Original assignment in pivotal trial | Duration of time on IFNB-1b treatment | ||||||
Placebo | IFNB-1b 50 μg | IFNB-1b 250 μg | <10% | 10–79% | ≥80% | ||
Number of patients | N | 79 | 85 | 96 | 70 | 162 | 28 |
Gender | N (% female) | 56 (70.9) | 59 (69.4) | 64 (66.7) | 50 (71.4) | 111 (68.5) | 18 (64.3) |
Age (y) at onset of disease | Mean (SD) | 27.7 (6.7) | 27.6 (7.9) | 26.8 (5.9) | 27.3 (7.2) | 27.5 (6.8) | 26.2 (6.5) |
Median | 28.0 | 26.0 | 27.0 | 27.0 | 27.0 | 26.5 | |
Age (y) at start of trial | Mean (SD) | 35.5 (6.9) | 35.6 (8.3) | 35.0 (6.9) | 35.7 (7.9) | 35.2 (7.2) | 35.2 (6.9) |
Median | 36.0 | 36.0 | 35.0 | 36.0 | 35.0 | 35.5 | |
EDSS at baseline | Mean (SD) | 2.85 (1.29) | 2.82 (1.35) | 2.99 (1.34) | 2.95 (1.28) | 2.85 (1.38) | 2.96 (1.09) |
Median | 3.00 | 2.50 | 3.00 | 3.00 | 3.00 | 3.00 | |
Baseline EDSS ≥3.0 | % | 55.7 | 49.4 | 54.2 | 54.3 | 51.9 | 57.1 |
Duration of disease since onset (y) | Mean (SD) | 7.86 (6.28) | 7.97 (6.56) | 8.19 (5.72) | 8.38 (6.20) | 7.70 (6.25) | 8.97 (5.48) |
Median | 6.10 | 5.70 | 7.10 | 6.35 | 6.00 | 7.50 | |
MSSS at baseline | Mean (SD) | 4.42 (2.46) | 4.20 (2.27) | 4.34 (2.13) | 4.25 (2.24) | 4.37 (2.34) | 4.20 (1.99) |
Median | 4.55 | 3.90 | 4.33 | 3.87 | 4.28 | 4.18 | |
MRI T2 BOD (mm3) at baseline | Mean (SD) | 1949.85 (1969.59) | 2097.78 (2457.43) | 1847.14 (1590.06) | 1845.97 (1896.34) | 1969.90 (2102.89) | 2191.69 (1853.52) |
Median | 1398.32 | 1333.10 | 1482.90 | 1404.53 | 1362.28 | 1820.00 | |
Relapse rate in prior 2 y | Mean (SD) | 1.70 (0.71) | 1.64 (0.71) | 1.69 (0.87) | 1.59 (0.61) | 1.69 (0.82) | 1.80 (0.82) |
Median | 1.50 | 1.50 | 1.50 | 1.50 | 1.50 | 1.50 |
EDSS, Expanded Disability Status Scale; MSSS, Multiple Sclerosis Severity Score32; MRI T2 BOD, magnetic resonance imaging T2-weighted burden of disease.