Yiu Chin Hang, Yau Grace Tsz Yan, Wong Zoi Hei, Lin Chen-Yun, Day Richard O, Raubenheimer Jacques, Lu Christine Y
The University of Sydney School of Pharmacy, Camperdown, NSW, Australia.
Kolling Institute, Faculty of Medicine and Health, The University of Sydney and the Northern Sydney Local Health District, Sydney, NSW, Australia.
Int J Clin Pharm. 2025 Jun 25. doi: 10.1007/s11096-025-01956-6.
Effective management of rheumatoid arthritis (RA) often requires the use of biological disease-modifying antirheumatic drugs (bDMARDs). Biosimilar drugs (biosimilars), licensed pharmaceutical products that exhibit high similarity to their reference biological products (originators), have emerged as more affordable alternatives.
To compare the real-world effectiveness and safety of biosimilars and originators of bDMARDs in the management of RA at treatment initiation.
A systematic literature search was conducted using PubMed, MEDLINE, Embase, Scopus, International Pharmaceutical Abstract and CINAHL from database inception to 18th April 2025. Observational studies utilising real-world data (e.g., electronic health records, biologics registries) that compared clinical outcomes between patients initiating treatment with either a biosimilar or an originator for RA were included. Quality assessment was conducted using the Newcastle-Ottawa Scale (NOS) and a narrative synthesis was conducted to summarise key findings.
A total of 13 retrospective cohort studies were included, providing data on 34,280 patients initiating treatment with bDMARDs for RA. Treatment retention was the most investigated effectiveness outcome (n = 11), and all studies found that biosimilars were associated with comparable retention profiles compared to originators. No significant differences were identified for other effectiveness outcomes (e.g., disease activity indices). For safety outcomes, adverse events (AEs) were documented in eight studies. However, seven of these studies were of poor quality in assessing safety outcomes due to inadequate control for confounding factors.
In real-world settings, biosimilars generally demonstrate comparable effectiveness to originators. Future investigations are warranted to examine the comparative safety profiles of biosimilars and originators.
类风湿关节炎（RA）的有效管理通常需要使用生物改善病情抗风湿药（bDMARDs）。生物类似药作为价格更为亲民的替代品应运而生，它们是获得许可的药品，与参照生物制品（原研药）高度相似。
比较生物类似药和bDMARDs原研药在RA治疗起始阶段的实际有效性和安全性。
使用PubMed、MEDLINE、Embase、Scopus、国际药学文摘和护理学与健康领域数据库（CINAHL）进行系统文献检索，检索时间跨度从各数据库建库至2025年4月18日。纳入利用真实世界数据（如电子健康记录、生物制剂登记处数据）的观察性研究，这些研究比较了使用生物类似药或原研药起始治疗RA的患者之间的临床结局。使用纽卡斯尔-渥太华量表（NOS）进行质量评估，并进行叙述性综合分析以总结主要发现。
共纳入13项回顾性队列研究，提供了34280例使用bDMARDs起始治疗RA患者的数据。治疗保留率是研究最多的有效性结局（n = 11），所有研究均发现，与原研药相比，生物类似药的保留率情况相当。其他有效性结局（如疾病活动指数）未发现显著差异。在安全性结局方面，八项研究记录了不良事件（AE）。然而，其中七项研究在评估安全性结局时质量较差，原因是对混杂因素的控制不足。
在真实世界环境中，生物类似药的有效性通常与原研药相当。有必要开展进一步研究以考察生物类似药和原研药的相对安全性。
