BRUSSELS and ATLANTA, Jan. 21, 2022 /PRNewswire/ -- UCB, a global biopharmaceutical company, today 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.1
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 16.1
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.1
"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."
In BE COMPLETE, the safety profile of bimekizumab was consistent with safety data seen in previous studies with no new observed safety signals.1 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.1
Full results from the BE COMPLETE study will be presented at upcoming medical conferences and published in a peer-reviewed medical journal.
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, reported in November 2021.2 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.
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.3 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 66.3 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.3 For additional details on the study, visit BE COMPLETE on clinicaltrials.gov.
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a serious, highly heterogeneous, chronic systemic inflammatory condition affecting both the joints and skin, with a prevalence of 0.05 percent to 0.25 percent of the population, and 6 percent to 41 percent of patients with psoriasis.4 Symptoms include joint pain and stiffness, skin plaques, swollen toes and fingers (dactylitis), and persistent inflammation of the sites where tendons or ligaments insert into the bone (enthesitis).5
Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to selectively and directly inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.6
Bimekizumab is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of moderate-to-severe plaque psoriasis in adults, and its efficacy and safety have not been established for any indication in the U.S.
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7 600 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.
Forward looking statements UCB
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1 Data on file. UCB. January 2022.
2 Data on file. UCB. November 2021.
3 ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (BE COMPLETE). Available at: https://www.clinicaltrials.gov/ct2/show/NCT03896581. Last accessed: January 2022.
4 Ogdie A, Weiss P. The Epidemiology of Psoriatic Arthritis. Rheum Dis Clin North Am. 2015; 41(4): 545–568.
5 Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014; 74:423-441.
6 Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991-1001.
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