- 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.
- 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%).
- Phase 3 randomized controlled trial among 83 adolescent and adult patients with NMOSD.
- Randomization: satralizumab vs placebo, added to stable immunosuppressant therapy.
- Main outcome: first relapse.
- Funding: Chugai Pharmaceutical.
- Small group sizes.
- Lack of an active comparator.
- Inability to assess differences at weekly intervals.