Positive Top-Line Results for bimekizumab in Phase 3 Non-Radiographic Axial Spondyloarthritis Study
UCB announced positive interim results from its Phase 3 BE MOBILE 1 study assessing bimekizumab for non-radiographic axial spondyloarthritis. The primary endpoint, ASAS40 response at week 16, showed statistically significant improvement over placebo. All secondary endpoints were also met, including improvements in disease activity and spinal pain. The safety profile was consistent with prior studies, and UCB plans to submit regulatory applications in the U.S. and EU in Q3 2022. Bimekizumab is currently not approved for this indication.
- Phase 3 BE MOBILE 1 study met primary endpoint ASAS40 response.
- All ranked secondary endpoints were achieved.
- Bimekizumab showed statistically significant improvements in disease activity and spinal pain.
- Plans to submit regulatory applications in the U.S. and EU in Q3 2022.
- Bimekizumab is not approved for non-radiographic axial spondyloarthritis or ankylosing spondylitis.
- The efficacy and safety of bimekizumab in nr-axSpA have not been established.
BRUSSELS and ATLANTA, Jan. 18, 2022 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced positive top-line interim analysis results showing that the Phase 3 BE MOBILE 1 study met the primary and all ranked secondary endpoints.1 BE MOBILE 1 is the first study to evaluate the efficacy and safety of bimekizumab in adults with active non-radiographic axial spondyloarthritis (nr-axSpA).
In the BE MOBILE 1 study, bimekizumab demonstrated a statistically significant and clinically meaningful improvement over placebo in the proportion of patients who achieved the Assessment of SpondyloArthritis International Society 40 percent (ASAS40) response at week 16, the primary endpoint of the study.1 ASAS40 measures improvements in disease across four different domains – patient global assessment of disease activity, spinal pain, physical function and inflammation.2 The primary endpoint used in this study, ASAS40, set a high threshold for improvement in patient-reported outcomes, i.e., at least a 40 percent improvement relative to baseline.*
The study also met all ranked secondary endpoints. Patients treated with bimekizumab achieved significant improvements over placebo at week 16 in the signs and symptoms of disease as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI); achievement of ASAS partial remission (PR) and Ankylosing Spondylitis Disease Activity Score (ASDAS) Major Improvement (MI); and the nocturnal spinal pain score.1
"We're excited to share top-line findings from the second Phase 3 study in our clinical program of bimekizumab in axSpA. These positive results, together with the previously reported top-line data from the BE MOBILE 2 study, support the clinical potential of bimekizumab to improve patient outcomes across the full spectrum of axSpA, including both nr-axSpA and ankylosing spondylitis," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.
"Today's positive findings from the Phase 3 BE MOBILE 1 study provide clear evidence supporting bimekizumab in the treatment of nr-axSpA, and suggest that targeting IL-17F in addition to IL-17A may be a promising treatment approach for this painful, chronic rheumatic condition that often starts in young adulthood," said Prof. Atul Deodhar, MD, MRCP, Professor of Medicine, Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, U.S.
In BE MOBILE 1, 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 nr-axSpA have not been established. Bimekizumab is not approved for use in nr-axSpA or ankylosing spondylitis (AS) by any regulatory authority worldwide.
Results from the BE MOBILE 1 study will be presented at upcoming medical conferences and published in a peer-reviewed medical journal.
The top-line results from the BE MOBILE 1 study build on the positive top-line results from the BE MOBILE 2 study3 in AS, reported in December 2021. Based on these results, UCB plans to submit regulatory applications for bimekizumab in axSpA in the United States and the European Union in Q3 2022.
* ASAS40 is achieved when there is at least a 40 percent improvement relative to baseline, and an absolute improvement of at least two units on a 0-10 numeric rating scale in at least three of the four domains that make up the ASAS response criteria – patient global assessment of disease activity, spinal pain, physical function and inflammation – with no worsening in the remaining domain.2
About BE MOBILE 1
BE MOBILE 1 is 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 non-radiographic axial spondyloarthritis (nr-axSpA).2 BE MOBILE is the first Phase 3 bimekizumab research program to include patients from China in its study population. The 52-week study is ongoing with top-line interim analysis results presented above. For additional details on the study, visit BE MOBILE 1 on clinicaltrials.gov.
