Table 1 Demographic and Baseline Characteristics According to DB Randomization (OLE Safety Analysis Set)
Placeboa(n = 262) | Quarterly fremanezumaba(n = 271) | Monthly fremanezumaba(n = 274) | Total(n = 807) | |
|---|---|---|---|---|
Age, mean (SD), years | 46.9 (11.2) | 46.0 (11.0) | 46.1 (11.0) | 46.4 (11.0) |
Female sex, n (%) | 218 (83) | 226 (83) | 230 (84) | 674 (84) |
Race, n (%) | ||||
White | 247 (94) | 258 (95) | 254 (93) | 759 (94) |
Black/African American | 1 (<1) | 1 (<1) | 4 (1) | 6 (<1) |
Asian | 1 (<1) | 0 | 2 (<1) | 3 (<1) |
American Indian or Alaska Native | 0 | 0 | 1 (<1) | 1 (<1) |
Other | 1 (<1) | 2 (<1) | 1 (<1) | 4 (<1) |
Not reported | 12 (5) | 10 (4) | 12 (4) | 34 (4) |
Weight, mean (SD), kg | 71.3 (13.9) | 70.5 (13.3) | 71.1 (13.8) | 71.0 (13.7) |
Height, mean (SD), cm | 167.6 (9.0) | 167.6 (7.9) | 167.4 (7.6) | 167.6 (8.2) |
Body mass index, mean (SD), kg/m2 | 25.3 (4.1) | 25.0 (4.1) | 25.3 (4.4) | 25.2 (4.2) |
Years since initial migraine diagnosis, mean (SD) | 24.3 (13.4) | 24.4 (12.9) | 24.3 (13.7) | 24.3 (13.3) |
Migraine classification, n (%) | ||||
Episodic migraine | 105 (40) | 102 (38) | 106 (39) | 313 (39) |
Chronic migraine | 157 (60) | 169 (62) | 168 (61) | 494 (61) |
Number of prior preventive medications failed, n (%) | ||||
2 | 131 (50) | 138 (51) | 129 (47) | 398 (49) |
3 | 77 (29) | 82 (30) | 94 (34) | 253 (31) |
4 | 54 (21) | 49 (18) | 49 (18) | 152 (19) |
Monthly average number of migraine days, mean (SD)b | 14.4 (6.2) | 14.2 (5.6) | 14.0 (5.5) | 14.2 (5.8) |
Headache days of at least moderate severity, mean (SD)b | 12.9 (5.9) | 12.5 (5.8) | 12.6 (5.7) | 12.7 (5.8) |
Days per month of acute headache medication use, mean (SD)b | 12.4 (6.3) | 12.9 (6.2) | 12.1 (5.9) | 12.5 (6.1) |
Days per month with photophobia/phonophobia, mean (SD)b | 9.9 (7.8) | 9.5 (6.8) | 9.4 (6.8) | 9.6 (7.2) |
Days per month with nausea/vomiting, mean (SD)b | 6.4 (6.0) | 6.7 (5.9) | 6.6 (5.9) | 6.5 (5.9) |
HIT-6 score, mean (SD)b | 64.1 (4.8) | 64.3 (4.3) | 63.9 (4.5) | 64.1 (4.5) |
MIDAS score, mean (SD)b | 62.0 (57.4) | 62.2 (49.3) | 61.8 (51.3) | 62.0 (50.6) |