New Phase III study of Bimzelx meets endpoint in psoriatic arthritis

Belgium’s largest drugmaker UCB (Euronext Brussels: UCB) today announced positive top-line results from the Phase III BE COMPLETE study, which evaluated the efficacy and safety of Bimzelx (bimekizumab) in the treatment of adults with active psoriatic arthritis, who were inadequate responders or intolerant to anti-tumor necrosis factor-alpha (anti-TNF-α) therapy.

BE COMPLETE met its primary endpoint, demonstrating that significantly more patients treated with bimekizumab achieved 50% percent or greater improvement in signs and symptoms of disease from baseline, compared with placebo, as measured by the American College of Rheumatology (ACR) 50 response at week 16.

The study also met all ranked secondary endpoints. Bimekizumab showed significant improvements over placebo at week 16 in physical function, as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI); skin clearance, as measured by at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI90); physical health status, as measured by the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) score; and low disease activity, as measured by the Minimal Disease Activity (MDA) index.