INTRODUCTION The use of ustekinumab and vedolizumab as second-line therapies in patients with Crohn's disease (CD) in which tumour necrosis factor alpha inhibitors (TNFi) failed is still debated. The aim of this study was to compare, in a large multicenter observational retrospective cohort, the effectiveness of ustekinumab and vedolizumab as second-line therapies, as assessed by clinical and objective outcomes including endoscopy and gastrointestinal imaging. METHODS Clinical response, remission, and steroid-free remission at weeks 26 and 52 were evaluated in a retrospective propensity score-weighted and propensity score-matched cohort of patients in which TNFi failed. Objective response and remission were evaluated by 1 or more techniques among endoscopy, magnetic resonance/computed tomography enteroclysis, and small bowel ultrasound. RESULTS A total of 470 patients with CD (239 treated with ustekinumab and 231 treated with vedolizumab) were included in the study. At week 26, clinical outcomes were similar between the 2 groups. At week 52, clinical remission (ustekinumab 42.5% vs vedolizumab 55.5%, P = 0.01) and steroid-free remission (ustekinumab 40.6% vs vedolizumab 51.1%, P = 0.038) rates were significantly higher in vedolizumab-treated patients. Three hundred two patients (hundred thirty-five treated with ustekinumab and hundred sixty-seven treated with vedolizumab) had an objective evaluation of disease activity at baseline and week 52. At week 52, objective response and remission rates were similar between the 2 groups. Clinical response at week 26 predicted steroid-free remission at week 52 in both ustekinumab-treated and vedolizumab-treated patients. Safety profiles were similar between the 2 groups. DISCUSSION In patients with CD in which TNFi failed, both ustekinumab and vedolizumab showed similar clinical effectiveness after 26 weeks of treatment. At 1 year, vedolizumab was associated with a higher rate of clinical remission when compared with ustekinumab. However, no difference was observed between the 2 groups when objective outcomes were investigated at this time point.

中文翻译：

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客观比较 Vedolizumab 和 Ustekinumab 在克罗恩病患者 TNF-α 抑制剂治疗失败中的有效性。

引言 在肿瘤坏死因子 α 抑制剂 (TNFi) 失败的克罗恩病 (CD) 患者中使用优特克单抗和维多珠单抗作为二线疗法仍有争议。本研究的目的是在一个大型多中心观察性回顾性队列中比较优特克单抗和维多珠单抗作为二线疗法的有效性，通过临床和客观结果（包括内窥镜检查和胃肠道成像）进行评估。方法 在 TNFi 失败的患者的回顾性倾向评分加权和倾向评分匹配队列中评估第 26 周和第 52 周的临床反应、缓解和无类固醇缓解。通过内窥镜检查、磁共振/计算机断层扫描肠灌洗术和小肠超声中的一种或多种技术评估客观反应和缓解。结果 共有 470 名 CD 患者（239 名接受优特克单抗治疗，231 名接受维多珠单抗治疗）被纳入研究。第 26 周时，两组的临床结果相似。第 52 周时，接受维多珠单抗治疗的患者的临床缓解率（优特克单抗 42.5% 对比维多珠单抗 55.5%，P = 0.01）和无类固醇缓解率（优特克单抗 40.6% 对比维多珠单抗 51.1%，P = 0.038）显着更高。322 名患者（135 名接受优特克单抗治疗，167 名接受维多珠单抗治疗）在基线和第 52 周时对疾病活动进行了客观评估。在第 52 周时，两组的客观缓解率和缓解率相似。第 26 周的临床反应预示着接受优特克单抗治疗和接受维多珠单抗治疗的患者在第 52 周时无类固醇缓解。两组之间的安全性相似。讨论 在 TNFi 失败的 CD 患者中，优特克单抗和维多珠单抗在治疗 26 周后显示出相似的临床疗效。在 1 年时，与优特克单抗相比，维多珠单抗与更高的临床缓解率相关。然而，当在这个时间点调查客观结果时，两组之间没有观察到差异。