ArticleDrug safety2025
A Longitudinal Post-authorization Safety Study of Golimumab in Treatment of Ulcerative Colitis: A Cohort Study in Denmark and Sweden, 2013-2021.
Article in 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.
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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
20 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundWhen golimumab (GLM) was approved for the treatment of moderate to severe ulcerative colitis (UC) in 2013, a post-authorization safety study was conducted.
objectiveOur objective was to examine whether exposure to GLM was associated with an increased incidence of all-cause total colectomy, colorectal cancer, and hepatosplenic T-cell lymphoma in Denmark and Sweden.
methodsWe conducted a new-user, active comparator cohort study of patients with UC in 2013-2021. Exposure to GLM, other anti-tumor necrosis factor (TNF) agents (infliximab and adalimumab) and thiopurines was a time-varying variable. Therapies were based on prescription redemptions and hospital-based administration of medications from national prescription and hospital registers. The association between exposure to study therapies and outcomes was evaluated using Poisson regression of incidence rates (IRs), presented as IR ratios (IRRs) and 95% confidence intervals (CIs).
resultsA total of 5177 and 7469 patients were included in Denmark and Sweden, respectively. The IR of all-cause total colectomy per 1000 person-years was higher in Denmark (IR 42.6; 95% CI 38.9-46.2) than in Sweden (IR 16.1; 95% CI 14.2-18.0). No significant difference was observed in all-cause total colectomy between GLM and other anti-TNF agents (Denmark: adjusted IRR [aIRR] 1.28; 95% CI 0.98-1.66; Sweden: aIRR 1.17; 95% CI 0.72-1.90). A significant difference was observed between GLM and thiopurines (Denmark: aIRR 13.62; 95% CI 8.73-21.26; Sweden: aIRR 4.52; 2.75-7.41). Privacy regulations prevented analysis of a few colorectal cancer events. No hepatosplenic T-cell lymphoma events were identified.
conclusionThe IR of all-cause total colectomy with GLM was similar to that with other anti-TNF agents but was much higher than with thiopurines, probably related to confounding by indication.
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