- For patients with neuromyelitis optica spectrum disorder (NMOSD), satralizumab alone is efficacious and safe for reducing relapses.
Why this matters
- 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>
- 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).
- Modest group sizes.
- Relatively low relapse rate.