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

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 evaluate

SUBMITTER: Domenech E 

PROVIDER: S-EPMC12319186 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature