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
Objective Assess long-term safety, tolerability and efficacy of bimekizumab in ankylosing spondylitis (radiographic axial spondyloarthritis (r-axSpA)).Methods Patients with active r-axSpA completing the dose-ranging 48-week randomised controlled trial could enrol in the open-label extension, where p...
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BMJ Publishing Group
2025-01-01
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| Online Access: | https://rmdopen.bmj.com/content/11/1/e005081.full |
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| author | Sofia Ramiro Désirée van der Heijde Atul Deodhar Xenofon Baraliakos Denis Poddubnyy Lianne S Gensler Helena Marzo-Ortega Natasha de Peyrecave Victoria Navarro-Compán Tetsuya Tomita Carmen Fleurinck Ute Massow Thomas Vaux |
| author_facet | Sofia Ramiro Désirée van der Heijde Atul Deodhar Xenofon Baraliakos Denis Poddubnyy Lianne S Gensler Helena Marzo-Ortega Natasha de Peyrecave Victoria Navarro-Compán Tetsuya Tomita Carmen Fleurinck Ute Massow Thomas Vaux |
| author_sort | Sofia Ramiro |
| collection | DOAJ |
| description | Objective Assess long-term safety, tolerability and efficacy of bimekizumab in ankylosing spondylitis (radiographic axial spondyloarthritis (r-axSpA)).Methods Patients with active r-axSpA completing the dose-ranging 48-week randomised controlled trial could enrol in the open-label extension, where patients received bimekizumab 160 mg every 4 weeks. Safety (exposure-adjusted incidence rates/100 patient-years (EAIRs)) and efficacy outcomes (binary: non-responder imputation (NRI) and observed case (OC); continuous: multiple imputation (MI)) are presented through 256 weeks.Results From Weeks 0–256, 289/303 (95.4%) patients had ≥1 treatment-emergent adverse event (TEAE); most frequent were nasopharyngitis (21.8%) and upper respiratory tract infection (14.5%). The EAIR of fungal infections was 7.4 (Candida infections: 2.6; oral candidiasis: 2.2); none systemic. EAIR of serious infections was 1.4; no active tuberculosis was reported. Active inflammatory bowel disease and anterior uveitis EAIRs were 0.8 and 0.7, respectively. 202/303 (66.7%) patients completed Week 256. 42 (13.9%) patients discontinued treatment due to TEAEs.Efficacy at Week 48 was maintained for 5 years. At Week 256, NRI analysis showed 49.7% (OC: 73.1%) and 41.6% (OC: 71.1%) of patients achieved Assessment of SpondyloArthritis International Society 40% (ASAS40) response and Axial Spondyloarthritis Disease Activity Score (ASDAS) low disease activity, respectively. Mean (SE; MI) ASDAS improved from 3.9 (0.1) at baseline to 2.1 (0.1) at Week 48, which was maintained to Week 256. Improvements in pain, fatigue, physical function and health-related quality of life were sustained.Conclusions The safety profile of bimekizumab after 5 years of treatment remained consistent with previous reports, with no new safety signals identified. 5-year efficacy was sustained in this r-axSpA population following robust disease control achieved at Week 48.Trial registration numbers NCT02963506; NCT03355573. |
| format | Article |
| id | doaj-art-e65c5b903df34ea6afb459674fa519a2 |
| institution | Kabale University |
| issn | 2056-5933 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-e65c5b903df34ea6afb459674fa519a22025-02-01T04:45:10ZengBMJ Publishing GroupRMD Open2056-59332025-01-0111110.1136/rmdopen-2024-005081Long-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 extensionSofia Ramiro0Désirée van der Heijde1Atul Deodhar2Xenofon Baraliakos3Denis Poddubnyy4Lianne S Gensler5Helena Marzo-Ortega6Natasha de Peyrecave7Victoria Navarro-Compán8Tetsuya Tomita9Carmen Fleurinck10Ute Massow11Thomas Vaux12Department of Rheumatology, Zuyderland Medical Centre Heerlen, Heerlen, NetherlandsRheumatology, Leiden University Medical Center, Leiden, The NetherlandsDivision of Arthritis and Rheumatic Diseases, Oregon Health and Science University, Portland, Oregon, USARheumazentrum Ruhrgebiet, Ruhr University Bochum, Herne, GermanyDepartment of Gastroenterology, Infectious Diseases and Rheumatology, Charite - Universitatsmedizin Berlin, Berlin, GermanyDepartment of Medicine/Rheumatology, University of California San Francisco, San Francisco, California, USALTHT, NIHR Leeds Biomedical Research Centre, Leeds, UKUCB, Brussels, Belgium8 Department of Rheumatology, University Hospital La Paz, IdiPaz, Madrid, SpainGraduate School of Health Science, Morinomiya University of Medical Sciences, Osaka City, Osaka, JapanUCB, Brussels, BelgiumUCB, Monheim am Rhein, GermanyUCB, Slough, UKObjective Assess long-term safety, tolerability and efficacy of bimekizumab in ankylosing spondylitis (radiographic axial spondyloarthritis (r-axSpA)).Methods Patients with active r-axSpA completing the dose-ranging 48-week randomised controlled trial could enrol in the open-label extension, where patients received bimekizumab 160 mg every 4 weeks. Safety (exposure-adjusted incidence rates/100 patient-years (EAIRs)) and efficacy outcomes (binary: non-responder imputation (NRI) and observed case (OC); continuous: multiple imputation (MI)) are presented through 256 weeks.Results From Weeks 0–256, 289/303 (95.4%) patients had ≥1 treatment-emergent adverse event (TEAE); most frequent were nasopharyngitis (21.8%) and upper respiratory tract infection (14.5%). The EAIR of fungal infections was 7.4 (Candida infections: 2.6; oral candidiasis: 2.2); none systemic. EAIR of serious infections was 1.4; no active tuberculosis was reported. Active inflammatory bowel disease and anterior uveitis EAIRs were 0.8 and 0.7, respectively. 202/303 (66.7%) patients completed Week 256. 42 (13.9%) patients discontinued treatment due to TEAEs.Efficacy at Week 48 was maintained for 5 years. At Week 256, NRI analysis showed 49.7% (OC: 73.1%) and 41.6% (OC: 71.1%) of patients achieved Assessment of SpondyloArthritis International Society 40% (ASAS40) response and Axial Spondyloarthritis Disease Activity Score (ASDAS) low disease activity, respectively. Mean (SE; MI) ASDAS improved from 3.9 (0.1) at baseline to 2.1 (0.1) at Week 48, which was maintained to Week 256. Improvements in pain, fatigue, physical function and health-related quality of life were sustained.Conclusions The safety profile of bimekizumab after 5 years of treatment remained consistent with previous reports, with no new safety signals identified. 5-year efficacy was sustained in this r-axSpA population following robust disease control achieved at Week 48.Trial registration numbers NCT02963506; NCT03355573.https://rmdopen.bmj.com/content/11/1/e005081.full |
| spellingShingle | Sofia Ramiro Désirée van der Heijde Atul Deodhar Xenofon Baraliakos Denis Poddubnyy Lianne S Gensler Helena Marzo-Ortega Natasha de Peyrecave Victoria Navarro-Compán Tetsuya Tomita Carmen Fleurinck Ute Massow Thomas Vaux 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://rmdopen.bmj.com/content/11/1/e005081.full |
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