Table 1.
Demographic characteristics, treatment history and disease characteristics at baseline (randomized population).
| Fingolimod 0.5 mg (N = 1214) | Placebo (N = 773) | IFNβ-1a IM (N = 435) | |
|---|---|---|---|
| Demographic characteristics | |||
| Age, years, mean (SD) | 37.8 (8.9) | 38.6 (8.6) | 36.0 (8.3) |
| Sex, female, n (%) | 853 (70.3) | 586 (75.8) | 295 (67.8) |
| Treatment history, n (%) | |||
| Treatment-naïve | 531 (43.7) | 345 (44.6) | 190 (43.7) |
| Previous MS treatment | |||
| Interferon-β 1a SC | 236 (19.4) | 143 (18.5) | 72 (16.6) |
| Interferon-β 1a IM | 313 (25.8) | 185 (23.9) | 118 (27.1) |
| Interferon-β 1b SC | 173 (14.3) | 120 (15.5) | 69 (15.9) |
| Glatiramer acetate | 228 (18.8) | 190 (24.6) | 67 (15.4) |
| Natalizumab | 25 (2.1) | 25 (3.2) | 1 (0.2) |
| Other | 87 (7.2) | 79 (10.2) | 16 (3.7) |
| Disease characteristics, mean (SD) | |||
| Number of Gd-enhancing lesions at baseline | 1.3 (4.1) | 1.2 (3.1) | 1.1 (2.8) |
| Number of relapses in the previous year | 1.5 (1.0) | 1.5 (0.8) | 1.5 (0.8) |
| Number of relapses in the previous 2 years | 2.2 (1.7) | 2.2 (1.3) | 2.3 (1.2) |
| EDSS score | 2.3 (1.3) | 2.5 (1.3) | 2.2 (1.3) |
| Time since MS diagnosis, years | 5.2 (5.3) | 5.7 (5.5) | 4.9 (5.4) |
EDSS, Expanded Disability Status Scale; Gd, gadolinium; IFN, interferon; IM, intramuscular; MS, multiple sclerosis; SC, subcutaneous; SD, standard deviation.