ArticlePharmacoepidemiology and drug safety2025
Colectomy and Neoplasia Outcomes of Patients With Ulcerative Colitis Receiving Golimumab: A Post-Authorisation Safety Study Using the Spanish ENEIDA Registry.
Article in Pharmacoepidemiology and drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
1 citing paper in PubMed.
- 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 · 2025Article
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Authors and funding
13 authors.
Funding
Abstract
purposeGolimumab (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.
methodsThis 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.
resultsSixty-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.
conclusionsFindings 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).
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