Table 2 Primary and key secondary efficacy outcomes (FAS)
Placebo (n = 100) | Eptinezumab 100 mg (n = 90) | |
|---|---|---|
Primary endpoint | ||
Change from baseline in MMDs (Weeks 1–12; FAS) | ||
Change in mean from baseline (SE) | -5.9 (0.68) | -7.2 (0.73) |
Difference from placebo (95% CI) | -1.2 (-2.9 to 0.4) | |
p-value vs placebo | 0.1484 | |
Key secondary endpoints | ||
Changes from baseline in MMDs with AHM (Weeks 1–12) | ||
Change in mean from baseline (SE) | -6.2 (0.69) | -7.5 (0.73) |
Difference from placebo (95% CI) | -1.3 (-3.0 to 0.4) | |
p-value vs placebo | 0.1363 | |
≥ 50% reduction from baseline in MMDs (Weeks 1–12), n/N (%) | 24/100 (24.0) | 28/90 (31.1) |
Difference to placebo (%) | 7.1 | |
Odds ratio vs placebo (95% CI) | 1.45 (0.76 to 2.77) | |
p-value vs placebo | 0.2563 | |
Migraine rate on the day after dosing (Day 1) | ||
Baseline, n (%) | 100 (70.5) | 90 (69.5) |
Day 1, n (%) | 99 (59.2) | 90 (44.2) |
p-value vs placebo | 0.0315 | |
≥ 75% reduction from baseline in MMDs (Weeks 1–4), n/N (%) | 1/99 (1.0) | 16/90 (17.8) |
Difference to placebo (%) | 16.8 | |
Odds ratio vs placebo (95% CI) | 20.74 (4.07 to 378.98) | |
p-value vs placebo | < 0.0001 | |
Change from baseline in the number of MHDs (Weeks 1–12) | ||
Change in mean from baseline (SE) | -5.9 (0.67) | -7.1 (0.70) |
Difference from placebo (95% CI) | -1.2 (-2.9 to 0.5) | |
p-value vs placebo | 0.1516 | |
≥ 75% reduction from baseline in MMDs (Weeks 1–12), n/N (%) | 2/100 (2.0) | 15/90 (16.7) |
Difference to placebo (%) | 14.7 | |
Odds ratio vs placebo (95% CI) | 9.78 (2.64 to 63.44) | |
p-value vs placebo | 0.0002 | |