Kobayashi Taku, Ito Hiroaki, Ashida Toshifumi, Yokoyama Tadashi, Nagahori Masakazu, Inaba Tomoki, Shikamura Mitsuhiro, Yamaguchi Takayoshi, Hori Tetsuharu, Pinton Philippe, Watanabe Mamoru, Hibi Toshifumi
Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
Infusion clinic, Osaka, Japan.
Intest Res. 2021 Oct;19(4):448-460. doi: 10.5217/ir.2020.00026. Epub 2020 Aug 18.
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.
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.
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.
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).
背景/目的：在参与3期VISIBLE 1研究的日本中重度溃疡性结肠炎（UC）患者中进行了亚组分析，该研究评估了维多珠单抗皮下注射（SC）新制剂的安全性和有效性。
符合条件的患者在诱导期第0周和第2周接受300 mg维多珠单抗静脉注射（IV）的开放标签输注。在第6周通过完整梅奥评分获得临床缓解的患者进入双盲维持期，并随机分为每2周接受108 mg维多珠单抗皮下注射、安慰剂或每8周接受300 mg维多珠单抗静脉注射。主要终点是第52周时的临床缓解（完整梅奥评分≤2分；无单项评分>1分）。
在进入诱导期的49例患者中，49例患者中有22例（45%）在第6周有临床缓解，并被随机分为接受108 mg维多珠单抗皮下注射（n = 10）、安慰剂（n = 10）或300 mg维多珠单抗静脉注射（n = 2）。在第52周时，接受维多珠单抗皮下注射的10例患者中有4例（40%）实现临床缓解，而接受安慰剂的10例患者中有2例（20%）实现临床缓解（差异：20% [95%置信区间，-27.9至61.8]）。接受维多珠单抗皮下注射的2例患者（2/10，20%）出现注射部位反应，而接受安慰剂的患者无此反应。
我们的结果表明，维多珠单抗皮下注射在日本UC患者亚组中的疗效与整个VISIBLE 1研究人群中的疗效相似，也与维多珠单抗静脉注射所确立的疗效相似。维多珠单抗皮下注射的安全性和耐受性总体上与维多珠单抗静脉注射所确立的相似。（ClinicalTrials.gov标识符NCT02611830；EudraCT 2015-000480-14）
