UCB Releases Positive Top-line Results for Bimekizumab in Second Phase 3 Psoriatic Arthritis Study

UCB plans to submit regulatory applications for bimekizumab in psoriatic arthritis in the United States and the European Union in Q3 2022.

UCB’s bimekizumab performed well in a Phase 3 study of active psoriatic arthritis patients who were inadequate responders or intolerant to anti-tumor necrosis factor-alpha (anti-TNF-α) therapy.

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 new study showed.

The top-line results from the BE COMPLETE study build on the positive top-line interim analysis results from the Phase 3 BE OPTIMAL study in adults with active psoriatic arthritis, who were biologic disease-modifying anti-rheumatic drug (bDMARD) naïve. Based on these results, UCB plans to submit regulatory applications for bimekizumab in psoriatic arthritis in the United States and the European Union in Q3 2022.

In BE COMPLETE, 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, the study showed.

"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," says Dr. Joseph F. Merola, MD, MMSc, Associate Professor, Harvard Medical School and Brigham and Women's Hospital, Boston, MA, U.S, in a news release.

"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," adds 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."

In BE COMPLETE, the safety profile of bimekizumab was consistent with safety data seen in previous studies with no new observed safety signals. 

The safety and efficacy of bimekizumab in psoriatic arthritis have not been established, and it is not approved for use in psoriatic arthritis by any regulatory authority worldwide. Full results from the BE COMPLETE study will be presented at upcoming medical conferences and published in a peer-reviewed medical journal.

About BE COMPLETE
BE COMPLETE is a randomized, multicenter, double-blind, placebo-controlled, parallel group, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in adults with active psoriatic arthritis who were inadequate responders or intolerant to anti-tumor necrosis factor-alpha (anti-TNF-α) therapy. BE COMPLETE enrolled 400 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. All enrolled study participants had a history of inadequate response (lack of efficacy after at least three months of therapy at an approved dose) or intolerance to treatment with one or two tumor necrosis factor alpha (TNFα) inhibitors for either psoriatic arthritis or psoriasis. For additional details on the study, visit BE COMPLETE on clinicaltrials.gov.