Table 3.
Demographic and Baseline Clinical Characteristics: Intent‐to‐Treat Population
| EVOLVE‐1 (N = 858) | EVOLVE‐2 (N = 915) | REGAIN (N = 1113) | |
|---|---|---|---|
| Patient demographics | |||
| Mean age, years (SD) | 40.7 (11.6) | 41.9 (11.1) | 41.0 (12.1) |
| Female, n (%) | 718 (83.7) | 781 (85.4) | 946 (85.0) |
| White, n (%) | 690 (80.4) | 643 (70.3) | 879 (79.1) |
| Clinical characteristics | |||
| Mean duration of migraine diagnosis, years (SD) | 20.1 (12.4) | 20.6 (12.4) | 21.1 (12.8) |
| Mean number of monthly migraine headache days, days (SD) | 9.1 (3.0) | 9.1 (2.9) | 19.4 (4.5) |
| Mean severity of migraine headaches per month (SD)† | 2.1 (0.4) | 2.1 (0.4) | 2.2 (0.4) |
| Mean number of monthly migraine headache days with acute medication use, days (SD) | 7.4 (3.5) | 7.5 (3.3) | 15.2 (6.4) |
| Prior preventive treatment in past 5 years, n (%) | 515 (60.0) | 599 (65.5) | 866 (77.8) |
| Failed ≥2 preventives in past 5 years, n (%) | 42 (4.9) | 131 (14.3) | 328 (29.5) |
| Mean number of comorbidities other than migraine (SD)‡ | 4.7 (3.6) | 3.6 (3.1) | 4.3 (3.5) |
| Patient‐reported outcomes § | |||
| MIDAS, mean total score (SD) | 33.2 (27.7) | 33.0 (29.7) | 67.2 (57.3) |
| MIDAS disability¶: | |||
| little or no, n (%) | 68 (8.4) | 92 (10.7) | 48 (4.7) |
| Mild, n (%) | 75 (9.3) | 75 (8.7) | 43 (4.2) |
| Moderate, n (%) | 163 (20.2) | 196 (22.7) | 94 (9.3) |
| Severe, n (%) | 274 (34.0) | 252 (29.2) | 223 (21.9) |
| Very severe, n (%) | 226 (28.0) | 249 (28.8) | 608 (59.8) |
| MSQ total, mean (SD) | 57.6 (16.8) | 58.4 (16.4) | 44.9 (18.0) |
| MSQ role function‐restrictive, mean (SD) | 51.5 (16.0) | 51.7 (15.6) | 38.7 (17.2) |
| MSQ role function‐preventive, mean (SD) | 67.0 (18.9) | 67.6 (19.3) | 55.7 (21.1) |
| MSQ emotional function, mean (SD) | 59.4 (24.6) | 61.9 (24.0) | 44.9 (26.3) |
†
Severity ratings defined as 0 = none, 1 = mild, 2 = moderate, 3 = severe.
‡
Numbers of patients from whom the mean number of comorbidities were collected were 772 for EVOLVE‐1, 718 for EVOLVE‐2, and 937 for REGAIN.
§
Numbers of patients from whom patient‐reported outcomes were collected were 851 for EVOLVE‐1, 909 for EVOLVE‐2, and 1090 for REGAIN.
¶
MIDAS disability category was determined only for patients with both a baseline and ending MIDAS score (806 for EVOLVE‐1, 864 for EVOLVE‐2, and 1016 for REGAIN).
MIDAS = Migraine Disability Assessment; MSQ = Migraine‐Specific Quality of Life Questionnaire v2.1; SD = standard deviation.