着增加(RR:11.65;95%CI:9.01-15.06),PASI90(RR:21.74;95%CI:14.28-33.10),PASI100(RR:31.56;95%CI:14.66-67.96),PGA0/1(OR:23.21;95%CI:14.61-36.89),和DLQI0/1(RR:10.29;95%CI:7.52-14.09)被鉴定为抗IL-23p19mAb与安慰剂,和PASI75(RR:1.25;95%CI:1.18-1.32),PASI90(OR:2.56;95%CI:2.13-3.09),PASI100(OR:2.38,95%CI:1.89-2.99),和DLQI0/1(RR:1.33;95%CI:1.20-1.47)与用于治疗牛皮癣的肿瘤坏死因子(TNF)拮抗剂。此外,安慰剂和TNF拮抗剂之间的不良事件无显著差异.抗IL-23p19单克隆抗体是有效的,具有可接受的安全性作为治疗牛皮癣,并且可能优于TNF拮抗剂。需要更多样本量更大的RCT来验证当前的发现。