Table 2.
Baseline demographics and disease characteristics in the individual trials
| EVOLVE-1a | EVOLVE-2a | REGAINb | CONQUERc EM | CONQUERc CM | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| PBO (N = 433) | GMB 120 mg (N = 213) |
PBO (N = 461) | GMB 120 mg (N = 231) |
PBO (N = 558) | GMB 120 mg (N = 278) |
PBO (N = 132) | GMB 120 mg (N = 137) |
PBO (N = 98) | GMB 120 mg (N = 95) |
|
| Age, years, mean (SD) | 41.3 (11.4) | 40.9 (11.9) | 42.3 (11.3) | 40.9 (11.2) | 41.6 (12.1) | 39.7 (11.9)d | 46.3 (11.8) | 45.9 (11.2) | 44.8 (13.1) | 45.8 (11.6) |
| Female, n (%) | 362 (83.6) | 181 (85.0) | 393 (85.3) | 197 (85.3) | 483 (86.6) | 237 (85.3) | 117 (88.6) | 112 (81.8) | 85 (86.7) | 83 (87.4) |
| Number of comorbidities, mean (SD) | 4.8 (3.6) | 4.7 (3.8) | 3.7 (3.1) | 3.6 (3.4) | 4.4 (3.7) | 4.1 (3.3) | 4.1 (3.9)e | 4.0 (3.7)f | 4.3 (3.5)g | 4.4 (3.7)h |
| Migraine illness duration, years, mean (SD) | 19.9 (12.3) | 21.1 (13.0) | 21.2 (12.8) | 19.9 (11.7) | 21.9 (12.9) | 20.4 (12.7) | 22.9 (13.1) | 21.7 (12.7) | 24.9 (14.9) | 24.2 (13.9) |
| Number of monthly migraine headache days, mean (SD) | 9.1 (3.0) | 9.2 (3.1) | 9.2 (3.0) | 9.1 (2.9) | 19.6 (4.6) | 19.4 (4.3) | 9.2 (2.7) | 9.5 (3.0) | 18.1 (4.7) | 19.2 (4.7) |
| Patients with failure of ≥ 2 prior preventive treatments, n (%) | 22 (5.1) | 10 (4.7) | 63 (13.7) | 34 (14.7) | 177 (31.7) | 74 (26.6) | 132 (100) | 137 (100) | 98 (100) | 95 (100) |
| MIDAS total score, mean (SD) | 31.8 (27.3) | 32.9 (28.2) | 34.3 (31.0) | 30.9 (27.9) | 68.7 (57.4) | 62.5 (49.5) | 37.1 (26.2) | 41.3 (34.3) | 69.6 (57.9) | 64.7 (56.2) |
CM chronic migraine, EM episodic migraine, GMB galcanezumab, MIDAS Migraine Disability Assessment, N number of patients in the analysis treatment group, n number of patients with each respective outcome, PBO placebo, SD standard deviation
aIncluded patient population with EM
bIncluded patient population with CM
cIncluded patient population with EM (58%) and CM (42%)
dp ≤ 0.05 versus placebo based on analysis of variance model for continuous parameters
eN = 95
fN = 108
gN = 92
hN = 84