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

Annette Kjær Ersbøll (), Zhiping Huang, Deanna D. Hill, Simone Møller Hede, Vibeke Andersen, Kristian Bolin, Marie Skov Kristensen, Suzan Esslinger, Frida Richter Hansen, Erik Hertervig, Lila Kallio, Thora Majlund Kjærulff, Stine Kloster, Alexis Krumme, James D. Lewis, Laila Mehkri, Niels Qvist, Lau Caspar Thygesen, Cindy Weinstein and Anders Green
Additional contact information
Annette Kjær Ersbøll: University of Southern Denmark
Zhiping Huang: Merck Sharp & Dohme, LLC
Deanna D. Hill: Merck Sharp & Dohme, LLC
Simone Møller Hede: MedEngine DK ApS
Vibeke Andersen: University of Southern Denmark
Kristian Bolin: University of Gothenburg
Marie Skov Kristensen: University of Copenhagen
Suzan Esslinger: Cilag GmbH International
Frida Richter Hansen: Frederiksberg Hospital
Erik Hertervig: Skåne University Hospital
Lila Kallio: Auria Biobank, Turku University Hospital and University of Turku
Thora Majlund Kjærulff: University of Southern Denmark
Stine Kloster: University of Southern Denmark
Alexis Krumme: Janssen Research & Development
James D. Lewis: University of Pennsylvania
Laila Mehkri: MedEngine DK ApS
Niels Qvist: University of Southern Denmark
Lau Caspar Thygesen: University of Southern Denmark
Cindy Weinstein: Merck Sharp & Dohme, LLC
Anders Green: Odense University Hospital

Drug Safety, 2025, vol. 48, issue 5, No 7, 558 pages

Abstract: Abstract 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.

Date: 2025
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DOI: 10.1007/s40264-025-01519-8

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