Table 2.
Patient demographics and baseline characteristics (randomised; intention-to-treat cohort)
| Characteristic | Fingolimod | IFN β-1a | Total |
| N=107 | N=108 | N=215 | |
| Age (years) | 15.2±2.00 | 15.4±1.60 | 15.3±1.81 |
| Median (range) | 16.0 (10–17) | 16.0 (11–18*) | 16.0 (10–18*) |
| Sex, female, n (%) | 70 (65.4) | 64 (59.3) | 134 (62.3) |
| Race, n (%) | |||
| Caucasian | 100 (93.5) | 97 (89.8) | 197 (91.6) |
| American Indian or Alaska Native | 3 (2.8) | 2 (1.9) | 5 (2.3) |
| Black | 1 (0.9) | 4 (3.7) | 5 (2.3) |
| Asian | 1 (0.9) | 0 | 1 (0.5) |
| Other | 2 (1.9) | 5 (4.6) | 7 (3.3) |
| Weight group (kg), n (%) | |||
| >40 | 98 (91.6) | 107 (99.1) | 205 (95.3) |
| Pubertal status (Tanner staging score)†, n (%) | |||
| Prepubertal (<2) | 7 (6.5) | 3 (2.8) | 10 (4.7) |
| Pubertal (score ≥2) | 98 (91.6) | 105 (97.2) | 203 (94.4) |
| Duration of MS since diagnosis (years) | 1.1±1.25 | 1.4±1.48 | 1.2±1.38 |
| Median (range) | 0.7 (0–8) | 0.8 (0–7) | 0.7 (0–8) |
| No. of relapses in the year before screening | 1.5±0.95 | 1.5±0.92 | 1.5±0.93 |
| Median (range) | 1.0 (0–4) | 1.0 (0–7) | 1.0 (0–7) |
| No. of relapses in the 2 years before screening | 2.4±1.44 | 2.5±1.32 | 2.4±1.38 |
| Median (range) | 2.0 (0–8) | 2.0 (1–9) | 2.0 (0–9) |
| Treatment history, n (%) | |||
| Treatment-naïve | 69 (64.5) | 67 (62.0) | 136 (63.3) |
| Any IFN β | 34 (31.8) | 35 (32.4) | 69 (32.1) |
| Glatiramer acetate | 6 (5.6) | 9 (8.3) | 15 (7.0) |
| Natalizumab | 2 (1.9) | 2 (1.9) | 4 (1.9) |
| Dimethyl fumarate | 0 (0.0) | 1 (0.9) | 1 (0.5) |
| No. of Gd+ T1 lesions | n=106 | n=107 | n=213 |
| Mean (SD) | 2.6±6.01 | 3.1±6.49 | 2.9±6.25 |
| Median (range) | 1.0 (0–52) | 0.0 (0–37) | 1.0 (0–52) |
| Proportion of patients free from Gd+ lesions, n (%) | 47 (44.3) | 59 (55.1) | 106 (49.8) |
| Volume of Gd+ T1 lesions (mm3) | n=106 | n=107 | n=213 |
| Mean (SD) | 454 (1190.4) | 412 (936.6) | 433 (1068.1) |
| Median (range) | 73 (0–9662) | 0 (0–6160) | 23 (0–9662) |
| No. of T2 lesions | n=107 | n=107 | n=214 |
| Mean (SD) | 41.9 (30.33) | 45.6 (33.85) | 43.7 (32.11) |
| Median (range) | 31.0 (2–126) | 32.0 (4–145) | 31.5 (2–145) |
| Proportion of patients free from T2 lesions, n (%) | 0 | 0 | 0 |
| Volume of T2 lesions (mm3) | n=107 | n=107 | n=214 |
| Mean (SD) | 8902 (13 147.6) | 11 512 (15 087.0) | 10 207 (14 177.8) |
| Median (range) | 5245 (52–116 533) | 6197 (189–101 099) | 5548 (52–116 533) |
| Volume of T1 hypointense lesions (mm3) | n=107 | n=107 | n=214 |
| Mean (SD) | 1591 (3906.5) | 2609 (5823.8) | 2100 (4973.3) |
| Median (range) | 484 (0–35 394) | 753 (0–46 893) | 592 (0–46 893) |
| Whole brain volume (cm3) | n=107 | n=105 | n=212 |
| Mean (SD) | 1154 (126.8) | 1160 (121.5) | 1157 (124.0) |
| Median (range) | 1146 (917–1633) | 1136 (910–1487) | 1139 (910–1633) |
*These individuals were confirmed as being <18 years of age at randomisation; local laws permitted only their birth year to be recorded.
†Tanner staging scores, based on the higher score assigned for breast development and for pubic hair assessment in female patients, and the higher score assigned for genital stage and for pubic hair assessment in male patients. A bone age ≥16 years and/or menarche for female patients was considered as pubertal if the Tanner staging score was missing. n, number of patients included in each analysis.
Gd+, gadolinium-enhancing; IFN, interferon; MS, multiple sclerosis.