*Result*: A Longitudinal Post-authorization Safety Study of Golimumab in Treatment of Ulcerative Colitis: A Cohort Study in Denmark and Sweden, 2013-2021.

*Background: When golimumab (GLM) was approved for the treatment of moderate to severe ulcerative colitis (UC) in 2013, a post-authorization safety study was conducted.
Objective: Our 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.
Methods: We 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).
Results: A 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.
Conclusion: The 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.
(© 2025. The Author(s).)*

*Declarations. Funding: Open access funding provided by University of Southern Denmark. This post-authorization safety study was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and Janssen Research & Development, LLC, Spring House, PA, USA. MedEngine DK ApS (formerly the Institute of Applied Economics and Health Research ApS, ApHER), an independent research institute, was contracted by Merck Sharp & Dohme LLC to conduct the study. Conflict of interest: JL has consulted or served on an advisory board for AbbVie, Amgen, Arena Pharmaceuticals, Bridge Biotherapeutics, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Entasis Therapeutics, Galapagos, Gilead, Janssen Pharmaceuticals, Samsung Bioepis, Merck, Nestle Health Science, UCB, Pfizer, Protagonist Therapeutics, Sanofi, and Scipher Medicine; has received research funding from Nestle Health Science, Takeda, Janssen Pharmaceuticals, and AbbVie; has received educational grants from Takeda and Janssen; and has received in-kind support from Eli Lilly and Company. VA is member of the Merck advisory board and has consulted for Janssen. LM, SMH, and LK were employees at ApHER/MedEngine while the study was conducted. ZH, DDH, and CW are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and may hold stock and/or stock options in Merck & Co., Inc., Rahway, NJ, USA. SE and AK were employees at Janssen while the study was conducted. KB and AG were responsible for the study in Sweden as consultants for ApHER/MedEngine. AKE, LCT, TMK, MSK, SK, FRH, NQ, and EH have no conflicts of interest to declare. Availability of data and material: Register-based micro-level data sharing is not permitted. The researchers (AKE and AG) have access to data at secure servers at the Danish Health Data Authority and at secure local servers. Ethics approval: Different ethical approvals are needed in Denmark and Sweden [26, 43]. In Denmark, register-based studies do not need ethical approval [25]. The study was approved by the Research and Innovation Organisation at University of Southern Denmark (reference number: 10.186). The Swedish Ethical Review Authority approved the initial study protocol (reference 2019-04411) and amendments (reference 2020-00038). In Denmark, a minimum of five observations is needed to present results because of privacy regulations. Consequently, numbers less than five are masked as “<5” for results. So that the masked number cannot be calculated, further results have been masked and indicated as not permissible. Consent to participate: Not applicable. Consent to publication: Not applicable. Code availability: Not applicable. Author contributions: AKE: conceptualization, methodology, software, validation, formal analysis, investigation, resources, data curation, writing – original draft, writing – review and editing, visualization, and project administration. LCT: conceptualization, methodology, software, investigation, resources, data curation, writing – review and editing, and supervision. TMK: conceptualization, methodology, software, investigation, resources, data curation, and writing – review and editing. MSK: conceptualization, methodology, software, investigation, resources, data curation, and writing – review and editing. SK: methodology, software, resources, writing – review and editing, and visualization. FRH: methodology, software, resources, and writing – review and editing. NQ: conceptualization, investigation, writing – review and editing, visualization, and supervision. VA: conceptualization, investigation, writing – review and editing, visualization, and supervision. EH: conceptualization, investigation, writing – review and editing, visualization, and supervision. JL: conceptualization, investigation, writing – review and editing, and visualization. LM: software, formal analysis, investigation, resources, data curation, writing – review and editing, and project administration. SMH: conceptualization, investigation, writing – review and editing, and project administration. LK investigation, resources, writing – review and editing, visualization, and project administration. SE: conceptualization, investigation, and writing – review and editing. AK: conceptualization, investigation, and writing – review and editing. CW: conceptualization, methodology, investigation, writing – review and editing, and supervision. DDH: conceptualization, investigation, methodology, writing – review and editing, supervision, and project administration. ZH: conceptualization, methodology, validation, investigation, writing – review and editing, supervision, and project administration. KB: conceptualization, resources, data curation, and writing – review and editing. AG: conceptualization, methodology, software, validation, formal analysis, investigation, resources, data curation, writing – review and editing, visualization, supervision, and project administration. All authors read and approved the final manuscript.*