Ozanimod

(Zeposia®)

Ozanimod

Drug updated on 9/4/2024

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.

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Summary
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  • Zeposia (ozanimod) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults; and for treating moderately to severely active ulcerative colitis (UC) in adults.
  • This summary is based on the review of 11 systematic review(s)/meta-analysis(es). [1-11]
  • Annualized Relapse Rate (ARR) in RRMS: Ozanimod significantly reduced ARR compared to placebo and teriflunomide (rate ratio: 0.73; 95% CI: 0.62-0.84). Monoclonal antibody therapies (e.g., alemtuzumab, ofatumumab, ublituximab) were more effective than ozanimod in reducing ARR.
  • Disability Progression in RRMS: Ozanimod showed a significant improvement in 3-month confirmed disability progression (3mCDP) compared to teriflunomide (hazard ratio: 0.78; 95% CI: 0.66-0.92), but not in 6-month confirmed disability progression (6mCDP) (hazard ratio: 0.78; 95% CI: 0.60-1.01). Monoclonal antibody therapies were superior to ozanimod for both 3mCDP and 6mCDP.
  • MRI Lesion Activity in RRMS: Ozanimod was associated with a reduction in gadolinium-enhancing lesions (RR, -0.20; 95% CI, -0.34, -0.06) and new or enlarging T2 lesions (RR, -1.12; 95% CI, -1.52, -0.71) during the treatment period.
  • Clinical Remission in Ulcerative Colitis: Upadacitinib was superior to ozanimod in inducing clinical remission in patients with moderate-to-severe ulcerative colitis.
  • Adverse Events (AEs): Ozanimod showed a lower rate of overall AEs compared to teriflunomide (OR: 0.35; 95% CI: 0.29-0.43) and dimethyl fumarate (OR: 0.11; 95% CI: 0.08-0.16). However, it ranked highest for serious adverse events (SUCRA: 0.831) in moderate-to-severe ulcerative colitis.
  • Specific Adverse Events: Ozanimod was associated with a higher risk of hypertension (RR: 1.76; 95% CI: 1.10-2.82) and an increased risk of cardiovascular AEs among S1PR modulators (RR: 2.21; 95% CI: 1.58-3.10). No increased risk of bradyarrhythmia was observed.
  • Discontinuations Due to AEs: The rate of discontinuations due to AEs was lower with ozanimod compared to teriflunomide (OR: 0.14; 95% CI: 0.09-0.21) and dimethyl fumarate (OR: 0.11; 95% CI: 0.07-0.17).
  • There is no population types or subgroups information available in the reviewed studies.

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