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Table 1 (abstract O31). Summary of overall results

From: 12th European Headache Federation Congress jointly with 32nd National Congress of the Italian Society for the Study of Headaches

Δ from BL in: EVOLVE-1
Galcanezumab
EVOLVE-2
Galcanezumab
REGAIN
Galcanezumab
120 mg
(N=210)
240 mg
(N=208)
120 mg
(N=226)
240 mg
(N=220)
120 mg
(N=273)
240 mg
(N=274)
Moderate to severe monthly HDs Δ (SE) vs. BL (PBO) -2.89 (0.21) -2.31 (0.18) -2.92 (0.33)
Δ (SE) vs. BL -4.24 (0.25) -4.15 (0.25) -3.90 (0.22) -3.78 (0.22) -4.90 (0.40) -4.64 (0.39)
Δ (SE) vs. PBO -1.35 (0.23) -1.26 (0.24) -1.59 (0.23) -1.47 (0.24) -1.98 (0.38) -1.72 (0.38)
95% CI vs. PBO (-1.81, -0.89) (-1.72, -0.80) (-2.05, -1.13) (-1.93, -1.01) (-2.73, -1.23) (-2.47, -0.97)
p-value vs. PBO <.001 <.001 <.001 <.001 <.001 <.001
Mean severity of remaining MHDs Δ (SE) vs. BL (PBO) -0.17 (0.02) -0.15 (0.02) -0.12 (0.02)
Δ (SE) vs. BL -0.19 (0.03) -0.22 (0.03) -0.20 (0.03) -0.22 (0.03) -0.19 (0.02) -0.19 (0.02)
Δ (SE) vs. PBO -0.02 (0.03) -0.05 (0.03) -0.06 (0.03) -0.08 (0.03) -0.07 (0.02) -0.07 (0.02)
95% CI vs. PBO (-0.07, 0.03) (-0.10, 0.01) (-0.11, -0.01) (-0.13, -0.03) (-0.11, -0.03) (-0.11, -0.03)
p-value vs. PBO .447 .086 .031 .004 <.001 <.001
Monthly MHDs with nausea and/or vomiting Δ (SE) vs. BL (PBO) -1.17 (0.16) -0.87 (0.13) -1.92 (0.27)
Δ (SE) vs. BL -1.91 (0.19) -2.05 (0.19) -2.02 (0.17) -1.77 (0.17) -3.13 (0.33) -3.20 (0.33)
Δ (SE) vs. PBO -0.74 (0.18) -0.88 (0.18) -1.14 (0.18) -0.90 (0.18) -1.21 (0.32) -1.28 (0.31)
95% CL for Δ (-1.10, -0.39) (-1.23, -0.52) -0.90 (0.18)) (-1.25, -0.55) (-1.82, -0.59) (-1.90, -0.66)
p-value vs. PBO <.001 <.001 <.001 <.001 <.001 <.001
Monthly MHDs with photophobia and phonophobia Δ (SE) vs. BL (PBO) -2.10 (0.23) -1.47 (0.19) -2.25 (0.36)
Δ (SE) vs. BL -3.50 (0.27) -3.54 (0.27) -3.22 (0.24) -3.00 (0.24) -3.81 (0.43) -3.58 (0.43)
Δ (SE) vs. PBO -1.39 (0.26) -1.43 (0.26) -1.76 (0.25) -1.53 (0.25) -1.56 (0.41) -1.33 (0.41)
95% CI vs. PBO (-1.90, -0.89) (-1.94, -0.93) (-2.25, -1.27) (-2.02, -1.04) (-2.37, -0.75) (-2.14, -0.52)
p-value vs. PBO <.001 <.001 <.001 <.001 <.001 .001
Monthly MHDs with aura Δ (SE) vs. BL (PBO) -0.96 (0.12) -0.97 (0.12) -1.42 (0.24)
Δ (SE) vs. BL -1.39 (0.14) -1.38 (0.15) -1.45 (0.15) -1.44 (0.16) -1.40 (0.29) -1.89 (0.29)
Δ (SE) vs. PBO -0.43 (0.14) -0.42 (0.14) -0.48 (0.17) -0.48 (0.17) 0.03 (0.28) -0.47 (0.28)
95% CI vs. PBO (-0.70, -0.16) (-0.70, -0.15) (-0.81, -0.16) (-0.80, -0.15) (-0.53, 0.58) (-1.02, 0.09)
p-value vs. PBO .002 .002 .004 .004 .922 .098
Monthly MHDs with prodromal symptoms other than aura Δ (SE) vs. BL (PBO) -1.23 (0.14) -1.01 (0.14) -1.15 (0.28)
Δ (SE) vs. BL -1.83 (0.17) -1.69 (0.17) -1.84 (0.17) -1.74 (0.17) -1.81 (0.34) -2.18 (0.33)
Δ (SE) vs. PBO -0.61 (0.17) -0.46 (0.17) -0.83 (0.18) -0.72 (0.18) -0.66 (0.32) -1.03 (0.32)
95% CI vs. PBO (-0.93, -0.28) (-0.79, -0.14) (-1.18, -0.47) (-1.08, -0.36) (-1.29, -0.02) (-1.67, -0.40)
p-value vs. PBO <.001 . 006 <.001 <.001 .042 .001
  1. Abbreviations: Δ change in least squares mean; BL baseline, CI confidence interval, HDs headache days, MHDs migraine headache days, N number of intent-to-treat patients who have non-missing baseline value and at least one post-baseline value; N’s differed slightly for mean severity of remaining MHDs. PBO placebo, SE standard error
  2. Shaded cells represent change from baseline for placebo groups; N=425, 450, and 538 for EVOLVE-1, EVOLVE-2, and REGAIN, respectively