Colectomy and Neoplasia Outcomes of Patients With Ulcerative Colitis Receiving Golimumab : A Post-Authorisation Safety Study Using the Spanish ENEIDA Registry

Purpose: Golimumab (GLM), an anti-tumour necrosis factor alpha (anti-TNFα) agent, is indicated for moderate to severe ulcerative colitis (UC). This post-authorisation safety study evaluated the risk of colectomy due to intractable disease and advanced colonic neoplasia (high-grade dysplasia and/or c...

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Detalles Bibliográficos
Autor: the ENEIDA Study Group of GETECCU
Tipo de recurso: artículo
Fecha de publicación:2025
País:España
Institución:Universidad Francisco de Vitoria
Repositorio:DDFV. Repositorio Institucional de la Universidad Francisco de Vitoria
Idioma:inglés
OAI Identifier:oai:ddfv.ufv.es:10641/7163
Acceso en línea:https://hdl.handle.net/10641/7163
Access Level:acceso abierto
Palabra clave:biologics
colectomy
colorectal cancer
epidemiology
inflammatory bowel disease (IBD)
ulcerative colitis
Epidemiology
Pharmacology (medical)
SDG 3 - Good Health and Well-being
Journal Article
Yes
yes
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network_acronym_str ES
network_name_str España
repository_id_str
spelling Colectomy and Neoplasia Outcomes of Patients With Ulcerative Colitis Receiving Golimumab : A Post-Authorisation Safety Study Using the Spanish ENEIDA Registrythe ENEIDA Study Group of GETECCUbiologicscolectomycolorectal cancerepidemiologyinflammatory bowel disease (IBD)ulcerative colitisEpidemiologyPharmacology (medical)SDG 3 - Good Health and Well-beingJournal ArticleYesyesPurpose: Golimumab (GLM), an anti-tumour necrosis factor alpha (anti-TNFα) agent, is indicated for moderate to severe ulcerative colitis (UC). This post-authorisation safety study evaluated the risk of colectomy due to intractable disease and advanced colonic neoplasia (high-grade dysplasia and/or colorectal cancer) under real-world conditions of GLM use. Methods: This bidirectional cohort study using Spanish ENEIDA registry data (2013–2022) included adults with UC who initiated GLM, other anti-TNFα agents, or thiopurines (TPs). Crude risk analyses—and, when feasible, multivariable models—in cohort and nested case-control designs were performed. For colectomy, we evaluated exposure to GLM only, other anti-TNFα agents, and both (i.e., overlapping exposure). For ACN, we evaluated exposure to GLM, other anti-TNFα agents, and TPs. Results: Sixty-four colectomy cases and 10 ACN cases were identified among patients exposed to GLM (N = 474), other anti-TNFα agents (N = 1737), or TPs (N = 1380). Incidence rates per 1000 person-years and 95% confidence intervals were reported for colectomy (GLM–only [4.4, 1.2–11.2] and other anti-TNFα agents only [12.4, 9.1–16.5]) and ACN (GLM [1.5, 0.2–5.4], other anti-TNFα agents [1.3, 0.5–2.8], and TPs [1.0, 0.3–2.6]). In comparisons excluding overlapping exposure, GLM was not associated with an increased risk of colectomy versus other anti-TNFα agents. GLM was also not associated with an increased risk of ACN versus either comparator. Observed events, especially for ACN, were limited for all exposures. Conclusions: Findings do not indicate an increased risk of colectomy due to intractable disease or ACN with GLM use versus other therapies for similar disease severity in routine UC care (EUPAS15752).Facultad de Medicina20252025-08-0120252025-08-01journal articlehttp://purl.org/coar/resource_type/c_6501info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/10641/7163reponame:DDFV. Repositorio Institucional de la Universidad Francisco de Vitoriainstname:Universidad Francisco de VitoriaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2http://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:ddfv.ufv.es:10641/71632026-06-11T12:44:57Z
dc.title.none.fl_str_mv Colectomy and Neoplasia Outcomes of Patients With Ulcerative Colitis Receiving Golimumab : A Post-Authorisation Safety Study Using the Spanish ENEIDA Registry
title Colectomy and Neoplasia Outcomes of Patients With Ulcerative Colitis Receiving Golimumab : A Post-Authorisation Safety Study Using the Spanish ENEIDA Registry
