维多珠单抗用于初治生物疗法的轻至中度克罗恩病患者：一项多中心观察性研究。
Vedolizumab in Mild-to-Moderate Crohn's Disease Patients Naïve to Biological Therapy: A Multicentric Observational Study.
作者信息
Dotti Adriana Zanoni, Magro Daniela Oliveira, Vilela Eduardo Garcia, Chebli Julio Maria Fonseca, Chebli Liliana Andrade, Steinwurz Flavio, Argollo Marjorie, Carvalho Nayara Salgado, Parente Jose Miguel Luz, Lima Murilo Moura, Parra Rogério Serafim, Perin Ramir Luan, Flores Cristina, Morsoletto Eloá Marussi, da Costa Ferreira Sandro, Ludvig Juliano Coelho, Kaiser Junior Roberto Luiz, Faria Mikaell Alexandre Gouvea, Nicollelli Guilherme Mattioli, Andrade Adriana Ribas, Queiroz Natalia Sousa Freitas, Kotze Paulo Gustavo
机构信息
Hospital de Clínicas das UFPR, Curitiba, Brazil.
Universidade Estadual de Campinas (UNICAMP), Campinas, Brazil.
出版信息
Crohns Colitis 360. 2023 Sep 22;5(4):otad053. doi: 10.1093/crocol/otad053. eCollection 2023 Oct.
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.
背景
在实际临床经验中，将维多珠单抗作为一线生物治疗药物的患者数量较少。我们旨在评估维多珠单抗在初治的轻至中度克罗恩病（CD）患者中的有效性和安全性。
方法
我们进行了一项回顾性多中心队列研究，研究对象为在基线、第12周、第26周、第52周以及最后一次随访时进行了临床活动评分（哈维-布拉德肖指数[HBI]）测量的患者。临床缓解定义为HBI降低≥3，而临床缓解为HBI≤4。黏膜愈合定义为结肠镜检查时结肠完全无溃疡。采用Kaplan-Meier生存分析评估维多珠单抗的持续使用情况。
结果
在总共66例患者中，53%（35/66）在第12周达到临床缓解。这一比例在第26周升至69.7%（46/66），在第52周升至78.8%（52/66）。62.3%（33/53）的患者实现了黏膜愈合。维多珠单抗耐受性良好，大多数不良事件为轻度。在维多珠单抗治疗期间，66例患者中有3例接受了手术。
结论
本研究证明了维多珠单抗作为轻至中度CD患者一线生物制剂的有效性和安全性。
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