中国临床药理学与治疗学2024，Vol.29Issue(7)：722-734,13.DOI:10.12092/j.issn.1009-2501.2024.07.001
阿达木单抗生物类似药是否可进行临床互换用药:基于系统评价与Meta分析的证据
Can adalimumab biosimilars be clinically interchanged:evidence based on a systematic review and Meta-analysis
摘要
Abstract
AIM:To systematically evaluate the clinical interchangeability of adalimumab biosimi-lars in terms of efficacy,safety,and immunogenici-ty,and to provide evidence-based reference for clinical interchangeability.METHODS:Randomized Controlled Trials(RCTs)on the interchangeability of adalimumab biosimilars were systematically searched in PubMed,Embase,Cochrane Library,CNKI,WANFANG and SinoMed from inceptions to October 2023.Data were extracted from the litera-ture that met the inclusion criteria,risk of bias was assessed using the Cochrane Handbook for System-atic Reviews of Interventions 5.0 bias risk assess-ment tool.Meta-analysis was performed using Rev-man 5.4 software.The certainty of evidence was graded using the GRADE tool recommended by the Cochrane Collaboration.This study was conducted according to the PRISMA guideline.RESULTS:Eigh-teen studies were included,with 7 focusing on pso-riasis and 11 on rheumatoid arthritis.Regarding ef-ficacy,for psoriasis,there were no statistical differ-ences in PASI 75 response rates and sPGA scores of ≤1 after 1-4 switches between biosimilars and the reference drug(P＞0.05,moderate-quality evi-dence).For rheumatoid arthritis,there were no sta-tistical differences in ACR 20/50/70 response rates after 1-3 switches(P＞0.05,moderate-quality evi-dence).Regarding safety,there were no statistical differences in the risk of adverse events after single or multiple switches for both diseases(P＞0.05,moderate-quality evidence).Regarding immunoge-nicity,there were no statistical differences in the rate of anti-drug antibody production after single or multiple switches(P＞0.05,moderate-quality evi-dence).High-quality evidence is still lacking for the interchangeability of adalimumab biosimilars in other indications.CONCLUSION:The switches be-tween adalimumab biosimilars and the reference drug have no significant impact on clinical efficacy,safety and immunogenicity for psoriasis and rheu-matoid arthritis patients.关键词
生物类似药/阿达木单抗/互换用药/转换用药/Meta分析Key words
biosimilars/adalimumab/inter-changeability/switching/meta-analysis分类
医药卫生引用本文复制引用
胡杨,宋再伟,高媛,冉怡雯,姜丹,赵荣生..阿达木单抗生物类似药是否可进行临床互换用药:基于系统评价与Meta分析的证据[J].中国临床药理学与治疗学,2024,29(7):722-734,13.基金项目
国家自然科学基金资助项目(72074005) （72074005）
国家自然科学基金资助项目(72304007) （72304007）
吴阶平医学基金(320.6750.2021-10-49) （320.6750.2021-10-49）
北京市卫生健康科技成果和适宜技术推广项目(BHTPP2022079) （BHTPP2022079）
