BE AGILE Study Reveals 5-Year Success of Bimekizumab in Ankylosing Spondylitis Treatment

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In a groundbreaking development for rheumatology practice, long-term data from the BE AGILE clinical trial and its open-label extension published IN Rheumatic & Musculoskeletal Diseases Open demonstrated remarkable safety and sustained efficacy of bimekizumab in treating radiographic axial spondyloarthritis (r-axSpA) over a five-year period. 

Patients with active r-axSpA who completed the initial 48-week randomized controlled trial were eligible to enter the open-label extension, receiving bimekizumab 160 mg every four weeks.  Among 303 enrolled patients, 289 (95.4%) experienced at least one treatment-emergent adverse event (TEAE). The most frequently reported TEAEs included nasopharyngitis (21.8%) and upper respiratory tract infections (14.5%). The exposure-adjusted incidence rates/100 patient-years (EAIRs) of fungal infections was 7.4, with Candida infections occurring at 2.6 and oral candidiasis at 2.2; no systemic fungal infections were reported. Serious infections had an EAIR of 1.4, and no active tuberculosis cases were observed. The EAIRs for active inflammatory bowel disease and anterior uveitis were 0.8 and 0.7, respectively. Over the five-year period, 202 (66.7%) patients completed treatment, while 42 (13.9%) discontinued due to TEAEs. 

Efficacy outcomes demonstrated that the disease control achieved at week 48 was sustained through 5 years. By the end of the study, 49.7% of patients achieved an ASAS40 response based on non-responder imputation (NRI) analysis, with observed case (OC) analysis showing a response rate of 73.1%. Additionally, 41.6% (NRI) and 71.1% (OC) of patients achieved ASDAS low disease activity. Mean ASDAS improved from 3.9 at baseline to 2.1 at week 48, maintaining this level through Week 256. Sustained improvements were also observed in pain, fatigue, physical function, and health-related quality of life. 

Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits both IL-17A and IL-17F. It is the first monoclonal antibody targeting these cytokines to receive approval from both the European Medicines Agency and the U.S. Food and Drug Administration for the treatment of axSpA. Clinical studies have demonstrated that dual inhibition of IL-17A and IL-17F with bimekizumab leads to rapid and sustained clinical improvements across the full spectrum of axSpA. Findings from the phase 2b BE AGILE study, which evaluated bimekizumab in adults with r-axSpA, showed significant and rapid reductions in disease activity by Week 12, with these benefits persisting through Week 48. The treatment was well tolerated, contributing to notable improvements in patient-reported outcomes (PROs) and health-related quality of life. Long-term data, extending up to 156 weeks (three years), further confirmed the sustained efficacy and safety of bimekizumab. 

The five-year data reaffirmed the long-term safety and durability of bimekizumab in patients with r-axSpA. No new safety concerns emerged, supporting its continued use in managing the disease. These findings represent a significant advancement in the management of r-axSpA, offering rheumatologists compelling evidence for the long-term use of bimekizumab. The sustained improvements in pain, fatigue, physical function, and health-related quality of life, combined with the consistent safety profile, position bimekizumab as a promising long-term treatment option for patients with r-axSpA. 

References 

  1. Deodhar A, Navarro-Compán V, Poddubnyy D, Gensler LS, Ramiro S, Tomita T, et al. Long-term safety and sustained efficacy of bimekizumab in patients with ankylosing spondylitis (radiographic axial spondyloarthritis): 5-year results from BE AGILE (phase 2b) and its open-label extension. RMD Open. 2025 Jan 31;11(1):e005081.  
  2. van der Heijde D, Gensler LS, Deodhar A, Baraliakos X, Poddubnyy D, Kivitz A, et al. Dual neutralisation of interleukin-17A and interleukin-17F with bimekizumab in patients with active ankylosing spondylitis: results from a 48-week phase IIb, randomised, double-blind, placebo-controlled, dose-ranging study. Ann Rheum Dis. 2020 May;79(5):595-604. doi: 10.1136/annrheumdis-2020-216980. Epub 2020 Apr 6. Erratum in: Ann Rheum Dis. 2020 Sep;79(9):e121. 
  3. Baraliakos X, Deodhar A, Dougados M, Gensler LS, Molto A, Ramiro S, et al. Safety and Efficacy of Bimekizumab in Patients With Active Ankylosing Spondylitis: Three-Year Results From a Phase IIb Randomized Controlled Trial and Its Open-Label Extension Study. Arthritis Rheumatol. 2022 Dec;74(12):1943-1958.