Annals of the Rheumatic Diseases Publishes Results from Two Bimekizumab Phase 3 Studies in Axial Spondyloarthritis
- 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
"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
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
Bimekizumab is an investigational product; its efficacy and safety have not been established for any indication in the
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
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
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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.
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- 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:
- BIMZELX® (bimekizumab) GB Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/product/12834/smpc#gref Last Accessed:
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