Add-on satralizumab cuts relapse risk in neuromyelitis optica spectrum disorder

  • Yamamura T & al.
  • N Engl J Med
  • 28 Nov 2019

  • International Clinical Digest
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Takeaway

  • Adding satralizumab, an antibody targeting interleukin-6 receptor, to stable immunosuppressant therapy reduced relapse risk in patients with neuromyelitis optica spectrum disorder (NMOSD) but did not reduce pain or fatigue.

Why this matters

  • Lack of safe, effective treatments for this disorder.

Key results

  • Median treatment duration during double-blind period: 107.4 weeks.
  • Relapse rate: 20% with satralizumab, 43% with placebo (HR, 0.38; 95% CI, 0.16-0.88).
  • Findings were similar with multiple imputations for censored data.
  • Benefit by anti–aquaporin-4 (AQP4-IgG) status:
    • Significant among seropositive patients (11% vs 43%; HR, 0.21; 95% CI, 0.06-0.75).
    • Not significant among seronegative patients (36% vs 43%; HR, 0.66; 95% CI, 0.20-2.24).
  • Groups statistically indistinguishable on change in:
    • Mean visual-analogue scale pain score (difference, 4.08; 95% CI, −8.44 to 16.61).
    • Mean Functional Assessment of Chronic Illness Therapy–Fatigue score (difference, −3.10; 95% CI, −8.38 to 2.18).
  • Groups were similar on rates of serious adverse events (90% vs 95%), infections (68% vs 62%).

Study design

  • Phase 3 randomised controlled trial among 83 adolescent and adult patients with NMOSD.
  • Randomisation: satralizumab vs placebo, added to stable immunosuppressant therapy.
  • Main outcome: first relapse.
  • Funding: Chugai Pharmaceutical.

Limitations

  • Small group sizes.
  • Lack of an active comparator.
  • Inability to assess differences at weekly intervals.