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Abstract

Ozanimod is the first sphingosine 1-phosphate (S1P) receptor modulator approved for the treatment of moderately to severely active ulcerative colitis (UC). In clinical trials, participants with moderately to severely active UC who received once-daily oral ozanimod demonstrated significantly improved rates of clinical, endoscopic, and histologic outcomes than participants receiving placebo. Ozanimod is also approved for the treatment of relapsing forms of multiple sclerosis (MS). This review summarizes safety data from UC and MS clinical trials and discusses treatment considerations when using ozanimod in clinical practice. Ozanimod is an oral, small molecule agent with a novel mechaism of action that differentiates it from other UC therapies. Ozanimod was generally well tolerated in clinical trials, and the incidence of adverse events of special interest based on prior associations with S1P receptor modulation was low overall. Of note, the risk for clinically significant bradycardia upon treatment initiation was mitigated by gradual dose titration, few patients experienced lymphopenia or serious infections, macular edema and malignancy occurred infrequently, and most hepatic events were transient and did not require treatment discontinuation. Given the safety and efficacy profile of ozanimod, it may be an early treatment option in patients with moderate disease or in those hesitant to use biologics, and it could also be beneficial after other treatments have failed. Further investigation is needed to determine the positioning of ozanimod within the UC treatment armamentarium.

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