Ulcerative colitis (UC) is a chronic inflammatory bowel disease that often requires advanced therapies to manage moderate to severe symptoms. The clinical course of UC is unpredictable; there is no cure and it is a lifelong disorder that has a significant impact on a patient’s mental and physical well-being. Ozanimod is a selective sphingosine-1-phosphate receptor modulator approved for use in UC.
Research challenge
While clinical trial data have demonstrated ozanimod’s efficacy and short-term safety, there remains a critical need to understand its long-term safety profile in real-world settings, where patient demographics, comorbidities, and treatment patterns may differ substantially from controlled trial environments.
The objective is to evaluate whether ozanimod is associated with increased risks of serious adverse events compared with other advanced UC therapies, specifically focusing on malignancies, serious opportunistic infections (SOIs), major adverse cardiovascular events (MACE), venous thromboembolism (VTE), severe liver injury, and rare neurological events such as macular edema, posterior reversible encephalopathy syndrome (PRES), and progressive multifocal leukoencephalopathy (PML). This analysis needed to account for variations in age, disease history, and previous adverse outcomes, while integrating data from multiple European and UK health systems in a robust, reproducible way.
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