BACKGROUND: Simponi (golimumab [GLM]), an anti–tumor necrosis factor α (anti-TNFα) agent, was approved to treat moderately to severely active ulcerative colitis (UC) in 2013. Given theoretical concerns about a greater risk of malignancy and colectomy with anti-TNFα therapy, a post-authorization study was conducted under real-world conditions.
OBJECTIVES: To evaluate the risk of colectomy due to intractable disease (hereafter “colectomy”) and advanced colonic neoplasia (ACN) (colorectal cancer or high-grade dysplasia) in UC among new GLM users compared with new users of (i) other anti-TNFα agents and (ii) thiopurines (TPs).
METHODS: This observational study used a new-user cohort design with a secondary nested case-control analysis. It used data from the ENEIDA registry, a database maintained by the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU). Patients with UC were included who were aged ≥ 18 years, initiated GLM, an anti-TNFα agent other than GLM, or TP from September 2013 through December 2021; and had not had a study outcome before study entry. Crude risk analyses were performed for each outcome, and multivariable models were fit for outcomes with sufficient events.
RESULTS: There were 474 patients in the GLM cohort, 1,737 patients in the other anti-TNFα cohort, and 1,380 patients in the TP cohort identified in 30 hospitals. Median age was 43 years. A total of 64 colectomy cases and 10 ACN cases occurred over the 8.5-year study. Incidence rates (IRs) of colectomy were 4.4 (95% confidence interval [CI], 1.2-11.2) per 1,000 person-years (PY) with GLM use only, 12.4 (95% CI, 9.1-16.5) per 1,000 PY with other anti-TNFα agent use only, and 78.6 (95% CI, 16.2-229.7) per 1,000 PY with overlapping exposure to both GLM and other anti-TNFs around times of therapy switch. Compared with use of only other anti-TNFα agents, GLM-only use was not associated with an increased risk of colectomy in adjusted Poisson and Cox models (IR ratio = 0.40; 95% CI, 0.14-1.13; hazard ratio = 0.41; 95% CI, 0.15-1.15). (The TP comparator was evaluated only for ACN risk). The IR of ACN was 1.5 (95% CI, 0.2-5.4) per 1,000 PY in the GLM cohort, 1.3 (95% CI, 0.5-2.8) per 1,000 PY in the other anti-TNFα agent cohort, and 1.0 (95% CI, 0.3-2.6) per 1,000 PY in the TP cohort. Compared with use of other anti-TNFα agents, GLM use was not associated with an increased risk of ACN (adjusted hazard ratio = 1.09; 95% CI, 0.22-5.44). Similar results were found for the comparison with TPs. For both outcomes, results from age-adjusted nested case-control analyses were consistent with the main results
CONCLUSIONS: Results from this study do not indicate an increased risk of colectomy due to intractable disease or of ACN among GLM users compared with users of other anti-TNFα agents in adult patients with UC in Spain.
Domenech E, Fortuny J, Martinez D, Tormos A, Huang Z, Hill D, Weinstein C, Esslinger S, Krumme A, Mines D, Gisbert J. A post-authorization safety study of golimumab in ulcerative colitis using the Spanish ENEIDA registry (MK8259-042). Poster presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
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