Positive topline results were announced from a phase 3 study evaluating bimekizumab, an investigational interleukin (IL)-17A and IL-17F inhibitor, in adults with active nonradiographic axial spondyloarthritis (nr-axSpA).
The ongoing 52-week, multicenter, randomized, double-blind, placebo-controlled BE MOBILE 1 study (ClinicalTrials.gov Identifier: NCT03928704) compared the efficacy and safety of bimekizumab to placebo in adults with active nr-axSpA with adult-onset axial spondyloarthritis meeting Assessment of SpondyloArthritis International Society (ASAS) classification criteria, inflammatory back pain for at least 3 months, and no definitive radiographic sacroiliitis.
The primary endpoint was the proportion of patients who achieved the Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at week 16. ASAS40 measures improvements in disease across 4 different domains, including a patient global assessment of disease activity, spinal pain, physical function and inflammation.
Results showed that a higher proportion of patients treated with bimekizumab achieved a statistically significant and clinically meaningful improvement in ASAS40 response at week 16 compared with placebo. Bimekizumab was also associated with significant improvements in the signs and symptoms of disease as measured by the Bath Ankylosing Spondylitis Disease Activity Index; achievement of ASAS partial remission and Ankylosing Spondylitis Disease Activity Score major improvement; and the nocturnal spinal pain score.
The safety profile of bimekizumab was consistent with that seen in previous studies. Detailed study results will be presented at upcoming medical conferences and published in a peer-reviewed medical journal.
“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 US, UCB.
The Biologics License Application for bimekizumab is currently under review by the Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis.
Positive top-line results for bimekizumab in phase 3 non-radiographic axial spondyloarthritis study. News release. UCB. Accessed January 18, 2022. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/positive-top-line-results-bimekizumab-phase-3-non-radiographic-axial-spondyloarthritis-study