Patient and disease characteristics at baseline
| Characteristics . | All patients (N = 21) . | Safety run-in (n = 3) . | Cohort 1 (n = 9) . | Cohort 2 (n = 9) . |
|---|---|---|---|---|
| Median age (IQR), y | 51 (34-65) | 55 (33-75) | 51 (36-67) | 49 (33-59) |
| Sex, n (%) | ||||
| Male | 14 (66.7) | 2 (66.7) | 5 (55.6) | 7 (77.8) |
| Female | 7 (33.3) | 1 (33.3) | 4 (44.4) | 2 (22.2) |
| Median BMI (IQR), kg/m2 | 29.3 (26.0-33.3) | 35.0 (28.0-42.2) | 29.4 (26.0-32.2) | 28.7 (25.3-33.3) |
| Median platelet count at screening (IQR), ×109/L | 17.0 (10.0-20.0) | 17.0 (16.0-26.0) | 19.0 (15.0-22.0) | 16.0 (10.0-19.0) |
| Median duration of ITP∗ (IQR), mo | 60.5 (13.5- 231.7) | 108.8 (13.5-136.8) | 18.3 (7.3-60.5) | 231.4 (42.0- 272.9) |
| Median number of different prior ITP treatments (range) | 4 (2-11) | 5 (3-6) | 4 (2-9) | 4 (3-11) |
| Prior ITP therapy, n (%) | ||||
| Corticosteroids | 21 (100) | 3 (100) | 9 (100) | 9 (100) |
| IVIG | 14 (67) | 2 (67) | 5 (56) | 7 (78) |
| Rituximab | 16 (76) | 3 (100) | 6 (67) | 7 (78) |
| TPO-RA† | 18 (86) | 3 (100) | 8 (67) | 7 (78) |
| Fostamatinib | 1 (5) | 0 | 0 | 1 (11) |
| Rilzabrutinib | 1 (5) | 1 (33) | 0 | 0 |
| Azathioprine | 2 (10) | 0 | 1 (11) | 1 (11) |
| Mycophenolate mofetil | 2 (10) | 0 | 0 | 2 (22) |
| Dapsone | 1 (5) | 0 | 0 | 1 (11) |
| Danazol | 1 (5) | 0 | 1 (11) | 0 |
| Cyclosporine | 2 (10) | 0 | 0 | 2 (22) |
| Hydroxychloroquine | 1 (5) | 0 | 0 | 1 (11) |
| Splenectomy | 5 (24) | 0 | 2 (22) | 3 (33) |
| Response to previous steroid therapy | 19 (90) | 2 (67) | 9 (100) | 8 (89) |
| Concomitant ITP-directed therapy (at the date of the first daratumumab injection), n (%) | ||||
| Corticosteroid monotherapy | 3 (14) | 0 | 0 | 3 (33) |
| TPO-RA monotherapy | 5 (24) | 1 (33) | 2 (22) | 2 (22) |
| TPO-RA and corticosteroids combined | 5 (24) | 2 (67) | 1 (11) | 2 (22) |
| WHO bleeding score at baseline, n (%) | ||||
| 0 | 11 (52) | 1 (33) | 8 (89) | 2 (22) |
| 1 | 9 (43) | 2 (67) | 1 (11) | 6 (67) |
| 2 | 1 (5) | 0 | 0 | 1 (11) |
| 3/4/5 | 0 | 0 | 0 | 0 |
| Median IgG level at baseline (IQR), g/L | 10.1 (8.6-12.7) | 10.1 (9.6-12.0) | 12.4 (11.7-14.3) | 8.6 (6.3-10.1) |
| Characteristics . | All patients (N = 21) . | Safety run-in (n = 3) . | Cohort 1 (n = 9) . | Cohort 2 (n = 9) . |
|---|---|---|---|---|
| Median age (IQR), y | 51 (34-65) | 55 (33-75) | 51 (36-67) | 49 (33-59) |
| Sex, n (%) | ||||
| Male | 14 (66.7) | 2 (66.7) | 5 (55.6) | 7 (77.8) |
| Female | 7 (33.3) | 1 (33.3) | 4 (44.4) | 2 (22.2) |
| Median BMI (IQR), kg/m2 | 29.3 (26.0-33.3) | 35.0 (28.0-42.2) | 29.4 (26.0-32.2) | 28.7 (25.3-33.3) |
| Median platelet count at screening (IQR), ×109/L | 17.0 (10.0-20.0) | 17.0 (16.0-26.0) | 19.0 (15.0-22.0) | 16.0 (10.0-19.0) |
| Median duration of ITP∗ (IQR), mo | 60.5 (13.5- 231.7) | 108.8 (13.5-136.8) | 18.3 (7.3-60.5) | 231.4 (42.0- 272.9) |
| Median number of different prior ITP treatments (range) | 4 (2-11) | 5 (3-6) | 4 (2-9) | 4 (3-11) |
| Prior ITP therapy, n (%) | ||||
| Corticosteroids | 21 (100) | 3 (100) | 9 (100) | 9 (100) |
| IVIG | 14 (67) | 2 (67) | 5 (56) | 7 (78) |
| Rituximab | 16 (76) | 3 (100) | 6 (67) | 7 (78) |
| TPO-RA† | 18 (86) | 3 (100) | 8 (67) | 7 (78) |
| Fostamatinib | 1 (5) | 0 | 0 | 1 (11) |
| Rilzabrutinib | 1 (5) | 1 (33) | 0 | 0 |
| Azathioprine | 2 (10) | 0 | 1 (11) | 1 (11) |
| Mycophenolate mofetil | 2 (10) | 0 | 0 | 2 (22) |
| Dapsone | 1 (5) | 0 | 0 | 1 (11) |
| Danazol | 1 (5) | 0 | 1 (11) | 0 |
| Cyclosporine | 2 (10) | 0 | 0 | 2 (22) |
| Hydroxychloroquine | 1 (5) | 0 | 0 | 1 (11) |
| Splenectomy | 5 (24) | 0 | 2 (22) | 3 (33) |
| Response to previous steroid therapy | 19 (90) | 2 (67) | 9 (100) | 8 (89) |
| Concomitant ITP-directed therapy (at the date of the first daratumumab injection), n (%) | ||||
| Corticosteroid monotherapy | 3 (14) | 0 | 0 | 3 (33) |
| TPO-RA monotherapy | 5 (24) | 1 (33) | 2 (22) | 2 (22) |
| TPO-RA and corticosteroids combined | 5 (24) | 2 (67) | 1 (11) | 2 (22) |
| WHO bleeding score at baseline, n (%) | ||||
| 0 | 11 (52) | 1 (33) | 8 (89) | 2 (22) |
| 1 | 9 (43) | 2 (67) | 1 (11) | 6 (67) |
| 2 | 1 (5) | 0 | 0 | 1 (11) |
| 3/4/5 | 0 | 0 | 0 | 0 |
| Median IgG level at baseline (IQR), g/L | 10.1 (8.6-12.7) | 10.1 (9.6-12.0) | 12.4 (11.7-14.3) | 8.6 (6.3-10.1) |