REAL WORLD EFFECTIVENESS AND SAFETY OF OZANIMOD: INITIAL RESULTS FROM A LARGE TERTIARY CENTER

Abstract

Abstract BACKGROUND In May 2021 the United Stated Food and Drug Administration (FDA) approved the use of ozanimod for moderate to severe ulcerative colitis (UC) based on the results of the pivotal phase 3 TRUE NORTH trials. We present the first report of real world data describing the use of ozanimod in clinical practice. METHODS This prospective, observational cohort study includes consecutive patients with active UC who initiated ozanimod at our center following FDA approval. We collected demographic, clinical, and laboratory data. Clinical disease activity was assessed using the Simple Clinical Colitis Activity Index (SCCAI). Clinical response was defined as a decrease in ≥3 points in SCCAI from baseline, and clinical remission was defined as an SCCAI score of ≤ 2. Adverse events were extracted from the electronic medical records (EMR) and regular clinical pharmacist follow up. RESULTS 18 patients have initiated ozanimod therapy at our center. We observed 15 patients with UC, 1 patient with indeterminate colitis (IC), 1 patient with Crohn’s colitis, and 1 patient with lymphocytic colitis. All patients were included in the safety analysis and only patients with UC or IC were included in the effectiveness analysis. The mean age was 44.7 ± 18.5 with a mean age at disease duration of 9.6 ± 10.4. Ten (62%) patients were male, most patients 11 (69) had left sided colitis; 12 (75%) had previous biologic exposure. Additional demographics are described in Table 1. At week 4, follow up was available for 11 patients. Among these, 7 (64%) patients demonstrated clinical response, 2 (18%) were in clinical remission, and 1 patient achieved corticosteroid (CS) free remission. At week 8, follow up data was available for 7 patients; 3 (43%) patients had a clinical response and 1 (14%) patient achieved CS free remission (Figure 1A). 7 patients had complete blood counts at weeks 0 and 4, and all of these patients had a reduction in absolute lymphocyte counts (mean ± SD 1.46±0.47 109 cells/liter) (Figure 1B). There were 5 adverse events during the follow up period, none of which required treatment cessation. 1 patient had self-limited gastroenteritis, 1 patient had transient fatigue and another transient nausea. 1 patient developed mild liver enzyme derangement. 1 patient had non-specific chest pain and therapy was paused for a day until investigations returned negative. CONCLUSION This is the first real world data from a relatively treatment refractory cohort of UC patients and shows promising effectiveness and safety of ozanimod. Longer follow-up in larger patient cohorts is required to assess ozanimod’s role in clinical practice.