Bimekizumab demonstrated at ACR Convergence 2022, sustained clinical responses to week 52 in phase III studies in non-radiographic axial spondyloarthritis and ankylosing spondylitis
UCB announced the first presentation of long-term, 52-week data from three Phase III studies evaluating the efficacy and safety of bimekizumab in adults with active psoriatic arthritis (PsA) who were biologic-naïve (BE OPTIMAL), in adults with active non-radiographic axial spondyloarthritis (nr-axSpA; BE MOBILE 1), and in adults with active ankylosing spondylitis, also known as radiographic axSpA (AS; BE MOBILE 2)
These late-breaking data are being presented at ACR Convergence 2022 in Philadelphia, November 10–14, 2022.
In BE MOBILE 1 and BE MOBILE 2, treatment with bimekizumab resulted in sustained clinical responses to week 52, including suppression of inflammation and improvements in function and quality of life across the full spectrum of axial spondyloarthritis .
BE MOBILE 1 and BE MOBILE 2 (axSpA): Phase III Study Results (52 weeks): In BE MOBILE 1 and BE MOBILE 2, patients were randomized to bimekizumab (160 mg Q4W; N=128 for BE MOBILE 1 and N=221 for BE MOBILE 2) or to placebo (N=126 for BE MOBILE 1 and N=111 for BE MOBILE 2). Patients initially randomized to placebo were switched to bimekizumab at week 16. A total of 86.6 percent randomized patients with nr-axSpA and 89.8 percent with AS completed week 52. Key 52-week results from the BE MOBILE 1 and BE MOBILE 2 studies are presented at ACR Convergence 2022 and build upon previously announced 16- and 24-week results: ASAS40: At week 52, 60.9 percent of nr-axSpA patients and 58.4 percent of AS patients continuously treated with bimekizumab achieved ASAS40, with consistent outcomes across both TNFi-naïve and TNFi-inadequate responder populations. Low Disease Activity and Remission: At week 52, 61.6 percent of nr-axSpA patients and 57.1 percent of AS patients continuously treated with bimekizumab achieved low disease activity (ASDAS<2.1); at week 52, inactive disease or clinical remission (asdas><1.3) was achieved by 25.2 percent of nr-axspa patients and 23.4 percent of as patients continuously treated with bimekizumab. Objective Inflammation: The reductions from baseline in objective signs of inflammation (Magnetic Resonance Imaging [MRI], hs-C-Reactive Protein [hs-CRP]) for patients with nr-axSpA and AS were sustained through week 52. In addition, improvements in function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) and quality of life, as measured by Ankylosing Spondylitis Quality of Life (ASQoL), were sustained through week 52.
“Results presented at ACR Convergence 2022 from BE MOBILE 1 and BE MOBILE 2 demonstrate that treatment with bimekizumab provided consistent and sustained improvements to one year in key signs and symptoms across the full spectrum of axial spondyloarthritis, with similar outcomes regardless of previous treatment with TNF inhibitors. These positive results are the first Phase III data evaluating a dual IL-17A and IL-17F inhibitor, bimekizumab, in the long-term treatment of patients living with non-radiographic axial spondyloarthritis and ankylosing spondylitis,” said Professor Xenofon Baraliakos, Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Germany.
Over 52 weeks, 75.0 percent of nr-axSpA patients treated with bimekizumab and 75.5 percent of AS patients had greater than 1 TEAE. The most frequent TEAEs were nasopharyngitis (nr-axSpA 12.3 percent; AS 9.1 percent), upper respiratory tract infection (nr-axSpA 9.4 percent; AS 6.4 percent) and oral candidiasis (nr-axSpA 7.4 percent; AS 6.1 percent); few COVID-19 infections were reported (nr-axSpA: 7.0 percent; AS; 2.1 percent). The incidence of serious TEAEs was low (nr-axSpA 4.4 percent; AS 7.1 percent).
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