Otilimab for RA disappoints in ContRAst 3

In the treatment of select patients with rheumatoid arthritis (RA), otilimab is neither better than placebo nor noninferior to sarilumab in terms of the proportion of patients achieving an American College of Rheumatology ≥20 percent response (ACR20), according to the results of the phase III ContRAst 3 study.

ContRAst 3 included 549 patients with active RA who had an inadequate response to conventional synthetic (cs) and biologic disease-modifying antirheumatic drugs (DMARDs) and/or Janus kinase inhibitors.

The patients were randomly assigned to receive subcutaneous otilimab (90/150 mg once weekly), subcutaneous sarilumab (200 mg every 2 weeks), or placebo for 12 weeks. The study treatment was administered in addition to csDMARDs. Those in the placebo group were switched to active interventions at week 12 and treatment continued to week 24.

The number of ACR20 responders at week 12, the primary study endpoint, did not differ between the otilimab 90- and 150-mg groups and the placebo group (45 percent and 51 percent vs 38 percent; p=0.2868 and p=0.0596, respectively).

Furthermore, otilimab did not yield significant improvements in Clinical Disease Activity Index, Health Assessment Questionnaire-Disability Index, pain Visual Analogue Scale or Functional Assessment of Chronic Illness Therapy-Fatigue scores at week 12 compared with placebo.

Meanwhile, sarilumab was superior to otilimab in terms of ACR20 response and secondary endpoints.

The frequency of adverse or serious adverse events was similar across treatment groups.