UCB releases results from phase 3 BE COMPLETE study of Bimzelx to treat active psoriatic arthritis

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Phase 3 BE COMPLETE study 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-a) therapy, according to UCB, a global biopharmaceutical company.

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

All of the study’s secondary endpoints were likewise met. At week 16, bimekizumab showed significant improvements over placebo in physical function, as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI); skin clearance, as measured by at least a 90% improvement in the Psoriasis Area and Severity Index (PASI90); physical health status, as measured by the SF-36 Physical Component Summary (PCS) score; and low disease activity, as measured by the Minimal Disease Activity (MDA) score.

“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, US.

“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,” 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.”

said Emmanuel Caeymaex, executive vice president, immunology solutions and head of US, UCB.

Bimekizumab’s safety profile in BE COMPLETE was comparable with earlier safety data, with no new safety flags reported. Bimekizumab’s safety and efficacy in psoriatic arthritis have not been established, and it has not been licensed for use in psoriatic arthritis by any regulatory authority anywhere in the world.

The BE COMPLETE study’s full findings will be presented at a future medical conference and published in a peer-reviewed medical publication.

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) naive, reported in November 2021, 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) naive. UCB intends to submit regulatory applications for bimekizumab in psoriatic arthritis in the United States and the European Union in Q3 2022 based on these findings.

BE COMPLETE is a phase 3 randomized, multicenter, double-blind, placebo-controlled research in persons with active psoriatic arthritis who were insufficient responders or intolerant to anti-tumor necrosis factor-alpha (anti-TNF-a) medication. BE COMPLETE included 400 people who had been sick for at least six months and had a tender joint count (TJC) of three out of 68 and a swollen joint count (SJC) of three out of 66 at the start of the study. All research participants had a history of poor response (lack of efficacy after at least three months of medication at an approved dose) or intolerance to one or both TNFa inhibitors for psoriatic arthritis or psoriasis.

Bimekizumab is a humanized monoclonal IgG1 antibody that inhibits both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two important cytokines that drive inflammatory processes, selectively and directly.

Bimzelx is approved for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy in the European Union (EU)/European Economic Area (EEA) and the United Kingdom. The US Food and Drug Administration (FDA) is now reviewing bimekizumab for the treatment of moderate to severe plaque psoriasis in adults.

UCB, headquartered in Brussels, Belgium, is a global biopharmaceutical firm dedicated to the discovery and development of novel medications and solutions to improve the lives of individuals suffering from the severe immune system or central nervous system diseases.

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