Table 3.
Summary of time to first TE ADA+ titer during treatment phase.
| Study | N | Time to first TE ADA+ titer, n (%) |
||||
|---|---|---|---|---|---|---|
| ≤1 month | ≤2 months | ≤3 months | ≤6 months | ≤12 months | ||
| REGAIN (3-month DB phase) | 536 | 7 (1.3) | 9 (1.7) | 14 (2.6) | – | – |
| EVOLVE-1 (6-month DB phase) | 415 | 4 (1.0) | 6 (1.5) | 12 (2.9) | 20 (4.8) | – |
| EVOLVE-2 (6-month DB phase) | 437 | 2 (0.5) | 3 (0.7) | 10 (2.3) | 32 (7.3) | – |
| Study CGAJ (12-month OL phase) | 266 | 4 (1.5) | 6 (2.3) | 8 (3.0) | 21 (7.9) | 26 (9.8) |
DB: double blind; N: number of patients in the analysis population; n: number of patients within each specific category; OL: open label; TE ADA: treatment emergent anti-drug antibody.