S121 Ozanimod in Ulcerative Colitis: A Tertiary Care Center’s Experience Over One Year

Abstract

Background: It is estimated that the prevalence of ulcerative colitis (UC) in the United States is 465 per 100,000 people, with its incidence projected to increase further in the upcoming years. Although the advent of biologics has revolutionized UC therapeutics, a substantial proportion of patients suffer from refractory disease. Ozanimod is an oral sphingosine-1-phosphate receptor modulator that has been recently approved by the US Food and Drug Administration for moderate to severe UC therapy. Real-world experience with ozanimod in UC remains to be defined. The aim of this study is to evaluate the safety and efficacy of ozanimod in patients with UC at a tertiary medical center. Methods: We performed a retrospective chart review of patients with UC treated with ozanimod within the MedStar health system between June 2021 to June 2022. The following inclusion criteria were applied: individuals 18 years or older, histological diagnosis of UC, and initiated on ozanimod at a MedStar Gastroenterology site. Results: Eight patients with UC (mean age = 35.5 years; 50% women; mean disease duration = 12.4 years; 63 percent pancolitis, 25 percent proctosigmoiditis, 13 percent left-sided colitis) were identified and included in this study, all of whom were seen at MedStar Georgetown University Hospital. Baseline disease characteristics: mean Mayo Endoscopic Score = 2.4, mean CRP = 9.8 μg/g, and mean Fecal Calprotectin = 1276 μg/g. All patients had previously failed treatment with at least one biologic agent. Following ozanimod initiation, one patient entered clinical remission, 3 patients showed improvement in UC symptoms, 3 patients showed no improvement or worsening of UC symptoms (including one who had total colectomy within 10 days of initiation), and one patient discontinued ozanimod use due to relocating abroad. After a mean follow-up time of 4 months post-ozanimod initiation, patients had the following disease characteristics: mean CRP = 14.4 μg/g, and mean Fecal Calprotectin = 912.5 μg/g. Patients treated with ozanimod reported adverse events such as fatigue (n = 4), eye irritation (n = 3), joint pain (n = 2), nausea and vomiting (n = 2), shortness of breath (n = 1), chest pain (n = 1), and brain fog (n = 1). One patient discontinued ozanimod due to adverse events potentially related to ozanimod. Conclusion(s): Ozanimod is well-tolerated with minimal side effects in patients with UC. The overall clinical response to ozanimod was variable; however, most patients experienced improvement in UC symptoms. Considering that all patients had previously failed at least one biologic therapy, our experience indicates that ozanimod is effective in improving symptoms and inducing remission in patients with refractory disease. Future studies with a larger sample and extended follow-up period are warranted to define the efficacy and time to remission of ozanimod in UC patients.