Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials

van der Heijde D, Deodhar A, Baraliakos X, Brown MA, Dobashi H, Dougados M, Elewaut D, Ellis AM, Fleurinck C, Gaffney K, Gensler LS, et al. (2023)
Annals of the Rheumatic Diseases.

Zeitschriftenaufsatz | E-Veröff. vor dem Druck | Englisch
 
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van der Heijde, Desiree; Deodhar, Atul; Baraliakos, Xenofon; Brown, Matthew A; Dobashi, Hiroaki; Dougados, Maxime; Elewaut, Dirk; Ellis, Alicia M; Fleurinck, Carmen; Gaffney, Karl; Gensler, Lianne S; Haroon, Nigil
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Abstract / Bemerkung
OBJECTIVES: Axial spondyloarthritis (axSpA) is a complex disease with diverse manifestations, for which new treatment options are warranted. BE MOBILE 1 (non-radiographic (nr)-axSpA) and BE MOBILE 2 (radiographic axSpA (r-axSpA)) are double-blind, phase 3 trials designed to evaluate efficacy and safety of bimekizumab, a novel dual interleukin (IL)-17A and IL-17F inhibitor, across the axSpA spectrum.; METHODS: In parallel 52-week trials, patients with active disease were randomised 1:1 (nr-axSpA) or 2:1 (r-axSpA) to bimekizumab 160mg every 4 weeks:placebo. From week 16, all patients received bimekizumab 160mg every 4 weeks. Primary (Assessment of SpondyloArthritis international Society ≥40% improvement (ASAS40)) and secondary endpoints were assessed at week 16. Here, efficacy and treatment-emergent adverse events (TEAEs) are reported up to week 24.; RESULTS: 254 patients with nr-axSpA and 332 with r-axSpA were randomised. At week 16, primary (ASAS40, nr-axSpA: 47.7% bimekizumab vs 21.4% placebo; r-axSpA: 44.8% vs 22.5%; p<0.001) and all ranked secondary endpoints were met in both trials. ASAS40 responses were similar across TNFi-naive and TNFi-inadequate responder patients. Improvements were observed in Ankylosing Spondylitis Disease Activity Score (ASDAS) states and objective measures of inflammation, including high-sensitivity C-reactive protein (hs-CRP) and MRI of the sacroiliac joints and spine. Most frequent TEAEs with bimekizumab (>3%) included nasopharyngitis, upper respiratory tract infection, pharyngitis, diarrhoea, headache and oral candidiasis. More fungal infections (all localised) were observed with bimekizumab vs placebo; no major adverse cardiovascular events (MACE) or active tuberculosis were reported. Incidence of uveitis and adjudicated inflammatory bowel disease was low.; CONCLUSIONS: Dual inhibition of IL-17A and IL-17F with bimekizumab resulted in significant and rapid improvements in efficacy outcomes vs placebo and was well tolerated in patients with nr-axSpA and r-axSpA.
Erscheinungsjahr
2023
Zeitschriftentitel
Annals of the Rheumatic Diseases
eISSN
1468-2060
Page URI
https://pub.uni-bielefeld.de/record/2968388

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van der Heijde D, Deodhar A, Baraliakos X, et al. Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials. Annals of the Rheumatic Diseases. 2023.
van der Heijde, D., Deodhar, A., Baraliakos, X., Brown, M. A., Dobashi, H., Dougados, M., Elewaut, D., et al. (2023). Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials. Annals of the Rheumatic Diseases. https://doi.org/10.1136/ard-2022-223595
van der Heijde, Desiree, Deodhar, Atul, Baraliakos, Xenofon, Brown, Matthew A, Dobashi, Hiroaki, Dougados, Maxime, Elewaut, Dirk, et al. 2023. “Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials”. Annals of the Rheumatic Diseases.
van der Heijde, D., Deodhar, A., Baraliakos, X., Brown, M. A., Dobashi, H., Dougados, M., Elewaut, D., Ellis, A. M., Fleurinck, C., Gaffney, K., et al. (2023). Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials. Annals of the Rheumatic Diseases.
van der Heijde, D., et al., 2023. Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials. Annals of the Rheumatic Diseases.
D. van der Heijde, et al., “Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials”, Annals of the Rheumatic Diseases, 2023.
van der Heijde, D., Deodhar, A., Baraliakos, X., Brown, M.A., Dobashi, H., Dougados, M., Elewaut, D., Ellis, A.M., Fleurinck, C., Gaffney, K., Gensler, L.S., Haroon, N., Magrey, M., Maksymowych, W.P., Marten, A., Massow, U., Oortgiesen, M., Poddubnyy, D., Rudwaleit, M., Shepherd-Smith, J., Tomita, T., Van den Bosch, F., Vaux, T., Xu, H.: Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials. Annals of the Rheumatic Diseases. (2023).
van der Heijde, Desiree, Deodhar, Atul, Baraliakos, Xenofon, Brown, Matthew A, Dobashi, Hiroaki, Dougados, Maxime, Elewaut, Dirk, Ellis, Alicia M, Fleurinck, Carmen, Gaffney, Karl, Gensler, Lianne S, Haroon, Nigil, Magrey, Marina, Maksymowych, Walter P, Marten, Alexander, Massow, Ute, Oortgiesen, Marga, Poddubnyy, Denis, Rudwaleit, Martin, Shepherd-Smith, Julie, Tomita, Tetsuya, Van den Bosch, Filip, Vaux, Thomas, and Xu, Huji. “Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials”. Annals of the Rheumatic Diseases (2023).
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