The Edinburgh IBD Unit, Western General Hospital, Edinburgh, UK.
Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK.
J Crohns Colitis. 2019 Sep 19;13(9):1111-1120. doi: 10.1093/ecco-jcc/jjz042.
BACKGROUND & AIMS: Vedolizumab is an anti-a4b7 monoclonal antibody that is licensed for the treatment of moderate to severe Crohn's disease and ulcerative colitis. The aims of this study were to establish the real-world effectiveness and safety of vedolizumab for the treatment of inflammatory bowel disease. METHODS: This was a retrospective study involving seven NHS health boards in Scotland between June 2015 and November 2017. Inclusion criteria included: a diagnosis of ulcerative colitis or Crohn's disease with objective evidence of active inflammation at baseline (Harvey-Bradshaw Index[HBI] ≥5/Partial Mayo ≥2 plus C-reactive protein [CRP] >5 mg/L or faecal calprotectin ≥250 µg/g or inflammation on endoscopy/magnetic resonance imaging [MRI]); completion of induction; and at least one clinical follow-up by 12 months. Kaplan-Meier survival analysis was used to establish 12-month cumulative rates of clinical remission, mucosal healing, and deep remission [clinical remission plus mucosal healing]. Rates of serious adverse events were described quantitatively. RESULTS: Our cohort consisted of 180 patients with ulcerative colitis and 260 with Crohn's disease. Combined median follow-up was 52 weeks (interquartile range [IQR] 26-52 weeks). In ulcerative colitis, 12-month cumulative rates of clinical remission, mucosal healing, and deep remission were 57.4%, 47.3%, and 38.5%, respectively. In Crohn's disease, 12-month cumulative rates of clinical remission, mucosal healing, and deep remission were 58.4%, 38.9%, and 28.3% respectively. The serious adverse event rate was 15.6 per 100 patient-years of follow-up. CONCLUSIONS: Vedolizumab is a safe and effective treatment for achieving both clinical remission and mucosal healing in ulcerative colitis and Crohn's disease.
背景与目的:维得利珠单抗是一种抗 a4b7 单克隆抗体,已获许可用于治疗中重度克罗恩病和溃疡性结肠炎。本研究旨在评估维得利珠单抗治疗炎症性肠病的真实世界疗效和安全性。
方法:这是一项回顾性研究,纳入了苏格兰 7 个NHS 卫生委员会在 2015 年 6 月至 2017 年 11 月间的数据。纳入标准包括:溃疡性结肠炎或克罗恩病诊断明确,基线时有客观炎症证据(HBI≥5/部分 Mayo≥2 加上 CRP>5mg/L 或粪便钙卫蛋白>250μg/g 或内镜/磁共振成像[MRI]有炎症);完成诱导治疗;且至少在 12 个月时有一次临床随访。采用 Kaplan-Meier 生存分析评估临床缓解、黏膜愈合和深度缓解(临床缓解+黏膜愈合)的 12 个月累积缓解率。描述严重不良事件的发生率。
结果:本队列包括 180 例溃疡性结肠炎患者和 260 例克罗恩病患者。联合中位随访时间为 52 周(26-52 周)。在溃疡性结肠炎中,12 个月时的临床缓解、黏膜愈合和深度缓解的累积缓解率分别为 57.4%、47.3%和 38.5%。在克罗恩病中,12 个月时的临床缓解、黏膜愈合和深度缓解的累积缓解率分别为 58.4%、38.9%和 28.3%。严重不良事件的发生率为每 100 患者-年 15.6 例。
结论:维得利珠单抗治疗溃疡性结肠炎和克罗恩病,既能安全有效地实现临床缓解,又能实现黏膜愈合。
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