Table I. Subject demographics and baseline characteristics (ITT population).
| Characteristica | Cohort 1 (single-dose IV)b N=13 | Cohort 2 (multiple-dose SC)b N=14 | ||||
|---|---|---|---|---|---|---|
|
|
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| Placebo n = 5 |
Benralizumab 1 mg/kg n= 8 |
Placebo n= 5 |
Benralizumab 100 mg n= 4 |
Benralizumab 200 mg n= 5 |
Benralizumab total n= 9 |
|
| Age, y, mean (SD) | 34.4 (9.7) | 38.9 (14.7) | 40.2 (14.5) | 41.0 (14.9) | 37.2 (14.4) | 38.9 (13.8) |
| Sex, n, Male/Female | 3 / 2 | 2 / 6 | 1 / 4 | 3 / 1 | 2 / 3 | 5 /4 |
| Race, n (%) | ||||||
| White | 4 (80.0) | 8 (100) | 5 (100) | 4 (100) | 4 (80.0) | 8 (88.9) |
| Other | 1 (20.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (20.0) | 1 (11.1) |
| Weight, kg, mean (SD) | 72.2 (10.8) | 72.9 (17.5) | 74.6 (19.9) | 92.4 (14.5) | 80.4 (12.6) | 85.7 (14.1) |
| ≥1 asthma controller medication, n | 4 | 6 | 5 | 2 | 4 | 6 |
| ICS dose (budesonide equivalent μg/day), median (range) | 400 (0–2000) | 550 (0–1300) | 800 (400–3520) | 400 (0–2400) | 800 (0–1600) | 800 (0–2400) |
| Forced expiratory volume (FEV) | ||||||
| FEV1 (L), mean (SD) | 2.5 (0.8) | 2.3 (0.6) | 1.9 (0.4) | 3.0 (1.2) | 2.2 (0.6) | 2.6 (1.0) |
| Predicted FEV1 (%)c, mean (SD) | 67.2 (9.1) | 70.5 (15.6) | 60.5 (6.6) | 72.5 (13.1) | 65.7 (10.2) | 68.7 (11.4) |
| FEV1/FVC (%)c, mean (SD) | 66.7 (10.0) | 70.7 (9.8) | 67.0 (12.7) | 69.6 (5.9) | 67.2 (4.2) | 68.3 (4.8) |
| Sputum eosinophil counts %, mean (SD) | 13.9 (10.3) | 6.6 (2.2) | 34.1 (32.7) | 10.5 (7.7) | 4.9 (2.4) | 7.4 (5.8) |
Abbreviations: FEV1 = forced expiratory volume in 1 second; FVC = forced vital capacity; ICS = inhaled corticosteroid; ITT = intent to treat; IV = intravenous; SC = subcutaneous; SD = standard deviation.
a
Subject baseline values were recorded at the visit occurring just prior to receiving the first dose of study medication; this may have been day 0 or screening.
b
Note that cohorts were consecutive (non-parallel) in this study.
c
Screening postbronchodilator FEV1 predicted (%) and screening prebronchodilator FEV1/ FVC (%) were used as part of the eligibility criteria.