Comparative efficacy and safety of biosimilar-infliximab and originator-infliximab in combination with methotrexate in patients with active rheumatoid arthritis: a meta-analysis of randomized controlled trials

초록

Objective We aimed to assess the relative efficacy and safety of biosimilar-infliximab and originator-infliximab in combination with methotrexate (MTX) compared to placebo plus MTX in active rheumatoid arthritis (RA). Methods We performed a Bayesian network meta-analysis to combine direct and indirect evidence from randomized controlled trials (RCTs) examining the efficacy and safety of biosimilar + MTX and infliximab + MTX and placebo + MTX (MTX group) in patients with active RA despite treatment with MTX. Results Seven RCts involving 2606 patients met the inclusion criteria. The American College of Rheumatology (ACR)20 response rate was significantly higher in the biosimilar + MTX group than in the MTX group (odds ratio [OR] 3.31, 95% credible interval [CrI] 1.74–6.06). Similarly, the ACR20 response rate was significantly higher in the infliximab + MTX group than in the MTX group (OR 3.15, 95% CrI 1.99–4.70). There was no difference in the ACR20 response rate between the biosimilar+ MTX and infliximab + MTX groups. Ranking probability based on surface under the cumulative ranking curve (SUCRA) indicated that treatment with biosimilar + MTX had the highest probability of achieving the ACR20 response rate (SUCRA = 0.7964), followed by infliximab + MTX (SUCRA = 0.7018) and MTX alone (SUCRA = 0.0018). The ACR50 and ACR70 response rates showed a similar distribution pattern to the ACR20 response rate. By contrast, the safety based on the number of serious adverse events (SAEs) did not differ significantly among the three interventions. Conclusions Biosimilar- and originator-infliximab, in combination with MTX, represent effective interventions for active RA, with a low risk of SAEs. No significant difference between biosimilar- and originator-infliximab was found in terms of efficacy and safety.

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