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

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. METHOD(S): 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