Olokizumab versus Placebo or Adalimumab in Rheumatoid Arthritis

N Engl J Med. 2022;387(8):715–726. doi: 10.1056/NEJMoa2201302

Phase 3 trial of olokizumab, a direct inhibitor of the IL-6 ligand, demonstrates superiority to placebo with respect to an ACR20 response at week 12 and noninferiority to adalimumab (all combined with methotrexate), in patients with RA.

October 2015

This Phase II study assessed the safety and efficacy of olokizumab in Asian patients with moderate-to-severe rheumatoid arthritis, previously exposed to anti-TNF therapy. After 12 weeks of treatment, olokizumab was found to rapidly improve disease activity in patients who had previously failed anti-TNF therapy. There was also a significant decrease in ACR20 and ACR50 responder rates at week 12. The safety findings were consistent with the safety profile expected for this drug class. These findin...