Table 1.
Summary of baseline demographics, clinical characteristics, and analysis subgroups
| Mepolizumab (100 mg SC) | Placebo | Total | |
|---|---|---|---|
| N = 468 | N = 468 | N = 936 | |
| Overall population | |||
| Mean (SD) age, years | 50.4 (14.25) | 50.9 (13.55) | 50.6 (13.90) |
| Female, n (%) | 265 (57) | 283 (60) | 548 (59) |
| Mean (SD) % predicted FEV1 | 58.9 (16.74) | 60.1 (16.93) | 59.5 (16.84) |
| Mean (SD) SGRQ total score | 47.6 (18.64) | 46.5 (19.25) | 47.1 (18.94) |
| Mean (SD) ACQ-5 score | 2.25 (1.17) | 2.21 (1.18) | 2.23 (1.17) |
| Receiving maintenance OCS therapy, n (%) | 116 (25) | 111 (24) | 227 (24) |
| Exacerbations in previous year, n (%) | |||
| 2 | 248 (53) | 273 (58) | 521 (56) |
| 3 | 96 (21) | 94 (20) | 190 (20) |
| ≥ 4 | 124 (26) | 101 (22) | 225 (24) |
| Geometric mean (SD log) eosinophil count, cells/μL | 320 (0.965) | 340 (0.929) | 330 (0.947) |
| Subgroups, n (%) | |||
| Age of asthma onset ( years) | |||
| < 18 | 132 (28) | 122 (26) | 254 (27) |
| 18– < 40 | 173 (37) | 172 (37) | 345 (37) |
| ≥ 40 | 162 (35) | 174 (37) | 336 (36) |
| Lung function | |||
| ≤ 60% predicted FEV1 | 245 (52) | 244 (52) | 489 (52) |
| > 60–80% predicted FEV1 | 177 (38) | 177 (38) | 354 (38) |
| > 80% predicted FEV1 | 46 (10) | 47 (10) | 93 (10) |
| Airway reversibility | |||
| na | 457 | 460 | 917 |
| Reversibleb | 312 (68) | 299 (65) | 611 (67) |
| Non-reversiblec | 145 (32) | 161 (35) | 306 (33) |
| Allergen sensitivity | |||
| na | 454 | 457 | 911 |
| Sensitivity to ≥ 1 allergen | 215 (47) | 216 (47) | 496 (54) |
| Sensitivity to ≥ 1 seasonal allergen | 144 (32) | 146 (32) | 290 (32) |
| Asthma control | |||
| na | 465 | 462 | 927 |
| Uncontrolled asthmad | 334 (72) | 314 (68) | 648 (70) |
| Partially or fully controlled asthmae | 131 (28) | 148 (32) | 279 (30) |
ACQ-5 Asthma Control Questionnaire, 5 item, FEV1 forced expiratory volume in 1 s, SC subcutaneous, SD standard deviation
aNot all patients had data available on airway reversibility, asthma control and allergen sensitivity; those without ≥ 1 result were not included in the relevant subanalyses
bDefined as patients with a ≥ 12% change in FEV1
cDefined as patients with a < 12% change in FEV1
dDefined as an ACQ-5 score ≥ 1.5
edefined as an ACQ-5 score < 1.5