2026-04-13T01:25:35Zhttps://recercat.cat/oai/request

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

00925njm 22002777a 4500 dc Domènech, Eugeni author Márquez-Mosquera, Lucía author Montoro Huguet, Miguel author ENEIDA Project of GETECCU author 2026-03-25T08:30:48Z 2026-03-25T08:30:48Z 2025 2026-03-25T08:30:48Z 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). https://hdl.handle.net/10230/72896 Biologics Colectomy Colorectal cancer Epidemiology Inflammatory bowel disease (IBD) Ulcerative colitis Colectomy and neoplasia outcomes of patients with ulcerative colitis receiving golimumab: A post-authorisation safety study using the spanish ENEIDA registry