Anti-tumour necrosis factor discontinuation in inflammatory bowel disease patients in remission : study protocol of a prospective, multicentre, randomized clinical trial

Background: Patients with inflammatory bowel disease who achieve remission with anti-tumour necrosis factor (anti-TNF) drugs may have treatment withdrawn due to safety concerns and cost considerations, but there is a lack of prospective, controlled data investigating this strategy. The primary study...

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Detalhes bibliográficos
Autor: on behalf of the EXIT study group of GETECCU
Formato: artículo
Fecha de publicación:2019
País:España
Recursos:Universidad de Málaga
Repositorio:DDFV. Repositorio Institucional de la Universidad Francisco de Vitoria
Idioma:inglés
OAI Identifier:oai:ddfv.ufv.es:10641/6804
Acesso em linha:https://hdl.handle.net/10641/6804
Access Level:acceso abierto
Palavra-chave:anti-tumour necrosis factor
inflammatory bowel disease
withdrawal
Gastroenterology
Journal Article
Yes
yes
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spelling Anti-tumour necrosis factor discontinuation in inflammatory bowel disease patients in remission : study protocol of a prospective, multicentre, randomized clinical trialon behalf of the EXIT study group of GETECCUanti-tumour necrosis factorinflammatory bowel diseasewithdrawalGastroenterologyJournal ArticleYesyesBackground: Patients with inflammatory bowel disease who achieve remission with anti-tumour necrosis factor (anti-TNF) drugs may have treatment withdrawn due to safety concerns and cost considerations, but there is a lack of prospective, controlled data investigating this strategy. The primary study aim is to compare the rates of clinical remission at 1 year in patients who discontinue anti-TNF treatment versus those who continue treatment. Methods: This is an ongoing, prospective, double-blind, multicentre, randomized, placebo-controlled study in patients with Crohn’s disease or ulcerative colitis who have achieved clinical remission for ⩾6 months with an anti-TNF treatment and an immunosuppressant. Patients are being randomized 1:1 to discontinue anti-TNF therapy or continue therapy. Randomization stratifies patients by the type of inflammatory bowel disease and drug (infliximab versus adalimumab) at study inclusion. The primary endpoint of the study is sustained clinical remission at 1 year. Other endpoints include endoscopic and radiological activity, patient-reported outcomes (quality of life, work productivity), safety and predictive factors for relapse. The required sample size is 194 patients. In addition to the main analysis (discontinuation versus continuation), subanalyses will include stratification by type of inflammatory bowel disease, phenotype and previous treatment. Biological samples will be obtained to identify factors predictive of relapse after treatment withdrawal. Results: Enrolment began in 2016, and the study is expected to end in 2020. Conclusions: This study will contribute prospective, controlled data on outcomes and predictors of relapse in patients with inflammatory bowel disease after withdrawal of anti-TNF agents following achievement of clinical remission.Facultad de Medicina20192019-01-0120192019-01-01journal articlehttp://purl.org/coar/resource_type/c_6501info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/10641/6804reponame:DDFV. Repositorio Institucional de la Universidad Francisco de Vitoriainstname:Universidad de MálagaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2http://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:ddfv.ufv.es:10641/68042026-06-11T12:44:57Z
dc.title.none.fl_str_mv Anti-tumour necrosis factor discontinuation in inflammatory bowel disease patients in remission : study protocol of a prospective, multicentre, randomized clinical trial
title Anti-tumour necrosis factor discontinuation in inflammatory bowel disease patients in remission : study protocol of a prospective, multicentre, randomized clinical trial
spellingShingle Anti-tumour necrosis factor discontinuation in inflammatory bowel disease patients in remission : study protocol of a prospective, multicentre, randomized clinical trial
on behalf of the EXIT study group of GETECCU
anti-tumour necrosis factor
inflammatory bowel disease
withdrawal
Gastroenterology
Journal Article
Yes
yes
title_short Anti-tumour necrosis factor discontinuation in inflammatory bowel disease patients in remission : study protocol of a prospective, multicentre, randomized clinical trial
title_full Anti-tumour necrosis factor discontinuation in inflammatory bowel disease patients in remission : study protocol of a prospective, multicentre, randomized clinical trial
title_fullStr Anti-tumour necrosis factor discontinuation in inflammatory bowel disease patients in remission : study protocol of a prospective, multicentre, randomized clinical trial
title_full_unstemmed Anti-tumour necrosis factor discontinuation in inflammatory bowel disease patients in remission : study protocol of a prospective, multicentre, randomized clinical trial
title_sort Anti-tumour necrosis factor discontinuation in inflammatory bowel disease patients in remission : study protocol of a prospective, multicentre, randomized clinical trial
dc.creator.none.fl_str_mv on behalf of the EXIT study group of GETECCU
author on behalf of the EXIT study group of GETECCU
author_facet on behalf of the EXIT study group of GETECCU
author_role author
dc.contributor.none.fl_str_mv Facultad de Medicina
dc.subject.none.fl_str_mv anti-tumour necrosis factor
inflammatory bowel disease
withdrawal
Gastroenterology
Journal Article
Yes
yes
topic anti-tumour necrosis factor
inflammatory bowel disease
withdrawal
Gastroenterology
Journal Article
Yes
yes
description Background: Patients with inflammatory bowel disease who achieve remission with anti-tumour necrosis factor (anti-TNF) drugs may have treatment withdrawn due to safety concerns and cost considerations, but there is a lack of prospective, controlled data investigating this strategy. The primary study aim is to compare the rates of clinical remission at 1 year in patients who discontinue anti-TNF treatment versus those who continue treatment. Methods: This is an ongoing, prospective, double-blind, multicentre, randomized, placebo-controlled study in patients with Crohn’s disease or ulcerative colitis who have achieved clinical remission for ⩾6 months with an anti-TNF treatment and an immunosuppressant. Patients are being randomized 1:1 to discontinue anti-TNF therapy or continue therapy. Randomization stratifies patients by the type of inflammatory bowel disease and drug (infliximab versus adalimumab) at study inclusion. The primary endpoint of the study is sustained clinical remission at 1 year. Other endpoints include endoscopic and radiological activity, patient-reported outcomes (quality of life, work productivity), safety and predictive factors for relapse. The required sample size is 194 patients. In addition to the main analysis (discontinuation versus continuation), subanalyses will include stratification by type of inflammatory bowel disease, phenotype and previous treatment. Biological samples will be obtained to identify factors predictive of relapse after treatment withdrawal. Results: Enrolment began in 2016, and the study is expected to end in 2020. Conclusions: This study will contribute prospective, controlled data on outcomes and predictors of relapse in patients with inflammatory bowel disease after withdrawal of anti-TNF agents following achievement of clinical remission.
publishDate 2019
dc.date.none.fl_str_mv 2019
2019-01-01
2019
2019-01-01
dc.type.none.fl_str_mv journal article
http://purl.org/coar/resource_type/c_6501
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/10641/6804
url https://hdl.handle.net/10641/6804
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2

http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2

http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:DDFV. Repositorio Institucional de la Universidad Francisco de Vitoria
instname:Universidad de Málaga
instname_str Universidad de Málaga
reponame_str DDFV. Repositorio Institucional de la Universidad Francisco de Vitoria
collection DDFV. Repositorio Institucional de la Universidad Francisco de Vitoria
repository.name.fl_str_mv
repository.mail.fl_str_mv
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