Hiroshi Goto1, Masahiro Zako2, Kenichi Namba3, Noriyasu Hashida4, Toshikatsu Kaburaki5, Masanori Miyazaki6, Koh-Hei Sonoda6, Toshiaki Abe7, Nobuhisa Mizuki8, Koju Kamoi9, Antoine P Brézin10, Andrew D Dick11, Glenn J Jaffe12, Quan Dong Nguyen13, Noritaka Inomata14, Nisha V Kwatra15, Anne Camez16, Alexandra P Song15, Martina Kron16, Samir Tari15, Shigeaki Ohno3. 1. a Department of Ophthalmology , Tokyo Medical University , Tokyo , Japan. 2. b Department of Ophthalmology , Asai Hospital , Aichi , Japan. 3. c Department of Ophthalmology, Faculty of Medicine and Graduate School of Medicine , Hokkaido University , Sapporo , Japan. 4. d Department of Ophthalmology , Osaka University Graduate School of Medicine , Osaka , Japan. 5. e Department of Ophthalmology , The University of Tokyo Graduate School of Medicine , Tokyo , Japan. 6. f Department of Ophthalmology , Kyushu University Graduate School of Medicine , Fukuoka , Japan. 7. g Division of Clinical Cell Therapy , Tohoku University Graduate School of Medicine , Miyagi , Japan. 8. h Department of Ophthalmology , Yokohama City University School of Medicine , Yokohama , Japan. 9. i Department of Ophthalmology & Visual Science , Tokyo Medical and Dental University , Tokyo , Japan. 10. j Centre d'ophtalmologie de l'Assistance Publique , Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes , Paris , France. 11. k University of Bristol, Bristol Eye Hospital, Bristol, United Kingdom, and National Institute for Health Research (NIHR) Biomedical Research Centre at Moorfields Eye Hospital and University College London, Institute of Ophthalmology , London , UK . 12. l Duke Eye Center , Duke University Hospital , Durham , North Carolina , USA. 13. m Department of Ophthalmology , Byers Eye Institute, Stanford University , Palo Alto , California , USA. 14. n AbbVie GK Japan , Tokyo , Japan. 15. o AbbVie Inc ., North Chicago , Illinois , USA. 16. p AbbVie Deutschland GmbH & Co KG , Ludwigshafen , Germany.
Abstract
PURPOSE: Report global adalimumab safety and efficacy outcomes in patients with non-infectious uveitis. METHODS:Adults with non-infectious intermediate, posterior, or panuveitis were randomized 1:1 to receive placebo or adalimumab in the VISUAL I (active uveitis) or VISUAL II (inactive uveitis) trials. Integrated global and Japan substudy results are reported. The primary endpoint was time to treatment failure (TF). RESULTS: In the integrated studies, TF risk was significantly reduced (hazard ratio [95% CI]) with adalimumab versus placebo (VISUAL I: HR = 0.56 [0.40-0.76], p < 0.001; VISUAL II: HR = 0.52 [0.37-0.74], p < 0.001). In Japan substudies, no consistent trends were observed between groups (VISUAL I: HR = 1.20 [0.41-3.54]; VISUAL II: HR = 0.45 [0.20-1.03]). Adverse event rates were similar between treatment groups in both studies (854 to 1063 events/100 participant-years). CONCLUSIONS:Adalimumab lowered time to TF versus placebo in the integrated population; no consistent trends were observed in Japan substudies. Safety results were consistent between studies.
RCT Entities:
PURPOSE: Report global adalimumab safety and efficacy outcomes in patients with non-infectious uveitis. METHODS: Adults with non-infectious intermediate, posterior, or panuveitis were randomized 1:1 to receive placebo or adalimumab in the VISUAL I (active uveitis) or VISUAL II (inactive uveitis) trials. Integrated global and Japan substudy results are reported. The primary endpoint was time to treatment failure (TF). RESULTS: In the integrated studies, TF risk was significantly reduced (hazard ratio [95% CI]) with adalimumab versus placebo (VISUAL I: HR = 0.56 [0.40-0.76], p < 0.001; VISUAL II: HR = 0.52 [0.37-0.74], p < 0.001). In Japan substudies, no consistent trends were observed between groups (VISUAL I: HR = 1.20 [0.41-3.54]; VISUAL II: HR = 0.45 [0.20-1.03]). Adverse event rates were similar between treatment groups in both studies (854 to 1063 events/100 participant-years). CONCLUSIONS:Adalimumab lowered time to TF versus placebo in the integrated population; no consistent trends were observed in Japan substudies. Safety results were consistent between studies.
Entities:
Keywords:
Active uveitis; adalimumab; inactive uveitis; non-infectious uveitis; ocular inflammation
Authors: Carmen Antía Rodríguez-Fernández; Manuel Busto Iglesias; Begoña de Domingo; Kelly Conde-Pérez; Juan A Vallejo; Lorena Rodríguez-Martínez; Miguel González-Barcia; Victor Llorenç; Cristina Mondelo-Garcia; Margarita Poza; Anxo Fernández-Ferreiro Journal: Int J Mol Sci Date: 2022-06-24 Impact factor: 6.208