Comparative efficacy and safety of tofacitinib, with or without methotrexate, in patients with active rheumatoid arthritis: a Bayesian network meta-analysis of randomized controlled trials.

Abstract

This study aimed to assess the relative efficacy and safety of tofacitinib 5 and 10mg twice daily, or in combination with methotrexate (MTX), in patients with active RA. Randomized controlled trials (RCTs) examining the efficacy and safety of tofacitinib in patients with active RA were included in this network meta-analysis. We performed a Bayesian network meta-analysis to combine the direct and indirect evidence from the RCTs. Ten RCTs including 4867 patients met the inclusion criteria. There were 21 pairwise comparisons including 11 direct comparisons of seven interventions. The ACR20 response rate was significantly higher in the tofacitinib 10mg+MTX group than in the placebo and MTX groups (OR 7.56, 95% credible interval (CrI) 3.07-21.16; OR 3.67, 95% CrI 2.60-5.71, respectively). Ranking probabilities based on the surface under the cumulative ranking curve (SUCRA) indicated that tofacitinib 10mg+MTX had the highest probability of being the best treatment for achieving the ACR20 response rate (SUCRA=0.9254), followed by tofacitinib 5mg+MTX (SUCRA=0.7156), adalimumab 40mg+MTX (SUCRA=0.6097), tofacitinib 10mg (SUCRA=0.5984), tofacitinib 5mg (SUCRA=0.4749), MTX (SUCRA=0.1674), and placebo (SUCRA=0.0086). In contrast, the safety based on the number of withdrawals due to adverse events did not differ significantly among the seven interventions. Tofacitinib, at dosages 5 and 10mg twice daily, in combination with MTX, was the most efficacious intervention for active RA and was not associated with a significant risk for withdrawals due to adverse events.