Table 1 Baseline demographics and clinical characteristics of patients at entry to the core study (extension randomized population)
Characteristic | Placebo-fingolimod 0.5 mg (n = 27) | Placebo-fingolimod 1.25 mg (n = 23) | Fingolimod 0.5 mg (n = 47) | Fingolimod 1.25 mg (n = 46) |
|---|---|---|---|---|
Age, years | ||||
Mean (SD) | 34.2 (9.1) | 35.5 (8.4) | 34.9 (9.0) | 35.7 (8.8) |
Median (range) | 34.0 (18–52) | 34.0 (21–51) | 34.0 (19–52) | 36.0 (18–55) |
Female, n (%) | 19 (70.4) | 14 (60.9) | 33 (70.2) | 31 (67.4) |
BMI, kg/m2 | ||||
Mean (SD) | 21.0 (2.6) | 20.7 (3.1) | 21.8 (3.2) | 22.0 (3.9) |
Median (range) | 20.8 (15.0–26.2) | 20.2 (13.8–28.8) | 21.5 (15.1–32.6) | 21.1 (18.1–36.2) |
Duration of MS since first symptom, years | ||||
Mean (SD) | 8.4 (8.1) | 8.4 (7.2) | 8.2 (6.6) | 7.6 (5.5) |
Median (range) | 5.4 (1–27) | 5.9 (1–24) | 6.4 (1–26) | 6.2 (0–21) |
Number of relapses within previous year | ||||
Mean (SD) | 2.1 (2.1) | 1.4 (0.7) | 1.4 (0.9) | 1.5 (1.0) |
Median (range) | 2.0 (1–12) | 1.0 (0–3) | 1.0 (0–3) | 1.0 (0–4) |
EDSS score | ||||
Mean (SD) | 1.9 (1.6) | 2.4 (1.6) | 2.4 (1.9) | 1.9 (1.7) |
Median (range) | 1.5 (0.0–5.0) | 2.0 (0.0–5.5) | 2.0 (0.0–6.0) | 2.0 (0.0–6.0) |
Patients free of Gd-enhancing lesions | ||||
n (%) | 13 (48.1) | 17 (73.9) | 28 (59.6) | 22 (47.8) |
Number of Gd-enhancing lesions | ||||
Mean (SD) | 1.7 (2.5) | 0.7 (1.5) | 1.0 (1.6) | 1.7 (2.42) |
Median (range) | 1.0 (0–9) | 0.0 (0–5) | 0.0 (0–5) | 1.0 (0–9) |
Number of T2 lesions | ||||
Mean (SD) | 28.9 (23.2) | 33.3 (23.1) | 30.3 (22.8) | 34.6 (24.2) |
Median (range) | 23.0 (3–98) | 35.0 (1–91) | 24.0 (4–100) | 29.5 (5–119) |