Table 2.
Baseline characteristics
| Items | All | Patients from phase 2 study | Natalizumab-naïve patients |
|---|---|---|---|
| Total number of patients, n (%) | 106 | 33 | 73 |
| Female, n (%) | 66 (62.3) | 21 (63.6) | 45 (61.6) |
| Inpatient/outpatient status, n (%) | |||
| Outpatient | 94 (88.7) | 33 (100.0) | 61 (83.6) |
| Inpatient | 7 (6.6) | 0 (0.0) | 7 (9.6) |
| Inpatient/outpatient | 5 (4.7) | 0 (0.0) | 5 (6.8) |
| Age (years)a | |||
| Mean ± SD | 39.3 ± 10.8 | 40.2 ± 8.5 | 38.8 ± 11.7 |
| Median [min, max] | 39.0 [15, 78] | 39.5 [26, 59] | 39.0 [15, 78] |
| < 15 | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| ≥ 15 and < 65 | 94 (88.7) | 32 (97.0) | 62 (84.9) |
| ≥ 65 | 2 (1.9) | 0 (0.0) | 2 (2.7) |
| Body weight (kg)b | |||
| Mean ± SD | 55.3 ± 10.9 | 56.8 ± 11.0 | 54.7 ± 9.7 |
| Median [min, max] | 53.5 [39.9, 86.0] | 54.5 [43.0, 86.0] | 52.0 [39.9, 74.0] |
| MS typec, n (%) | |||
| Clinically isolated syndrome | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Relapsing–remitting type | 93 (87.7) | 29 (87.9) | 64 (87.7) |
| Secondary progressive type | 13 (12.3) | 4 (12.1) | 9 (12.3) |
| Primary progressive type | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Years from onset of MS (years)d | |||
| Mean ± SD | 10.0 ± 6.6 | 10.8 ± 5.9 | 9.7 ± 6.8 |
| Median [min, max] | 8.5 [0.5, 33.4] | 8.6 [3.2, 26.3] | 8.1 [0.5, 33.4] |
| Prior MS therapy, n (%) | |||
| DMT-naïve | 20 (18.9) | 7 (21.2) | 13 (17.8) |
| IFN only | 34 (32.1) | 21 (63.6) | 13 (17.8) |
| Fingolimod only | 19 (17.9) | 0 (0.0) | 19 (26.0) |
| Switched between IFN and fingolimod | 33 (31.1) | 5 (15.2) | 28 (38.4) |
| Number of relapses in past 1 year, n (%) | |||
| 0 | 58 (54.7) | 26 (78.8) | 32 (43.8) |
| 1e | 25 (23.6) | 3 (9.1) | 22 (30.1) |
| 2e | 13 (12.3) | 2 (6.1) | 11 (15.1) |
| ≥ 3e | 7 (6.6) | 1 (3.0) | 6 (8.2) |
| Unknown | 3 (2.8) | 1 (3.0) | 2 (2.7) |
| Mean ± SDe | 0.7 ± 1.0 | 0.3 ± 0.9 | 0.9 ± 1.1 |
| Median [min, max]e | 0.0 [0, 4] | 0.0 [0, 4] | 1.0 [0, 4] |
| EDSS scoref | |||
| Mean ± SD | 2.89 ± 2.33 | 2.53 ± 1.97 | 3.05 ± 2.47 |
| Median [min, max] | 2.00 [0.0, 8.5] | 2.00 [0.0, 7.0] | 2.50 [0.0, 8.5] |
MS multiple sclerosis, DMT disease-modifying therapy, EDSS expanded disability status scale, SD standard deviation
a n = 96 overall; patients from phase 2 study, n = 32; natalizumab-naïve patients, n = 64
b n = 93 overall; patients from phase 2 study, n = 28; natalizumab-naïve patients, n = 65
cMS type was diagnosed by physicians
d n = 105 overall; natalizumab-naïve patients, n = 72
eExcept for unknown patients (n = 103 overall; patients from the phase 2 study, n = 32; natalizumab-naïve patients, n = 71)
f n = 104 overall; patients from the phase 2 study, n = 32; natalizumab-naïve patients, n = 72