Bimekizumab improves ASAS40 response rate over placebo in non-radiographic axial SpA
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Bimekizumab demonstrates statistically significant improvement over placebo in the proportion of patients achieving Assessment of Spondyloarthritis International Society 40 response at week 16, according to interim results released by UCB.
The finding comes as part of a top-line interim analysis of the phase 3 BE MOBILE 1 trial, the first study to assess the efficacy and safety of bimekizumab (UCB) in adults with active, non-radiographic axial spondyloarthritis (nr-axSpA). According to the company, the study met its primary endpoint and all ranked secondary outcomes.
“We’re excited to share top-line findings from the second phase 3 study in our clinical program of bimekizumab in [axial SpA (axSpA)],” Emmanuel Caeymaex, executive vice president of immunology and U.S. solutions at UCB, said in a press release. “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.”
According to BE MOBILE 1 interim results, bimekizumab, a humanized monoclonal IgG1 antibody targeting interleukin-17A and IL-17F, demonstrated a statistically significant and clinically meaningful improvement in the proportion of patients who achieved ASAS40 response — the trial’s primary endpoint — at week 16 compared with placebo.
In addition, patients who received bimekizumab achieved significant improvements over placebo in signs and symptoms — as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), ASAS partial remission and Ankylosing Spondylitis Disease Activity Score (ASDAS) Major Improvement, and the nocturnal spinal pain score — at week 16.
According to UCB, bimekizumab’s safety profile was consistent with data reported in previous studies with no new observed signals.
These findings follow top-line results from the BE MOBILE 2 study in ankylosing spondylitis, first reported in Dec. 2021. UCB plans to use these results as the basis for its regulatory applications requesting the approval of bimekizumab for axial SpA in the United States and the European Union later in 2022.
“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,” Atul Deodhar, MD, MRCP, of Oregon Health & Science University, in Portland, said in the release.
Full results from the BE MOBILE 1 trial will be presented at an upcoming meeting and published in a peer-reviewed medical journal, UCB said.
Bimekizumab is not currently approved for non-radiographic axial SpA or AS anywhere in the world.
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