BACKGROUND Following induction therapy with a calcineurin inhibitor (CNI) in severe ulcerative colitis, transitioning to vedolizumab as maintenance therapy could be an option. AIM To report on the largest cohort of patients successfully induced with CNIs who were transitioned to vedolizumab maintenance therapy. METHODS This is a retrospective observational study of adult patients with severe steroid-refractory ulcerative colitis. Patients were included if they were induced with a CNI followed by maintenance therapy with vedolizumab between January 2014 and December 2018. The primary endpoint was colectomy-free survival. Secondary endpoints included survival without vedolizumab discontinuation as well as clinical, steroid-free and biochemical remission at week 14. RESULTS A total of 71 patients (59% male) were treated with vedolizumab after induction therapy with CNIs for severe steroid-refractory colitis. Patients were followed for a median time of 25 months (IQR 16-36). Colectomy-free survival rates from vedolizumab initiation were 93% at 3 months, 67% at 1 year and 55% at 2 years. At the end of induction with vedolizumab at week 14, 50% of patients were in clinical remission, and 62% of patients had a normal CRP. At 1 and 2 years following vedolizumab initiation, 43% and 28% of patients were still on vedolizumab respectively. Vedolizumab was dose escalated to infusions every 4 weeks in 44% of patients. The median time to dose escalation was 5.6 months (IQR 4.1-8.2). No serious adverse events were recorded in our patient cohort. CONCLUSIONS Transitioning to vedolizumab following induction of remission with CNIs is effective and safe.

中文翻译：

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钙调神经磷酸酶抑制剂随后维多珠单抗维持治疗对71例严重类固醇难治性溃疡性结肠炎患者的疗效和安全性。

背景技术在严重溃疡性结肠炎中用钙调神经磷酸酶抑制剂（CNI）诱导治疗后，过渡为维多珠单抗作为维持治疗可能是一种选择。目的报告成功转为维多珠单抗维持治疗的CNI成功诱导患者的最大队列。方法这是一项对成人类固醇难治性溃疡性结肠炎患者的回顾性观察研究。如果患者在2014年1月至2018年12月之间被CNI诱导并接受维多珠单抗维持治疗，则被纳入研究。主要终点为无结肠切除术的生存期。次要终点包括未停用维多珠单抗的生存期以及第14周的临床，无类固醇和生化缓解情况。结果总共71例患者（男性占59％）在严重的类固醇难治性结肠炎CNI诱导治疗后接受了维多珠单抗治疗。随访患者的中位时间为25个月（IQR 16-36）。维多珠单抗起始的3个月无结肠切除术生存率分别为93％，1年67％和25％5％。在第14周接受vedolizumab诱导结束时，有50％的患者处于临床缓解期，而62％的患者CRP正常。在开始使用维多单抗后的第1年和第2年，分别有43％和28％的患者仍在使用维多单抗。Vedolizumab的剂量逐步增加至每4周输注一次，占44％的患者。剂量递增的中位时间为5.6个月（IQR 4.1-8.2）。在我们的患者队列中没有记录到严重的不良事件。