Ozanimod

(Zeposia®)

Zeposia®

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Drug updated on 5/17/2024

Dosage FormCapsule (oral; 0.23 mg, 0.46 mg, 0.92 mg)
Drug ClassSphingosine 1-phosphate receptor modulators
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
  • Indicated for treating moderately to severely active ulcerative colitis (UC) in adults.

Summary
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  • Ozanimod (Zeposia) is indicated for the treatment of relapsing forms of multiple sclerosis (MS) and moderately to severely active ulcerative colitis (UC) in adults. It significantly reduces the annualized relapse rate and the number of new or enlarging T2 lesions, highlighting its efficacy.
  • Eleven systematic reviews/meta-analyses provided insights into the safety, efficacy, and comparison of Ozanimod with other drugs across different populations and subgroups.
  • In terms of cardiovascular safety, Ozanimod presents an increased risk compared to placebo, but may have a more favorable profile than similar agents like fingolimod, suggesting careful consideration of its use.
  • For treating ulcerative colitis, Ozanimod has proven to be effective without leading to a significantly higher increase in adverse events, making it a viable option for induction therapy.
  • Compared to classic immunosuppressants such as alemtuzumab for the treatment of RRMS, Ozanimod offers better safety while maintaining reasonable efficacy levels, thus presenting itself as an attractive alternative where high-efficacy treatments pose significant risks.
  • When used for treating ulcerative colitis patients who are not responding well enough or are intolerant towards traditional biologics or newer small molecule options, Ozanimod can serve as an effective induction therapy with a manageable side effects profile.
  • Subgroup considerations suggest that Ozanimod might be preferable among patients where cardiovascular risk factors exist, due to its relatively moderate impact on heart rate and blood pressure compared to other S1PR modulators.
  • Ozanimod's balance between effectiveness at reducing disease activity and managing side effect profiles makes it competitive within both the MS and UC therapeutic landscapes. However, further direct comparisons within specific population groups would help elucidate optimal use cases.

Product Monograph / Prescribing Information

Document TitleYearSource
Zeposia (ozanimod) Prescribing Information.2023Celgene Corporation, Summit, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis.2024The Cochrane Database of Systematic Reviews
Comparative efficacy of therapies for relapsing multiple sclerosis: a systematic review and network meta-analysis.2023Journal of Comparative Effectiveness Research
Efficacy and safety of biologics and small molecule drugs for patients with moderate-to-severe ulcerative colitis: a systematic review and network meta-analysis.2022The Lancet. Gastroenterology & Hepatology
Comparative safety of high-efficacy disease-modifying therapies in relapsing–remitting multiple sclerosis: a systematic review and network meta-analysis.2022Neurological Sciences
Risk for cardiovascular adverse events associated with sphingosine-1-phosphate receptor modulators in patients with multiple sclerosis: Insights from a pooled analysis of 15 randomised controlled trials.2021Frontiers in Immunology
Efficacy and acceptability of the S1P receptor in the treatment of multiple sclerosis: a meta-analysis.2021Neurological Sciences
Efficacy classification of modern therapies in multiple sclerosis.2021Journal of Comparative Effectiveness Research
Matching-adjusted indirect treatment comparison of ozanimod versus teriflunomide for relapsing multiple sclerosis.2021Multiple Sclerosis and Related Disorders
Comparative efficacy and safety of ozanimod and dimethyl fumarate for relapsing-remitting multiple sclerosis using matching-adjusted indirect comparison.2021CNS Drugs
Cardiac autonomic dysfunction in multiple sclerosis: a systematic review of current knowledge and impact of immunotherapies.2020Journal of Clinical Medicine
Ozanimod for treatment of relapsing-remitting multiple sclerosis in adults: a systematic review and meta-analysis of randomized controlled trials.2020Frontiers in Pharmacology

Clinical Practice Guidelines

Document TitleYearSource
Clinician's guide to using ozanimod for the treatment of ulcerative colitis.2023Journal of Crohn's & Colitis