TY - JOUR
T1 - Systematic review and meta-analysis of biosimilar for the treatment of rheumatoid arthritis informing the 2020 update of the Japan College of Rheumatology clinical practice guidelines for the management of rheumatoid arthritis
AU - Tanaka, Eiichi
AU - Kawahito, Yutaka
AU - Kohno, Masataka
AU - Hirata, Shintaro
AU - Kishimoto, Mitsumasa
AU - Kaneko, Yuko
AU - Tamai, Hiroya
AU - Seto, Yohei
AU - Morinobu, Akio
AU - Sugihara, Takahiko
AU - Murashima, Atsuko
AU - Kojima, Masayo
AU - Mori, Masaaki
AU - Ito, Hiromu
AU - Kojima, Toshihisa
AU - Sobue, Yasumori
AU - Nishida, Keiichiro
AU - Matsushita, Isao
AU - Nakayama, Takeo
AU - Yamanaka, Hisashi
AU - Harigai, Masayoshi
N1 - Publisher Copyright:
© 2021 Japan College of Rheumatology.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - Biological disease modifying antirheumatic drug
KW - GRADE system
KW - biosimilar
KW - meta-analysis
KW - rheumatoid arthritis
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U2 - 10.1080/14397595.2021.1899591
DO - 10.1080/14397595.2021.1899591
M3 - Article
C2 - 33706664
AN - SCOPUS:85103635581
JO - Japanese Journal of Rheumatology
JF - Japanese Journal of Rheumatology
SN - 1439-7595
ER -