Table 1 Efficacy outcomes (efficacy population)
Weeks 1–12 (Dose 1) | Weeks 13–24 (Dose 2) | |||||
|---|---|---|---|---|---|---|
Eptinezumab 100 mg n = 356 | Eptinezumab 300 mg n = 350 | Placebo n = 366 | Eptinezumab 100 mg n = 356 | Eptinezumab 300 mg n = 350 | Placebo n = 366 | |
Monthly migraine daysa | ||||||
Actual | ||||||
Mean | 8.5 | 7.9 | 10.5 | 8.0 | 7.3 | 10.0 |
Change from baseline | ||||||
Mean | −7.7 | −8.2 | −5.6 | −8.2 | −8.8 | −6.2 |
Difference from placebo | −2.03 | −2.60 | − 1.98 | −2.65 | ||
95% CI | (−2.88, − 1.18) | (− 3.45, − 1.74) | (− 2.94, − 1.01) | (− 3.62, − 1.68) | ||
≥50% migraine responder rate | ||||||
Patients, n (%) | 205 (57.6) | 215 (61.4) | 144 (39.3) | 217 (61.0) | 224 (64.0) | 161 (44.0) |
Difference from placebo | 18.2 | 22.1 | 17.0 | 20.0 | ||
95% CI | (11.1, 25.4) | (14.9, 29.2) | (9.8, 24.1) | (12.9, 27.2) | ||
≥75% migraine responder rate | ||||||
Patients, n (%) | 95 (26.7) | 116 (33.1) | 55 (15.0) | 140 (39.3) | 151 (43.1) | 87 (23.8) |
Difference from placebo | 11.7 | 18.1 | 15.6 | 19.4 | ||
95% CI | (5.8, 17.5) | (12.0, 24.3) | (8.9, 22.2) | (12.6, 26.2) | ||
100% migraine responder rateb | ||||||
Rate, % | 10.8 | 15.1 | 5.1 | 17.8 | 20.8 | 9.3 |
Difference from placebo | 5.8 | 10.1 | 8.5 | 11.5 | ||
95% CI | (2.9, 8.6) | (6.7, 13.4) | (4.5, 12.5) | (7.2, 15.7) | ||
Monthly headache days | ||||||
Actual | ||||||
Mean | 12.2 (6.68) | 11.7 (6.96) | 14.1 (6.38) | 10.8 (7.42) | 9.9 (7.44) | 12.5 (7.25) |
Change from baseline | ||||||
Mean | −8.2 (5.78) | −8.8 (6.10) | −6.4 (5.99) | −9.6 (6.62) | −10.6 (6.83) | −8.1 (6.90) |
Difference from placebo | −1.7 | −2.3 | −1.5 | −2.4 | ||
95% CI | (−2.59, −0.87) | (−3.22, −1.44) | (−2.44, −0.47) | (−3.43, −1.42) | ||
Acute migraine medication daysc | ||||||
Actual | ||||||
Mean | 3.3 (4.84) | 3.2 (4.71) | 4.3 (5.67) | 3.2 (4.94) | 2.8 (4.49) | 4.0 (5.59) |
Change from baseline | ||||||
Mean | −3.3 (4.89) | − 3.5 (4.62) | −1.9 (4.18) | −3.4 (5.14) | −3.9 (4.96) | −2.2 (4.73) |
Difference from placebo | −1.2 | −1.4 | −1.1 | −1.7 | ||
95% CI | (−1.66, −0.65) | (−1.88, −0.87) | (−1.86, −0.42) | (−2.44, −1.01) | ||