Table 2 MRI and clinical endpoints in the core (months 0–6) and extension phases (months 7–12) (MRI and clinical analysis populations)
Continuous fingolimod groups | Placebo to fingolimod switch groups | |||
|---|---|---|---|---|
Fingolimod 0.5 mg | Fingolimod 1.25 mg | Placebo-fingolimod 0.5 mg | Placebo-fingolimod 1.25 mg | |
MRI outcomes (MRI analysis population) | n = 45 | n = 42 | n = 23 | n = 20 |
Patients free of Gd-enhancing lesions, n/totala (%) | ||||
Both months 3 and 6 | 35/45 (77.8) | 37/42 (88.1) | 6/23 (26.1) | 11/20 (55.0) |
Both months 9 and 12 | 38/45 (84.4) | 36/42 (85.7) | 16/23 (69.6) | 13/19 (68.4) |
Number of Gd-enhancing lesions | ||||
Month 6 | 0.1 (0.32) | 0.2 (1.08) | 1.3 (1.84) | 1.2 (1.96) |
Month 12 | 0.0 (0.15) | 0.0 (0.15) | 0.1 (0.31) | 0.2 (0.54) |
Patients free of new/newly enlarged T2 lesions, n/totala (%) | ||||
Months 0–6 | 30/45 (66.7) | 24/42 (57.1) | 5/23 (21.7) | 10/19 (52.6) |
Months 7–12 | 39/45 (86.7) | 37/42 (88.1) | 13/21 (61.9) | 11/17 (64.7) |
Number of new/newly enlarged T2 lesions | ||||
Months 0–6 | 0.9 (2.1) | 1.0 (2.0) | 7.7 (14.5) | 5.1 (6.8) |
Months 7–12 | 0.3 (1.1) | 0.2 (0.5) | 0.6 (1.2) | 0.5 (0.9) |
Clinical outcomes (clinical analysis population) | n = 47 | n = 46 | n = 27 | n = 23 |
Patients free of relapse, nb (%) | ||||
Months 0–6 | 38 (80.9) | 38 (82.6) | 18 (66.7) | 14 (60.9) |
Months 7–12 | 42 (89.4) | 41 (89.1) | 24 (88.9) | 21 (91.3) |
Annualized relapse ratec | ||||
Months 0–6 | 0.47 | 0.39 | 0.97 | 1.22 |
Months 7–12 | 0.23 | 0.28 | 0.26 | 0.21 |
EDSS score change from core baseline | ||||
Month 6 | 0.00 (0.36) | −0.21 (0.59) | 0.04 (1.00) | 0.26 (0.78) |
Month 12 | −0.02 (0.46) | −0.02 (0.83) | −0.32 (0.66) | −0.11 (0.95) |