肿瘤坏死因子-α抑制剂原研药及其类似物治疗强直性脊柱炎疗效比较的网状Meta分析

Mesh meta-analysis of the efficacy of original and biosimilar TNF-αinhibitors in the treatment of ankylosing spondylitis

目的通过网状Meta分析方法比较依那西普、英夫利西单抗、阿达木单抗及其类似物治疗AS的临床疗效。方法计算机检索数据库Ovid生物医学、Embase、Cochrane Library以及中国知网、万方数据库、维普数据库(截止2023年3月8日)中所有TNF-α抑制剂治疗AS的随机对照试验(RCT),语种不限。2名评价员根据纳入标准及排除标准独立采用非盲法进行筛选,评价其方法学质量并提取数据。基于贝叶斯网络对纳入研究统计分析,运用统计软件R 3.6.1、R Studio实现。结果相对森林图结果显示,对于主要结局指标ASAS20,英夫利西单抗相对于依那西普[OR值(95%CI)=1.4(0.54,3.5)],安慰剂相对于依那西普[OR值(95%CI)=0.35(0.17,0.67)],依那西普、英夫利西单抗、阿达木单抗及其类似物间差异无统计学意义。对于BASDAI,英夫利西单抗相对于依那西普[OR值(95%CI)=-0.89(-1.8,0.081)],安慰剂相对于依那西普[OR值(95%CI)=1.7(0.86,2.5)],依那西普、英夫利西单抗、阿达木单抗及其类似物间差异无统计学意义。对于BASFI,英夫利西单抗相对于依那西普[OR值(95%CI)=-0.46(-1.3,0.47)],安慰剂相对于依那西普[OR值(95%CI)=1.6(0.8,2.3)],依那西普、英夫利西单抗、阿达木单抗及其类似物间差异无统计学意义。结论依那西普、英夫利西单抗、阿达木单抗及其类似物治疗AS在ASAS20、BASDAI、BASFI、CRP、ESR方面显著优于安慰剂,也显著优于柳氮磺吡啶。有限的证据说明依那西普、英夫利西单抗、阿达木单抗类似药在上述方面的疗效与其相应的原研药相当。

Objective In order to understand the difference of clinical efficacy between original TNF-αinhibitors(TNFi)and their biosimilars,Bayesian mesh Meta-analysis was compare Etanercept,Infliximab,Adalimumab with their biosimilars in the treatment of ankylosing spondylitis(AS).Methods A systematic literature search was performed,using Ovid Biomedical,Embase,Cochrane Library,CNKI,Wanfang Database and Weipu Database(up to March 8,2023 for all resources above),to search publications of randomized controlled trial(RCT)about all original and biosimilar TNFi for the treatment of AS in all language.Two reviewers independently identified the eligible trails,evaluated bias risk and extracted relevant data.Based on Bayesian network,data analysis of included studies was conducted using statistical software R3.6.1 and R Studio.Results The results of the network meta-analysis showed that,no significant differences was observed among.Etanercept,Infliximab,Adalimumab,and their biosimilars for ASAS20 when Infliximab was compared with Etanercept[OR(95%CI)=1.4(0.54,3.5)],placebo was compared with Etanercept[OR(95%CI)=0.35(0.17,0.67)],No significant differences were observed among Etanercept,Infliximab,Adalimumab,and their biosimilars for BASDAI,when Infliximab was compared with Ctanercept[OR(95%CI)=-0.89(-1.8,0.081)],placebo was compared with Etanercept[OR(95%CI)=1.7(0.86,2.5)],No significant differences were observed among Etanercept,Infliximab,Adalimumab,and their biosimilars for BASFI,when Infliximab was compared with Etanercept[OR(95%CI)=-0.46(-1.3,0.47)],placebo was compared with Etanercept[OR(95%CI)=1.6(0.8,2.3)].Conclusion Etanercept,Infliximab,Adalimumab with their biosimilars are significantly superior to placebo and sulfasalazine in terms of ASAS20,BASDAI,BASFI,CRP,ESR.Limited evidence have shown that the efficacy of biological biosimilars are similar to that of their corresponding original drugs.