Efficacy and safety of methotrexate plus certolizumab pegol or placebo in active rheumatoid arthritis

This study aimed to assess the relative efficacy and safety of certolizumab pegol (CZP) 200 and 400 mg + methotrexate (MTX) compared to placebo + MTX in patients with active rheumatoid arthritis (RA).

We performed a Bayesian network meta-analysis to combine the direct and indirect evidence from randomized controlled trials (RCTs) examining the efficacy and safety of CZP 200 and 400 mg + MTX and placebo + MTX (MTX group) in patients with active RA despite receiving MTX or a disease-modifying antirheumatic drug (DMARD).

Six RCTs (30349 patients) met the inclusion criteria. The ACR20 response rate was significantly higher in the CZP 200 and 400 mg + MTX group than in the MTX group (OR 7.30, 95 % credible interval [CrI] 3.31–16.92 and OR 5.48, 95 % CrI 2.98–10.30, respectively). CZP 400 mg + MTX tended to be more efficacious than CZP 200 mg + MTX (OR 1.33, 95 % CrI 0.61–2.97). A surface under the cumulative ranking curve (SUCRA)-based ranking probability indicated that CZP 400 mg + MTX had the highest probability of achieving the ACR20 response rate, followed by CZP 200 mg + MTX and MTX (SUCRA = 0.9007, 0.7156, and 0.0002, respectively). The ACR20, 50, and 70 response rate distributions were comparable. However, the safety based on the number of adverse event (AE)-related withdrawals did not differ significantly among the three interventions.

CZP, at dosages of 200 and 400 mg, in combination with MTX, was the efficacious intervention for active RA without causing a significant risk of AE-related withdrawals.