BE MOBILE 1 enrolled participants with active disease.2 Study participants had to have adult-onset axial spondyloarthritis meeting Assessment of SpondyloArthritis International Society (ASAS) classification criteria, inflammatory back pain for at least three months and no definitive radiographic sacroiliitis confirmed by central reading.2 Patients needed to demonstrate objective signs of inflammation by elevated C-reactive protein (CRP) and/or positive magnetic resonance imaging (MRI). Study participants also had to have either failed to respond to two different nonsteroidal anti-inflammatory drugs (NSAIDs) given at the maximum tolerated dose for a total of four weeks or have had a history of intolerance to or a contraindication to NSAID therapy.2 Patients who had taken a tumor necrosis factor alpha (TNFα) inhibitor had to have experienced an inadequate response or intolerance to treatment.2
About Axial Spondyloarthritis
Non-radiographic axSpA (nr-axSpA) falls under the umbrella of axial spondyloarthritis (axSpA), which also includes ankylosing spondylitis (AS).4 AxSpA is a painful chronic inflammatory disease that primarily affects the spine and the joints linking the pelvis and lower spine (sacroiliac joints).5 nr-axSpA is defined clinically by the absence of definitive x-ray evidence of structural damage to the sacroiliac joints.4 The leading symptom of axSpA is inflammatory back pain that improves with exercise, but not with rest.4 Fatigue and stiffness are additional key symptoms. Other common clinical features frequently include acute anterior uveitis (eye inflammation), enthesitis (inflammation of the points of insertion of tendons and ligaments into bone), peripheral arthritis, psoriasis, inflammatory bowel disease (chronic inflammation of the digestive tract) and dactylitis (inflammation of the fingers or toes).4 The overall prevalence of axSpA is 0.2 percent to 1.4 percent of adults.6,7 Approximately half of all patients with axSpA are patients with nr-axSpA.4 Approximately two-thirds of patients with AS are men,8 while nr-axSpA is more common among women with the disease.8 AxSpA onset usually occurs before the age of 45, often in the 20s.4 10 to 40 percent of patients with nr-axSpA progress to AS over 2 to 10 years.4
About bimekizumab
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.9
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.
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 more than 7,600 people in approximately 40 countries, the company generated revenue of
Forward looking statements UCB
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For further information, contact UCB:
Corporate Communications Nicole Herga, U.S. Immunology T+1.404.226.7591 | Investor Relations Antje Witte, Investor Relations, UCB T +32.2.559.94.14, | Brand Communications Eimear O'Brien, Brand Communications, UCB T + 32.2.559.92.71,
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References
1 Data on file. UCB. January 2022. | ||
2 ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis (BE MOBILE 1). Available at: https://clinicaltrials.gov/ct2/show/NCT03928704. Last accessed: January 2022. | ||
3 Data on file. UCB. December 2021. | ||
4 Deodhar A. Understanding Axial Spondyloarthritis: A Primer for Managed Care. Am J Manag Care. 2019;25:S319-S330. | ||
5 van der Heijde D, Gensler L, Deodhar A, et al. Dual Neutralisation of interleukin-17A and interleukin-17F With Bimekizumab in Patients With Active Ankylosing Spondylitis: Results From a 48-week Phase IIb, Randomised, Double-Blind, Placebo-Controlled, Dose-Ranging Study. Ann Rheum Dis. 2020;79(5):595-604. | ||
6 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. | ||
7 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. | ||
8 Boonen A, Sieper J, van der Heijde D, et al. The burden of non-radiographic axial spondyloarthritis. Semin Arthritis Rheum. 2015;44(5):556-562. | ||
9 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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