TABLE 1.
Demographics and asthma characteristics of patients on long-term mepolizumab at first clinic visit in part C and study treatment exposure
| Stopped mepolizumab (switched to placebo) | Continued mepolizumab 100 mg s.c. | Total | |
| Patients, n | 151 | 144 | 295 |
| Females, n (%) | 86 (57) | 87 (60) | 173 (59) |
| Age, years, mean±sd | 55.7±11.42 | 56.6±11.53 | 56.1±11.46 |
| Race, n (%) | |||
| Asian | 24 (16) | 24 (17) | 48 (16) |
| Black | 2 (1) | 5 (3) | 7 (2) |
| White | 125 (83) | 115 (80) | 240 (81) |
| Body mass index, kg·m−2, mean±sd | 28.0±5.63 | 29.1±6.29 | 28.5±5.98 |
| Duration of asthma, years, mean±sd | 22.8±13.82 | 25.1±14.54 | 23.9±14.20 |
| Current concomitant medication#, n (%) | |||
| LABA | 145 (96) | 141 (98) | 286 (97) |
| ICS | 146 (97) | 137 (95) | 283 (96) |
| Using maintenance OCS, n (%) | 17 (11) | 21 (15) | 38 (13) |
| Dose, mg·day−1 (prednisone equivalent), median (range) | 5.0 (0.0–20.0) | 5.0 (0.0–20.0) | 5.0 (0.0–20.0) |
| Blood eosinophil count, cells·µL−1, geometric mean±sd of log | 40±0.870 | 50±0.881 | 50±0.876 |
| Exacerbations in previous year, mean±sd | 0.6±1.08 | 0.8±1.51 | 0.7±1.31 |
| Exacerbations requiring hospitalisation or ED visit in the previous year, n (%) | 5 (3) | 5 (3) | 10 (3) |
| Exacerbations requiring hospitalisation in the previous year, n (%) | 4 (3) | 3 (2) | 7 (2) |
| ACQ-5 score, mean±sd | 1.2±1.04 | 1.4±1.05 | 1.3±1.05 |
| SGRQ total score, mean±sd | 32.2±17.82 | 33.1±17.42 | 32.7±17.60 |
| Pre-bronchodilator FEV1, mL, mean±sd | 1921±655 | 1774±666 | 1849±663 |
| Pre-bronchodilator FEV1, % predicted, mean±sd | 65.5±19.64 | 61.6±19.08 | 63.6±19.43 |
| Mepolizumab continuous exposure prior to randomisation at visit C1 | |||
| Time on mepolizumab, months, median (range) | 44.1 (36–59) | 43.6 (32–58) | 44.1 (32–59) |
| Total exposure, patient-years | 588.0 | 557.2 | 1145.2 |
| Smoking history, n (%) | |||
| Never-smoker | 128 (85) | 123 (85) | 251 (85) |
| Former smoker | 23 (15) | 21 (15) | 44 (15) |
| Study treatment exposure during COMET (part C) | |||
| Total exposure, patient-years | 93.9 | 114.6 | 208.5 |
LABA: long-acting β2-agonist; ICS: inhaled corticosteroid; OCS: oral corticosteroid; ED: emergency department; ACQ: Asthma Control Questionnaire; SGRQ: St George's Respiratory Questionnaire; FEV1: forced expiratory volume in 1 s. #: only selected concomitant medications are shown.