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.

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.