TABLE 4.
Baseline demographics and clinical characteristics of tezepelumab recipients grouped by whether they had PAO at baseline and/or week 52
| Demographic/characteristic | Patients with PAO at baseline and at week 52 | Patients without PAO at baseline or at week 52 | Patients without PAO at baseline and with PAO at week 52 | Patients with PAO at baseline and without PAO at week 52 |
|---|---|---|---|---|
| Patients, n | 283 | 220 | 25 | 73 |
| Age years, mean±sd | 56.2±11.4 | 45.1±17.2 | 54.2±14.8 | 48.5±14.7 |
| Female, n (%) | 171 (60.4) | 146 (66.4) | 15 (60.0) | 51 (69.9) |
| Time since asthma diagnosis years, mean±sd | 26.1±17.5 | 16.5±13.4 | 21.2±13.7 | 19.1±14.3 |
| BMI kg·m−2, mean±sd | 28.5±6.8 | 29.0±6.9 | 27.1±6.6 | 28.3±5.4 |
| ICS dose, n (%)# | ||||
| Medium | 69 (24.4) | 87 (39.5) | 10 (40.0) | 17 (23.3) |
| High | 214 (75.6) | 133 (60.5) | 15 (60.0) | 56 (76.7) |
| OCS use, n (%) | 28 (9.9) | 12 (5.5) | 0 (0.0) | 7 (9.6) |
| Number of exacerbations in the past 12 months, per patient | ||||
| Mean±sd | 2.8±1.5 | 2.6±1.1 | 3.0±1.9 | 2.8±1.6 |
| Median (min, max) | 2.0 (1, 15) | 2.0 (1, 10) | 2.0 (2, 10) | 2.0 (2, 13) |
| Pre-bronchodilator FEV1 L, mean±sd | 1.49±0.50 | 2.24±0.70 | 2.01±0.70 | 1.79±0.56 |
| Post-bronchodilator FEV1 L, mean±sd | 1.73±0.58 | 2.54±0.75 | 2.20±0.72 | 2.06±0.65 |
| % predicted pre-bronchodilator FEV1, mean±sd | 52.65±14.08 | 73.69±13.42 | 67.53±15.58 | 60.15±12.56 |
| Pre-bronchodilator FVC L, mean±sd | 2.83±0.89 | 2.99±0.92 | 2.95±1.05 | 2.92±0.91 |
| Post-bronchodilator FVC L, mean±sd | 3.13±0.96 | 3.20±0.94 | 2.98±1.04 | 3.18±0.96 |
| Pre-bronchodilator FEV1/FVC %, mean±sd | 53.07±9.20 | 75.14±8.01 | 68.81±8.87 | 61.56±7.46 |
| Post-bronchodilator FEV1/FVC %, mean±sd | 55.56±9.27 | 79.53±6.73 | 74.65±5.69 | 64.75±5.12 |
| Reversibility in FEV1 L, mean±sd | 58.15±159.49 | 105.75±295.52 | 55.82±139.19 | 57.65±175.73 |
| FEV1 % reversibility, n (%) | ||||
| <12 | 119 (42.0) | 119 (54.1) | 14 (56.0) | 35 (47.9) |
| ≥12 to <15 | 26 (9.2) | 23 (10.5) | 2 (8.0) | 1 (1.4) |
| ≥15 | 138 (48.8) | 78 (35.5) | 9 (36.0) | 37 (50.7) |
| Serum total IgE IU·mL−1, median (min, max) | 196 (2, 12 823) | 142 (2, 3665) | 255 (21, 2877) | 173 (2, 5115) |
| FEIA positive for any perennial aeroallergen, n (%)¶ | 168 (59.4) | 143 (65.0) | 18 (72.0) | 38 (52.1) |
| BEC cells·µL−1, median (IQR) | 260 (160–450) | 215 (120–375) | 200 (120–310) | 340 (240–540) |
| FENO ppb, median (min, max) | 26.0 (4.0, 198.0) | 27.0 (5.0, 235.0) | 23.0 (8.0, 121.7) | 45.0 (5.0, 174.0) |
PAO: persistent airflow obstruction; BMI: body mass index; ICS: inhaled corticosteroid; OCS: oral corticosteroid; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; IgE: immunoglobulin E; FEIA: fluorescence enzyme immunoassay; BEC: blood eosinophil count; FENO: fractional exhaled nitric oxide. #: medium-dose ICS: fluticasone propionate 250–500 μg·day−1 or equivalent; high-dose ICS: fluticasone propionate >500 μg·day−1 or equivalent. There was one patient from NAVIGATOR with PAO (placebo group) who received fluticasone propionate <500 µg·day−1 or equivalent. ¶: positive for at least one perennial aeroallergen (cat dander, dog dander, cockroach, dust mite (Dermatophagoides farinae or D. pteronyssinus) and mould mix).