Table 1.
Characteristic | Total | Fremanezumab | Placebo | |||||
---|---|---|---|---|---|---|---|---|
Quarterly | Monthly | |||||||
CM–CM n = 548 | CM–EM n = 540 | CM–CM n = 181 | CM–EM n = 185 | CM–CM n = 169 | CM–EM n = 196 | CM–CM n = 198 | CM–EM n = 159 | |
Age, mean (SD), year | 41.8 (12.3) | 41.1 (12.0) | 42.7 (12.6) | 40.9 (12.2) | 41.4 (12.2) | 40.7 (11.7) | 41.3 (12.1) | 41.7 (12.1) |
BMI, mean (SD), kg/m2 | 26.3 (5.2) | 26.7 (5.2) | 26.6 (5.2) | 26.6 (5.5) | 26.4 (5.1) | 26.6 (5.1) | 26.0 (5.2) | 27.0 (5.0) |
Sex, female, n (%) | 479 (87) | 472 (87) | 157 (87) | 165 (89) | 145 (86) | 172 (88) | 177 (89) | 135 (85) |
Years since initial migraine diagnosis, mean (SD) | 20.2 (13.0) | 19.8 (12.2) | 20.2 (13.5) | 19.0 (12.1) | 20.9 (12.7) | 20.0 (11.4) | 19.6 (12.9) | 20.6 (13.3) |
Concomitant preventive medication use, n (%) | 132 (24) | 98 (18) | 43 (24) | 30 (16) | 44 (26) | 40 (20) | 45 (23) | 28 (18) |
Any acute headache medication use, n (%) | 516 (94) | 520 (96) | 171 (94) | 178 (96) | 157 (93) | 189 (96) | 188 (95) | 153 (96) |
Medication overuse, n (%)‡ | 314 (57) | 268 (50) | 105 (58) | 94 (51) | 95 (56) | 102 (52) | 114 (58) | 72 (45) |
Previous onabotulinumtoxinA use, n (%) | 108 (20) | 55 (10) | 44 (24) | 21 (11) | 31 (18) | 19 (10) | 33 (17) | 15 (9) |
Previous topiramate use, n (%) | 182 (33) | 148 (27) | 58 (32) | 47 (25) | 54 (32) | 58 (30) | 70 (35) | 43 (27) |
Based on the <15 monthly average number of headache days for the 3‐month treatment period criteria for reversion.
Medication overuse was defined as the use of acute headache medication on ≥15 days or use of migraine‐specific acute medication on ≥10 days or use of combination medications for headache on ≥10 days.
BMI = body mass index; SD = standard deviation.