Table 3.
Clinical and MRI endpoints: PRISMS subgroup
| Placebo (n = 28) | sc IFN β-1a 44 µg tiw (n = 31) | p | |
|---|---|---|---|
| Number of relapses at year 2 | |||
| Mean (SD) | 3.1 (1.84) | 1.2 (1.20) | |
| Median | 3.0 | 1.0 | < 0.0001a |
| Patients relapse free at year 2, n (%) | 2 (7.1) | 10 (32.3) | 0.0177b |
| Time to first relapse | |||
| Median, days (months) | 84 (2.8) | 324 (10.6) | 0.0012c |
| Time to 3-month confirmed disability progression | |||
| First quartile, days (months) | 218 (7.2) | 638 (21.0) | 0.0481c |
| T2 burden of disease, % change | |||
| Median (mean) | 5.4 (12.2) | –6.9 (0.7) | 0.0207d |
| Active T2 lesions per patient per scan | |||
| Median (mean) | 1.9 (2.6) | 0.5 (0.9) | 0.0002d |
EDSS Expanded Disability Status Scale, IFN β-1a interferon beta-1a, MRI magnetic resonance imaging, sc subcutaneous, SD standard deviation, tiw three times weekly
aIndependent sample t test
bCochran–Mantel–Haenszel chi-square test
cLog-rank test
dAnalysis of variance on the ranks with effects for baseline EDSS subgroup, center, and interaction between treatment and baseline EDSS subgroups