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  • Title: Ozanimod: A Review in Ulcerative Colitis.
    Author: Paik J.
    Journal: Drugs; 2022 Aug; 82(12):1303-1313. PubMed ID: 35994200.
    Abstract:
    Ozanimod (Zeposia®) is the first sphingosine-1-phosphate receptor (S1PR) modulator to be approved for the treatment of adults with moderately to severely active ulcerative colitis in the USA, and in adults with moderately to severely active ulcerative colitis who have had an inadequate or lost response to, or were intolerant of, either conventional therapy or a biologic in the EU. An oral agent, ozanimod is administered once daily as induction and maintenance therapy. In the randomized, double-blind, multinational phase 2 Touchstone and phase 3 True North clinical trials, ozanimod was effective in inducing clinical remission and maintaining remission relative to placebo in adults with moderately to severely active ulcerative colitis. Ozanimod was generally well tolerated in these studies, with manageable or transient adverse events (AEs). Current data from the Touchstone and True North open-label extensions are consistent with the primary studies with respect to therapeutic efficacy and tolerability, with no new safety signals observed. Although further data will be beneficial, ozanimod expands the treatment options for adults with moderately to severely active ulcerative colitis. Ulcerative colitis is a chronic inflammatory bowel disease involving a dysregulated immune response in the intestinal mucosa. Conventional therapy options for moderate to severe ulcerative colitis are initially effective, but associated with increased risk of adverse events, resistance to treatment, or loss of response over time. Consequently, small molecule drugs have become of interest as alternative treatment options. Ozanimod (Zeposia®) is an oral drug that targets and modulates the activity of sphingosine-1-phosphate receptors to reduce the movement of lymphocytes from the lymph nodes to sites of inflammation. Compared with placebo, ozanimod significantly improved rates of clinical remission and was generally well tolerated in adults with moderately to severely active ulcerative colitis. Findings from open-label extension studies suggest that ozanimod remains efficacious and generally well tolerated with long-term use. Although further data will be beneficial, ozanimod expands the treatment options for adults with moderately to severely active ulcerative colitis.
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