阿达木单抗生物类似药和原研药治疗类风湿关节炎的有效性、安全性和免疫原性的Meta分析

Meta⁃analysis of efficacy,safety and immunogenicity of adalimumab biosimilars and original drugs in the treatment of rheumatoid arthritis

目的:系统评价阿达木单抗生物类似药与阿达木单抗原研药治疗类风湿关节炎(RA)的有效性、安全性和免疫原性。方法:通过检索中英文数据库,筛选符合纳入标准、不符合排除标准的随机对照研究,并提取数据,通过偏倚风险评估工具对纳入的研究进行文献质量评价后,采用RevMan 5.4.1统计软件进行Meta分析。结果:共纳入14项研究,10种生物类似药,合计6933例RA患者。结果显示,两组疗效评估美国风湿病学会20%改善标准(ACR20)、抗药抗体阳性率比较差异均无统计学意义;两组总不良反应发生率相比具有统计学差异,试验组总不良反应发生率和严重不良反应发生率较对照组低;亚组分析结果显示均无统计学差异。结论:阿达木单抗生物类似药治疗RA在疗效和免疫原性上与原研药相当,安全性不亚于原研药。

Objective:To systematically evaluate the efficacy,safety and immunogenicity of aldamumab bioanalogues and aldamumab antigenics in the treatment of rheumatoid arthritis.Methods:By searching the databases in Chinese and English,randomized controlled studies that were inclusive and exclusive to the criterias were screened,and the data were extracted.After the quality of the included studies was evaluated by the bias risk assessment tool,the RevMan 5.4.1 statistical software is used for Meta analysis.Results:A total of 14 studies regarding 10 biosimilar drugs were included,with a total of 6933 RA patients.The results showed that there was no significant difference in ACR20 and the positive rate of anti⁃drug antibody between the two groups.Compared with the total number of adverse reactions in the two groups,statistical differences are found.The total number of adverse reactions and serious adverse reactions in the trial group is lower than that of the control group.The results of the subgroup analysis show that there is no statistical difference.Conclusion:The efficacy and immunogenicity of adamumab biosimilars in the treatment of rheumatoid arthritis are equivalent to the original drug,and safe as the original drug.