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      저자 : ( Mitsuhiro Shikamura ) (검색결과 1 건)
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        Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis

        ( Taku Kobayashi ),( Hiroaki Ito ),( Toshifumi Ashida ),( Tadashi Yokoyama ),( Masakazu Nagahori ),( Tomoki Inaba ),( Mitsuhiro Shikamura ),( Takayoshi Yamaguchi ),( Tetsuharu Hori ),( Philippe Pinton 대한장연구학회 2021 Intestinal Research Vol.19 No.4

        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) for-mulation. 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 pa-tients (40%) who received vedolizumab SC had clinical remission versus 2 out of 10 patients (20%) who received placebo (dif-ference: 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) (Intest Res 2021;19:448-460)

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