spellingShingle Colectomy and Neoplasia Outcomes of Patients With Ulcerative Colitis Receiving Golimumab : A Post-Authorisation Safety Study Using the Spanish ENEIDA Registry
the ENEIDA Study Group of GETECCU
biologics
colectomy
colorectal cancer
epidemiology
inflammatory bowel disease (IBD)
ulcerative colitis
Epidemiology
Pharmacology (medical)
SDG 3 - Good Health and Well-being
Journal Article
Yes
yes
title_short Colectomy and Neoplasia Outcomes of Patients With Ulcerative Colitis Receiving Golimumab : A Post-Authorisation Safety Study Using the Spanish ENEIDA Registry
title_full Colectomy and Neoplasia Outcomes of Patients With Ulcerative Colitis Receiving Golimumab : A Post-Authorisation Safety Study Using the Spanish ENEIDA Registry
title_fullStr Colectomy and Neoplasia Outcomes of Patients With Ulcerative Colitis Receiving Golimumab : A Post-Authorisation Safety Study Using the Spanish ENEIDA Registry
title_full_unstemmed Colectomy and Neoplasia Outcomes of Patients With Ulcerative Colitis Receiving Golimumab : A Post-Authorisation Safety Study Using the Spanish ENEIDA Registry
title_sort Colectomy and Neoplasia Outcomes of Patients With Ulcerative Colitis Receiving Golimumab : A Post-Authorisation Safety Study Using the Spanish ENEIDA Registry
dc.creator.none.fl_str_mv the ENEIDA Study Group of GETECCU
author the ENEIDA Study Group of GETECCU
author_facet the ENEIDA Study Group of GETECCU
author_role author
dc.contributor.none.fl_str_mv Facultad de Medicina
dc.subject.none.fl_str_mv biologics
colectomy
colorectal cancer
epidemiology
inflammatory bowel disease (IBD)
ulcerative colitis
Epidemiology
Pharmacology (medical)
SDG 3 - Good Health and Well-being
Journal Article
Yes
yes
topic biologics
colectomy
colorectal cancer
epidemiology
inflammatory bowel disease (IBD)
ulcerative colitis
Epidemiology
Pharmacology (medical)
SDG 3 - Good Health and Well-being
Journal Article
Yes
yes
description Purpose: Golimumab (GLM), an anti-tumour necrosis factor alpha (anti-TNFα) agent, is indicated for moderate to severe ulcerative colitis (UC). This post-authorisation safety study evaluated the risk of colectomy due to intractable disease and advanced colonic neoplasia (high-grade dysplasia and/or colorectal cancer) under real-world conditions of GLM use. Methods: This bidirectional cohort study using Spanish ENEIDA registry data (2013–2022) included adults with UC who initiated GLM, other anti-TNFα agents, or thiopurines (TPs). Crude risk analyses—and, when feasible, multivariable models—in cohort and nested case-control designs were performed. For colectomy, we evaluated exposure to GLM only, other anti-TNFα agents, and both (i.e., overlapping exposure). For ACN, we evaluated exposure to GLM, other anti-TNFα agents, and TPs. Results: Sixty-four colectomy cases and 10 ACN cases were identified among patients exposed to GLM (N = 474), other anti-TNFα agents (N = 1737), or TPs (N = 1380). Incidence rates per 1000 person-years and 95% confidence intervals were reported for colectomy (GLM–only [4.4, 1.2–11.2] and other anti-TNFα agents only [12.4, 9.1–16.5]) and ACN (GLM [1.5, 0.2–5.4], other anti-TNFα agents [1.3, 0.5–2.8], and TPs [1.0, 0.3–2.6]). In comparisons excluding overlapping exposure, GLM was not associated with an increased risk of colectomy versus other anti-TNFα agents. GLM was also not associated with an increased risk of ACN versus either comparator. Observed events, especially for ACN, were limited for all exposures. Conclusions: Findings do not indicate an increased risk of colectomy due to intractable disease or ACN with GLM use versus other therapies for similar disease severity in routine UC care (EUPAS15752).
publishDate 2025
dc.date.none.fl_str_mv 2025
2025-08-01
2025
2025-08-01
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/10641/7163
url https://hdl.handle.net/10641/7163
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 Francisco de Vitoria
instname_str Universidad Francisco de Vitoria
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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score 15,81155

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