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

Inflammatory bowel disease; Inflixmab; Ulcerative colitis

Detalles Bibliográficos
Autores: Gisbert, Javier Pérez, Donday, María G, Riestra Menéndez, Sabino, Benitez, Jose Manuel, Navarro-Llavat, Mercè, Busquets, David, Serra Nilsson, Katja, Lucendo, Alfredo J, Morales Alvarado, Víctor Jair
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Departament de Salut de la Generalitat de Catalunya (DS)
Repositorio:Scientia. Dipòsit d'Informació Digital del Departament de Salut
OAI Identifier:oai:scientiasalut.gencat.cat:11351/13073
Acceso en línea:http://hdl.handle.net/11351/13073
Access Level:acceso abierto
Palabra clave:Aparell digestiu - Malalties
Colitis ulcerosa
Malalties - Recaiguda
DISEASES::Digestive System Diseases::Gastrointestinal Diseases::Gastroenteritis::Inflammatory Bowel Diseases
DISEASES::Digestive System Diseases::Gastrointestinal Diseases::Gastroenteritis::Colitis::Colitis, Ulcerative
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Infliximab
ENFERMEDADES::enfermedades del sistema digestivo::enfermedades gastrointestinales::gastroenteritis::enfermedad inflamatoria intestinal
ENFERMEDADES::enfermedades del sistema digestivo::enfermedades gastrointestinales::gastroenteritis::colitis::colitis ulcerosa
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales::infliximab
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network_acronym_str ES
network_name_str España
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dc.title.none.fl_str_mv Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission: a randomised placebo-controlled clinical trial of GETECCU
title Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission: a randomised placebo-controlled clinical trial of GETECCU
spellingShingle Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission: a randomised placebo-controlled clinical trial of GETECCU
Gisbert, Javier Pérez
Aparell digestiu - Malalties
Colitis ulcerosa
Malalties - Recaiguda
DISEASES::Digestive System Diseases::Gastrointestinal Diseases::Gastroenteritis::Inflammatory Bowel Diseases
DISEASES::Digestive System Diseases::Gastrointestinal Diseases::Gastroenteritis::Colitis::Colitis, Ulcerative
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Infliximab
ENFERMEDADES::enfermedades del sistema digestivo::enfermedades gastrointestinales::gastroenteritis::enfermedad inflamatoria intestinal
ENFERMEDADES::enfermedades del sistema digestivo::enfermedades gastrointestinales::gastroenteritis::colitis::colitis ulcerosa
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales::infliximab
title_short Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission: a randomised placebo-controlled clinical trial of GETECCU
title_full Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission: a randomised placebo-controlled clinical trial of GETECCU
title_fullStr Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission: a randomised placebo-controlled clinical trial of GETECCU
title_full_unstemmed Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission: a randomised placebo-controlled clinical trial of GETECCU
title_sort Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission: a randomised placebo-controlled clinical trial of GETECCU
dc.creator.none.fl_str_mv Gisbert, Javier Pérez
Donday, María G
Riestra Menéndez, Sabino
Benitez, Jose Manuel
Navarro-Llavat, Mercè
Busquets, David
Serra Nilsson, Katja
Lucendo, Alfredo J
Morales Alvarado, Víctor Jair
author Gisbert, Javier Pérez
author_facet Gisbert, Javier Pérez
Donday, María G
Riestra Menéndez, Sabino
Benitez, Jose Manuel
Navarro-Llavat, Mercè
Busquets, David
Serra Nilsson, Katja
Lucendo, Alfredo J
Morales Alvarado, Víctor Jair
author_role author
author2 Donday, María G
Riestra Menéndez, Sabino
Benitez, Jose Manuel
Navarro-Llavat, Mercè
Busquets, David
Serra Nilsson, Katja
Lucendo, Alfredo J
Morales Alvarado, Víctor Jair
author2_role author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv [Gisbert JP, Donday MG] Gastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS- Princesa), Universidad Autónoma de Madrid (UAM), Madrid, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain. [Riestra S] Gastroenterology Department, Hospital Universitario Central de Asturias, e Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain. [Lucendo AJ] Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain. Gastroenterology Department, Hospital General de Tomelloso, Instituto de Investigación Sanitaria de Castilla- La Mancha (IDISCAM), Tomelloso, Spain. [Benítez JM] Gastroenterology Department, Hospital Universitario Reina Sofía, IMIBIC, Cordoba, Spain. [Navarro-Llavat M] Servei de Digestologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona, Spain. [Morales-Alvarado VJ] Àrea d’aparell digestiu, Hospital General de Granollers, Granollers, Spain. [Busquets D] Servei de Digestiu, Hospital Dr. Josep Trueta, IDIBGI, Girona, Spain. [Serra Nilsson] Servei d'Aparell Digestiu, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Spain
Hospital General de Granollers
dc.subject.none.fl_str_mv Aparell digestiu - Malalties
Colitis ulcerosa
Malalties - Recaiguda
DISEASES::Digestive System Diseases::Gastrointestinal Diseases::Gastroenteritis::Inflammatory Bowel Diseases
DISEASES::Digestive System Diseases::Gastrointestinal Diseases::Gastroenteritis::Colitis::Colitis, Ulcerative
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Infliximab
ENFERMEDADES::enfermedades del sistema digestivo::enfermedades gastrointestinales::gastroenteritis::enfermedad inflamatoria intestinal
