Antibody reduces bleeding in hemophilia A patients with inhibitors
July 11, 2017|Hematology and Oncology
*Negative binomial regression model
Safety
Safety results in patients who received emicizumab prophylaxis (n=103) are as follows.
| Total number of AEs | 198 |
| Total number of participants experiencing ≥ 1 AE, n (%) | 73 (70.9) |
| Related AEs | 23 (22.3) |
| Serious AEs | 9 (8.7) |
| Grade ≥3 AEs | 8 (7.8) |
| Local injection site reaction | 15 (14.6) |
| Headache | 12 (11.7) |
| Upper respiratory tract infection | 9 (8.7) |
| Fatigue | 6 (5.8) |
| Joint pain (arthralgia) | 6 (5.8) |
| Thrombotic microangiopathy* | 3 (2.9) |
| Serious thromboembolic event** | 2 (1.9) |
| Death* | 1 (<1) |
*The third thrombotic microangiopathy event occurred after the primary data cut-off. This patient also experienced fatal rectal hemorrhage.
**Serious thromboembolic events consisted of skin necrosis/superficial thrombophlebitis in 1 patient and cavernous sinus thrombosis in a second patient.
None of the patients tested positive for anti-drug antibodies.
