Comparative efficacy and safety of baricitinib 2 mg and 4 mg in patients with active rheumatoid arthritis : A Bayesian network meta-analysis of randomized controlled trials.

ABSTRACT

OBJECTIVE: This study aimed to assess the relative efficacy and safety of once-daily baricitinib 2 mg and 4 mg administration in patients with active rheumatoid arthritis (RA). METHODS: In this network meta-analysis, randomized controlled trials (RCTs) examining the efficacy and safety of baricitinib in patients with active RA were included. A Bayesian network meta-analysis was conducted to combine the direct and indirect evidence from the RCTs. RESULTS: Seven RCTs involving 3461 patients met the inclusion criteria. There were ten pairwise comparisons, including seven direct comparisons and five interventions. The ACR20 response rate was significantly higher in the baricitinib 4 mg in combination with disease-modifying antirheumatic drugs (DMARD) group than in the placebo+DMARD group (odds ratio, OR 3.13; 95% credible interval, CrI 2.32-4.33). Compared with the placebo+DMARD group, the baricitinib 4 mg, baricitinib 2 mg + DMARD, and adalimumab 40 mg + methotrexate (MTX) groups showed a significantly higher ACR20 response rate. The ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated that baricitinib 4 mg + DMARD was likely to elicit the best ACR20 response rate (SUCRA = 0.7930), followed by baricitinib 4 mg (SUCRA = 0.7034), baricitinib 2 mg + DMARD (SUCRA = 0.6304), adalimumab 40 mg + MTX (SUCRA = 0.3687), and placebo+DMARD (SUCRA = 0.0045). By contrast, the safety based on the number of treatment-emergent adverse events (TEAEs) did not differ significantly among the five interventions. CONCLUSION: Baricitinib 2 mg and 4 mg administered once daily, in combination with DMARD, were efficacious interventions for active RA that had no significant risk of TEAE development.