2026-04-14T07:14:13Zhttps://recercat.cat/oai/request

oai:recercat.cat:10230/728962026-03-26T20:17:41Zcom_2072_6col_2072_452952

Colectomy and neoplasia outcomes of patients with ulcerative colitis receiving golimumab: A post-authorisation safety study using the spanish ENEIDA registry Domènech, Eugeni Márquez-Mosquera, Lucía Montoro Huguet, Miguel ENEIDA Project of GETECCU Biologics Colectomy Colorectal cancer Epidemiology Inflammatory bowel disease (IBD) Ulcerative colitis Purpose: Golimumab (GLM), an anti-tumour necrosis factor alpha (anti-TNFa) 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-TNFa 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-TNFa agents, and both (i.e., overlapping exposure). For ACN, we evaluated exposure to GLM, other anti-TNFa agents, and TPs. Results: Sixty-four colectomy cases and 10 ACN cases were identified among patients exposed to GLM (N = 474), other anti-TNFa 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-TNFa agents only [12.4, 9.1-16.5]) and ACN (GLM [1.5, 0.2-5.4], other anti-TNFa 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-TNFa 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). 2026-03-25T08:30:48Z 2026-03-25T08:30:48Z 2025 2026-03-25T08:30:48Z info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Domenech E, Fortuny J, Martinez D, Tormos A, Huang Z, Hill DD, Weinstein C, Esslinger S, Krumme AA, Otero-Lobato M, Mines D, Gisbert JP, Sicilia B, Monfort I Miquel D, Calvet Calvo X, Minguez Perez M, Fernandez Salazar L, Garcia Planella E, de Hinojosa de Val J, Lorente Poyatos RH, Bujanda L, Garcia Sepulcre MF, Gutierrez Casbas A, Domenech E, Marquez Mosquera L, Martin Arranz MD, Gisbert JP, Esteve Comas M, Lopez San Roman A, Bastida Paz G, Benitez Cantero JM, Van Domselaar M, Aldeguer X, Bermejo F, Perez Calle JL, Rivero Tirado M, Garcia Lopez S, Barrio Andres J, Alcain Martinez G, Ricart Gomez E, Gargallo Puyuelo CJ, Montoro Huguet MA. Colectomy and neoplasia outcomes of patients with ulcerative colitis receiving golimumab: A post-authorisation safety study using the spanish ENEIDA registry. Pharmacoepidemiol Drug Saf. 2025 Aug;34(8):e70176. DOI: 10.1002/pds.70176 1053-8569 https://hdl.handle.net/10230/72896 http://dx.doi.org/10.1002/pds.70176 https://hdl.handle.net/10230/72896 eng Pharmacoepidemiology and Drug Safety. 2025;34(8) © 2025 Merck Sharp & Dohme LLC. Johnson & Johnson Innovative Medicine and The Author(s). Pharmacoepidemiology and Drug Safety published by John Wiley &Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium,provided the original work is properly cited. (http://creativecommons.org/licenses/by/4.0/) http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess application/pdf application/pdf Wiley