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논문 기본 정보

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학술저널
저자정보
Taku Kobayashi (Kitasato University Kitasato Institute Hospital) Hiroaki Ito (Infusion clinic) Toshifumi Ashida (Sapporo Tokushukai Hospital) Tadashi Yokoyama (Yokoyama IBD Clinic) Masakazu Nagahori (Tokyo Medical and Dental University) Tomoki Inaba (Kagawa Prefectural Central Hospital) Mitsuhiro Shikamura (Takeda Pharmaceutical Company Limited) Takayoshi Yamaguchi (Takeda Pharmaceutical Company Limited) Tetsuharu Hori (Takeda Pharmaceutical Company Limited) Philippe Pinton (Japan Medical Office Takeda Pharmaceutical Company Limited) Mamoru Watanabe (Tokyo Medical and Dental University) Toshifumi Hibi (Kitasato University Kitasato Institute Hospital)
저널정보
대한장연구학회 Intestinal research Intestinal research Vol.19 No.4
발행연도
2021.10
수록면
448 - 460 (13page)
DOI
10.5217/ir.2020.00026

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Background/Aims: A subgroup analysis was conducted in Japanese patients with moderate to severe ulcerative colitis (UC) enrolled in the phase 3 VISIBLE 1 study, which evaluated the safety and efficacy of a new vedolizumab subcutaneous (SC) formulation.Methods: Eligible patients received open-label infusions of vedolizumab 300 mg intravenous (IV) at weeks 0 and 2 in the induction phase. Patients with clinical response by complete Mayo score at week 6 entered the double-blind maintenance phase and were randomized to vedolizumab 108 mg SC every 2 weeks, placebo, or vedolizumab 300 mg IV every 8 weeks. The primary endpoint was clinical remission (complete Mayo score ≤ 2 points; no individual subscore > 1 point) at week 52.Results: Of 49 patients who entered the induction phase, 22 out of 49 patients (45%) had clinical response at week 6 and were randomized to vedolizumab 108 mg SC (n = 10), placebo (n = 10), or vedolizumab 300 mg IV (n = 2). At week 52, 4 out of 10 patients (40%) who received vedolizumab SC had clinical remission versus 2 out of 10 patients (20%) who received placebo (difference: 20% [95% confidence interval, ?27.9 to 61.8]). Two patients (2/10, 20%) who received vedolizumab SC experienced an injection-site reaction versus none who received placebo.Conclusions: Our results indicate that the efficacy of vedolizumab SC in a subgroup of Japanese patients with UC are similar with those in the overall VISIBLE 1 study population, and with those established with vedolizumab IV. The safety and tolerability of vedolizumab SC were generally similar to that established for vedolizumab IV. (ClinicalTrials.gov ID NCT02611830; EudraCT 2015-000480-14)

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