TABLE 2.
Overall immunogenicity status
| HAVEN 1 | HAVEN 2 | HAVEN 3 | HAVEN 4 | HAVEN 5 | HOHOEMI | STASEY | Total | |
|---|---|---|---|---|---|---|---|---|
| No. of PwHA evaluable for ADA | 111 | 88 | 151 | 48 | 64 | 13 | 193 | 668 |
| n (%) of PwHA with positive test for ADAs at baseline a | 2 (1.8) | 4 (4.5) | 4 (2.6) | 3 (6.3) | 4 (6.3) | 2 (15.4) | 5 (2.6) | 24 (3.6) |
| n (%) of ADA‐negative PwHA | 109 (98.2) | 82 (93.2) | 145 (96.0) | 46 (95.8) | 56 (87.5) | 13 (100) | 183 (94.8) | 634 (94.9) |
| Negative (all samples) | 107 (96.4) | 78 (88.6) | 142 (94.0) | 43 (89.6) | 52 (81.3) | 11 (84.6) | 180 (93.3) | 613 (91.8) |
| Negative (treatment unaffected) | 2 (1.8) | 4 (4.5) | 3 (2.0) | 3 (6.3) | 4 (6.3) | 2 (15.4) | 3 (1.6) | 21 (3.1) |
| n (%) of ADA‐positive PwHA | 2 (1.8) | 6 (6.8) | 6 (4.0) | 2 (4.2) | 8 (12.5) | 0 (0) | 10 (5.2) | 34 (5.1) |
| Positive (treatment induced) | 2 (1.8) | 6 (6.8) | 5 (3.3) | 2 (4.2) | 8 (12.5) | 0 (0) | 8 (4.2) | 31 (4.6) |
| Positive (treatment boosted) | 0 (0) | 0 (0) | 1 (.7) | 0 (0) | 0 (0) | 0 (0) | 2 (1.0) | 3 (.5) |
| n (%) of PwHA with neutralising ADAs | 2 (1.8) | 3 (3.4) | 4 (2.6) | 1 (2.1) | 3 (4.7) | 0 (0) | 5 (2.6) | 18 (2.7) |
| n (%) of PwHA with ADAs with decreased exposure b | 1 (.9) | 2 (2.3) | 0 (0) | 0 (0) | 1 (1.6) | 0 (0) | 0 (0) | 4 (.6) |
Abbreviations: ADA, anti‐drug antibody; PwHA, persons with haemophilia A.
a
Missing sample at baseline was considered negative.
b
All PwHA with ADAs with decreased exposure had neutralising ADAs.