Table 2.
Endpoint | Time frame | LS Mean Change (SE) | LS Mean Change Difference / Odds Ratio (95% CI) | p-value | |
---|---|---|---|---|---|
Galcanezumab 120 mg | Placebo | ||||
Monthly MHDs | Month 1–3 | -3.81 (0.23) | -1.99 (0.23) | -1.82 (-2.32, -1.32)a | < 0.0001 |
≥ 50% response rate | Month 1–3 | 54.9 (2.4)b | 32.9 (2.3)b | 2.48 (1.87, 3.29)c | < 0.0001 |
MSQ-RFR | Month 1–3 | 21.01 (0.85) | 13.94 (0.88) | 7.07 (5.20, 8.95)a | < 0.0001 |
≥ 75% response rate | Month 1–3 | 29.2 (2.1)b | 12.7 (1.6)b | 2.82 (2.01, 3.97)c | < 0.0001 |
100% response rate | Month 1–3 | 11.9 (1.4)b | 3.9 (0.9)b | 3.31 (1.99, 5.50)c | < 0.0001 |
Monthly MHDs treated with acute medication | Month 1–3 | -2.49 (0.22) | -0.71 (0.22) | -1.78 (-2.25, -1.31)a | < 0.0001 |
MSQ-Total Score | Month 1–3 | 19.73 (0.81) | 13.56 (0.84) | 6.17 (4.39, 7.95)a | < 0.0001 |
MSQ-RFP | Month 1–3 | 18.79 (0.87) | 12.76 (0.90) | 6.03 (4.10, 7.95)a | < 0.0001 |
MSQ-EF | Month 1–3 | 17.88 (0.98) | 13.72 (1.02) | 4.16 (2.00, 6.32)a | 0.0002 |
PGI-S | Month 3 | -0.83 (0.09) | -0.61 (0.10) | -0.22 (-0.43, -0.02)a | 0.0284 |
MIDAS Total Score | Month 3 | -22.61 (2.96) | -10.18 (3.06) | -12.43 (-18.81, -6.05)a | 0.0001 |
aLS mean change difference
bModel estimated rate
cOdds ratio
CI Confidence interval, LS Least squares, MHD Migraine headache day, MIDAS Migraine Disability Assessment, MSQ-EF Migraine Specific Quality of Life Questionnaire Emotional Function, MSQ-RFP Migraine Specific Quality of Life Questionnaire Role Function-Preventive, MSQ-RFR Migraine Specific Quality of Life Questionnaire Role Function-Restrictive, PGI-S Patient Global Impression of Severity, SE Standard error