Chen Minhu, Gao Xiang, Cao Qian, Rossiter Guillermo, Kitagawa Tadayuki, Sun Yue, Yang Lili
The First Affiliated Hospital, Sun Yat-sen University, Guangdong, PR China.
The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong, PR China.
Clin Res Hepatol Gastroenterol. 2025 Jun;49(6):102591. doi: 10.1016/j.clinre.2025.102591. Epub 2025 Apr 12.
BACKGROUND & AIMS: Vedolizumab is a gut-selective monoclonal anti-αβ integrin antibody treatment for Crohn's disease (CD). A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial (NCT03234907) assessed vedolizumab efficacy and safety in Chinese patients with moderate-to-severe CD and inadequate/loss of response/intolerance to previous conventional or anti-tumor necrosis factor-α therapy.
Eligible patients aged ≥18 to ≤80 years with moderate-to-severe CD (CD Activity Index [CDAI] total score 220-400) were randomized 2:1 to vedolizumab 300 mg intravenous infusion or placebo at Weeks 0, 2, 6 of induction, and every 4/8 weeks during Week 14-58 maintenance treatment. Primary and secondary endpoints at Week 10 were enhanced clinical response (≥100-point decrease from baseline CDAI score), and clinical remission (CDAI score ≤150), respectively. Additional Week 10 and/or Week 60 assessments included endoscopic and biomarker (C-reactive protein and fecal calprotectin) measurements.
The study was conducted at 30 centers (August 2017 through August 2020). Enrolled patients (n = 215) were randomized to vedolizumab (n = 144) or placebo (n = 71). By Week 10, 19.4 % vedolizumab-treated versus 24.3 % placebo-treated patients achieved an enhanced clinical response. The Cui-Hung-Wang-adjusted p-value for the primary endpoint was 0.347. After maintenance treatment at Week 60, rates of enhanced clinical response, clinical remission, endoscopic response, mucosal healing, and biomarker improvements appeared greater for vedolizumab-treated than placebo-treated patients.
There were no new safety findings for vedolizumab treatment of Chinese patients with CD. Although the primary endpoint was not met, vedolizumab-treated patients showed improvements in other disease activity measures at Weeks 10 and 60.
维多珠单抗是一种用于治疗克罗恩病（CD）的肠道选择性单克隆抗αβ整合素抗体。一项多中心、随机、双盲、安慰剂对照的3期试验（NCT03234907）评估了维多珠单抗在中国中重度CD患者以及对先前常规治疗或抗肿瘤坏死因子-α治疗反应不足/反应丧失/不耐受患者中的疗效和安全性。
年龄≥18至≤80岁、患有中重度CD（CD活动指数[CDAI]总分220 - 400）的符合条件患者按2:1随机分组，在诱导期第0、2、6周接受300mg维多珠单抗静脉输注或安慰剂治疗，并在第14 - 58周维持治疗期间每4/8周接受一次治疗。第10周的主要和次要终点分别为增强临床反应（CDAI评分较基线降低≥100分）和临床缓解（CDAI评分≤150）。第10周和/或第60周的额外评估包括内镜检查和生物标志物（C反应蛋白和粪便钙卫蛋白）测量。
该研究在30个中心进行（2017年8月至2020年8月）。入组患者（n = 215）被随机分为维多珠单抗组（n = 144）或安慰剂组（n = 71）。到第10周时，接受维多珠单抗治疗的患者中有19.4%达到增强临床反应，而接受安慰剂治疗的患者为24.3%。主要终点的Cui - Hung - Wang校正p值为0.347。在第60周维持治疗后，接受维多珠单抗治疗的患者在增强临床反应、临床缓解、内镜反应、黏膜愈合和生物标志物改善方面的发生率似乎高于接受安慰剂治疗的患者。
维多珠单抗治疗中国CD患者未发现新的安全性问题。虽然未达到主要终点，但接受维多珠单抗治疗的患者在第10周和第60周的其他疾病活动指标方面有所改善。
