Real-World Outcomes of Vedolizumab Therapy in Ulcerative Colitis and Crohn's Disease at a Tertiary Referral Center
Real-World Outcomes of Vedolizumab Therapy in Ulcerative Colitis and Crohn's Disease at a Tertiary Referral Center
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DOI：
10.1159/000492322
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发表时间：
2019-01-01
影响因子：
2.3
通讯作者：
Gauss, Annika
中科院分区：
文献类型：
--
作者：
Hoffmann, Peter;Krisam, Johannes;Gauss, Annika
背景：Vedolizumab于2014年年中被批准用于治疗溃疡性结肠炎和克罗恩病。真实世界的治疗数据对于平衡评估其在其他治疗方案中的地位是必要的。总结：2014年6月1日至2016年8月31日期间在海德堡大学医院炎症性肠病门诊开始vedolizumab治疗的溃疡性结肠炎或克罗恩病患者基于电子病历招募。主要研究终点是第30周的反应，而次要终点是由于反应不足或不良事件而需要手术和停止治疗。纳入25例溃疡性结肠炎患者（40%抗肿瘤坏死因子[TNF]初始）和28例克罗恩病患者（10.7%抗肿瘤坏死因子初始，53.6%至少接受过一次肠道手术）。在溃疡性结肠炎患者中，20%达到缓解，32%部分缓解，48%对vedolizumab无反应。在克罗恩病中，14.3%的患者获得缓解，46.4%部分缓解，39.4%无反应。两名患者因疑似副作用而停止维多单抗治疗。关键信息：在炎症性肠病患者的相对治疗难治性队列中，vedolizumab在实现应答方面是有效的。然而，大多数患者没有得到满意的治疗，因为他们没有达到缓解。
Background: Vedolizumab was approved for the therapy of ulcerative colitis and Crohn's disease in mid-2014. Real-world treatment data are necessary for a balanced assessment of its position among other therapeutic options. Summary: Patients with ulcerative colitis or Crohn's disease, initiating vedolizumab therapy at the outpatient clinic for inflammatory bowel diseases at the University Hospital Heidelberg between June 1, 2014 and August 31, 2016, were recruited based on electronic medical records. The primary study endpoint was response at week 30, while the secondary endpoints were the need for surgery and discontinuation of therapy due to inadequate response, or adverse events. Twenty-five patients with ulcerative colitis (40% anti-tumor necrosis factor [TNF] naive) and 28 patients with Crohn's disease (10.7% anti-TNF naive, 53.6% having undergone at least one intestinal surgery) were enrolled. Among the ulcerative colitis patients, 20% achieved remission, 32% partial response, and 48% were non-responders to vedolizumab. In Crohn's disease, 14.3% of the patients achieved remission, 46.4% partial response, and 39.4% were non-responders. Two patients discontinued vedolizumab therapy due to suspected side effects. Key Message: In a relatively treatment-refractory cohort of inflammatory bowel disease patients, vedolizumab was efficacious in achieving response. However, the majority of the patients were not satisfactorily treated, as they did not reach remission.