Annals of the Rheumatic Diseases Publishes Results from Two Bimekizumab Phase 3 Studies in Axial Spondyloarthritis
UCB announced the publication of 24-week results from the Phase 3 BE MOBILE 1 and BE MOBILE 2 studies on bimekizumab, an IL-17A and IL-17F inhibitor, in treating active axial spondyloarthritis (axSpA). The studies met their primary and secondary endpoints, showing significant improvements in ASAS40 response rates at Week 16 and continuing to Week 24. Bimekizumab demonstrated a favorable safety profile consistent with previous studies. As an investigational product, its efficacy and safety have not been established in the U.S., and it remains unapproved by the FDA. The studies reinforce confidence in bimekizumab as a potential treatment option for axSpA.
- 24-week study results show significant improvements in ASAS40 response rates in both BE MOBILE 1 and BE MOBILE 2 studies.
- Bimekizumab met all primary and ranked secondary endpoints at Week 16.
- Consistent safety profile with no new observed safety signals.
- Bimekizumab is still an investigational product; safety and efficacy not established in the U.S.
- No FDA approval, which may limit market potential.
- Publication of 24-week results from the BE MOBILE 1 and BE MOBILE 2 studies, evaluating bimekizumab, an IL-17A and IL-17F inhibitor, across the full spectrum of axial spondyloarthritis
BRUSSELS and ATLANTA, Jan. 18, 2023 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced that Annals of the Rheumatic Diseases has published 24-week results from the Phase 3 BE MOBILE 1 and BE MOBILE 2 studies, evaluating the efficacy and safety of bimekizumab in the treatment of adults with active axial spondyloarthritis (axSpA), including active non-radiographic axial spondyloarthritis (nr-axSpA; BE MOBILE 1) and active ankylosing spondylitis (AS; BE MOBILE 2).1
"BE MOBILE 1 and BE MOBILE 2 represent the first phase 3 studies to evaluate the inhibition of IL-17F in addition to IL-17A with bimekizumab across the spectrum of axSpA. In both studies, treatment with bimekizumab resulted in rapid and clinically relevant improvements in outcomes, compared with placebo. The observed depth of response as well as the consistency of results in nr-axSpA and AS reinforce our confidence in bimekizumab as a potential new treatment option across the full spectrum of the disease," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.
The two phase 3 studies, BE MOBILE 1 and BE MOBILE 2, met all primary and ranked secondary endpoints at Week 16.1 In both studies, a significantly higher proportion of patients treated with bimekizumab achieved statistically significant and clinically meaningful improvements in nr-axSpA and AS, as defined by the primary endpoint of Assessment of SpondyloArthritis international Society ≥40 percent improvement (ASAS40) response at Week 16 compared with placebo (p<0.001).1 In patients who received bimekizumab from baseline, the proportion of patients achieving ASAS40 response continued to increase to Week 24, and in patients who switched from placebo to bimekizumab at Week 16, the ASAS40 responses at Week 24 reached similar levels to those seen in bimekizumab-randomized patients.1 The safety profile of bimekizumab was consistent with safety data seen in previous studies, with no new observed safety signals.1
The publication of results from two Phase 3 axSpA studies in Annals of the Rheumatic Diseases closely follows UCB news in December 2022 that The Lancet published two articles detailing results from two Phase 3 studies evaluating bimekizumab in adults with active psoriatic arthritis (PsA).
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).
Notes to editors:
About BE MOBILE 1
BE MOBILE 1 was a randomized, multicenter, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in the treatment of adult patients with active nr-axSpA. For additional details on the study, see the article published in Annals of the Rheumatic Diseases.1
About BE MOBILE 2
BE MOBILE 2 was a randomized, multicenter, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in the treatment of adult patients with active AS. For additional details on the study, see the article published in Annals of the Rheumatic Diseases.1
About Axial Spondyloarthritis
Axial Spondyloarthritis (axSpA), which includes both non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), is a chronic, immune-mediated, inflammatory disease.2 nr-axSpA is defined clinically by the absence of definitive x-ray evidence of structural damage to the sacroiliac joints.2 axSpA is a painful condition that primarily affects the spine and the joints linking the pelvis and lower spine (sacroiliac joints).2 The leading symptom of axSpA in a majority of patients is inflammatory back pain that improves with exercise, but not with rest.2 Other common clinical features frequently include anterior uveitis, enthesitis, peripheral arthritis, psoriasis, inflammatory bowel disease and dactylitis.2 The overall prevalence of axSpA is 0.3 percent to 1.3 percent of adults.3,4 Approximately half of all patients with axSpA are patients with nr-axSpA.2 axSpA onset usually occurs before the age of 45.2 Approximately 10 to 40 percent of patients with nr-axSpA progress to AS over 2 to 10 years.2
About bimekizumab
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:
Investor Relations
Antje Witte
T +32.2.559.94.14
email antje.witte@ucb.com
U.S. Communications, Immunology
Nicole Herga
T +1.773.960.5349
email nicole.herga@ucb.com
About UCB
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
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References
- van der Heijde D, Deodhar A, Baraliakos X, et al. Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomized controlled trials. Ann Rheum Dis. Epub ahead of print: 2023; doi:10.1136/ard-2022-223595.
- Deodhar A. Understanding axial spondyloarthritis: A primer for managed care. Am J Manag Care. 2019;25:S319–S330.
- Reveille J, Witter J, Weisman M. Prevalence of axial spondylarthritis in the United States: Estimates from a cross-sectional survey. Arthritis Care Res. 2012;64(6):905–910.
- Hamilton L, Macgregor A, Toms A, et al. The prevalence of axial spondyloarthritis in the UK: A cross-sectional cohort study. BMC Musculoskelet Disord. 2015;21(16):392.
- 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: January 2023. - BIMZELX® (bimekizumab) GB Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/product/12834/smpc#gref Last Accessed: January 2023.
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