Colectomy and Neoplasia Outcomes of Patients With Ulcerative Colitis Receiving Golimumab : A Post-Authorisation Safety Study Using the Spanish ENEIDA Registry

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Abstract

Purpose: Golimumab (GLM), an anti-tumour necrosis factor alpha (anti-TNFα) agent, is indicated for moderate to severe ulcerative colitis (UC). This post-authorisation safety study evaluated the risk of colectomy due to intractable disease and advanced colonic neoplasia (high-grade dysplasia and/or colorectal cancer) under real-world conditions of GLM use. Methods: This bidirectional cohort study using Spanish ENEIDA registry data (2013–2022) included adults with UC who initiated GLM, other anti-TNFα agents, or thiopurines (TPs). Crude risk analyses—and, when feasible, multivariable models—in cohort and nested case-control designs were performed. For colectomy, we evaluated exposure to GLM only, other anti-TNFα agents, and both (i.e., overlapping exposure). For ACN, we evaluated exposure to GLM, other anti-TNFα agents, and TPs. Results: Sixty-four colectomy cases and 10 ACN cases were identified among patients exposed to GLM (N = 474), other anti-TNFα agents (N = 1737), or TPs (N = 1380). Incidence rates per 1000 person-years and 95% confidence intervals were reported for colectomy (GLM–only [4.4, 1.2–11.2] and other anti-TNFα agents only [12.4, 9.1–16.5]) and ACN (GLM [1.5, 0.2–5.4], other anti-TNFα agents [1.3, 0.5–2.8], and TPs [1.0, 0.3–2.6]). In comparisons excluding overlapping exposure, GLM was not associated with an increased risk of colectomy versus other anti-TNFα agents. GLM was also not associated with an increased risk of ACN versus either comparator. Observed events, especially for ACN, were limited for all exposures. Conclusions: Findings do not indicate an increased risk of colectomy due to intractable disease or ACN with GLM use versus other therapies for similar disease severity in routine UC care (EUPAS15752).