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 journalArticle

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 - Jan 2 2019

Fingerprint

Uveitis
Treatment Failure
Japan
Placebos
Panuveitis
Safety
Adalimumab
Population
Therapeutics

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Ophthalmology

Cite this

Adalimumab in Active and Inactive, Non-Infectious Uveitis : Global Results from the VISUAL I and VISUAL II Trials. / Goto, Hiroshi; Zako, Masahiro; Namba, Kenichi; Hashida, Noriyasu; Kaburaki, Toshikatsu; Miyazaki, Masanori; Sonoda, Koh Hei; Abe, Toshiaki; Mizuki, Nobuhisa; Kamoi, Koju; Brézin, Antoine P.; Dick, Andrew D.; Jaffe, Glenn J.; Nguyen, Quan Dong; Inomata, Noritaka; Kwatra, Nisha V.; Camez, Anne; Song, Alexandra P.; Kron, Martina; Tari, Samir; Ohno, Shigeaki.

In: Ocular Immunology and Inflammation, Vol. 27, No. 1, 02.01.2019, p. 40-50.

Research output: Contribution to journalArticle

Goto, H, Zako, M, Namba, K, Hashida, N, Kaburaki, T, Miyazaki, M, Sonoda, KH, 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 2019, 'Adalimumab in Active and Inactive, Non-Infectious Uveitis: Global Results from the VISUAL I and VISUAL II Trials', Ocular Immunology and Inflammation, vol. 27, no. 1, pp. 40-50. https://doi.org/10.1080/09273948.2018.1491605
Goto, Hiroshi ; Zako, Masahiro ; Namba, Kenichi ; Hashida, Noriyasu ; Kaburaki, Toshikatsu ; Miyazaki, Masanori ; Sonoda, Koh Hei ; Abe, Toshiaki ; Mizuki, Nobuhisa ; Kamoi, Koju ; Brézin, Antoine P. ; Dick, Andrew D. ; Jaffe, Glenn J. ; Nguyen, Quan Dong ; Inomata, Noritaka ; Kwatra, Nisha V. ; Camez, Anne ; Song, Alexandra P. ; Kron, Martina ; Tari, Samir ; Ohno, Shigeaki. / Adalimumab in Active and Inactive, Non-Infectious Uveitis : Global Results from the VISUAL I and VISUAL II Trials. In: Ocular Immunology and Inflammation. 2019 ; Vol. 27, No. 1. pp. 40-50.
@article{988b01ce121f41b7ad092b676a256a43,
title = "Adalimumab in Active and Inactive, Non-Infectious Uveitis: Global Results from the VISUAL I and VISUAL II Trials",
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.",
author = "Hiroshi Goto and Masahiro Zako and Kenichi Namba and Noriyasu Hashida and Toshikatsu Kaburaki and Masanori Miyazaki and Sonoda, {Koh Hei} and Toshiaki Abe and Nobuhisa Mizuki and Koju Kamoi and Br{\'e}zin, {Antoine P.} and Dick, {Andrew D.} and Jaffe, {Glenn J.} and Nguyen, {Quan Dong} and Noritaka Inomata and Kwatra, {Nisha V.} and Anne Camez and Song, {Alexandra P.} and Martina Kron and Samir Tari and Shigeaki Ohno",
year = "2019",
month = "1",
day = "2",
doi = "10.1080/09273948.2018.1491605",
language = "English",
volume = "27",
pages = "40--50",
journal = "Ocular Immunology and Inflammation",
issn = "0927-3948",
publisher = "Informa Healthcare",
number = "1",

}

TY - JOUR

T1 - Adalimumab in Active and Inactive, Non-Infectious Uveitis

T2 - Global Results from the VISUAL I and VISUAL II Trials

AU - Goto, Hiroshi

AU - Zako, Masahiro

AU - Namba, Kenichi

AU - Hashida, Noriyasu

AU - Kaburaki, Toshikatsu

AU - Miyazaki, Masanori

AU - Sonoda, Koh Hei

AU - Abe, Toshiaki

AU - Mizuki, Nobuhisa

AU - Kamoi, Koju

AU - Brézin, Antoine P.

AU - Dick, Andrew D.

AU - Jaffe, Glenn J.

AU - Nguyen, Quan Dong

AU - Inomata, Noritaka

AU - Kwatra, Nisha V.

AU - Camez, Anne

AU - Song, Alexandra P.

AU - Kron, Martina

AU - Tari, Samir

AU - Ohno, Shigeaki

PY - 2019/1/2

Y1 - 2019/1/2

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85049977756&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85049977756&partnerID=8YFLogxK

U2 - 10.1080/09273948.2018.1491605

DO - 10.1080/09273948.2018.1491605

M3 - Article

C2 - 30015528

AN - SCOPUS:85049977756

VL - 27

SP - 40

EP - 50

JO - Ocular Immunology and Inflammation

JF - Ocular Immunology and Inflammation

SN - 0927-3948

IS - 1

ER -