Objectives: 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. Methods: 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. Results: 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. Conclusion: Biosimilars and reference bDMARDs were equally useful for the management of RA.
- Biological disease modifying antirheumatic drug
- GRADE system
- rheumatoid arthritis
ASJC Scopus subject areas