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), also known as radiographic axSpA. (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 adult patients with active psoriatic arthritis (PsA).
In September 2022, UCB announced that the European Medicines Agency had accepted for regulatory review the marketing authorization application for bimekizumab for the treatment of adult patients with active axSpA and active PsA. The efficacy and safety of bimekizumab in the treatment of axSpA and PsA have not been established and it is not approved for the treatment of active axSpA or active PsA by any regulatory authority worldwide.
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