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ASAS40 responses increased between week 16 and week 52 in patients with non-radiographic axial spondyloarthritis and ankylosing spondylitis.
In the first part of our interview, Xenofon Baraliakos, MD, discusses his American College of Rheumatology Convergence 2022 presentation “Bimekizumab Maintains Improvements in Efficacy Endpoints and Has a Consistent Safety Profile Through 52 Weeks in Patients with Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis: Results from Two Parallel Phase 3 Studies.” Baraliakos is a Senior Consultant and scientific coordinator at Rheumazentrum Ruhrgebiet Herne and Associate Professor for Internal Medicine and Rheumatology at Ruhr-University Bochum, Germany.
In the phase placebo-controlled 3 BE MOBILE 1 (NCT03928704) and BE MOBILE 2 (NCT03928743) studies, subcutaneous bimekizumab met all primary and secondary endpoints at week 16. This study focused on results up to week 52 of treatment in patients with active non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS).
“For both studies, primary endpoint was a 40% improvement in the Assessment in SpondyloArthritis international Society (ASAS40) domains,” Baraliakos explained. “And the frequency of endpoints altogether were assessed through week 52. So, we assessed clinical efficacy in both stages and we assessed not only the primary and secondary efficacy endpoints, but also the treatment emergent adverse events and any safety signals that may have come in that population over 52 weeks.”
In total, 86.6% of patients with nr-axSpA and 89.8% of patients with AS completed week 52 with sustained efficacy. ASAS40 responses increased between week 16 (nr-axSpA: 47.7%; AS: 44.8%; non-responder imputation [NRI]) and week 52 (nr-axSpA: 60.9%; AS: 58.4%; NRI). At the end of the study, Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1 was obtained by 61.6% of patients with nr-axSpA and 57.1% of AS and ASDAS < 1.3 was achieved by 25.2% and 23.4%, respectively.