Adalimumab in Active and Inactive, Non-Infectious Uveitis: Global Results from the VISUAL I and VISUAL II Trials

Ocular Immunology and Inflammation
Hiroshi GotoShigeaki Ohno

Abstract

Report global adalimumab safety and efficacy outcomes in patients with non-infectious uveitis. 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). 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). 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.

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Citations

Sep 9, 2020·Current Opinion in Ophthalmology·De-Kuang Hwang, Shwu-Jiuan Sheu
Oct 9, 2018·Taiwan Journal of Ophthalmology·Chang-Ping Lin
Jun 9, 2020·Frontiers in Pharmacology·Rodrigo A ValenzuelaCristhian A Urzua
Jan 26, 2021·Expert Review of Clinical Pharmacology·Ogugua Ndili ObiRobert P Baughman
Feb 25, 2021·The British Journal of Ophthalmology·Marina Lourenço De ContiTammy Hentona Osaki
Oct 4, 2020·Current Opinion in Ophthalmology·De-Kuang Hwang, Shwu-Jiuan Sheu
Jun 13, 2021·Ophthalmology and Therapy·Michal KramerUNKNOWN International EyeCOPE Study Group
Nov 10, 2021·Translational Vision Science & Technology·Hideo KohnoTadashi Nakano

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