CM With MO | CM Without MO | |||||
---|---|---|---|---|---|---|
Fremanezumab | Fremanezumab | |||||
Quarterly (n = 201) | Monthly (n = 198) | Placebo (n = 188) | Quarterly (n = 174) | Monthly (n = 177) | Placebo (n = 183) | |
Age, mean (SD), y | 44.6 (11.6) | 44.8 (10.9) | 45.0 (10.8) | 39.0 (12.6) | 36.2 (11.5) | 37.7 (12.1) |
Sex, female, n (%) | 183 (91) | 173 (87) | 168 (89) | 147 (84) | 154 (87) | 158 (86) |
BMI, mean (SD), kg/m2 | 26.4 (5.3) | 26.4 (5.0) | 26.0 (5.0) | 26.9 (5.5) | 26.7 (5.3) | 26.9 (5.1) |
Disease history | ||||||
Years since initial migraine diagnosis, mean (SD) | 21.0 (12.7) | 22.8 (12.3) | 23.2 (13.8) | 18.3 (12.9) | 17.1 (11.0) | 16.7 (11.0) |
Current preventive medication use, n (%) | 47 (23.4) | 54 (27.3) | 38 (20.2) | 30 (17.2) | 31 (17.5) | 39 (21.3) |
Current use of triptans or ergots, n (%) | 141 (70.1) | 138 (69.7) | 128 (68.1) | 67 (38.5) | 49 (27.7) | 64 (35.0) |
Prior topiramate use, n (%) | 65 (32.3) | 72 (36.4) | 77 (41.0) | 41 (23.6) | 43 (24.3) | 40 (21.9) |
Prior onabotulinumtoxinA use, n (%) | 38 (18.9) | 34 (17.2) | 32 (17.0) | 28 (16.1) | 16 (9.0) | 17 (9.3) |
Disease characteristics during the 28-day pretreatment period | ||||||
Number of headache days of at least moderate severity,b mean (SD) | 15.5 (5.0) | 14.9 (5.4) | 14.8 (5.4) | 10.5 (4.8) | 10.5 (5.3) | 11.7 (5.8) |
Number of migraine days,c mean (SD) | 17.2 (4.6) | 17.5 (4.9) | 17.3 (5.0) | 15.0 (4.9) | 14.3 (5.0) | 15.4 (5.1) |
Number of days of acute medication use, mean (SD) | 18.1 (4.0) | 18.4 (4.5) | 18.2 (4.4) | 7.4 (4.4) | 7.1 (4.5) | 7.7 (4.5) |
HIT-6 score, mean (SD) | 64.5 (5.1) | 65.3 (4.4) | 63.8 (5.2) | 64.0 (4.3) | 63.9 (4.3) | 64.3 (4.4) |
PHQ-9 score, mean (SD) | 4.3 (5.5) | 5.9 (6.7) | 3.7 (5.7) | 4.1 (5.6) | 4.0 (5.6) | 4.0 (5.6) |
MSQoL domain scores | ||||||
RFR, mean (SD) | 49.1 (18.9) | 46.8 (19.7) | 49.7 (20.5) | 48.2 (18.3) | 49.7 (18.7) | 48.8 (19.2) |
RFP, mean (SD) | 67.5 (21.1) | 63.2 (23.5) | 67.5 (22.9) | 67.1 (20.4) | 68.7 (20.6) | 67.4 (21.7) |
EF, mean (SD) | 58.4 (26.2) | 54.3 (27.1) | 58.0 (27.5) | 55.8 (26.9) | 60.4 (25.1) | 57.7 (25.4) |