P701 评估维多珠单抗对克罗恩病患者的疗效:阿根廷一项多中心实际生活研究

D C Balderramo, J Etchevers, C Fuxman, P Lubrano, M Bellicoso, G Correa, J Trakal, M R Defago, J Montero, M Toro, A Novillo, M Bonardo, N Arancibia, S Motañez, S Quines, S Huernos, A Gil, R Gonzalez, S Goncalves
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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. 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引用次数: 0

摘要

背景 韦多珠单抗(VDZ)是一种肠道选择性整合素抑制剂,用于治疗克罗恩病(CD)。有关 VDZ 反应的真实数据信息大多发表于北美和欧洲队列,拉丁美洲有关 VDZ 对 CD 患者疗效的信息很少。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 适用于哪种生物疗法;iii) 评估一年后的临床反应以及随访期间治疗的持续性。方法 在阿根廷的 18 个中心开展了一项回顾性多中心研究。我们纳入了2015年6月1日至2023年10月31日期间开始接受VDZ治疗并至少完成VDZ诱导治疗的CD成人患者(年龄≥18岁)。评估了基线人口统计学特征、12个月时的反应(m)、优化需求以及随访期间的治疗持续性。采用逻辑回归评估12个月时的反应和治疗持续性的预测因素。结果 共纳入 113 名 CD 患者(57% 为男性),平均年龄 52 岁(18-87 岁不等)。结肠(47%)和回肠(29%)是 CD 最常累及的部位。与狭窄型(23%)和瘘管型(9%)相比,炎症型(68%)是最常见的表型。9%的患者肛周受累。61例(54%)患者将VDZ作为一线用药,31例(27.4%)患者作为二线用药,17例(15%)患者作为三线用药,4例(3.5%)患者作为四线用药。在 12 个月的随访中,37 名患者(32.7%)出现临床缓解,56 名患者(49.6%)出现临床反应。18名患者(15.9%)出现无应答/初步失败。有 2 例(1.8%)患者因不良反应而在 12m 前停用 VDZ。这些患者中有 35 人(37.6%)需要优化剂量,69 人(74.2%)在随访期间坚持治疗。男性性别(OR 2.93,95%CI 1.04-8.26)和炎症表型(OR 5.37,95%CI 1.16-24.9)是12 m时临床反应/缓解的独立预测因素。一线治疗中的 VDZ(OR 3,95%CI 1.05-8.52)和炎症表型(OR 2.96,95%CI 1.07-8.22)是在 12 个月时获得临床缓解/应答的患者坚持治疗的独立预测因素。结论 这是阿根廷第一项关于 VZD 对 CD 疗效的实际多中心研究,也是拉丁美洲最大的研究之一。在现实生活中,VDZ 是一种有效的治疗选择。在男性、炎症表型和生物制剂无效患者中观察到了更高的疗效。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
P701 Evaluation of the effectiveness of vedolizumab in patients with Crohn's disease: a multicenter real-life study from Argentina
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.
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