Table 1 Baseline demographic and clinical characteristics for overall PREEMPT group and the non-responder subgroupa
From: The impact of onabotulinumtoxinA on severe headache days: PREEMPT 56-week pooled analysis
Characteristic | Overall PREEMPT Group | Non-Responder Subgroup | ||||
|---|---|---|---|---|---|---|
O/O (n = 688) | P/O (n = 696) | P-valueb | O/O (n = 285) | P/O (n = 360) | P-valueb | |
Mean (SD) age, y | 41.1 (10.4) | 41.5 (10.7) | 0.58 | 42.3 (10.4) | 42.8 (10.5) | 0.56 |
Age ≥ 40 y, n (%) | 395 (57.4) | 408 (58.6) | 0.65 | 179 (62.8) | 224 (62.2.) | 0.94 |
Sex, n (%) | ||||||
Female | 603 (87.6) | 593 (85.2) | 0.19 | 242 (84.9) | 309 (85.8) | 0.74 |
Race/Ethnicity, n (%) | 0.60 | 0.40 | ||||
White | 617 (89.7) | 630 (90.5) | 257 (90.2) | 333 (92.5) | ||
Black | 34 (4.9) | 40 (5.7) | 15 (5.3) | 17 (4.7) | ||
Hispanic | 27 (3.9) | 19 (2.7) | 9 (3.2) | 9 (2.5) | ||
Other | 10 (1.5) | 7 (1.0) | 4 (1.4) | 1 (0.3) | ||
Mean (SD) age of onset of CM, y | 21.2 (11.0) | 21.9 (11.9) | 0.46 | 21.3 (11.4) | 22.5 (12.1) | 0.19 |
Mean (SD) CM duration, y | 19.4 (12.4) | 19.0 (12.7) | 0.49 | 20.4 (12.2) | 19.7 (12.8) | 0.46 |
Mean (SD) headache days (≥4 h) per 28-day period | 19.9 (3.7) | 19.8 (3.7) | 0.52 | 20.5 (3.9) | 20.4 (4.0) | 0.61 |
Prestudy headache prophylactic use, n (%) | 425 (61.8) | 454 (65.2) | 0.18 | 197 (69.1) | 263 (73.1) | 0.29 |
Acute headache medicine overuse, n (%) | 446 (64.8) | 460 (66.1) | 0.62 | 195 (68.4) | 251 (69.7) | 0.73 |
Mean (SD) HIT-6 scorec | 65.5 (4.1) | 65.4 (4.3) | 0.64 | 65.4 (3.8) | 65.3 (4.4) | 0.84 |
Patients with severe headache impact | ||||||
(HIT-6 total score ≥ 60), %c | 93.5 | 92.7 | 0.57 | 93.7 | 92.8 | 0.75 |
Mean (SD) MSQ scored | ||||||
Role restrictive | 38.5 (16.6) | 38.7 (17.3) | 0.97 | 37.9 (16.7) | 38.4 (17.5) | 0.67 |
Role preventive | 56.0 (21.2) | 56.1 (21.7) | 0.83 | 57.0 (21.9) | 56.1 (21.7) | 0.62 |
Emotional functioning | 42.1 (24.1) | 42.4 (25.0) | 0.81 | 42.7 (23.6) | 44.6 (24.7) | 0.31 |