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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2024, Vol. 29 ›› Issue (7): 722-734.doi: 10.12092/j.issn.1009-2501.2024.07.001

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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

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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