Massano Alessandro, Savarino Edoardo Vincenzo, Saibeni Simone, Bezzio Cristina, Bertani Lorenzo, Caviglia Gian Paolo, Vernero Marta, Armandi Angelo, Ribaldone Davide Giuseppe
Gastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, Azienda Ospedale Università Padova, University of Padua, 35121 Padova, Italy.
IBD Centre, Gastroenterology Unit, Rho Hospital, ASST Rhodense, 20017 Rho, Italy.
J Clin Med. 2025 Mar 7;14(6):1793. doi: 10.3390/jcm14061793.
: In the current era of tailored therapy, biologics such as vedolizumab (VDZ) and ustekinumab (UST) are increasingly administered to inflammatory bowel disease (IBD) patients. The decision to discontinue biologics after side effects or a lack of response is usually simple, but the decision to stop treatment in patients in remission is more difficult: to date, no study has been conducted to investigate the effects of VDZ or UST withdrawal. Our study aims to investigate the rates and predictors of relapse of IBD after the discontinuation of VDZ and UST during a well-controlled disease phase and to evaluate the response to retreatment. : In this observational, multicenter, retrospective study, we included IBD patients who discontinued VDZ or UST during a well-controlled disease phase after at least 1 year of treatment. We collected demographic and clinical data for each patient at the time of discontinuation and at follow-up visits. : We included 36 IBD patients from 5 different centers; 80.0%, 58.5%, and 48.3% of patients maintained clinical remission at 12, 24, and 48 months after discontinuation, respectively. Crohn's disease (CD) patients were more likely to maintain remission than ulcerative colitis (UC) patients at 48 months (70.0% vs. 40.0%). No predictors of relapse were identified, but UC patients had a higher risk of early relapse than CD patients (HR = 3.23); 81.3% of retreated IBD patients achieved clinical remission after induction and at 12 months. : No predictors of disease relapse after treatment discontinuation were identified. Half of the patients had a relapse within 48 months after discontinuation, but most of them achieved clinical remission after retreatment.
在当前的精准治疗时代，诸如维多珠单抗（VDZ）和优特克单抗（UST）等生物制剂越来越多地应用于炎症性肠病（IBD）患者。因副作用或缺乏反应而停用生物制剂的决定通常比较简单，但对于病情缓解的患者而言，停止治疗的决定则更为困难：迄今为止，尚未有研究对停用VDZ或UST的影响进行调查。我们的研究旨在调查在疾病得到良好控制阶段停用VDZ和UST后IBD复发的发生率及预测因素，并评估再次治疗的反应。在这项观察性、多中心、回顾性研究中，我们纳入了在经过至少1年治疗且疾病得到良好控制阶段停用VDZ或UST的IBD患者。我们收集了每位患者停药时及随访时的人口统计学和临床数据。我们纳入了来自5个不同中心的36例IBD患者；分别有80.0%、58.5%和48.3%的患者在停药后12个月、24个月和48个月时维持临床缓解。在48个月时，克罗恩病（CD）患者比溃疡性结肠炎（UC）患者更有可能维持缓解（70.0%对40.0%）。未发现复发的预测因素，但UC患者早期复发的风险高于CD患者（HR = 3.23）；81.3%接受再次治疗的IBD患者在诱导治疗后及12个月时实现了临床缓解。未发现停药后疾病复发的预测因素。一半的患者在停药后48个月内复发，但大多数患者在再次治疗后实现了临床缓解。
