Department of Rheumatology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.
Inflammation and Immunology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Mod Rheumatol. 2022 Jan 5;32(1):74-86. doi: 10.1080/14397595.2021.1899591.
To evaluate the efficacy and safety of biosimilars compared with reference biological disease modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA) as a part of the process of developing the 2020 update of the Japan College of Rheumatology guidelines for the management of RA.
PubMed, Cochrane Library, and Japan Centra Revuo Medicina were searched for articles to conduct a systematic review (SR). The quality of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation system.
Twenty randomized controlled trials were included (biosimilars of infliximab, etanercept, and adalimumab). A meta-analysis revealed that the risk ratios (RRs) and 95% confidence intervals (CIs) of achieving the American College of Rheumatology 50% response (ACR50) at week 24 and serious adverse events (SAEs) for biosimilars compared with the reference bDMARDs were 1.04 (0.98-1.10) and 0.84 (0.61-1.18), respectively. The RRs of achieving ACR50 and SAEs at week 24 were respectively 0.93 (0.69-1.26) and 2.15 (0.55-8.35) in the patients who switched to biosimilars from the reference bDMARDs and 0.92 (0.76-1.12) and 1.41 (0.32-6.15) in those who continued the reference bDMARDs.
Biosimilars and reference bDMARDs were equally useful for the management of RA.
评估生物类似药相对于类风湿关节炎（RA）患者的参照生物改善病情抗风湿药（bDMARDs）的疗效和安全性，这是制定 2020 年日本风湿病学会 RA 管理指南更新的一部分。
检索 PubMed、Cochrane Library 和日本 Central Revuo Medicina，以进行系统评价（SR）。使用推荐评估、制定与评价系统（Grading of Recommendations Assessment, Development, and Evaluation system）评估证据质量。
纳入了 20 项随机对照试验（英夫利昔单抗、依那西普和阿达木单抗的生物类似药）。荟萃分析显示，生物类似药与参照 bDMARD 相比，在第 24 周达到美国风湿病学会 50%缓解（ACR50）和严重不良事件（SAEs）的风险比（RR）及其 95%置信区间（CI）分别为 1.04（0.98-1.10）和 0.84（0.61-1.18）。在从参照 bDMARD 转换为生物类似药的患者中，第 24 周达到 ACR50 和 SAE 的 RR 分别为 0.93（0.69-1.26）和 2.15（0.55-8.35），而在继续使用参照 bDMARD 的患者中，RR 分别为 0.92（0.76-1.12）和 1.41（0.32-6.15）。
生物类似药和参照 bDMARDs 对 RA 的治疗同样有效。
