Prospective data of vedolizumab treatment for patients with inflammatory bowel disease (IBD) beyond 1 year of treatment is scarce but needed for clinical decision making. We prospectively enrolled 310 patients with IBD (191 with Crohn's disease (CD) and 119 patients with ulcerative colitis (UC)) with a follow-up period of 104 weeks (interquartile range: 103-104) in a nationwide registry. The corticosteroid-free clinical remission rate (Harvey Bradshaw Index ≤ 4, Short Clinical Colitis Activity index ≤ 2) at weeks 52 and 104 were 28% and 19% for CD and 27% and 28% for UC, respectively. Fifty-nine percent maintained corticosteroid-free clinical remission between weeks 52 and 104. Vedolizumab with concomitant immunosuppression showed comparable effectiveness outcomes compared with vedolizumab monotherapy (week 104: 21% vs. 23%; P = 0.77), whereas 8 of 13 severe infections occurred in patients treated with concomitant immunosuppression. To conclude, the clinical effect was 19% for CD and 28% for UC after 2 years of follow-up regardless of concomitant immunosuppression.

中文翻译：

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维多珠单抗用于炎症性肠病：克罗恩和结肠炎（ICC）注册倡议的两年结果，一项全国性的前瞻性观察性队列研究：ICC注册-维多珠单抗。

对于治疗1年以上的炎症性肠病（IBD）患者，vedolizumab治疗的前瞻性数据很少，但需要临床决策。我们在全国范围内登记了310例IBD患者（191例克罗恩病（CD）和119例溃疡性结肠炎（UC）），随访时间为104周（四分位间距：103-104）。在第52周和第104周，CD的无皮质类固醇的临床缓解率（Harvey Bradshaw指数≤4，临床结肠炎短期活动指数≤2）分别为CD的28％和19％，UC的分别为27％和28％。在52周至104周之间，百分之59的患者维持了无皮质类固醇的临床缓解。与维多珠单抗单药治疗相比，伴有免疫抑制作用的维多珠单抗显示出相当的疗效结果（第104周：21％比23％； P = 0.77），13例严重感染中有8例同时接受了免疫抑制治疗。综上所述，无论是否伴有免疫抑制，随访2年后，CD的临床疗效为19％，UC的临床效果为28％。