Table 1 (abstract O31). Summary of overall results
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 | |