Adalimumab in Active and Inactive, Non-Infectious Uveitis: Global Results from the VISUAL I and VISUAL II Trials.
(Clinical Trial, Phase III;Journal Article;Multicenter Study)
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.
Goto, H; Zako, M; Namba, K; Hashida, N; Kaburaki, T; Miyazaki, M; Sonoda, K-H; Abe, T; Mizuki, N; Kamoi, K; Brézin, AP; Dick, AD; Jaffe, GJ; Nguyen, QD; Inomata, N; Kwatra, NV; Camez, A; Song, AP; Kron, M; Tari, S; Ohno, S
Volume / Issue
Start / End Page
Electronic International Standard Serial Number (EISSN)
Digital Object Identifier (DOI)