Table 1.
Baseline patient demographics and disease characteristics (safety set)
| Characteristic | Rozanolixizumab | |||||
|---|---|---|---|---|---|---|
| Single-dose cohorts | Multiple-dose cohorts | All patients | ||||
| 20 mg/kg (n = 12) | 15 mg/kg (n = 12) | 2 × 10 mg/kg (n = 12) | 3 × 7 mg/kg (n = 15) | 5 × 4 mg/kg (n = 15) | (N = 66) | |
| Median age (range), y | 60.5 (25-78) | 49.5 (23-69) | 46.0 (23-69) | 54.0 (20-73) | 66.0 (21-86) | 54.0 (20-86) |
| Sex, n (%) | ||||||
| Female | 9 (75.0) | 7 (58.3) | 7 (58.3) | 11 (73.3) | 8 (53.3) | 42 (63.6) |
| Male | 3 (25.0) | 5 (41.7) | 5 (41.7) | 4 (26.7) | 7 (46.7) | 24 (36.4) |
| Ethnicity, n (%) * | ||||||
| Asian | 0 | 0 | 0 | 0 | 2 (13.3) | 2 (3.0) |
| White | 12 (100) | 12 (100) | 12 (100) | 15 (100) | 13 (86.7) | 64 (97.0) |
| Platelet count, × 10 9 /L † | ||||||
| Median (range) | 19.0 (4-37) | 22.5 (6-38) | 14.0 (6-53) | 11.0 (5-24) | 15.0 (5-36) | 15.5 (4-53) |
| Mean (SD) | 18.0 (10.8) | 21.2 (9.3) | 18.4 (13.8) | 13.4 (5.4) | 18.4 (10.7) | 17.7 (10.2) |
| Median duration of disease (range), y | 4.9 (0.4-10.7) | 5.8 (0.5-24.1) | 8.1 (0.4-30.8) | 5.2 (0.3-36.2) | 7.1 (1.7-28.6) | 5.8 (0.3-36.2) |
| No. of previous lines of ITP therapy (%) | 10 (83.3) | 8 (66.7) | 11 (91.7) | 12 (80.0) | 13 (86.7) | 54 (81.8) |
| Median (range) | 2.0 (1-8) | 3.0 (1-8) | 2.0 (1-6) | 6.5 (1-15) | 6.0 (1-16) | 4.0 (1-16) |
| Treatment or drug, n (%) ‡ | ||||||
| Immunoglobulins | 2 (16.7) | 5 (41.7) | 3 (25.0) | 7 (46.7) | 8 (53.3) | 25 (37.9) |
| Azathioprine | 3 (25.0) | 4 (33.3) | 3 (25.0) | 6 (40.0) | 8 (53.3) | 24 (36.4) |
| Eltrombopag | 1 (8.3) | 1 (8.3) | 5 (41.7) | 7 (46.7) | 6 (40.0) | 20 (30.3) |
| Splenectomy | 3 (25.0) | 2 (16.7) | 2 (16.7) | 7 (46.7) | 5 (33.3) | 19 (28.8) |
| Romiplostim | 2 (16.7) | 1 (8.3) | 2 (16.7) | 6 (40.0) | 7 (46.7) | 18 (27.3) |
| Cyclosporin | 1 (8.3) | 3 (25.0) | 1 (8.3) | 4 (26.7) | 5 (33.3) | 14 (21.2) |
| Dexamethasone | 2 (16.7) | 1 (8.3) | 2 (16.7) | 4 (26.7) | 3 (20.0) | 12 (18.2) |
| Danazol | 1 (8.3) | 2 (16.7) | 1 (8.3) | 2 (13.3) | 5 (33.3) | 11 (16.7) |
| Rituximab | 1 (8.3) | 1 (8.3) | 0 | 6 (40.0) | 2 (13.3) | 10 (15.2) |
| Fostamatinib | 0 | 0 | 1 (8.3) | 1 (6.7) | 6 (40.0) | 8 (12.1) |
| Prednisolone | 3 (25.0) | 1 (8.3) | 1 (8.3) | 0 | 3 (20.0) | 8 (12.1) |
SD, standard deviation.
*
The study was open to patients of all ethnic groups.
†
Based upon central laboratory measurements.
‡
Data are shown based upon a data cutoff of >12% for the All patients column.