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

Journal Article (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.

Full Text

Duke Authors

Cited Authors

  • 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

Published Date

  • 2019

Published In

Volume / Issue

  • 27 / 1

Start / End Page

  • 40 - 50

PubMed ID

  • 30015528

Electronic International Standard Serial Number (EISSN)

  • 1744-5078

Digital Object Identifier (DOI)

  • 10.1080/09273948.2018.1491605


  • eng

Conference Location

  • England