TABLE 1.
Baseline demographics and clinical characteristics
| HALO CM | HALO EM | FOCUS | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Fremanezumab | Placebo (n = 375) | Fremanezumab | Placebo (n = 294) | Fremanezumab | Placebo (n = 279) | ||||
| Quarterly (n = 376) | Monthly (n = 379) | Quarterly (n = 291) | Monthly (n = 290) | Quarterly (n = 276) | Monthly (n = 283) | ||||
| Patient demographics | |||||||||
| Age, mean ± SD, years | 42.0 ± 12.4 | 40.6 ± 12.0 | 41.4 ± 12.0 | 41.1 ± 11.4 | 42.9 ± 12.7 | 41.3 ± 12.0 | 45.8 ± 10.9 | 45.9 ± 11.1 | 46.8 ± 11.1 |
| Female sex, n (%) | 331 (88) | 330 (87) | 330 (88) | 251 (86) | 244 (84) | 247 (84) | 229 (83) | 238 (84) | 233 (84) |
| Disease history | |||||||||
| Years since initial migraine diagnosis, mean ± SD | 19.7 ± 12.8 | 20.1 ± 12.0 | 19.9 ± 12.9 | 20.0 ± 12.1 | 20.7 ± 12.9 | 19.9 (11.9) | 24.3 ± 12.8 | 24.0 ± 13.7 | 24.3 ± 13.6 |
| Disease characteristics during the 28‐day pretreatment period | |||||||||
| Headache days of at least moderate severity,a mean ± SD | 13.2 ± 5.5 | 12.8 ± 5.8 | 13.3 ± 5.8 | 7.2 ± 3.1 | 6.8 ± 2.9 | 6.9 ± 3.1 | 12.4 ± 5.8 | 12.7 ± 5.8 | 12.8 ± 5.9 |
| Headache hours of any severity, mean ± SD | 119.1 ± 73.2 | 129.0 ± 88.6 | 127.2 ± 86.0 | 57.1 ± 30.0 | 57.1 ± 30.0 | 55.7 ± 26.5 | 107.9 ± 85.3 | 113.1 ± 89.0 | 115.9 ± 96.4 |
| Headache hours of at least moderate severity, mean ± SD | 66.4 ± 58.8 | 68.0 ± 53.9 | 68.5 ± 57.0 | 33.3 ± 25.4 | 31.7 ± 23.7 | 31.6 ± 23.2 | 59.2 ± 54.7 | 64.3 ± 65.2 | 65.9 ± 70.2 |
| Peak severity of headache days, mean ± SD | 1.9 ± 0.4 | 1.9 ± 0.4 | 1.9 ± 0.4 | 1.9 ± 0.4 | 1.9 ± 0.4 | 1.9 ± 0.4 | 2.0 ± 0.4 | 2.0 ± 0.4 | 2.0 ± 0.4 |
| Headache hours per headache day, mean ± SD | 5.7 ± 2.8 | 6.2 ± 3.4 | 6.1 ± 3.3 | 5.1 ± 2.2 | 5.2 ± 2.4 | 5.0 ± 2.3 | 6.4 ± 3.3 | 6.5 ± 3.7 | 6.6 ± 3.6 |
Abbreviations: CM, chronic migraine; EM, episodic migraine; SD, standard deviation.
a
A calendar day in which the patient reported either a day with headache pain that lasted ≥4 h consecutively and meeting criteria for migraine, probable migraine, or a day when a headache of any duration was treated with migraine‐specific medications (triptans or ergot compounds).