Efficacy and safety of olokizumab in Asian patients with moderate-to-severe rheumatoid arthritis, previously exposed to anti-TNF therapy: Results from a randomized phase II trial
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 findings support the growing body of evidence for the use of alternative therapeutic targets for RA patients, particularly those who fail to respond adequately to anti-TNFs.
This study consisted of a 12 week double-blind phase and a 12 week safety follow-up period. 179 patients were screened and 119 randomised to one of six treatment groups: receiving either OKZ 60 mg Q2W or Q4W, 120 mg Q2W or Q4W, or 240 mg Q4W, or placebo. The primary efficacy change from baseline in DAS28 (CRP) at Week 12 and the secondary variables were ACR20, ACR50 and ACR70 response rates at Week 12.