Table 2.
Patient disposition during the OLTP at time of interim analysis.
| Erenumab 70 mg n (%) | Erenumab 140 mg* n (%) | |
|---|---|---|
| Received erenumab during the OLTP | 383 (100.0) | 250 (100.0) |
| Continuing open-label erenumab 140 mg | NA | 236 (94.4) |
| Discontinued open-label erenumab | 132 (34.5) | 14 (5.6) |
| Ineligibility determined | 1 (0.3) | 0 (0.0) |
| Protocol deviation | 1 (0.3) | 0 (0.0) |
| Non-compliance | 6 (1.6) | 0 (0.0) |
| Adverse event† | 16 (4.2) | 1 (0.4) |
| Patient request | 68 (17.8) | 8 (3.2) |
| Decision by sponsor | 1 (0.3) | 1 (0.4) |
| Lost to follow up | 13 (3.4) | 1 (0.4) |
| Death | 1 (0.3)‡ | 0 (0.0) |
| Requirement for alternative therapy | 3 (0.8) | 1 (0.4) |
| Pregnancy | 5 (1.3) | 0 (0.0) |
| Lack of efficacy | 12 (3.1) | 0 (0.0) |
| Other | 5 (1.3) | 2 (0.8) |
OLTP: open-label treatment phase.
*
Following an amendment, patients were required to increase erenumab dose to 140 mg.
†Adverse events leading to discontinuation are detailed in Table 3.
‡Fatality, previously reported, due to arteriosclerosis, occurring in patient with prior history of hypertension and left anterior hemiblock (ECG), who on autopsy showed evidence of severe coronary artery disease and presence of cardiac stimulants (liver tissue) – considered not related to the investigational product by the investigator (12).