Table 2.
Summary of TEAEs by age groups (safety analysis set, double-blind treatment phase)
| Aged < 40 years, n (%) | Placebo (n = 597) | Erenumab 70 mg (n = 514) | Erenumab 140 mg (n = 382) | Erenumab 70 + 140 mg (n = 896) | Total (N = 1493) |
| All TEAEs | 265 (44.4) | 227 (44.2) | 167 (43.7) | 394 (44.0) | 659 (44.1) |
| Grade ≥ 2 | 135 (22.6) | 106 (20.6) | 65 (17.0) | 171 (19.1) | 306 (20.5) |
| Grade ≥ 3 | 12 (2.0) | 13 (2.5) | 6 (1.6) | 19 (2.1) | 31 (2.1) |
| Grade ≥ 4 | 0 | 0 | 0 | 0 | 0 |
| SAEs | 7 (1.2) | 6 (1.2) | 2 (0.5) | 8 (0.9) | 15 (1.0) |
| AEs leading to discontinuation of study drug | 5 (0.8) | 6 (1.2) | 4 (1.0) | 10 (1.1) | 15 (1.0) |
| Fatal AEs | 0 | 0 | 0 | 0 | 0 |
| Treatment-related AEs | 66 (11.1) | 71 (13.8) | 48 (12.6) | 119 (13.3) | 185 (12.4) |
| Aged 40–49 years, n (%) | Placebo (n = 421) | Erenumab 70 mg (n = 356) | Erenumab 140 mg (n = 275) | Erenumab 70 + 140 mg (n = 631) | Total (N = 1052) |
| All TEAEs | 207 (49.2) | 150 (42.1) | 118 (42.9) | 268 (42.5) | 475 (45.2) |
| Grade ≥ 2 | 104 (24.7) | 72 (20.2) | 51 (18.5) | 123 (19.5) | 227 (21.6) |
| Grade ≥ 3 | 11 (2.6) | 11 (3.1) | 9 (3.3) | 20 (3.2) | 31 (2.9) |
| Grade ≥ 4 | 0 | 1 (0.3) | 0 | 1 (0.2) | 1 (0.1) |
| SAEs | 8 (1.9) | 6 (1.7) | 5 (1.8) | 11 (1.7) | 19 (1.8) |
| AEs leading to discontinuation of study drug | 3 (0.7) | 5 (1.4) | 3 (1.1) | 8 (1.3) | 11 (1.0) |
| Fatal AEs | 0 | 0 | 0 | 0 | 0 |
| Treatment-related AEs | 54 (12.8) | 47 (13.2) | 27 (9.8) | 74 (11.7) | 128 (12.2) |
| Aged 50–59 years, n (%) | Placebo (n = 262) | Erenumab 70 mg (n = 214) | Erenumab 140 mg (n = 158) | Erenumab 70 + 140 mg (n = 372) | Total (N = 634) |
| All TEAEs | 109 (41.6) | 93 (43.5) | 80 (50.6) | 173 (46.5) | 282 (44.5) |
| Grade ≥ 2 | 54 (20.6) | 43 (20.1) | 43 (27.2) | 86 (23.1) | 140 (22.1) |
| Grade ≥ 3 | 6 (2.3) | 6 (2.8) | 5 (3.2) | 11 (3.0) | 17 (2.7) |
| Grade ≥ 4 | 0 | 0 | 0 | 0 | 0 |
| SAEs | 3 (1.1) | 4 (1.9) | 2 (1.3) | 6 (1.6) | 9 (1.4) |
| AEs leading to discontinuation of study drug | 2 (0.8) | 2 (0.9) | 3 (1.9) | 5 (1.3) | 7 (1.1) |
| Fatal AEs | 0 | 0 | 0 | 0 | 0 |
| Treatment-related AEs | 19 (7.3) | 28 (13.1) | 20 (12.7) | 48 (12.9) | 67 (10.6) |
| Aged ≥ 60 years, n (%) | Placebo (n = 69) | Erenumab 70 mg (n = 38) | Erenumab 140 mg (n = 35) | Erenumab 70 + 140 mg (n = 73) | Total (N = 142) |
| All TEAEs | 41 (59.4) | 15 (39.5) | 17 (48.6) | 32 (43.8) | 73 (51.4) |
| Grade ≥ 2 | 23 (33.3) | 11 (28.9) | 9 (25.7) | 20 (27.4) | 43 (30.3) |
| Grade ≥ 3 | 4 (5.8) | 0 | 1 (2.9) | 1 (1.4) | 5 (3.5) |
| Grade ≥ 4 | 0 | 0 | 1 (2.9) | 1 (1.4) | 1 (0.7) |
| SAEs | 0 | 0 | 0 | 0 | 0 |
| AEs leading to discontinuation of study drug | 1 (1.4) | 0 | 1 (2.9) | 1 (1.4) | 2 (1.4) |
| Fatal AEs | 0 | 0 | 0 | 0 | 0 |
| Treatment-related AEs | 9 (13.0) | 6 (15.8) | 3 (8.6) | 9 (12.3) | 18 (12.7) |
Data pooled from the phase 2 CM, STRIVE, ARISE, LIBERTY, and EMPOwER studies (safety analysis set). The summary contains TEAEs with onset day within the first 3 months (91 days) from the first administration of erenumab/placebo
Abbreviations: AE Adverse event, CM Chronic migraine, SAE Serious adverse event, TEAE Treatment-emergent adverse event