Neuromyelitis optica spectrum disorder: fewer relapses with satralizumab

  • Traboulsee A & al.
  • Lancet Neurol
  • 1 May 2020

  • curated by Susan London
  • Clinical Essentials
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Takeaway

  • For patients with neuromyelitis optica spectrum disorder (NMOSD), satralizumab alone is efficacious and safe for reducing relapses.

Why this matters

Key results

  • Median double-blind treatment duration: 92.3 weeks for satralizumab, 54.6 weeks for placebo.
  • Incidence of relapse:
    • 30% satralizumab vs 50% placebo.
    • HR, 0.45 (P=.018).
  • Greater efficacy with seropositivity for aquaporin-4 antibody (HR, 0.26; 95% CI, 0.11-0.63) vs seronegativity (HR, 1.19; 95% CI, 0.30-4.78).
  • Adverse event (AE) rates:
    • Satralizumab: 473.9 events per 100 patient-years. 
    • Placebo: 495.2 events per 100 patient-years.
  • Groups comparable for serious AEs, AEs leading to withdrawal.
  • Similar findings in open-label phase 2 randomized controlled trial (TANGO) of tocilizumab (another IL-6 receptor antibody) vs azathioprine in highly relapsing NMOSD (HR, 0.236; P<.0001>

Study design

  • Multinational phase 3 double-blind randomized controlled trial, 95 adults aged 18-74 years with NMOSD:
    • ≥1 attack or relapse in past year.
    • ≤6.5 score on Expanded Disability Status Scale.
  • Randomly allocated 2:1 to satralizumab or placebo subcutaneously, weeks 0, 2, 4, and every 4 weeks thereafter.
  • Main outcome: time to first relapse.
  • Funding: Chugai Pharmaceutical (Roche).

Limitations

  • Modest group sizes.
  • Relatively low relapse rate.