Table 2.
Headache characteristics and disability at baseline
| Characteristic | Primary analysis cohort (n = 257) | Sensitivity analysis cohorta (n = 172) | ||
|---|---|---|---|---|
| Before onabotulinumtoxinA | Baseline (before mAb) |
Before onabotulinumtoxinA | Baseline (before mAb) |
|
| Headache frequency, days/month | (n = 241) | (n = 246) | (n = 163) | (n = 172) |
| Mean (SD)b | 21 (8) | 12 (8) | 21 (8) | 13 (8) |
| Change from pre-onabotulinumtoxinA, mean (95% CI) | − 9 (− 11, − 8) | − 8 (− 10, − 6) | ||
| Category, n/N (%) | ||||
| ≤ 5 | 6/257 (2.3) | 59/257 (23.0) | 3/172 (1.7) | 25/172 (14.5) |
| 6–10 | 12/257 (4.7) | 84/257 (32.7) | 9/172 (5.2) | 65/172 (37.8) |
| 11–14 | 12/257 (4.7) | 24/257 (9.3) | 11/172 (6.4) | 20/172 (11.6) |
| 15–19 | 67/257 (26.1) | 29/257 (11.3) | 44/172 (25.6) | 22/172 (12.8) |
| ≥ 20 | 138/257 (53.7) | 50/257 (19.5) | 96/172 (55.8) | 40/172 (23.3) |
| Unknown | 22/257 (8.6) | 11/257 (4.3) | 9/172 (5.2) | 0 |
|
Headache intensityc Mean (SD) |
NA |
(n = 232) 6.5 (3.6) |
NA |
(n = 165) 6.7 (4.1) |
| MIDAS score | (n = 215) | (n = 171) | ||
| Mean (SD) | NA | 43.7 (43.4) | NA | 52.0 (44.7) |
| Moderate to very severe disability, n/N (%) | NA | 179/215 (83.3) | NA | 160/171 (93.6) |
| HIT-6 score | (n = 138) | (n = 116) | ||
| Mean (SD) | NA | 60.8 (7.2) | NA | 61.5 (6.3) |
| Substantial to severe impact, n/N (%) | NA | 112/138 (81.2) | NA | 98/116 (84.5) |
| PHQ-9 score | (n = 69) | (n = 56) | ||
| Mean (SD) | NA | 5.7 (5.0) | NA | 6.8 (4.8) |
| Moderate to severe depression, n/N (%) | NA | 14/69 (20.3) | NA | 14/56 (25.0) |
AHS American Headache Society, CGRP calcitonin gene–related peptide, HIT-6 6-item Headache Impact Test, MHD monthly headache day, MIDAS Migraine Disability Assessment, PHQ-9 9-item Patient Health Questionnaire, NA not available, mAb monoclonal antibody
aThe sensitivity analysis cohort was aligned to the AHS position statement’s recommendation for when to initiate preventive treatment with a CGRP mAb [31] and included only patients with at least four MHDs at baseline and at least moderate headache-related disability (MIDAS score > 11 or HIT-6 score > 50)
bStandardized to 30-day denominator
cHeadache intensity rated on a 0–10 scale