韦多利珠单抗治疗未接受生物治疗的轻度至中度克罗恩病患者：一项多中心观察研究。

IF 1.8 Q3 GASTROENTEROLOGY & HEPATOLOGY Crohn's & Colitis 360 Pub Date : 2023-09-22 eCollection Date: 2023-10-01 DOI:10.1093/crocol/otad053

Adriana Zanoni Dotti, Daniela Oliveira Magro, Eduardo Garcia Vilela, Julio Maria Fonseca Chebli, Liliana Andrade Chebli, Flavio Steinwurz, Marjorie Argollo, Nayara Salgado Carvalho, Jose Miguel Luz Parente, Murilo Moura Lima, Rogério Serafim Parra, Ramir Luan Perin, Cristina Flores, Eloá Marussi Morsoletto, Sandro da Costa Ferreira, Juliano Coelho Ludvig, Roberto Luiz Kaiser Junior, Mikaell Alexandre Gouvea Faria, Guilherme Mattioli Nicollelli, Adriana Ribas Andrade, Natalia Sousa Freitas Queiroz, Paulo Gustavo Kotze

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摘要

背景：根据现实世界的经验，使用维多利珠单抗作为一线生物治疗的患者数量很少。我们旨在评估维多利珠单抗治疗轻中度克罗恩病（CD）生物幼稚患者的有效性和安全性。方法：我们对在基线、第12、26、52周以及最后一次随访时测量了临床活动评分（Harvey-Bradshaw指数[HBI]）的患者进行了一项回顾性多中心队列研究。临床反应定义为HBI降低≥3，而临床缓解定义为HBI≤4。粘膜愈合被定义为对照结肠镜检查中完全没有溃疡。Kaplan-Meier生存率分析用于评估维多利珠单抗的持续性。结果：在总共66名患者中，53%（35/66）在第12周达到临床缓解。这一比例在第26周增至69.7%（46/66），在第52周增至78.8%（52/66）。62.3%（33/53）的患者实现了粘膜愈合。韦多利珠单抗耐受性良好，大多数不良事件轻微。在vedolizumab治疗期间，3/66名患者接受了手术。结论：本研究证明了维多利珠单抗作为一线生物制剂治疗轻中度CD的有效性和安全性。

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Vedolizumab in Mild-to-Moderate Crohn's Disease Patients Naïve to Biological Therapy: A Multicentric Observational Study.

Background: In real-world experience, the number of patients using vedolizumab as first-line biological therapy was low. We aimed to evaluate the effectiveness and safety of vedolizumab in mild-to-moderate Crohn's disease (CD) biologic-naïve patients.

Methods: We performed a retrospective multicentric cohort study with patients who had clinical activity scores (Harvey-Bradshaw Index [HBI]) measured at baseline and weeks 12, 26, 52, as well as at the last follow-up. Clinical response was defined as a reduction ≥3 in HBI, whereas clinical remission as HBI ≤4. Mucosal healing was defined as the complete absence of ulcers in control colonoscopies. Kaplan-Meier survival analysis was used to assess the persistence with vedolizumab.

Results: From a total of 66 patients, 53% (35/66) reached clinical remission at week 12. This percentage increased to 69.7% (46/66) at week 26, and 78.8% (52/66) at week 52. Mucosal healing was achieved in 62.3% (33/53) of patients. Vedolizumab was well tolerated, and most adverse events were minor. During vedolizumab treatment, 3/66 patients underwent surgery.

Conclusions: This study demonstrates the effectiveness and safety of vedolizumab as a first-line biological agent in patients with mild-to-moderate CD.

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