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13-11-2019 | Rheumatoid arthritis | ACR/ARP 2019 | News

Olokizumab shows promise for moderate-to-severe RA


medwireNews: Six months of treatment with olokizumab, a novel humanized monoclonal antibody targeting interleukin-6, significantly improves disease activity and physical function in patients already taking methotrexate for rheumatoid arthritis (RA), phase III study data show.

The CREDO1 multicenter trial included 428 patients with moderate-to-severe RA who were randomly assigned to receive subcutaneous olokizumab 64 mg once every 2 weeks (n=143), once every 4 weeks (n=142), or to receive placebo (n=143) for 24 weeks. During this time, all patients continued with their background methotrexate.

Mark Genovese (Stanford University, California, USA) and co-researchers report that “[b]oth regimens of [olokizumab] were significantly better than placebo in all primary and secondary endpoints.”

Specifically, the proportions achieving the primary outcome of ACR20 at week 24 were 70.4% and 63.6% with the 2-weekly and 4-weekly olokizumab regimens, respectively, versus 25.9% with placebo.

The corresponding ACR50 response rates at week 24 were 48.6%, 42.0%, and 7.7%.

Patients receiving olokizumab every 2 weeks and every 4 weeks were also significantly more likely to have low disease activity (DAS28-CRP <3.2 points) at week 12 and be in remission (CDAI ≤2.8 points) at week 24 than those receiving placebo.

In addition, olokizumab every 2 weeks and every 4 weeks resulted in significantly greater improvements in physical ability from baseline to week 12 versus placebo, with HAQ-DI falling by 0.56, 0.54, and 0.20 points, respectively.

The researchers also assessed the safety of the treatment and found that the adverse event (AE) profile was “consistent with Phase II data for [olokizumab] and with the data for the agents with similar mechanism of action.”

Overall, the treatment-emergent (TE)AE rates were 58.0% with olokizumab every 2 weeks, 57.0% with olokizumab every 4 weeks, and 43.7% with placebo, while the rates of serious TEAEs were 5.6%, 5.6%, and 2.8%, respectively.

Genovese and team note that there were no apparent differences in either efficacy or safety between the two olokizumab regimens, and more than 85% of participants have now enrolled in the open-label extension trial, CREDO4.

The study findings were presented in a poster at the 2019 ACR/ARP Annual Meeting in Atlanta, Georgia, USA.

By Laura Cowen

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

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Arthritis Rheumatol 2019; 71 (suppl 10)
ACR/ARP 2019; Atlanta, Georgia, USA: 8–13 November

Back to the ACR/ARP 2019 conference hub