Drug updated on 10/28/2024
Dosage Form | Capsule (oral; 0.23 mg, 0.46 mg, 0.92 mg) |
Drug Class | Sphingosine 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.
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Zeposia (ozanimod) Prescribing Information. | 2024 | Celgene Corporation, Summit, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Clinician's guide to using ozanimod for the treatment of ulcerative colitis | 2023 | Journal of Crohn's & Colitis |