UCB, announced positive top-line results from the Phase 3 BE COMPLETE study, which evaluated the efficacy and safety of 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.

"Psoriatic arthritis is a chronic inflammatory condition affecting both the joints and skin. The positive top-line results from the Phase 3 BE COMPLETE study show the potential of bimekizumab to improve the signs and symptoms of active psoriatic arthritis in a patient population who were inadequate responders or intolerant to anti-TNF therapy," said Dr. Joseph F. Merola, MD, MMSc, Associate Professor, Harvard Medical School and Brigham and Women's Hospital, Boston, MA, U.S.

"The BE COMPLETE results mark the latest positive data in a series of four Phase 3 readouts for bimekizumab in the treatment of psoriatic arthritis and axial spondyloarthritis. We believe that these consistent and robust results have the potential to elevate the standard of care for patients," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. "Both psoriatic arthritis studies in the program used ACR50 as the primary outcome measure. The positive findings in both studies highlight the clinical potential of bimekizumab in psoriatic arthritis for both biologic naïve and anti-TNF therapy experienced patients."