Table 2 Study outcomes
IFNB (n=9) | NTZ (n=10) | p-value | |
|---|---|---|---|
Median time to first on study relapse (primary endpoint)* | 103 days | - | 0.125 |
Number of relapses^ | 3 | 0 | 0.447 |
Proportion of relapse free patients (number)° | 78% (7) | 100% (10) | 0.206 |
Severity of relapses: | |||
- EDSS score change, median (range) | 0.5 (0.5 -1.5) | - | - |
Number of patients with 3 months confirmed disability progression°: | |||
(1 patient showed a disability progression of 1.5 points 1 month after an attack occurred during month 11 of study) | 0 | 0 | 1 |
Number of nT2L, median (range) ^ | |||
- at month 3 | 0.5 (0–2) | 0 (0–1) | 0.146 |
- at month 6 | 1.5 (0–9) | 0 (0–2) | 0.043 |
- at month 9 | 0.5 (0–6) | 0 (0) | 0.105 |
- at month 12 | 0 (0–12) | 0 (0) | 0.234 |
Number of Gd+L, median (range) ^ | |||
- at month 3 | 0 (0–1) | 0 (0) | 0.696 |
- at month 6 | 0 (0–5) | 0 (0) | 0.442 |
- at month 9 | 0 (0–1) | 0 (0) | 0.694 |
- at month 12 | 0 (0–2) | 0 (0–1) | 0.694 |
Adverse events | |||
- number of infection, median (range) ^ | 0 | 1 | 0.140 |
- proportion of patients with at least 1 infection ° | 3 (33%) | 7 (70%) | 0.179 |
- number of patients with injection site reactions | 4 | n.a. | - |