Baseline demographics and MS disease characteristics
| Characteristic | Fingolimod 0.5 mg (N=356) | IFN-switch fingolimod 0.5 mg (N=167) | Fingolimod 1.25 mg (N=330) | IFN-switch fingolimod 1.25 mg (N=174) | Total* (N=1027) |
|---|---|---|---|---|---|
| Demographics | |||||
| Age, years | 36.5 (8.7) | 36.1 (8.6) | 35.5 (8.4) | 36.1 (8.1) | 36 (8.5) |
| Female sex, n (%) | 235 (66) | 109 (65) | 227 (69) | 114 (66) | 685 (67) |
| Disease history | |||||
| First MS symptom to randomisation, years | 7.3 (6.2) | 7.6 (6.5) | 6.9 (5.8) | 7.0 (6.2) | 7.2 (6.1) |
| Relapses in the past year | 1.5 (1.3) | 1.4 (0.7) | 1.5 (0.9) | 1.4 (0.8) | 1.5 (1.0) |
| Relapses in the previous 2 years | 2.3 (2.3) | 2.2 (1.0) | 2.2 (1.2) | 2.2 (1.2) | 2.2 (1.7) |
| EDSS score | 2.2 (1.3) | 2.2 (1.2) | 2.2 (1.3) | 2.2 (1.2) | 2.2 (1.3) |
| MS treatment history | |||||
| Any therapy, n (%) | 202 (57) | 94 (56) | 190 (58) | 98 (56) | 584 (57) |
| Any IFNβ | 180 (51) | 77 (46) | 158 (48) | 81 (47) | 496 (48) |
| Glatiramer acetate | 42 (12) | 25 (15) | 44 (13) | 28 (16) | 139 (14) |
| Natalizumab | 2 (<1) | 1 (<1) | 3 (<1) | 0 (0) | 6 (<1) |
| MRI characteristics | |||||
| Patients free of Gd+ T1 lesions, n*/n (%) | 244/355 (69) | 104/165 (63) | 210/323 (65) | 110/170 (65) | 668/1013 (66) |
| Number of Gd+ T1 lesions | 1.0 (3.0) | 1.0 (2.5) | 1.5 (4.9) | 1.0 (3.1) | 1.2 (3.7) |
| Volume of T2 lesions, cm3 | 5.18 (6.93) | 4.79 (5.17) | 4.96 (5.75) | 4.52 (5.44) | 4.94 (6.05) |
| Normalised brain volume, cm3 | 1523.9 (82.8) | 1526.7 (73.6) | 1531.9 (73.1) | 1529.4 (77.2) | 1527.8 (77.4) |
Values are mean±SD unless otherwise stated.
n*=Number of patients free of Gd-enhanced T1 lesions.
n=Number of patients with values at the core baseline for the specified variable.
*Values indicated in the column entitled ‘Total’ also include fingolimod 1.25 mg and IFN-switch 1.25 mg groups’ data.
EDSS, Expanded Disability Status Scale; Gd+, gadolinium enhanced; IFN, interferon; MS, multiple sclerosis.