Relapsing MS: ozanimod does well in phase 3 trial

  • Lancet Neurol

  • International Clinical Digest
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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.
  • 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.

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.