Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis

• Published in: Intestinal research Vol. 19; no. 4; pp. 448 - 460
• Main Authors: Kobayashi, Taku, Ito, Hiroaki, Ashida, Toshifumi, Yokoyama, Tadashi, Nagahori, Masakazu, Inaba, Tomoki, Shikamura, Mitsuhiro, Yamaguchi, Takayoshi, Hori, Tetsuharu, Pinton, Philippe, Watanabe, Mamoru, Hibi, Toshifumi
• Format: Journal Article
• Language: English
• Published: Korean Association for the Study of Intestinal Diseases 01.10.2021; 대한장연구학회
• Subjects: inflammatory bowel disease; maintenance; Original; subcutaneous; ulcerative colitis; vedolizumab; 내과학
• ISSN: 1598-9100; 2288-1956
• DOI: 10.5217/ir.2020.00026

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)