Background Vedolizumab (VDZ) is a gut-selective integrin inhibitor used to treat Crohn's disease (CD). Most of the information regarding real-life data on response to VDZ has been published from North America and Europe cohorts and there is scarce information from Latin America related to effectiveness of VDZ in patients with CD. The aims of this study were: i) to describe the clinical characteristics of patients with CD who received VDZ, ii) to know in which biologic line VDZ was indicated, and iii) to evaluate the clinical response at one year and the persistence of treatment during follow-up. Methods A retrospective multicenter study was conducted in 18 Argentinean centers. We included CD adult patients (age ≥18y) who started VDZ between 01/06/2015 and 31/10/2023 and completed at least VDZ induction. Baseline demographic characteristics, response at 12 months (m), need for optimization, and treatment persistence during follow-up were assessed. Logistic regression was used to evaluate predictors for response at 12m and treatment persistence. Results A total of 113 CD patients (57% male), mean age 52 years (range 18-87 years) were included. Colonic (47%) and ileal (29%) were the most frequent CD involvement. Inflammatory (68%) was the most frequent phenotype compared to stenosing (23%) and fistulizing (9%). Perianal involvement was present in 9% of patients. VDZ was indicated as first-line in 61 (54%) patients, second-line 31 (27.4%) patients, third line 17 (15%) patients, and fourth-line 4 (3.5%) patients. At 12 m of follow-up, clinical remission was observed in 37 (32.7%) patients and clinical response in 56 (49.6%) patients. Eighteen (15.9%) patients presented a lack of response/primary failure. Adverse effects leading to VDZ discontinuation prior to 12m occurred in 2 (1.8%) patients. Mean follow-up time in those patients that achieved clinical remission/response at 12m was 23 (SD 15) m. Thirty-five (37.6%) of those patients required dose optimization and 69 (74.2%) persisted on treatment during follow-up. Male sex (OR 2.93, 95%CI 1.04-8.26) and inflammatory phenotype (OR 5.37, 95%CI 1.16-24.9) were independent predictors for clinical response/remission at 12m. VDZ in first-line (OR 3, 95%CI 1.05-8.52) and inflammatory phenotype (OR 2.96, 95%CI 1.07-8.22) were independent predictors for treatment persistence in those patients that achieved clinical remission/response at 12m. Conclusion This is the first real-life multicenter study on the effectiveness of VZD in CD in Argentina and one of the largest in Latin America. VDZ showed an effective therapeutic option in a real-life setting. A higher efficacy was observed in males, inflammatory phenotype and in biologic-naïve patients.

中文翻译：

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P701 评估维多珠单抗对克罗恩病患者的有效性：来自阿根廷的多中心现实研究

背景 维多珠单抗 (VDZ) 是一种肠道选择性整合素抑制剂，用于治疗克罗恩病 (CD)。大多数有关 VDZ 反应的现实数据信息已从北美和欧洲队列中发表，而来自拉丁美洲的有关 VDZ 对 CD 患者有效性的信息很少。本研究的目的是：i) 描述接受 VDZ 治疗的 CD 患者的临床特征，ii) 了解 VDZ 适合哪种生物制剂，以及 iii) 评估一年后的临床反应和治疗的持续性随访期间。方法 在阿根廷 18 个中心进行回顾性多中心研究。我们纳入了在 2015 年 6 月 1 日至 2023 年 10 月 31 日期间开始 VDZ 并至少完成 VDZ 诱导的 CD 成年患者（年龄≥18 岁）。评估了基线人口特征、12 个月 (m) 时的反应、优化需求以及随访期间的治疗持续性。Logistic 回归用于评估 12m 响应和治疗持续性的预测因子。结果共纳入113名CD患者（57%为男性），平均年龄52岁（范围18-87岁）。结肠 (47%) 和回肠 (29%) 是最常见的 CD 受累。与狭窄 (23%) 和瘘管 (9%) 相比，炎症 (68%) 是最常见的表型。9% 的患者存在肛周受累。VDZ 在 61 名 (54%) 患者中被指定为一线药物，二线 31 名 (27.4%) 患者，三线 17 名 (15%) 患者，四线 4 名 (3.5%) 患者。随访 12 m 时，37 名患者（32.7%）观察到临床缓解，56 名患者（49.6%）出现临床缓解。十八名 (15.9%) 患者表现出缺乏反应/初次失败。2 名 (1.8%) 患者出现不良反应，导致 12m 之前停止 VDZ。在 12 m 处实现临床缓解/缓解的患者的平均随访时间为 23 (SD 15) m。其中 35 名患者 (37.6%) 需要优化剂量，69 名患者 (74.2%) 在随访期间坚持接受治疗。男性（OR 2.93，95%CI 1.04-8.26）和炎症表型（OR 5.37，95%CI 1.16-24.9）是12m时临床反应/缓解的独立预测因素。一线 VDZ（OR 3，95%CI 1.05-8.52）和炎症表型（OR 2.96，95%CI 1.07-8.22）是 12m 时实现临床缓解/缓解的患者治疗持续性的独立预测因子。结论 这是阿根廷第一个关于 VZD 治疗 CD 有效性的真实多中心研究，也是拉丁美洲最大的研究之一。VDZ 在现实生活中展示了一种有效的治疗选择。在男性、炎症表型和未接受过生物制剂治疗的患者中观察到更高的疗效。