September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Adalimumab in patients with active and inactive, non-infectious uveitis: VISUAL I and VISUAL II trials
Author Affiliations & Notes
  • Antoine P Brezin
    INRA, CNRS, University of Burgundy, Hopital Cochin-Univ Paris Descartes, Paris, France
  • Andrew D Dick
    University of Bristol, Bristol Eye Hospital, Bristol, United Kingdom
    National Institute for Health Research (NIHR) Biomedical Research Centre at Moorfields Eye Hospital and University College London, Institute of Ophthalmology, London, United Kingdom
  • Glenn J. Jaffe
    Duke University, Durham, North Carolina, United States
  • Shigeaki Ohno
    Hokkaido University Graduate School of Medicine, Sapporo, Japan
  • Kenichi Namba
    Hokkaido University Graduate School of Medicine, Sapporo, Japan
  • Hiroshi Goto
    Tokyo Medical University, Tokyo, Japan
  • Noritaka Inomata
    AbbVie GK Japan, Tokyo, Japan
  • Alexandra P. Song
    AbbVie Inc., North Chicago, Illinois, United States
  • Martina Kron
    AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany
  • Anne Camez
    AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany
  • Quan Dong Nguyen
    Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, Nebraska, United States
  • Footnotes
    Commercial Relationships   Antoine Brezin, AbbVie (C); Andrew Dick, AbbVie (C); Glenn Jaffe, AbbVie (C); Shigeaki Ohno, AbbVie (C), Santen (C); Kenichi Namba, AbbVie (C); Hiroshi Goto, AbbVie (C); Noritaka Inomata, AbbVie (E); Alexandra Song, AbbVie (E); Martina Kron, AbbVie (E); Anne Camez, AbbVie (E); Quan Dong Nguyen, AbbVie (C), Bausch & Lomb (C), Santen (C), XOMA (C)
  • Footnotes
    Support  AbbVie
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 3308. doi:
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      Antoine P Brezin, Andrew D Dick, Glenn J. Jaffe, Shigeaki Ohno, Kenichi Namba, Hiroshi Goto, Noritaka Inomata, Alexandra P. Song, Martina Kron, Anne Camez, Quan Dong Nguyen; Adalimumab in patients with active and inactive, non-infectious uveitis: VISUAL I and VISUAL II trials. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3308.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To assess adalimumab (ADA) efficacy and safety in patients (pts) with active and inactive, non-infectious uveitis.

Methods : Adults with non-infectious intermediate, posterior, or panuveitis were enrolled in two global phase 3, double-masked trials: VISUAL I (pts with active uveitis despite ≥2 weeks [wk] of prednisone [PS] 10–60 mg/d) and VISUAL II (pts with inactive disease dependent on 10–35 mg/d of PS to maintain inactivity). Pts were randomized 1:1 to receive placebo (PBO) or ADA subcutaneously (80 mg wk 0, followed by 40 mg every other wk from wk 1 up to 80 wks). In VISUAL I, all pts received a PS burst followed by taper to 0 mg by wk 15. In VISUAL II, PS taper to 0 mg was mandatory by wk 19. Integrated data (main study and Japan sub-study) from VISUAL I and VISUAL II trials are reported. The primary endpoint was time to treatment failure (TF) at or after wk 6 for VISUAL I; and at or after wk 2 for VISUAL II. Nine ranked secondary endpoints were assessed, and adverse events (AEs) were monitored.

Results : The intent-to-treat analyses included 233 (217 main study, 16 Japan sub-study) and 258 (226 main study, 32 Japan sub-study) pts from VISUAL I and VISUAL II, respectively (VISUAL I and VISUAL II: female, 58% and 61%; mean age, 43.2 years [y] and 43.1 y; mean duration of uveitis, 46 months [mt] and 59 mt). Risk of TF was reduced by 44% (VISUAL I) and 48% (VISUAL II) in ADA group compared with PBO group (VISUAL I: HR=0.56, 95% CI, 0.40–0.76, P<0.001; VISUAL II: HR=0.52, 95% CI, 0.37–0.74, P<0.001). Median time to TF was 3 mt for PBO, 4.8 mt for ADA (VISUAL I); and 5.6 mt for PBO, not estimable for ADA: >18 mt, as more than half of the pts did not achieve TF by wk 80 (VISUAL II). ADA-treated pts had fewer TF criteria than PBO in both studies, and treatment effects were numerically in favor of ADA for most of the secondary efficacy variables (Table). ADA and PBO AE rates were similar in both studies (VISUAL I: 1063 vs 960 events/100 pt-y; VISUAL II: 854 vs 884 events/100 pt-y, respectively).

Conclusions : ADA lowered the risk of uveitic flare or visual acuity loss in pts with active and inactive disease when off PS. The safety profile was consistent with the known safety profile across the approved ADA indications.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

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