Ozanimod

(Zeposia®)

Zeposia®

Drug updated on 10/28/2024

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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  • This summary is based on the review of 10 systematic review(s)/meta-analysis(es). [1-10]
  • Ozanimod significantly reduced the annualized relapse rate (Bayesian NMAs for annualised relapse rate (ARR)) during the treatment period (Rate Ratio: -0.10 [95% CI (confidence interval): -0.15, -0.06]). Compared to teriflunomide, ozanimod further reduced ARR (Rate Ratio: 0.73; 95% CI: 0.62-0.84).
  • Ozanimod showed significant improvement in confirmed disability progression (adjusted indirect comparison to adjust for potential treatment effect modifiers and prognostic factors while assessing confirmed disability progression (CDP)) at 3 months compared to teriflunomide (Hazard Ratio [HR]: 0.78; 95% CI: 0.66-0.92), but the effect was not significant at 6 months (HR: 0.78; 95% CI: 0.60-1.01). A similar pattern was observed compared to dimethyl fumarate, with significant improvement at 3 months (HR: 0.67; 95% CI: 0.53-0.86) but not at 6 months (Rate Ratio: 0.89; 95% CI: 0.62-1.26).
  • Alemtuzumab, ofatumumab, and ublituximab ranked higher for ARR than ozanimod, though ozanimod was categorized as moderate-to-high efficacy depending on the comparison approach.
  • In ulcerative colitis (severe ulcerative colitis (UC)), ozanimod ranked lowest for induction of clinical response and remission at week 2 compared to upadacitinib and tofacitinib.
  • Ozanimod was associated with a lower rate of adverse events (AEs) compared to control (RR (relative risk): 0.64; 95% CI: 0.43–0.95), with a similar incidence of infection-related treatment-emergent AEs (nasopharyngitis and urinary tract infections) across groups.
  • S1PR modulators, including ozanimod, significantly increased the risk of cardiovascular adverse events (RR: 2.21; 95% CI: 1.58–3.10), and ozanimod was linked with a higher risk of hypertension (RR: 1.76; 95% CI: 1.10–2.82).
  • Compared with teriflunomide and dimethyl fumarate, ozanimod demonstrated significant reductions in overall AEs, serious AEs (SAEs), and discontinuations due to AEs.
  • Studies included adults with relapsing-remitting multiple sclerosis (remitting multiple sclerosis (RRMS)) and moderate-to-severe ulcerative colitis (UC). Gender distribution in RRMS participants was 68.6% female and 31.4% male. Ozanimod 1 mg showed superior efficacy over the 0.5 mg dose in RRMS without increasing adverse events.

Product Monograph / Prescribing Information

Document TitleYearSource
Zeposia (ozanimod) Prescribing Information.2024Celgene Corporation, Summit, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis2024The Cochrane Database of Systematic Reviews
Comparative efficacy of therapies for relapsing multiple sclerosis: a systematic review and network meta-analysis2023Journal of comparative effectiveness research
Comparative onset of effect of biologics and small molecules in moderate-to-severe ulcerative colitis: a systematic review and network meta-analysis2023EClinicalMedicine
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 Trials2021Frontiers in Immunology
Matching-adjusted indirect treatment comparison of ozanimod versus teriflunomide for relapsing multiple sclerosis2021Multiple Sclerosis and Related Disorders
Comparative Efficacy and Safety of Ozanimod and Dimethyl Fumarate for Relapsing-Remitting Multiple Sclerosis Using Matching-Adjusted Indirect Comparison2021CNS Drugs
Efficacy classification of modern therapies in multiple sclerosis2021Journal of Comparative Effectiveness Research
Efficacy and acceptability of the S1P receptor in the treatment of multiple sclerosis: a meta-analysis2021Neurological Sciences
Ozanimod for Treatment of Relapsing-Remitting Multiple Sclerosis in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials2020Frontiers in Pharmacology
Small molecule drugs in the treatment of inflammatory bowel diseases: which one, when and why? - a systematic review2020European Journal of Gastroenterology & Hepatology

Clinical Practice Guidelines

Document TitleYearSource
Clinician's guide to using ozanimod for the treatment of ulcerative colitis2023Journal of Crohn's & Colitis