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

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

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
Pages (from-to)40-50
Number of pages11
JournalOcular Immunology and Inflammation
Volume27
Issue number1
DOIs
Publication statusPublished - 2019 Jan 2

Keywords

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

ASJC Scopus subject areas

  • Immunology and Allergy
  • Ophthalmology

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