Table 5.
Main treatment-emergent adverse events reported by at least 2% of galcanezumab-treated patients in EVOLVE-1, EVOLVE-2, and REGAIN trials
| TAEs | |||
|---|---|---|---|
| EVOLVE-1 | Placebo (n=432) | Galcanezumab 120 mg (n=206) | Galcanezumab 240 mg (n=220) |
| Patients with ≥1 TAE | 261 (60.4%) | 135 (65.5%) | 149 (67.7%) |
| Injection-site pain | 75 (17.4%) | 33 (16%) | 45 (20.5%) |
| Nasopharyngitis | 27 (6.3%) | 16 (7.8) | 6 (2.7%) |
| Urinary tract infections | 15 (3.5%) | 8 (3.9) | 13 (5.9%) |
| Injection-site reaction | 4 (0.9%) | 7 (3.4)a | 12 (5.5%)a |
| Injection-site erythema | 11 (2.6%) | 10 (4.9) | 9 (4.1%) |
| Injection-site pruritus | 1 (0.2%) | 9 (4.4)a | 10 (4.6%)a |
| EVOLVE-2 | Placebo (n=461) | Galcanezumab 120 mg (n=226) | Galcanezumab 240 mg (n=228) |
| Patients with ≥1 TAE | 287 (62.3%) | 147 (65%) | 163 (71.5%)a |
| Injection-site pain | 39 (8.5%) | 21 (9.3%) | 20 (8.8%) |
| Nasopharyngitis | 41 (8.9%) | 19 (8.4%) | 16 (7%) |
| Upper respiratory tract infections | 16 (3.5%) | 13 (5.8%) | 12 (5.3%) |
| Injection-site reaction | 0 (0%) | 7 (3.1%)a | 18 (7.9%)a |
| Injection-site erythema | 4 (0.9) | 6 (2.7%) | 7 (3.1%)a |
| Injection-site pruritus | 0 (0%) | 6 (2.7%)a | 7 (3.1%)a |
| REGAIN | Placebo (n=558) | Galcanezumab 120 mg (n=273) | Galcanezumab 240 mg (n=282) |
| Patients with ≥1 TAE | 279 (50%) | 159 (58%)a | 160 (57%) |
| Injection-site pain | 24 (4%) | 17 (6%) | 20 (7%) |
| Nasopharyngitis | 26 (5%) | 17 (6%) | 9 (3%) |
| Upper respiratory tract infections | 13 (2%) | 9 (3%) | 9 (3%) |
| Injection-site reaction | 10 (2%) | 8 (3%) | 15 (5%)b |
| Injection-site erythema | 5 (1%) | 4 (1%) | 13 (5%)c,d |
| Injection-site pruritus | 1 (0%) | 0 (0%) | 7 (2%)c,d |
Notes:
a
P<0.05 vs placebo.
b
P<0.01 vs placebo.
c
P<0.001 vs placebo.
d
P<0.05 vs galcanezumab.
Abbreviation: TAE, treatment-emergent adverse event.