Table 1.
Baseline characteristics of the patients (full analysis set)
| Variable | Mogamulizumab n = 33 |
Placebo n = 32 |
|
|---|---|---|---|
| Sex | Female | 24 (72.7) | 19 (59.4) |
| Male | 9 (27.3) | 13 (40.6) | |
| Age (years) | Mean ± SD | 62.2 ± 9.1 | 60.1 ± 10.0 |
| < 65 | 20 (60.6) | 19 (59.4) | |
| ≥ 65 | 13 (39.4) | 13 (40.6) | |
| Weight (kg) | Mean ± SD | 56.37 ± 10.15 | 59.63 ± 11.91 |
| Height (cm) | Mean ± SD | 157.26 ± 7.81 | 158.63 ± 8.18 |
| BMI (kg/m2) | Mean ± SD | 22.73 ± 3.14 | 23.58 ± 3.94 |
| Duration of HAM/TSP symptom (years) | Mean ± SD | 12.20 ± 7.95 | 14.30 ± 8.64 |
| < 10 | 14 (42.4) | 9 (28.1) | |
| ≥ 10 | 19 (57.6) | 23 (71.9) | |
| Walking aids | Unnecessary | 11 (33.3) | 10 (31.3) |
| Unilateral cane | 10 (30.3) | 12 (37.5) | |
| Bilateral cane | 12 (36.4) | 10 (31.3) | |
| Therapy for HAM/TSP (before screening) (multiple choices) | Corticosteroids | 32 (97.0) | 25 (78.1) |
| IFN-α | 7 (21.2) | 8 (25.0) | |
| Salazosulfapyridine | 4 (12.1) | 1 (3.1) | |
| Vitamin C (≥ 1.5)g/day) | 1 (3.0) | 1 (3.1) | |
| Medical history (ongoing at screening) | No | 1 (3.0) | 2 (6.3) |
| Yes | 32 (97.0) | 30 (93.8) | |
| Medical history (before screening) | No | 19 (57.6) | 14 (43.8) |
| Yes | 14 (42.4) | 18 (56.3) | |
| Maintenance corticosteroid therapy (ongoing at screening) | No | 10 (30.3) | 12 (37.5) |
| Yes | 23 (69.7) | 20 (62.5) | |
| Self-catheterization | No | 25 (75.8) | 25 (78.1) |
| Yes | 8 (24.2) | 7 (21.9) | |
| Baseline OMDS | Mean ± SD | 4.7 ± 1.0 | 4.9 ± 0.9 |
| ≥ 3 to < 5 | 13 (39.4) | 10 (31.3) | |
| ≥ 5 to ≤ 6 | 20 (60.6) | 22 (68.8) |
Data are presented as n (%) of patients unless otherwise indicated
BMI body mass index, HAM/TSP human T-cell leukemia virus type 1-associated myelopathy/tropical spastic paraparesis, INF-α interferon-alpha, OMDS Osame motor disability score, SD standard deviation