培塞利珠单抗治疗中重度斑块状银屑病的疗效与安全性Meta分析

Efficacy and Safety of Certolizumab Pegol in the Treatment of Moderate-to-Severe Plaque Psoriasis:A Meta-Analysis

目的评价培塞利珠单抗治疗中重度斑块状银屑病的疗效与安全性。方法计算机检索PubMed,Embase,The Cochrane Library,以及中国知网、维普、万方等数据库和临床试验网站(ClinicalTrials.gov),纳入培塞利珠单抗与安慰剂比较的随机对照试验,由2名研究员依据纳入和排除标准筛选文献,根据Cochrane系统评价员手册5.1.0提供的偏倚风险评估工具评价纳入研究的质量,采用改良的Jadad量表对文献质量进行评分,使用RevMan 5.3软件进行Meta分析。结果共纳入4篇研究(5个随机对照试验),包括1 153例患者。Meta分析结果显示,与对照组(安慰剂)比较,试验组(培塞利珠单抗200 mg或400 mg)银屑病皮损面积和严重程度指数(PASI)较基线减少75%显著改善[200 mg剂量组:RR=13.01,95%CI(7.88,21.47),P <0.000 01;400 mg剂量组:RR=11.89,95%CI(7.19,19.64),P <0.000 01];PASI 90显著改善[200 mg剂量组:RR=23.59,95%CI(9.25,60.12),P <0.000 01;400 mg剂量组:RR=28.97,95%CI(11.35,73.91),P <0.000 01];医师全面评估指标(PGA)为0或1的患者比例(PGA 0/1)显著改善[200 mg剂量组:RR=19.06,95%CI(8.94,40.63),P <0.000 01;400 mg剂量组:RR=28.27,95%CI(12.30,64.98),P <0.000 01];与对照组比较,试验组总的不良反应发生率差异无统计学意义[200 mg剂量组:RR=0.93,95%CI(0.82,1.05),P=0.24;400 mg剂量组:RR=1.02,95%CI(0.90,1.15),P=0.78]。结论培塞利珠单抗治疗中重度斑块状银屑病的疗效优于安慰剂,且安全性相当,可作为治疗中重度斑块状银屑病的新选择。

Objective To evaluate the efficacy and safety of certolizumab pegol in the treatment of moderate-to-severe plaque psoriasis.Methods The randomized controlled trials(RCT) of the comparison between certolizumab pegol and placebo in the treatment of moderate-to-severe plaque psoriasis in PubMed,Embase,the Cochrane Library,CNKI,VIP and WanFang databases and clinical trials websites(ClinicalTrials.gov) were electronically searched.The studies were screened according to the inclusion and exclusion criteria by two researchers,the quality of the included studies was evaluated according to the bias risk assessment tool provided by the Cochrane Reviews’ Handbook 5.1.0,the quality of the included studies was scored by the modified Jadad scale,and the Meta-analysis was performed by the Rev Man 5.3 software.Results Four studies(five RCTs) including 1 153 patients were included.The results of Meta-analysis showed that compared with those the control group(placebo),the psoriasis area and severity index(PASI) reduction of 75% compared with the baseline(PASI 75) in the experimental group(200 mg or400 mg of certolizumab pegol) was significantly improved [200 mg dose group:RR=13.01,95% CI(7.88,21.47,P <0.000 01;400 mg dose group:RR=11.89,95% CI(7.19,19.64),P <0.000 01],and the PASI reduction of 90% compared with the baseline(PASI 90) in the experimental group was significantly improved [200 mg dose group:RR=23.59,95% CI(9.25,60.12),P <0.000 01;400 mg dose group:RR=28.97,95% CI(11.35,73.91),P <0.000 01],and the proportion of patients with physician’s global assessment(PGA) of 0 or 1(PGA 0/1) in the experimental group was significantly improved [200 mg dose group:RR=19.06,95% CI(8.94,40.63),P <0.000 01;400 mg dose group:RR=28.27,95% CI(12.30,64.98),P <0.000 01].Compared with those in the control group,there was no significant difference in the total adverse reactions in the experimental group [200 mg dose group:RR=0.93,95% CI(0.82,1.05),P=0.24;400 mg dose group:RR=1.02,95% CI(0.90,1.15),P=0.78].Conclusion Certolizumab pegol is superior to placebo in the treatment of moderate-to-severe plaque psoriasis,but its safety is equivalent to placebo.It can be used as a new choice for the treatment of moderate-to-severe plaque psoriasis.