Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission: a randomised placebo-controlled clinical trial of GETECCU

IF 23 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Gut Pub Date : 2024-12-20 DOI:10.1136/gutjnl-2024-333385
Javier P Gisbert, María G Donday, Sabino Riestra, Alfredo J Lucendo, José-Manuel Benítez, Mercè Navarro-Llavat, Jesús Barrio, Víctor J Morales-Alvarado, Montserrat Rivero, David Busquets, Eduardo Leo Carnerero, Olga Merino, Óscar Nantes Castillejo, Pablo Navarro, Manuel Van Domselaar, Ana Gutiérrez, Inmaculada Alonso-Abreu, Rafael Mejuto, Luis Fernández-Salazar, Marisa Iborra, María Dolores Martín-Arranz, Juan Ramón Pineda, Manuela Josefa Sampedro, Katja Serra Nilsson, Abdel Bouhmidi, Lissette Batista, Carmen Muñoz Villafranca, Iago Rodríguez-Lago, Daniel Ceballos, Iván Guerra, Miriam Mañosa, Ignacio Marín Jiménez, Emilio Torrella, Maribel Vera Mendoza, María José Casanova, Ruth de Francisco, Laura Arias-González, Sandra Marín Pedrosa, Orlando García-Bosch, Francisco Javier García-Alonso, Pedro Delgado-Guillena, María José García, Leyanira Torrealba, Andrea Núñez-Ortiz, Miren Vicuña Arregui, Marta Maia Bosca-Watts, Isabel Blázquez, Diana Acosta, Ana Garre, Montse Baldán, Concepción Martínez, Manuel Barreiro-de Acosta, Eugeni Domènech, Maria Esteve, Valle García-Sánchez, Pilar Nos, Julián Panés, María Chaparro
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Abstract

Background and objectives Primary objectives: to compare the rates of sustained clinical remission at 12 months in patients treated with antitumour necrosis factor (anti-TNF) and immunomodulators who withdraw anti-TNF treatment versus those who maintain it. Secondary objectives: to evaluate the effect of anti-TNF withdrawal on relapse-free time, endoscopic and radiological activity, safety, quality of life and work productivity; and to identify predictive factors for relapse. Design Prospective, quadruple-blind, multicentre, randomised, controlled trial. Patients with ulcerative colitis or Crohn’s disease in clinical remission for >6 months and absence of severe endoscopic (and radiological in Crohn’s disease) lesions were randomised to maintain anti-TNF treatment (maintenance arm (MA)) or to withdraw it (withdrawal arm (WA)). All patients maintained immunomodulators. Patients were followed-up until month 12 or up to clinical relapse. Results One-hundred forty patients were randomised: 70 were allocated to the MA and 70 to the WA. The proportion of patients with sustained clinical remission at 12 months was similar in the MA and WA: 59/70 (84%), 95% CI=74% to 92% versus 53/70 (76%), 95% CI=64% to 85%. The proportion of patients with significant endoscopic lesions at the end of follow-up was 8.5% in the MA and 19% in the WA (p=0.1); a higher proportion of patients had faecal calprotectin >250 µg/g at the end of follow-up in the WA (p=0.01). The same percentage of patients in both groups had at least one adverse event (69%). The proportion of patients with serious adverse events was also similar in both groups (4% in MA vs 7% in WA). Conclusion Anti-TNF withdrawal in selected patients with IBD in clinical, endoscopic and radiological remission has no impact on sustained clinical remission at 1 year although objective markers of activity were higher in patients who withdrew treatment. Trial registration number Data are available upon reasonable request.
炎症性肠病患者缓解期停用抗肿瘤坏死因子:GETECCU的随机安慰剂对照临床试验
背景和目的主要目的:比较接受抗肿瘤坏死因子(anti-TNF)和免疫调节剂治疗的患者退出抗肿瘤坏死因子治疗与维持抗肿瘤坏死因子治疗的患者12个月持续临床缓解率。次要目的:评价抗tnf停药对无复发时间、内镜和放射活性、安全性、生活质量和工作效率的影响;并确定复发的预测因素。设计前瞻性、四盲、多中心、随机对照试验。溃疡性结肠炎或克罗恩病临床缓解期为6个月且无严重内镜(克罗恩病中有放射学)病变的患者被随机分为维持抗tnf治疗组(维持组(MA))或停药组(停药组(WA))。所有患者维持免疫调节剂。患者随访至12个月或直至临床复发。结果140例患者随机分组:70例分配到MA组,70例分配到WA组。MA和WA在12个月时持续临床缓解的患者比例相似:59/70 (84%),95% CI=74%至92%,53/70 (76%),95% CI=64%至85%。随访结束时,MA组有明显内镜病变的比例为8.5%,WA组为19% (p=0.1);WA患者随访结束时粪便钙保护蛋白>250µg/g的比例较高(p=0.01)。两组患者中至少有一次不良事件的比例相同(69%)。两组患者发生严重不良事件的比例也相似(MA组为4%,WA组为7%)。结论在临床、内镜和放射学缓解的IBD患者中,停用抗tnf对1年的持续临床缓解没有影响,尽管停用治疗的患者的客观活性指标较高。如有合理要求,可提供试验注册号。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Gut
Gut 医学-胃肠肝病学
CiteScore
45.70
自引率
2.40%
发文量
284
审稿时长
1.5 months
期刊介绍: Gut is a renowned international journal specializing in gastroenterology and hepatology, known for its high-quality clinical research covering the alimentary tract, liver, biliary tree, and pancreas. It offers authoritative and current coverage across all aspects of gastroenterology and hepatology, featuring articles on emerging disease mechanisms and innovative diagnostic and therapeutic approaches authored by leading experts. As the flagship journal of BMJ's gastroenterology portfolio, Gut is accompanied by two companion journals: Frontline Gastroenterology, focusing on education and practice-oriented papers, and BMJ Open Gastroenterology for open access original research.
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