Characteristics of patients undergoing surgical procedures in the HAVEN 1-4 clinical trials
| . | HAVEN 1 n = 38 . | HAVEN 2 n = 27 . | HAVEN 3 n = 45 . | HAVEN 4 n = 16 . | Total N = 126 . |
|---|---|---|---|---|---|
| Median age (IQR), y | 31.5 (17.0-46.0) | 7.0 (5.0-8.0) | 44.0 (29.0-53.0) | 46.5 (35.5-57.5) | 33.5 (13.0-49.0) |
| Race, n (%) | |||||
| White | 27 (71.1) | 17 (63.0) | 33 (73.3) | 10 (62.5) | 87 (69.0) |
| Asian | 6 (15.8) | 4 (14.8) | 9 (20.0) | 5 (31.3) | 24 (19.0) |
| Black/African American | 2 (5.3) | 2 (7.4) | 0 | 1 (6.3) | 5 (4.0) |
| Other or unknown | 3 (7.9) | 4 (14.8) | 3 (6.7) | 0 | 10 (7.9) |
| Presence of FVIII inhibitors, n (%) | 38 (100) | 27 (100) | 0 | 4 (25.0) | 69 (54.8) |
| Median number of bleeds in 24 wk before study entry (IQR) | 9.5 (6.0-19.0) | 5.0 (4.0-9.0) | 7.0 (2.0-13.0) | 5.5 (3.0-13.0) | 7.0 (4.0-14.0) |
| Presence of target joints∗ at study entry, n (%) | 23 (62.2) | 13 (48.1) | 28 (62.2) | 11 (68.8) | 75 (60.0) |
| Patients who underwent: n (%) | |||||
| 1 surgical procedure | 21 (55.3) | 25 (92.6) | 25 (55.6) | 12 (75.0) | 83 (65.9) |
| 2 surgical procedures | 6 (15.8) | 2 (7.4) | 8 (17.8) | 2 (12.5) | 18 (14.3) |
| >2 surgical procedures | 11 (28.9) | 0 | 12 (26.7) | 2 (12.5) | 25 (19.8) |
| Median duration of emicizumab exposure (IQR), wk | 101.7 (84.1-127.1) | 79.1 (67.1-102.1) | 89.1 (80.3-97.1) | 68.1 (68.1–72.1) | 86.3 (75.1-102.1) |
| . | HAVEN 1 n = 38 . | HAVEN 2 n = 27 . | HAVEN 3 n = 45 . | HAVEN 4 n = 16 . | Total N = 126 . |
|---|---|---|---|---|---|
| Median age (IQR), y | 31.5 (17.0-46.0) | 7.0 (5.0-8.0) | 44.0 (29.0-53.0) | 46.5 (35.5-57.5) | 33.5 (13.0-49.0) |
| Race, n (%) | |||||
| White | 27 (71.1) | 17 (63.0) | 33 (73.3) | 10 (62.5) | 87 (69.0) |
| Asian | 6 (15.8) | 4 (14.8) | 9 (20.0) | 5 (31.3) | 24 (19.0) |
| Black/African American | 2 (5.3) | 2 (7.4) | 0 | 1 (6.3) | 5 (4.0) |
| Other or unknown | 3 (7.9) | 4 (14.8) | 3 (6.7) | 0 | 10 (7.9) |
| Presence of FVIII inhibitors, n (%) | 38 (100) | 27 (100) | 0 | 4 (25.0) | 69 (54.8) |
| Median number of bleeds in 24 wk before study entry (IQR) | 9.5 (6.0-19.0) | 5.0 (4.0-9.0) | 7.0 (2.0-13.0) | 5.5 (3.0-13.0) | 7.0 (4.0-14.0) |
| Presence of target joints∗ at study entry, n (%) | 23 (62.2) | 13 (48.1) | 28 (62.2) | 11 (68.8) | 75 (60.0) |
| Patients who underwent: n (%) | |||||
| 1 surgical procedure | 21 (55.3) | 25 (92.6) | 25 (55.6) | 12 (75.0) | 83 (65.9) |
| 2 surgical procedures | 6 (15.8) | 2 (7.4) | 8 (17.8) | 2 (12.5) | 18 (14.3) |
| >2 surgical procedures | 11 (28.9) | 0 | 12 (26.7) | 2 (12.5) | 25 (19.8) |
| Median duration of emicizumab exposure (IQR), wk | 101.7 (84.1-127.1) | 79.1 (67.1-102.1) | 89.1 (80.3-97.1) | 68.1 (68.1–72.1) | 86.3 (75.1-102.1) |
Out of the 126 participants who received emicizumab and had ≥1 surgery, 5 and 2 participants were patients with mild and moderate hemophilia, respectively; however, because these 7 patients had FVIII inhibitors, they were consequently considered as having severe hemophilia A phenotype.
Note that percentage totals may not total 100% because of rounding.
FVIII, factor VIII; IQR, interquartile range.
Target joints were defined according to the International Society on Thrombosis and Haemostasis as major joints (eg, hip, elbow, wrist, shoulder, knee, and ankle) with ≥3 bleeds during the 24-wk period before study enrollment.39