the ENEIDA Study Group of GETECCU2026-01-122026-01-122025-08the ENEIDA Study Group of GETECCU 2025, 'Colectomy and Neoplasia Outcomes of Patients With Ulcerative Colitis Receiving Golimumab : A Post-Authorisation Safety Study Using the Spanish ENEIDA Registry', Pharmacoepidemiology and Drug Safety, vol. 34, no. 8, e70176. https://doi.org/10.1002/pds.701761053-8569PubMedCentral: PMC12319186https://hdl.handle.net/10641/7163Publisher Copyright: © 2025 John Wiley & Sons Ltd.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).381464enghttp://creativecommons.org/licenses/by-nc-nd/4.0/biologicscolectomycolorectal cancerepidemiologyinflammatory bowel disease (IBD)ulcerative colitisEpidemiologyPharmacology (medical)SDG 3 - Good Health and Well-beingJournal ArticleYesyesjournal articleopen access10.1002/pds.70176https://www.scopus.com/pages/publications/105012445898https://www.scopus.com/pages/publications/105012445898#tab=citedBy