The phase 3 CREDO-1 trial showed that treatment with olokizumab over a 24-week period was associated with significant improvements in the signs, symptoms, and physical function of rheumatoid arthritis . The safety profile of olokizumab was consistent with previous phase 2 trials with this agent and with data for agents with a similar mechanism of action.
The randomized, double-blind, placebo-controlled, multicentre CREDO-1 study evaluated the safety and efficacy of olokizumab, a new humanized monoclonal antibody targeting IL-6, in patients with moderate-to-severe rheumatoid arthritis despite methotrexate treatment [2,3]. Prof. Rumen Stoilov (University Hospital St. Ivan Rilski, Bulgaria), who presented the study, explained that patients received injections of olokizumab 64 mg every 2 weeks (n=143), olokizumab 64 mg every 4 weeks (n=142), or placebo for 24 weeks (n=143). After week 24, patients could qualify for an open-label study extension. The primary endpoint of the study was ACR20 response at week 12, and secondary endpoints included percentage of patients with low disease activity and improvement of physical ability. Baseline characteristics were comparable between treatment arms.
The results showed that both regimens of olokizumab were significantly better than placebo in all primary and secondary endpoints, with 63.6% of patients in the 2-week dosing group and 70.4% of those in the 4-week dosing group achieving ACR20 at week 12 versus 25.9% of patients receiving placebo. The rates for DAS28 response were 33.6%, 38.7%, and 3.5%, respectively. The incidence of treatment-emergent serious adverse events was numerically higher in the olokizumab groups when compared with placebo, but no unexpected safety signals emerged.
1. Nasonov E, et al. Olokizumab, monoclonal antibody against IL6, in patients with moderately to severely active rheumatoid arthritis inadequately controlled by methotrexate: efficacy and safety results of phase III CREDO-1 study. Abstract OP0021. EULAR E-Congress, 3-6 June 2020.
2. Genovese MC, et al. Efficacy and Safety of Olokizumab in Patients With Rheumatoid Arthritis With an Inadequate Response to TNF Inhibitor Therapy: Outcomes of a Randomised Phase IIb Study. Ann Rheum Dis. 2014;73:1607-1615.
3. Takeuchi T, et al. Post-hoc Analysis Showing Better Clinical Response With the Loading Dose of Certolizumab Pegol in Japanese Patients With Active Rheumatoid Arthritis. Mod Rheumatol. 2016;26:473-480.