Patients with refractory asthma | Overall population | |||
Placebo (n=161) | Reslizumab 3 mg/kg (n=145) | Placebo (n=476) | Reslizumab 3 mg/kg (n=477) | |
Median age, years (range) | 49 (13–75) | 50 (13–75) | 49 (12–75) | 48 (12–76) |
Female sex, n (%) | 104 (65) | 87 (60) | 311 (65) | 286 (60) |
Median BMI, kg/m2 (range) | 27.3 (18.5–46.6) | 26.9 (17.4–53.7) | 26.9 (16.0–47.6) | 26.9 (15.3–53.7) |
Mean FEV1 L, (SD) | 1.78 (0.63) | 1.71 (0.60) | 1.97 (0.73) | 2.01 (0.76) |
Mean FVC, L (SD) | 2.87 (1.11) | 2.80 (0.85) | 3.01 (1.03) | 3.07 (1.01) |
Mean FEV1/FVC ratio (SD) | 0.63 (0.13) | 0.61 (0.12) | 0.66 (0.12) | 0.65 (0.12) |
Mean predicted FEV1, % (SD) | 59.1 (16.2) | 57.5 (15.7) | 66.5 (19.4) | 66.9 (20.0) |
Mean airway reversibility, % (SD) | 26.8 (17.9) | 27.1 (15.6) | 27.5 (21.1) | 27.0 (15.8) |
Mean ACQ score (SD) | 2.7 (1.0) | 2.6 (1.0) | 2.5 (0.9) | 2.4 (0.9) |
Mean blood eosinophil count, 109 cells/L, (SD) | 0.73 (0.88) | 0.71 (0.90) | 0.66 (0.64) | 0.65 (0.62) |
Mean no of asthma exacerbations per patient in the past 12 months (SD) | 2.7 (2.6) | 2.3 (2.1) | 2.06 (2.07) | 1.87 (1.60) |
Taking LABA, n (%) | 152 (94) | 139 (96) | 383 (80) | 397 (83) |
Taking high-dose ICS*, n (%) | 142 (88) | 127 (88) | 208 (44) | 203 (43) |
Taking high-dose ICS*+LABA, n (%) | 135 (84) | 123 (85) | 167 (35) | 165 (35) |
Taking OCS, n (%) | 49 (30) | 44 (30) | 73 (15) | 73 (15) |
*High-dose ICS, defined as a daily dose of fluticasone ≥1000 µg, mometasone ≥800 µg, budesonide ≥1600 µg, ciclesonide ≥320 µg, beclomethasone ≥1000 µg or triamcinolone ≥2000 µg.
ACQ, Asthma Control Questionnaire; AQLQ, Asthma Quality of Life Questionnaire; ASUI, Asthma Symptom Utility Index; BMI, body mass index; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; ICS, inhaled corticosteroid; LABA, long-acting beta-agonist; OCS, oral corticosteroid; SABA, short-acting beta-agonist; SD, standard deviation.