Low uveitis rates in patients with axial spondyloarthritis treated with bimekizumab: pooled results from phase 2b/3 trials.

Autor:	Brown MA; Genomics England, London, UK matt.brown@genomicsengland.co.uk.; Department of Medical and Molecular Genetics, Faculty of Life Sciences and Medicine, King's College London, London, UK., Rudwaleit M; Klinikum Bielefeld, University of Bielefeld, Bielefeld, Germany., van Gaalen FA; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands., Haroon N; University Health Network, Schroeder Arthritis Institute, Department of Medicine/Rheumatology, University of Toronto, Toronto, Ontario, Canada., Gensler LS; Department of Medicine/Rheumatology, University of California, San Francisco, California, USA., Fleurinck C; UCB Pharma, Brussels, Belgium., Marten A; UCB Pharma, Monheim am Rhein, Germany., Massow U; UCB Pharma, Monheim am Rhein, Germany., de Peyrecave N; UCB Pharma, Brussels, Belgium., Vaux T; UCB Pharma, Slough, UK., White K; UCB Pharma, Slough, UK., Deodhar A; Division of Arthritis and Rheumatic Diseases, Oregon Health and Science University, Portland, Oregon, USA., van der Horst-Bruinsma I; Department of Rheumatology, Radboud University Medical Centre, Nijmegen, The Netherlands.
Jazyk:	angličtina
Zdroj:	Annals of the rheumatic diseases [Ann Rheum Dis] 2024 Nov 14; Vol. 83 (12), pp. 1722-1730. Date of Electronic Publication: 2024 Nov 14.
DOI:	10.1136/ard-2024-225933
Abstrakt:	Objectives: Acute anterior uveitis ('uveitis') is a common axial spondyloarthritis (axSpA) extramusculoskeletal manifestation. Interleukin (IL)-17 is implicated in its pathogenesis, however, there is conflicting evidence for IL-17A inhibition in uveitis management. We report pooled analyses of uveitis incidence in patients receiving bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A, from phase 2b/3 trials. Methods: Data were pooled for patients receiving BKZ 160 mg or placebo in the double-blind treatment period of the phase 3 BE MOBILE 1 (NCT03928704; non-radiographic axSpA) and BE MOBILE 2 (NCT03928743; radiographic axSpA) trials. Data were separately pooled for patients treated with at least one BKZ dose in the BE MOBILE trials and their ongoing open-label extension (OLE; NCT04436640), and the phase 2b BE AGILE trial (NCT02963506; radiographic axSpA) and its ongoing OLE (NCT03355573). Uveitis rates and exposure-adjusted incidence rates (EAIR)/100 patient-years (PYs) are reported. Results: In the BE MOBILE 1 and 2 double-blind treatment period, 0.6% (2/349) of patients receiving BKZ experienced uveitis vs 4.6% (11/237) receiving placebo (nominal p=0.001; EAIR (95% CI): 1.8/100 PYs (0.2 to 6.7) vs 15.4/100 PYs (95% CI 7.7 to 27.5)). In patients with history of uveitis, EAIR was lower in patients receiving BKZ (6.2/100 PYs (95% CI 0.2 to 34.8); 1.9%) vs placebo (70.4/100 PYs (95% CI 32.2 to 133.7); 20.0%; nominal p=0.004). In the phase 2b/3 pool (N=848; BKZ exposure: 2034.4 PYs), EAIR remained low (1.2/100 PYs (95% CI 0.8 to 1.8)). Conclusions: Bimekizumab, a dual-IL-17A/F inhibitor, may confer protective effects for uveitis in patients with axSpA. Competing Interests: Competing interests: MAB: Grant/research support from UCB Pharma; consultant for Clementia, Grey Wolf Therapeutics, Incyte, Ipsen, Pfizer, Regeneron and Xinthera; speaker for Novartis and Pfizer; payment for expert testimony from Ipsen; participation on a Data Safety Monitoring Board or Advisory Board for Incyte, Ipsen and Regeneron. MR: Speakers bureau from AbbVie, Boehringer Ingelheim, Chugai, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma; consultant of AbbVie, Eli Lilly, Novartis and UCB Pharma. FAvG: Grants from Jacobus Stichting, Novartis, Stichting ASAS, Stichting Vrienden van Sole Mio and UCB Pharma; consultant for AbbVie, ASAS, BMS, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer and UCB Pharma. NH: Consultant for AbbVie, Eli Lilly, Janssen, Novartis and UCB Pharma. LSG: Consultant for Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma; grant/research support from Novartis and UCB Pharma paid to institution; participation on a Data Safety Monitoring Board or Advisory Board for Acelyrin; member of the Spondylitis Association of America Medical Scientific Advisory Board and ASAS Executive Committee. CF, KW: Employee and shareholder of UCB Pharma. AM, UM, TV, NdP: Employees of UCB Pharma. AD: Speaker for Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma; consultant for BMS, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer and UCB Pharma; grant/research support from BMS, Celgene, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer and UCB Pharma; support for attending meetings and/or travel from Eli Lilly; participation on a Data Safety Monitoring Board or Advisory Board for BMS, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer and UCB Pharma; member of the steering committee of GRAPPA. IvdH-B: Consultant for AbbVie, Eli Lilly, MSD, Novartis and UCB Pharma; unrestricted grants received for investigator-initiated studies from AbbVie, MSD, Pfizer and UCB Pharma; fees received for Lectures from AbbVie, BMS, MSD and Pfizer. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ on behalf of EULAR.)
Databáze:	MEDLINE
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