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
N1 - Funding Information:
AbbVie Inc. funded the VISUAL studies (NCT01138657 and NCT01124838), contributed to the study design, research, analysis, data collection, interpretation of data, and writing, reviewing, and approving of the publication. Medical writing support was provided by Gaurav Patki, PhD, of AbbVie.
Publisher Copyright:
© 2019, © 2019 AbbVie. Published with license by Taylor & Francis Group, LLC.
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.
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U2 - 10.1080/09273948.2018.1491605
DO - 10.1080/09273948.2018.1491605
M3 - Article
C2 - 30015528
AN - SCOPUS:85049977756
SN - 0927-3948
VL - 27
SP - 40
EP - 50
JO - Ocular Immunology and Inflammation
JF - Ocular Immunology and Inflammation
IS - 1
ER -