ENFERMEDADES::enfermedades del sistema digestivo::enfermedades gastrointestinales::gastroenteritis::colitis::colitis ulcerosa
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales::infliximab
topic Aparell digestiu - Malalties
Colitis ulcerosa
Malalties - Recaiguda
DISEASES::Digestive System Diseases::Gastrointestinal Diseases::Gastroenteritis::Inflammatory Bowel Diseases
DISEASES::Digestive System Diseases::Gastrointestinal Diseases::Gastroenteritis::Colitis::Colitis, Ulcerative
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Infliximab
ENFERMEDADES::enfermedades del sistema digestivo::enfermedades gastrointestinales::gastroenteritis::enfermedad inflamatoria intestinal
ENFERMEDADES::enfermedades del sistema digestivo::enfermedades gastrointestinales::gastroenteritis::colitis::colitis ulcerosa
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales::infliximab
description Inflammatory bowel disease; Inflixmab; Ulcerative colitis
publishDate 2025
dc.date.none.fl_str_mv 2025
2025
2025
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11351/13073
url http://hdl.handle.net/11351/13073
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Gut;74(3)
https://www.doi.org/10.1136/gutjnl-2024-333385
dc.rights.none.fl_str_mv Attribution-NonCommercial 4.0 International
https://creativecommons.org/licenses/by-nc/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution-NonCommercial 4.0 International
https://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv BMJ Publishing Group
publisher.none.fl_str_mv BMJ Publishing Group
dc.source.none.fl_str_mv Scientia
reponame:Scientia. Dipòsit d'Informació Digital del Departament de Salut
instname:Departament de Salut de la Generalitat de Catalunya (DS)
instname_str Departament de Salut de la Generalitat de Catalunya (DS)
reponame_str Scientia. Dipòsit d'Informació Digital del Departament de Salut
collection Scientia. Dipòsit d'Informació Digital del Departament de Salut
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869417460318339072
spelling Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission: a randomised placebo-controlled clinical trial of GETECCUGisbert, Javier PérezDonday, María GRiestra Menéndez, SabinoBenitez, Jose ManuelNavarro-Llavat, Mercè Busquets, DavidSerra Nilsson, KatjaLucendo, Alfredo JMorales Alvarado, Víctor JairAparell digestiu - MalaltiesColitis ulcerosaMalalties - RecaigudaDISEASES::Digestive System Diseases::Gastrointestinal Diseases::Gastroenteritis::Inflammatory Bowel DiseasesDISEASES::Digestive System Diseases::Gastrointestinal Diseases::Gastroenteritis::Colitis::Colitis, UlcerativeCHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::InfliximabENFERMEDADES::enfermedades del sistema digestivo::enfermedades gastrointestinales::gastroenteritis::enfermedad inflamatoria intestinalENFERMEDADES::enfermedades del sistema digestivo::enfermedades gastrointestinales::gastroenteritis::colitis::colitis ulcerosaCOMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales::infliximabInflammatory bowel disease; Inflixmab; Ulcerative colitisEnfermedad inflamatoria intestinal; Inflixmab; Colitis ulcerosaMalaltia inflamatòria intestinal; Inflixmab; Colitis ulcerosaPrimary 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. 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. 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. 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). 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. https://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-001410-10 https://clinicaltrials.gov/study/NCT02994836.This work has been supported by the Plataforma ISCIII de Soporte para la Investigación Clínica - SCReN (Spanish Clinical Research Network), funded by the Instituto de Salud Carlos III (ISCIII) through projects PT13/0002/0027 and PT17/0017/0017, both integrated in the Plan Estatal de I+D+I 2013-2016 and cofunded by the European Regional Development Fund (FEDER) ’A way to make Europe’, and project PT23/00060, funded by the ISCIII and cofunded by the European Union.BMJ Publishing Group[Gisbert JP, Donday MG] Gastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS- Princesa), Universidad Autónoma de Madrid (UAM), Madrid, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain. [Riestra S] Gastroenterology Department, Hospital Universitario Central de Asturias, e Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain. [Lucendo AJ] Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain. Gastroenterology Department, Hospital General de Tomelloso, Instituto de Investigación Sanitaria de Castilla- La Mancha (IDISCAM), Tomelloso, Spain. [Benítez JM] Gastroenterology Department, Hospital Universitario Reina Sofía, IMIBIC, Cordoba, Spain. [Navarro-Llavat M] Servei de Digestologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona, Spain. [Morales-Alvarado VJ] Àrea d’aparell digestiu, Hospital General de Granollers, Granollers, Spain. [Busquets D] Servei de Digestiu, Hospital Dr. Josep Trueta, IDIBGI, Girona, Spain. [Serra Nilsson] Servei d'Aparell Digestiu, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, SpainHospital General de Granollers202520252025info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11351/13073Scientiareponame:Scientia. Dipòsit d'Informació Digital del Departament de Salutinstname:Departament de Salut de la Generalitat de Catalunya (DS)InglésGut;74(3)https://www.doi.org/10.1136/gutjnl-2024-333385Attribution-NonCommercial 4.0 Internationalhttps://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:scientiasalut.gencat.cat:11351/130732026-06-12T09:38:37Z
score 15,811543

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