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Biosimilars Match Biologic Originators in Rheumatoid Arthritis

A systematic review and meta-analysis in JAMA Network Open has shown that biosimilars of adalimumab, infliximab, and etanercept were associated with clinically equivalent treatment effects compared with their reference biologics for the treatment of rheumatoid arthritis (RA).

This meta-analysis included 25 randomized clinical trials and 10 642 RA patients taking biosimilars of adalimumab, etanercept, and infliximab and were compared with their reference biologics in patients with RA.

Efficacy equivalence was tested using prespecified margins for the American College of Rheumatology criteria (ACR20) (ie, RR, 0.94 to 1.06), and for the Health Assessment Questionnaire–Disability Index (HAQ-DI) (ie, SMD, −0.22 to 0.22). Secondary outcomes included 14 items measuring safety and immunogenicity.

From 24 RCTs (10 259 RA patients) similar ACR20 responses (RR, 1.01; 95% CrI, 0.98 to 1.04; τ2 = 0.000) and changes in HAQ-DI scores (SMD, −0.04; 95% CrI, −0.11 to 0.02; τ2 = 0.002) conformed to the prespecified margins of equivalence. Overall, biosimilars were associated with similar safety and immunogenicity profiles compared with reference biologics.

This review finds that biosimilars may yield therapeutically equivalent outcomes compared with reference biologic drugs for the management of rheumatoid arthritis.

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Disclosures
The author has received compensation as an advisor or consultant on this subject