TABLE 1.
Baseline demographics and characteristics for randomised patients: Global Initiative for Asthma (GINA) Step 4 and GINA Step 5
| GINA Step 4 | GINA Step 5 | |||||
| Placebo | Reslizumab | Total | Placebo | Reslizumab | Total | |
| Patients n | 322 | 335 | 657 | 58 | 48 | 106 |
| Age years median (interquartile range) | 48.0 (12.0–74.0) | 48.0 (12.0–75.0) | 48.0 (12.0–75.0) | 52.0 (16.0–75.0) | 52.5 (20.0–69.0) | 52.0 (16.0–75.0) |
| Male | 107 (33) | 133 (40) | 240 (37) | 23 (40) | 22 (46) | 45 (42) |
| Race | ||||||
| White | 241 (75) | 250 (75) | 491 (75) | 55 (95) | 43 (90) | 98 (92) |
| Black | 13 (4) | 12 (4) | 25 (4) | 1 (2) | 1 (2) | 2 (2) |
| Asian | 46 (14) | 46 (14) | 92 (14) | 2 (3) | 4 (8) | 6 (6) |
| Other | 22 (7) | 27 (8) | 49 (7) | 0 | 0 | 0 |
| BMI kg·m−2, mean±sd | 27.5±5.62 | 27.3±5.68 | 27.4±5.65 | 26.9±5.23 | 27.5±5.92 | 27.2±5.54 |
| Patients with atopic history | 211 (66) | 212 (63) | 423 (64) | 37 (64) | 27 (56) | 64 (60) |
| Patients with seasonal allergies# | 103 (64) | 89 (52) | 192 (58) | 14 (35) | 8 (33) | 22 (34) |
| CAEs in the 12 months prior to enrolment n, mean±se | 1.8±0.08 | 1.8±0.08 | 1.8±0.06 | 3.4±0.46 | 2.6±0.37 | 3.0±0.30 |
| OCS use at enrolment per IVRS | 0 | 0 | 0 | 58 (100) | 48 (100) | 106 (100) |
| FEV1 L | 1.820 (0.340–4.680) | 1.920 (0.550–4.570) | – | 1.650 (0.540–3.930) | 1.485 (0.640–3.310) | – |
| ACQ-7 score | 2.571 (0.143–5.429) | 2.429 (0.429–5.000) | – | 3.071 (1.143–5.571) | 3.214 (1.286–5.286) | – |
| AQLQ score | 4.156 (1.406–7.000) | 4.469 (1.719–6.969) | – | 3.906 (1.656–6.125) | 3.797 (1.750–6.250) | – |
Data are presented as n (%) or median (range), unless otherwise stated. BMI: body mass index; CAE: clinical asthma exacerbation; OCS: oral corticosteroids; IVRS: interactive voice response system; FEV1: forced expiratory volume in 1 s; ACQ-7: asthma control questionnaire-7; AQLQ: asthma quality of life questionnaire. #: Data for patients with seasonal allergies only available for Study 2.