BACKGROUND The management of Crohn's disease patients with perianal lesions and anti-TNF failure is challenging. AIMS To assess the effectiveness of vedolizumab in perianal Crohn's disease and the predictors of success in a real-life cohort. METHODS We conducted a nationwide multicentre cohort study in patients with perianal Crohn's disease who received vedolizumab. In patients with active perianal Crohn's disease, the success of vedolizumab was defined by clinical success (no draining fistula at clinical examination and no anal ulcers for primary lesions) at 6 months without medical or surgical treatment for perianal Crohn's disease. Logistic regression analyses were performed to identify predictors of success. In patients with inactive perianal Crohn's disease, recurrence was defined by the occurrence of lesions and/or the need for medical or surgical treatments. RESULTS One hundred and fifty-one patients were included. Among them 102 patients had active perianal disease, 33 (32.4%) males, mean age 39.8 years, mean Crohn's disease duration 14.6 years; 101 (99%) had received at least one anti-TNF. The median follow-up time was 52 weeks. Sixty-eight per cent of patients discontinued therapy after a median time of 33 weeks. Vedolizumab success was reached in 23/102 (22.5%). Among patients with setons at initiation, 9/61(15%) had a successful removal. In multivariable analysis, factors associated with success were the number of prior biologic agents (≥3, odds ratio, OR: 0.13, 95% CI) and no antibiotics at initiation (OR: 4.12, 95% CI). In 49 patients with inactive perianal Crohn's disease, perianal disease recurred in 15/49 (30.6%), 11/49 (22.4%) needed dedicated treatments. Median time to recurrence was 22 weeks. CONCLUSIONS We identified a low rate of success of vedolizumab in patients with active perianal Crohn's disease, and nearly one third of patients with inactive perianal Crohn's disease had perianal recurrence. Further evaluation is warranted in prospective studies.

中文翻译：

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维多珠单抗治疗肛周克罗恩病：一项针对151名患者的多中心队列研究。

背景技术具有肛周病变和抗TNF失败的克罗恩氏病患者的治疗具有挑战性。目的评估维多珠单抗在肛周克罗恩病中的有效性以及在实际人群中成功的预测因素。方法我们对接受维多珠单抗的肛周克罗恩病患者进行了一项全国性的多中心队列研究。在活动性肛周克罗恩氏病患者中，维多珠单抗的成功由临床成功（临床检查中无引流性瘘管和原发性病变无肛门溃疡）定义，且未对肛周克罗恩氏病进行药物或手术治疗。进行逻辑回归分析以确定成功的预测因素。在非活动性肛周克罗恩病患者中，复发的定义是病变的发生和/或对医学或外科治疗的需求。结果共纳入151例患者。其中102例患有活动性肛周疾病，男性33例（32.4％），平均年龄39.8岁，平均克罗恩病病程14.6岁；101名（99％）已接受至少一种抗TNF。中位随访时间为52周。在中位时间为33周后，有68％的患者中止了治疗。维多珠单抗的成功率为23/102（22.5％）。在开始时有Setons的患者中，成功清除9/61（15％）的患者。在多变量分析中，与成功相关的因素是先前使用的生物制剂的数量（≥3，优势比，OR：0.13，95％CI），开始时未使用抗生素（OR：4.12，95％CI）。在49位非活动性肛周克罗恩病患者中，肛周疾病以15/49（30.6％）复发，其中11/49（22.4％）需要专门治疗。复发的中位时间为22周。结论我们发现维多珠单抗在活动性肛周克罗恩氏病患者中成功率低，并且近三分之一的非活动性肛周克罗恩氏病患者发生肛周复发。前瞻性研究需要进一步评估。