Samaan Mark A, Pavlidis Polychronis, Johnston Emma, Warner Ben, Digby-Bell Jonathan, Koumoutsos Ioannis, Fong Steven, Goldberg Rimma, Patel Kamal, Gulati Shraddha, Medcalf Lucy, Sastrillo Marlene, Brown-Clarke Cordella, Bidewell-Sullivan Johanna, Forsyth Katrina, Lee Emma, Stanton Anna, Duncan Julie, Chung-Faye Guy, Dubois Patrick, Powell Nick, Anderson Simon, Sanderson Jeremy, Hayee Bu'Hussain, Irving Peter M
IBD Centre, Guy's & St Thomas' NHS Foundation Trust, IBD Centre, London, UK.
IBD Service, King's College Hospital NHS Foundation Trust, London, UK.
Frontline Gastroenterol. 2017 Jul;8(3):196-202. doi: 10.1136/flgastro-2016-100720. Epub 2016 Aug 10.
To gain an understanding of the efficacy of vedolizumab in a 'real-world' setting.
Retrospective cohort study using prospectively maintained clinical records.
Two UK tertiary inflammatory bowel disease (IBD) centres.
Patients with IBD commenced on vedolizumab at Guy's & St Thomas' and King's College Hospitals during November 2014-November 2015.
Vedolizumab, a monoclonal antibody to α-4 β-7 integrins that selectively inhibit leucocyte migration into the gut.
Clinical disease activity was assessed at baseline, weeks 14 and 30 using Harvey-Bradshaw Index (HBI) for Crohn's disease (CD) and Simple Clinical Colitis Activity Index (SCCAI) for ulcerative colitis (UC). Response was defined as HBI or SCCAI reduction ≥3. Remission was defined as HBI <5 or SCCAI <3. Continuous data are summarised as medians, followed by range.
Fifty patients were included: 27 CD, 20 UC and 3 IBD-U (included in the UC group for analysis). At baseline visit, the median HBI was 8 (1-16) and SCCAI was 6 (0-15). At week 14, these values had fallen to 5 (0-15) (p=0.117) and 4 (0-10) (p=0.005), respectively. Additionally, week 30 data were available for 19 patients (9 CD, 10 UC). The clinical disease activity scores at that point were HBI 2 (0-7) (p=0.039) and SCCAI 2 (0-10) (p=0.023). At baseline, 37 (74%) of the 50 patients had clinically active disease. Of the patients with active disease, 22 (59%) responded and 14 (38%) achieved remission at week 14.
Our early experience with vedolizumab demonstrates a clear benefit in terms of disease control as well as a steroid-sparing effect in a cohort, which included patients with complex and previously refractory disease.
了解维多珠单抗在“真实世界”环境中的疗效。
使用前瞻性维护的临床记录进行回顾性队列研究。
英国两个三级炎症性肠病（IBD）中心。
2014年11月至2015年11月期间在盖伊和圣托马斯医院以及国王学院医院开始使用维多珠单抗治疗的IBD患者。
维多珠单抗，一种α-4β-7整合素单克隆抗体，可选择性抑制白细胞向肠道的迁移。
在基线、第14周和第30周使用克罗恩病（CD）的哈维-布拉德肖指数（HBI）和溃疡性结肠炎（UC）的简单临床结肠炎活动指数（SCCAI）评估临床疾病活动度。缓解定义为HBI或SCCAI降低≥3。缓解定义为HBI<5或SCCAI<3。连续数据总结为中位数，后跟范围。
纳入50例患者：27例CD，20例UC和3例未定型IBD（纳入UC组进行分析）。在基线访视时，HBI中位数为8（1-16），SCCAI中位数为6（0-15）。在第14周时，这些值分别降至5（0-15）（p=0.117）和4（0-10）（p=0.005）。此外，有19例患者（9例CD，10例UC）获得了第30周的数据。此时的临床疾病活动度评分为HBI 2（0-7）（p=0.039）和SCCAI 2（0-10）（p=0.023）。基线时，50例患者中有37例（74%）有临床活动性疾病。在有活动性疾病的患者中，22例（59%）有反应，14例（38%）在第14周达到缓解。
我们使用维多珠单抗的早期经验表明，在一个包括复杂和先前难治性疾病患者的队列中，在疾病控制方面有明显益处，并且有类固醇节省效应。
