UCB announced positive top-line interim analysis results from the Phase 3 BE OPTIMAL study assessing the efficacy and safety of Bimzelx (bimekizumab) in the treatment of adults with active psoriatic arthritis, who are biologic disease-modifying anti-rheumatic drug naïve. The study met the primary endpoint, and all ranked secondary endpoints with statistical significance. The study used the American College of Rheumatology (ACR) 50 response at week 16 as the primary outcome measure of improvement rather than the commonly used standard of ACR20 (i.e. 50 percent versus 20 percent improvement from baseline).
The randomized, multicenter, double-blind, placebo-controlled, non-inferential active reference arm (adalimumab), parallel group BE OPTIMAL study was designed to evaluate the efficacy and safety of bimekizumab in the treatment of adult patients with active psoriatic arthritis, who are biologic disease-modifying anti-rheumatic drug naïve. The trial enrolled 852 participants with disease for at least six months prior to screening, and a baseline tender joint count (TJC) ≥ three out of 68 and swollen joint count (SJC) ≥ three out of 66.
Significantly more patients treated wi...
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