Bimekizumab meets primary, ranked secondary endpoints in two psoriatic arthritis studies
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Adults with active psoriatic arthritis taking bimekizumab saw significant improvements in joint symptoms and skin clearance compared with those taking placebo, UCB announced in a press release.
The results of the BE OPTIMAL and BE COMPLETE studies were published in The Lancet.
Both of the multicenter, double-blind, placebo-controlled, parallel-group phase 3 studies evaluated bimekizumab, a humanized monoclonal IgG1 antibody that selectively inhibits interleukin-17A and interleukin-17F, which are key cytokines driving inflammation in psoriatic arthritis.
In addition to psoriatic arthritis, patients in BE OPTIMAL and BE COMPLETE were also biologic-naïve and tumor necrosis factor inhibitor inadequate responders (TNFi-IR), respectively.
According to the press release, results showed that bimekizumab met all primary and ranked secondary endpoints in both studies. A greater proportion of patients taking the study drug vs. placebo met the primary endpoint of improvement in joint symptoms at week 16, and these responses were consistent in both biologic-naïve and TNFi-IR populations (P < .0001 for both). As measured by PASI 90, a higher proportion of patients taking bimekizumab vs. placebo also achieved the secondary endpoint of high levels of skin clearance (P < .0001 for both).
In addition, safety data was consistent with previous studies, according to the press release.
“We look forward to continuing to work with regulatory agencies to make bimekizumab available to people living with psoriatic arthritis as soon as possible,” Emmanuel Caeymaex, executive vice president of immunology solutions and head of U.S., UCB, said in the release.
Although the European Medicines Agency accepted the marketing authorization application in September for bimekizumab for the treatment of active psoriatic arthritis in adults, the drug is still not approved for the treatment of psoriatic arthritis by any regulatory authority worldwide.
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