Takeaway
- Compared with intramuscular interferon β-1a, ozanimod is safe and more efficacious for reducing relapses among patients with relapsing multiple sclerosis (MS).
Key results
- RADIANCE trial:
- Adjusted annualised relapse rate:
- 0.28 interferon β-1a.
- 0.17 with ozanimod 1.0 mg (rate ratio, 0.62; P<.0001).
- 0.22 with ozanimod 0.5 mg (rate ratio, 0.79; P=.0167).
- No significant differences in disability progression.
- Treatment-emergent adverse events:
- 83.0% with interferon β-1a.
- 74.7% with ozanimod 1.0 mg.
- 74.3% with ozanimod 0.5 mg.
- Similar rates of infections, serious treatment-emergent adverse events.
- No ozanimod-related symptomatic reduction in heart rate, second- or third-degree atrioventricular block.
- Adjusted annualised relapse rate:
- SUNBEAM trial:
- Adjusted annualised relapse rate:
- 0.35 with interferon β-1a.
- 0.18 with ozanimod 1.0 mg (rate ratio, 0.52; P<.0001).
- 0.24 with ozanimod 0.5 mg (rate ratio, 0.69; P=.0013).
- Treatment-emergent adverse events:
- 75.5% with interferon β-1a.
- 59.8% with ozanimod 1.0 mg.
- 57.2% with ozanimod 0.5 mg.
- Similar rates of infection, serious treatment-emergent adverse events.
- No first-dose, clinically significant bradycardia; second- or third-degree atrioventricular block.
- Adjusted annualised relapse rate:
Expert comment
- In a comment, Ellen M. Mowry, MD, and John R. Corboy, MD, write, “How, if ozanimod is approved for use in multiple sclerosis, will it fit into the burgeoning landscape of sphingosine 1-phosphate receptor modulators or the crowded field of approved disease-modifying therapies?... Although its cost will be relevant, prescribers will almost certainly consider perceived effectiveness versus risks.”
Study design
- International phase 3 randomised controlled trials among adults with relapsing MS, recent inflammatory disease activity:
- RADIANCE: 1320 patients, 24-month follow-up.
- SUNBEAM: 1346 patients, mean 13.5-month follow-up.
- Randomisation: once-daily oral ozanimod 1.0 or 0.5 mg or weekly intramuscular interferon β-1a 30 μg.
- Main outcome: annualised relapse rate.
- Funding: Celgene International II.
Limitations
- Uncertain generalisability.
- Only single comparator.
- Long-term risk for progressive multifocal leukoencephalopathy unknown.
References
References