Table 2.
Anti-drug and neutralizing antibody findings across the phase 3 galcanezumab studies.
| Study | Study phase | Placebo n (%) |
Galcanezumab |
|||
|---|---|---|---|---|---|---|
| 120 mg n (%) |
240 mg n (%) |
Pooled n (%) |
||||
| REGAIN | Evaluable subjects DB phase | 535 | 264 | 272 | 536 | |
| Baseline | ADA present | 33 (6.2) | 22 (8.3) | 27 (9.9) | 49 (9.1) | |
| NAb present | 26 (4.9) | 15 (5.7) | 18 (6.6) | 33 (6.2) | ||
| 3-month DB treatment | TE ADA+ | 8 (1.5) | 7 (2.7) | 7 (2.6) | 14 (2.6) | |
| NAb present | 3 (0.6) | 6 (2.3) | 4 (1.5)a | 10 (1.9) | ||
| EVOLVE-1 | Evaluable subjects DB phase | 422 | 202 | 213 | 415 | |
| Baseline | ADA present | 25 (5.9) | 18 (8.9) | 23 (10.8) | 41 (9.9) | |
| NAb present | 11 (2.6) | 10 (5.0) | 17 (8.0) | 27 (6.5) | ||
| 6-month DB treatment | TE ADA+ | 7 (1.7) | 9 (4.5) | 11 (5.2)a | 20 (4.8)a | |
| NAb present | 6 (1.4) | 9 (4.5) | 11 (5.2)a | 20 (4.8)a | ||
| EVOLVE-2 | Evaluable subjects DB phase | 443 | 223 | 214 | 437 | |
| Baseline | ADA present | 37 (8.4) | 18 (8.1) | 24 (11.2) | 42 (9.6) | |
| NAb present | 19 (4.3) | 10 (4.5) | 13 (6.1) | 23 (5.3) | ||
| 6-month DB treatment | TE ADA+ | 2 (0.5) | 21 (9.4)b | 11 (5.1)b | 32 (7.3)b | |
| NAb present | 1 (0.2) | 21 (9.4)b | 9 (4.2)b | 30 (6.9)b | ||
| Study CGAJ | Evaluable subjects OL phase | – | 129 | 137 | 266 | |
| Baseline | ADA present | – | 8 (6.2) | 12 (8.8) | 20 (7.5) | |
| NAb present | – | 8 (6.2) | 6 (4.4) | 14 (5.3) | ||
| 12-month OL treatment | TE ADA+ | – | 16 (12.4) | 10 (7.3) | 26 (9.8) | |
| NAb present | – | 16 (12.4) | 10 (7.3) | 26 (9.8) | ||
ADA: anti-drug antibody; DB: double blind; n: number of patients within each specific category; Nab: neutralizing antibody; OL: open label; TE ADA: treatment-emergent ADA.
a
p < 0.05 versus placebo.
b
p < 0.001 versus placebo.