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中国临床药理学与治疗学 ›› 2024, Vol. 29 ›› Issue (7): 722-734.doi: 10.12092/j.issn.1009-2501.2024.07.001

• 生物类似药研发与临床个体化使用最新进展 • 上一篇    下一篇

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

胡杨1,2,3,宋再伟1,2,高媛1,2,冉怡雯1,2,3,姜丹1,2,3,赵荣生1,2   

  1. 1北京大学第三医院药学部,北京  100191;2北京大学医学部药物评价中心,北京  100191;3北京大学药学院药事管理与临床药学系,北京  100191

  • 收稿日期:2024-01-02 修回日期:2024-01-31 出版日期:2024-07-26 发布日期:2024-06-24
  • 通讯作者: 赵荣生,男,博士,教授、主任药师,博士生导师,研究方向:循证药学、临床药物治疗评价、治疗药物监测与个体化治疗、药学人工智能应用。 E-mail: zhaorongsheng@bjmu.edu.cn
  • 作者简介:胡杨,男,博士研究生在读,研究方向:循证药学、临床药物治疗评价。 E-mail: huyang97@bjmu.edu.cn 宋再伟,共同第一作者,男,硕士,主管药师,研究方向:循证药学、治疗药物监测。 E-mail: songzw445@126.com
  • 基金资助:
    国家自然科学基金资助项目(72074005);国家自然科学基金资助项目(72304007);吴阶平医学基金(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)

Can adalimumab biosimilars be clinically interchanged: evidence based on a systematic review and Meta-analysis

HU Yang1,2,3, SONG Zaiwei 1,2, GAO Yuan 1,2, RAN Yiwen 1,2,3, JIANG Dan 1,2,3, ZHAO Rongsheng 1,2   

  1. 1 Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China; 2 Peking University Health Science Center’s Institute for Drug Evaluation, Beijing 100191, China; 3 Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing 100191,China
  • Received:2024-01-02 Revised:2024-01-31 Online:2024-07-26 Published:2024-06-24

摘要:

目的:系统评价阿达木单抗生物类似药临床互换用药的有效性、安全性与免疫原性,为临床互换用药提供循证参考。方法:系统检索Pubmed、Embase、Cochrane Library、CNKI、WANFANG、Sinomed等数据库中阿达木单抗生物类似药互换用药的随机对照试验(randomized controlled trial, RCT),检索时间为建库至2023年10月。对符合纳入标准的文献进行资料提取,并采用Cochrane系统评价手册5.0版推荐的偏倚风险评估工具进行偏倚风险评价,应用Revman 5.4软件进行Meta分析。对于证据体,采用Cochrane协作网推荐的GRADE工具进行质量分级。本项系统评价遵循PRISMA声明进行设计与实施。结果:共纳入18项研究,其中7项关注银屑病患者,11项关注类风湿关节炎患者。有效性方面,对于银屑病患者,与未转换用药相比,参照药与生物类似药间进行1~4次转换用药后PASI 75达标率与sPGA评分≤1达标率均无统计学差异(P>0.05,中等质量证据)。对于类风湿关节炎患者,与未转换用药相比,参照药与生物类似药间进行1~3次转换用药后根据美国风湿病学会(american college of rheumatology,ACR)评估标准症状缓解20%(ACR 20)、缓解50%(ACR 50)、缓解70%(ACR 70)的达标率均无统计学差异(P>0.05,中等质量证据)。安全性方面,对于银屑病与类风湿关节炎患者,与未转换用药相比,单次或多次转换用药后不良事件发生风险均无统计学差异(P>0.05,中等质量证据)。免疫原性方面,对于银屑病与类风湿关节炎患者,与未转换用药相比,单次或多次转换用药后抗药抗体产生率无统计学差异(P>0.05,中等质量证据)。目前尚缺乏其他适应证中阿达木单抗生物类似药互换用药的高质量循证医学证据。结论:阿达木单抗生物类似药与参照药间的转换用药未对银屑病及类风湿关节炎患者的治疗有效性、安全性、免疫原性造成影响。

关键词: 生物类似药, 阿达木单抗, 互换用药, 转换用药, Meta分析

Abstract:

AIM: To systematically evaluate the clinical interchangeability of adalimumab biosimilars in terms of efficacy, safety, and immunogenicity, 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 literature that met the inclusion criteria, risk of bias was assessed using the Cochrane Handbook for Systematic Reviews of Interventions 5.0 bias risk assessment tool. Meta-analysis was performed using Revman 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: Eighteen studies were included, with 7 focusing on psoriasis and 11 on rheumatoid arthritis. Regarding efficacy, for psoriasis, there were no statistical differences 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 evidence). For rheumatoid arthritis, there were no statistical differences in ACR 20/50/70 response rates after 1-3 switches (P>0.05, moderate-quality evidence). 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 immunogenicity, there were no statistical differences in the rate of anti-drug antibody production after single or multiple switches (P>0.05, moderate-quality evidence). High-quality evidence is still lacking for the interchangeability of adalimumab biosimilars in other indications.CONCLUSION:The switches between adalimumab biosimilars and the reference drug have no significant impact on clinical efficacy, safety and immunogenicity for psoriasis and rheumatoid arthritis patients.

Key words: biosimilars, adalimumab, interchangeability, switching, meta-analysis

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