Table 3.
Safety results during the DBTP and OLTP
| DBTP | OLTP | ||
| Placebo (N=131) |
Erenumab 70 mg (N=130) |
Total (N=254) |
|
| All TEAEs, n (%) (r) | 78 (59.5) (197.7) | 86 (66.2) (251.0) | 181 (71.3) (219.7) |
| Grade ≥2 | 67 (51.1) (159.2) | 72 (55.4) (180.6) | 158 (62.2) (159.9) |
| Grade ≥3 | 2 (1.5) (3.4) | 4 (3.1) (6.8) | 12 (4.7) (7.1) |
| Serious AEs | 2 (1.5) (3.4) | 2 (1.5) (3.4) | 7 (2.8) (4.1) |
| Leading to IP discontinuation | 0 (0.0) (0.0) | 0 (0.0) (0.0) | 1 (0.4) (0.6) |
| Fatal AEs | 0 (0.0) (0.0) | 0 (0.0) (0.0) | 0 (0.0) (0.0) |
| Most common TEAEs, n (%) (r)* | |||
| Nasopharyngitis | 37 (28.2) (74.4) | 35 (26.9) (67.2) | 49 (19.3) (32.8) |
| Constipation | 1 (0.8) (1.7) | 6 (4.6) (10.3) | 13 (5.1) (7.8) |
| Influenza | 2 (1.5) (3.4) | 1 (0.8) (1.7) | 11 (4.3) (6.6) |
| Gastroenteritis | 4 (3.1) (6.7) | 4 (3.1) (6.8) | 11 (4.3) (6.5) |
| Urticaria | 0 (0.0) (0.0) | 1 (0.8) (1.7) | 10 (3.9) (5.9) |
| Developed antierenumab antibodies, n (%) | |||
| Developed binding anti-erenumab antibodies | NA | n’=129 7 (5.4) |
n’=254 9 (3.5) |
| Transient† | NA | 2 (28.6) | 4 (44.4) |
| Developed neutralising antierenumab antibodies | NA | NA | NA |
N=number of patients in the analysis set; n=number of patients with at least one occurrence of a TEAE or number of patients who developed anti-erenumab antibodies; n’=patients with a postbaseline result during the DBTP or OLTP; r=exposure-adjusted patient incidence rate per 100 patient-years.
*Exposure-adjusted rates of TEAEs of at least 5 per 100 patient-years during the OLTP.
†A negative result was reported at the patient’s last time point within the study period.
AE, adverse event; DBTP, double-blind treatment period; IP, investigational product; NA, not applicable; OLTP, open-label treatment period; TEAE, treatment-emergent adverse event.