Table 2 Effect of Quarterly and Monthly Fremanezumab Doses on Efficacy Responses in the 3 Top-recruiting Countriesa
Czech Republic | United States | Finland | |||||||
|---|---|---|---|---|---|---|---|---|---|
Placebo (n = 60) | Quarterly fremanezumab (n = 65) | Monthly fremanezumab (n = 63) | Placebo (n = 39) | Quarterly fremanezumab (n = 39) | Monthly fremanezumab (n = 41) | Placebo (n = 27) | Quarterly fremanezumab (n = 29) | Monthly fremanezumab (n = 29) | |
12 weeks | |||||||||
Monthly headache days of at least moderate severity | |||||||||
Change from baseline (SE) | − 0.9 (0.63) | − 3.1 (0.59) | − 4.1 (0.60) | − 0.6 (0.82) | − 3.4 (0.87) | − 5.2 (0.83) | − 0.6 (1.15) | − 3.5 (1.05) | − 4.2 (1.15) |
Difference from placebo (95% CI) | − 2.2 (− 3.56, − 0.90) | − 3.2 (− 4.52, − 1.83) | − 2.8 (− 4.86, − 0.76) | − 4.6 (− 6.62, − 2.60) | − 3.0 (− 5.33, − 0.60) | − 3.6 (− 6.06, − 1.17) | |||
P value | 0.001 | < 0.001 | 0.008 | < 0.001 | 0.01 | 0.004 | |||
Monthly days of any acute headache medication use | |||||||||
Change from baseline (SE) | − 1.1 (0.65) | − 3.0 (0.61) | − 4.2 (0.62) | − 0.3 (0.78) | − 3.0 (0.81) | − 3.2 (0.78) | − 0.7 (1.17) | − 3.5 (1.07) | − 3.8 (1.18) |
Difference from placebo (95% CI) | − 1.9 (− 3.27, − 0.53) | − 3.0 (− 4.41, − 1.64) | − 2.7 (− 4.62, − 0.73) | − 2.9 (− 4.80, − 1.00) | − 2.8 (− 5.23, − 0.40) | − 3.1 (− 5.61, − 0.60) | |||
P value | 0.007 | < 0.001 | 0.007 | 0.003 | 0.02 | 0.02 | |||
4 weeks | |||||||||
Monthly headache days of at least moderate severity | |||||||||
Change from baseline (SE) | − 0.6 (0.62) | − 3.3 (0.59) | − 4.1 (0.60) | − 0.5 (0.83) | − 3.3 (0.87) | − 5.1 (0.83) | − 0.6 (1.20) | − 4.7 (1.10) | − 4.7 (1.21) |
Difference from placebo (95% CI) | − 2.7 (− 4.04, − 1.36) | − 3.5 (− 4.83, − 2.13) | − 2.8 (− 4.84, − 0.69) | − 4.6 (− 6.61, − 2.55) | − 4.0 (− 6.61, − 1.44) | − 4.1 (− 6.76, − 1.41) | |||
P value | < 0.001 | < 0.001 | 0.01 | < 0.001 | 0.003 | 0.003 | |||