A comprehensive post-authorization safety study has revealed that golimumab (GLM) demonstrates comparable safety outcomes to other anti-TNF agents in treating moderate to severe ulcerative colitis (UC), with no significant difference in colectomy rates between treatments.
The study, conducted across Denmark and Sweden from 2013 to 2021, analyzed data from 12,646 patients (5,177 in Denmark and 7,469 in Sweden) following golimumab's approval for UC treatment in 2013. Researchers employed a new-user, active comparator cohort design to evaluate the medication's safety profile.
Safety Outcomes and Colectomy Rates
The incidence rate of all-cause total colectomy showed notable variation between the two countries, with Denmark reporting 42.6 cases per 1,000 person-years (95% CI: 38.9-46.2) compared to Sweden's 16.1 cases per 1,000 person-years (95% CI: 14.2-18.0).
When comparing golimumab to other anti-TNF agents (infliximab and adalimumab), researchers found no statistically significant difference in colectomy rates:
- Denmark: adjusted IRR 1.28 (95% CI: 0.98-1.66)
- Sweden: adjusted IRR 1.17 (95% CI: 0.72-1.90)
However, a significant difference emerged when comparing golimumab to thiopurines, with substantially higher colectomy rates in the golimumab group:
- Denmark: adjusted IRR 13.62 (95% CI: 8.73-21.26)
- Sweden: adjusted IRR 4.52 (95% CI: 2.75-7.41)
Cancer and Lymphoma Surveillance
The study's cancer surveillance component yielded limited data due to privacy regulations restricting the analysis of the few colorectal cancer events that occurred. Notably, no cases of hepatosplenic T-cell lymphoma were identified during the study period, an important finding given the historical safety concerns with immunosuppressive therapies.
Methodological Approach
The research team utilized national prescription and hospital registers to track medication exposure, treating it as a time-varying variable. This approach allowed for precise monitoring of treatment patterns and outcomes across both countries' healthcare systems.
The marked difference in colectomy rates between golimumab and thiopurines likely reflects confounding by indication, suggesting that patients prescribed golimumab may have had more severe disease or different risk profiles compared to those receiving thiopurines.
This post-authorization study provides valuable real-world evidence supporting the safety profile of golimumab in UC treatment, particularly in comparison to other established anti-TNF therapies.
