The Lancet Publishes Results from Two Bimekizumab Phase 3 Studies in Psoriatic Arthritis
- Two articles report results from the Phase 3 BE OPTIMAL and BE COMPLETE studies evaluating bimekizumab, an investigational, selective inhibitor of IL-17A and IL-17F, in patients with psoriatic arthritis
BRUSSELS and ATLANTA, Dec. 7, 2022 -- UCB, a global biopharmaceutical company, today announced that The Lancet has published two articles detailing 24-week results from the Phase 3 BE OPTIMAL study and 16-week results from the Phase 3 BE COMPLETE study, evaluating the efficacy and safety of bimekizumab in the treatment of adults with active psoriatic arthritis who were biologic naïve and tumor necrosis factor inhibitor inadequate responders (TNFi-IR), respectively.1,2
"Publication of two articles in tandem in The Lancet, one of the world's most prestigious peer-reviewed journals, highlights the significance of these Phase 3 bimekizumab studies to the medical community. We look forward to continuing to work with regulatory agencies to make bimekizumab available to people living with psoriatic arthritis as soon as possible," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of US, UCB.
Data from BE OPTIMAL and BE COMPLETE show that both studies met their primary and all ranked secondary endpoints.1,2 A significantly higher proportion of patients treated with bimekizumab achieved improvements in joint symptoms at week 16 compared with placebo – as measured by ACR50, the primary endpoint – with a consistent clinical response observed in both biologic-naïve and TNFi-IR populations (p<0.0001 for each). In addition, at week 16, a significantly higher proportion of bimekizumab-treated patients compared with placebo achieved high levels of skin clearance – as measured by PASI 90, a secondary endpoint – with a consistent clinical response in both populations (p<0.0001 for each). The safety profile of bimekizumab was consistent with safety data seen in previous studies with no new observed safety signals.1,2
Bimekizumab is an investigational product; its efficacy and safety have not been established for any indication in the U.S., and it is not approved by the U.S. Food and Drug Administration (FDA).
BE OPTIMAL was a randomized, multicenter, double-blind, placebo-controlled, active reference (adalimumab), parallel-group, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in the treatment of adult patients with active psoriatic arthritis, who are biologic disease-modifying anti-rheumatic drug naïve. For additional details on the study, see article in The Lancet.1
BE COMPLETE was 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 and an inadequate response to tumor necrosis factor-alpha inhibitors (TNFαi).2 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 TNFαi for either psoriatic arthritis or psoriasis. For additional details on the study, see article in The Lancet.2
Psoriatic arthritis (PsA) is a serious, highly heterogeneous, chronic, systemic inflammatory condition affecting both the joints and skin, with a prevalence of 0.02 percent to 0.25 percent of the population, and 6 percent to 41 percent of patients with psoriasis.3 Symptoms include joint pain and stiffness, skin plaques, swollen toes and fingers (dactylitis), and inflammation of the sites where tendons or ligaments insert into the bone (enthesitis).4
Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.5,6 In August 2021, bimekizumab was approved in the European Union (EU)/European Economic Area (EEA) and in Great Britain, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.6,7 Bimekizumab is an investigational product; its efficacy and safety have not been established for any indication in the U.S., and it is not approved by the U.S. Food and Drug Administration (FDA).
For further information, contact UCB:
U.S. Immunology Communications
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 approximately 8,600 people in approximately 40 countries, the company generated revenue of €5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.
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- McInnes I.B., Asahina A, Coates L.C. et al. Bimekizumab in patients with psoriatic arthritis, naïve to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL) The Lancet. 2022. Published online. Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02302-9/fulltext
- Merola J.F., Landewé R, McInnes I.B. et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE) The Lancet. 2022. Published online. Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02303-0/fulltext
- Ogdie A, Weiss P. The Epidemiology of Psoriatic Arthritis. Rheum Dis Clin North Am. 2015;41(4):545–568.
- Mease PJ, Armstrong AW. Managing patients with psoriatic disease: The diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014;74(4):423–441.
- 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.
- BIMZELX® (bimekizumab) EU Summary of Product Characteristics.
https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Last accessed: December 2022.
- BIMZELX® (bimekizumab) GB Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/12834; https://www.medicines.org.uk/emc/product/12833. Last accessed: December 2022.
BIMZELX® is a registered trademark of the UCB Group of Companies. ©2022 UCB, Inc., Smyrna, GA 30080. All rights reserved.
Date of preparation: December 2022
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