Ozanimod

(Zeposia®)

Zeposia®

Drug updated on 5/1/2024

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 used for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. It is also indicated for treating moderately to severely active ulcerative colitis (UC) in adults.
  • According to a systematic review with frequentist network meta-analysis, ozanimod was associated with fewer adverse events compared to other high-efficacy disease-modifying therapies such as natalizumab, fingolimod, alemtuzumab, cladribine and ocrelizumab among adult patients with relapsing-remitting MS.
  • A Bayesian network meta-analysis found that monoclonal antibody therapies were more efficacious than newer treatments like ozanimod for reducing annualised relapse rate and time to confirmed disability progression in patients with RMS.
  • In terms of safety outcomes among moderate-to-severe ulcerative colitis patients treated by biologics or small molecule drugs like ozanimod; vedolizumab ranked lowest while upadacitinib had the highest ranking based on surface under the cumulative ranking probabilities from a systematic review and network meta-analysis study.
  • The use of Sphongosine-1-phospate receptors modulators including Ozanimod increased cardiovascular adverse events risk by 1.21 times according to an analysis involving seventeen randomized controlled trials published through January 2021 which included over thirteen thousand participants suffering from MS.
  • From a total number of seven Systematic Reviews / Meta-Analyses documents reviewed on Zeposia's efficacy against Multiple Sclerosis & Ulcerative Colitis, it was observed that Amiselimod emerged as most effective therapeutic strategy amongst all sphongosine-1-phosphate receptor modulators studied so far but further research is needed before confirming these findings.

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
Ozanimod for treating moderately to severely active ulcerative colitis.2022NICE
Comparative safety of high‑efficacy disease‑modifying therapies. in relapsing–remitting multiple sclerosis: a systematic review and network meta‑analysis. 2022Neurological Sciences
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