Table 3.
Change from baseline to 4 weeks after the third dose of study drug in disability outcomes.
|
2 classes |
3 classes |
4 classes |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo(n = 141) | Quarterly fremanezumab(n = 140) | Monthly fremanezumab(n = 133) | Placebo(n = 82) | Quarterly fremanezumab(n = 85) | Monthly fremanezumab(n = 98) | Placebo(n = 54) | Quarterly fremanezumab(n = 49) | Monthly fremanezumab(n = 50) | |
| HIT-6 score | |||||||||
| LSM change from baseline (SE) | –2.7 (0.77) | –5.3 (0.78) | –6.4 (0.78) | –2.6 (0.90) | –5.4 (0.96) | –5.8 (0.94) | 0.6 (1.19) | –5.0 (1.18) | –6.2 (1.04) |
| LSMD versus placebo (95% CI) | –2.5 (–4.21, –0.88) | –3.6 (–5.32, –1.93) | –2.8 (–4.95, –0.57) | –3.2 (–5.28, –1.11) | –5.6 (–8.16, –3.03) | –6.8 (–9.25, –4.43) | |||
| p value | 0.003 | <0.001 | 0.014 | 0.003 | <0.001 | <0.001 | |||
| MIDAS score | |||||||||
| LSM change from baseline (SE) | –6.1 (4.10) | –14.7 (4.15) | –21.5 (4.11) | –9.1 (5.34) | –18.9 (5.69) | –25.3 (5.56) | 6.7 (10.59) | –25.0 (10.43) | –23.2 (9.12) |
| LSMD versus placebo (95% CI) | –8.7 (–17.47, 0.15) | –15.5 (–24.47, –6.46) | –9.8 (–22.68, 3.08) | –16.2 (–28.51, –3.90) | –31.7 (–54.07, –9.37) | –29.9 (–51.12, –8.70) | |||
| p value | 0.054 | <0.001 | 0.14 | 0.010 | 0.006 | 0.006 | |||
HIT-6, 6-item Headache Impact Test; LSM, least-squares mean; SE, standard error; LSMD, least-squares mean difference; CI, confidence interval; MIDAS, Migraine Disability Assessment.