Skip to main content

Table 1 Efficacy outcomes (efficacy population)

From: Eptinezumab for the prevention of chronic migraine: efficacy and safety through 24 weeks of treatment in the phase 3 PROMISE-2 (Prevention of migraine via intravenous ALD403 safety and efficacy–2) study

  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)  
  1. aThe estimated mean, mean difference from placebo, and 95% confidence interval are from an analysis of covariance model, with treatment as a factor and the stratification variables; baseline migraine days and preventive medication use as independent variables
  2. bCalculated as the average percentage of patients with 100% migraine response for any given 4-week study month during the respective dosing interval
  3. cDefined as a day with any triptan or ergot use as recorded in the eDiary
  4. Abbreviations: CI confidence interval, MHD monthly headache day, MMD monthly migraine day, SD standard deviation