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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

International Journal of Rheumatic Diseases Apr 27, 2018

Bae SC, et al. - Experts evaluated the relative effectiveness and safety of biosimilar-infliximab and originator-infliximab in combination with methotrexate (MTX) compared to placebo plus MTX in active rheumatoid arthritis (RA). Effective interventions for active RA, with a low risk of serious adverse events (SAEs) were represented with biosimilar- and originator-infliximab, in combination with MTX. In terms of efficacy and safety, authors did not note any significant difference between biosimilar- and originator-infliximab.

Methods

  • Authors performed a Bayesian network meta-analysis to combine direct and indirect evidence from randomized controlled trials (RCTs) examining the effectiveness and safety of biosimilar + MTX and infliximab + MTX and placebo + MTX (MTX group) in patients with active RA despite treatment with MTX.

Results

  • As per the data, 7 RCts involving 2,606 patients met the inclusion criteria.
  • Reserchers noted significantly higher response rate of the American College of Rheumatology (ACR)20 in the biosimilar + MTX group vs the MTX group (odds ratio [OR] 3.31, 95% credible interval [CrI] 1.74–6.06).
  • Findings suggested that, in the infliximab + MTX group the ACR20 response rate was significantly higher than in the MTX group (OR 3.15, 95% CrI 1.99–4.70).
  • Between the biosimilar + MTX and infliximab + MTX groups, no difference in the ACR20 response rate was seen.
  • It was demonstrated by the ranking probability based on surface under the cumulative ranking curve (SUCRA) 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).
  • Findings suggested that the ACR50 and ACR70 response rates demonstrated a similar distribution pattern to the ACR20 response rate.
  • By contrast, no significant difference in the safety based on the number of serious adverse events (SAEs) was seen among the 3 interventions.

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