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

Hiroshi Goto, Masahiro Zako, Kenichi Namba, Noriyasu Hashida, Toshikatsu Kaburaki, Masanori Miyazaki, Koh Hei Sonoda, Toshiaki Abe, Nobuhisa Mizuki, Koju Kamoi, Antoine P. Brézin, Andrew D. Dick, Glenn J. Jaffe, Quan Dong Nguyen, Noritaka Inomata, Nisha V. Kwatra, Anne Camez, Alexandra P. Song*, Martina Kron, Samir TariShigeaki Ohno

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)

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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.

Original languageEnglish
Number of pages11
JournalOcular Immunology and Inflammation
Early online date17 Jul 2018
DOIs
Publication statusE-pub ahead of print - 17 Jul 2018

Keywords

  • Active uveitis
  • adalimumab
  • inactive uveitis
  • non-infectious uveitis
  • ocular inflammation

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    Goto, H., Zako, M., Namba, K., Hashida, N., Kaburaki, T., Miyazaki, M., Sonoda, K. H., Abe, T., Mizuki, N., Kamoi, K., Brézin, A. P., Dick, A. D., Jaffe, G. J., Nguyen, Q. D., Inomata, N., Kwatra, N. V., Camez, A., Song, A. P., Kron, M., ... Ohno, S. (2018). Adalimumab in Active and Inactive, Non-Infectious Uveitis: Global Results from the VISUAL I and VISUAL II Trials. Ocular Immunology and Inflammation. https://doi.org/10.1080/09273948.2018.1491605