Ann Rheum Dis 2023;0:1–11 doi 10.1136/ard-2023-224482
Fleischmann, et al investigated the safety and efficacy of otilimab versus tofacitinib and placebo in RA patients treated with MTX (contRAst 1) or csDMARDs (contRAst 2). They found that while otilimab achieved the primary endpoint of ACR20 versus placebo in Week 12, it did not demonstrate non-inferiority to tofacitinib.
The two Phase 3, double-blind RCTs randomised participants to otilimab, tofacitinib or placebo, with the placebo group randomised to a treatment group in Week 12. Both cohorts were observed for 52 weeks.