A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis

Summary

The purpose of the study is to demonstrate the long-term safety, tolerability and efficacy of bimekizumab in patients with active axial spondyloarthritis (axSpA, also known as radiographic axSpa (r-axSpA)) including ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpa).

Timeline

Start

2020-06-16

Primary completion

2026-08-09

Completion

2026-08-09

Publications

• Results Brown MA, Rudwaleit M, van Gaalen FA, Haroon N, Gensler LS, Fleurinck C, Marten A, Massow U, de Peyrecave N, Vaux T, White K, Deodhar A, van der Horst-Bruinsma I. Low uveitis rates in patients with axial spondyloarthritis treated with bimekizumab: pooled results from phase 2b/3 trials. Ann Rheum Dis. 2024 Nov 14;83(12):1722-1730. doi: 10.1136/ard-2024-225933.
• Results Ramiro S, Poddubnyy D, Mease PJ, Lopez-Medina C, Kim M, Massow U, Taieb V, Kragstrup TW, McGonagle D. Sustained resolution of enthesitis and peripheral arthritis over 104 weeks with bimekizumab in axial spondyloarthritis. RMD Open. 2025 Oct 22;11(4):e005969. doi: 10.1136/rmdopen-2025-005969.
• Results Nikiphorou E, Tillett W, Deodhar A, Dubreuil M, Gossec L, Hwang M, Lubrano E, Machado PM, Rudwaleit M, de Wit M, Kavanagh S, de la Loge C, Ink B, Lambert J, Morup M, Boonen A, Walsh J. Effect of Bimekizumab Treatment on Health Status, Work Productivity, and Productivity Costs Through 3 Years in Axial Spondyloarthritis and Psoriatic Arthritis. J Rheumatol. 2026 Aug 1:jrheum.2026-0104. doi: 10.3899/jrheum.2026-0104. Online ahead of print.
• Results Baraliakos X, Deodhar A, van der Heijde D, Van den Bosch F, Magrey M, Maksymowych WP, Tomita T, Xu H, Coarse J, Prajapati C, Manente M, Marten A, Gensler LS. Bimekizumab Long-Term Safety and Efficacy Across the Spectrum of Axial Spondyloarthritis Over 3 Years: Results From 2 Phase III Studies. J Rheumatol. 2026 Aug 1:jrheum.2026-0113. doi: 10.3899/jrheum.2026-0113. Online ahead of print.
• Navarro-Compan V, Kiltz U, Mease PJ, Dubreuil M, Gaffney K, Deodhar A, de la Loge C, Prajapati C, Kavanagh S, Marzo-Ortega H. Bimekizumab treatment for sustained improvements in patient symptoms and health-related quality of life to 3 years in axial spondyloarthritis: results from the BE MOBILE studies and their open-label extension. RMD Open. 2026 May 13;12(2):e006670. doi: 10.1136/rmdopen-2025-006670.
• Mease PJ, Merola JF, Magrey M, Nash P, Poddubnyy D, Lebwohl M, Bajracharya R, Ink B, Marten A, Manente M, Peterson L, White K, Gensler LS. Bimekizumab longer-term safety profile in adult patients with axial spondyloarthritis or psoriatic arthritis: an updated analysis of six phase IIb/III clinical studies. RMD Open. 2026 Mar 10;12(1):e006174. doi: 10.1136/rmdopen-2025-006174.
• Ramiro S, Proft F, Sengupta R, van Tubergen A, Molto A, Gensler LS, Kishimoto M, Taieb V, Kavanagh S, Evans S, Navarro-Compan V. Impact of symptom duration on the short- and long-term efficacy of bimekizumab in axial spondyloarthritis: results up to 2 years. Arthritis Res Ther. 2026 Jan 19;28(1):40. doi: 10.1186/s13075-026-03729-6.
• Marzo-Ortega H, Navarro-Compan V, Dubreuil M, Mease PJ, Magrey M, Rudwaleit M, D'Agostino MA, Gaffney K, Kay J, de la Loge C, Massow U, Taieb V, Vaux T, Deodhar A. Sustained improvements in spinal pain, morning stiffness, fatigue, sleep, physical function and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: 2-year results from two phase 3 studies. RMD Open. 2025 Nov 28;11(4):e006013. doi: 10.1136/rmdopen-2025-006013.
• Mease PJ, Gensler LS, Orbai AM, Warren RB, Bajracharya R, Ink B, Marten A, Massow U, Shende V, Manente M, Peterson L, White K, Landewe R, Poddubnyy D. Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies. RMD Open. 2025 Apr 6;11(2):e005026. doi: 10.1136/rmdopen-2024-005026.

Drugs

Indications