Can adalimumab biosimilars be clinically interchanged:evidence based on a systematic review and Meta-analysis
10.12092/j.issn.1009-2501.2024.07.001
- VernacularTitle: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
- Author:
Yang HU
1
,
2
,
3
;
Zaiwei SONG
;
Yuan GAO
;
Yiwen RAN
;
Dan JIANG
;
Rongsheng ZHAO
Author Information
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
- Keywords:
biosimilars;
adalimumab;
inter-changeability;
switching;
meta-analysis
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2024;29(7):722-734
- CountryChina
- Language:Chinese
-
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.
