TABLE 1.
Baseline demographics and clinical characteristics in patients with and without PAO
| Patients with PAO | Patients without PAO | |||||
|---|---|---|---|---|---|---|
| Demographic/characteristic | Tezepelumab 210 mg Q4W | Placebo | Overall | Tezepelumab 210 mg Q4W | Placebo | Overall |
| Patients, n | 388 | 394 | 782 | 277 | 275 | 552 |
| Age years, mean±sd | 54.5±12.7 | 53.8±12.2 | 54.1±12.4 | 44.9±17.6 | 43.9±17.0 | 44.4±17.3 |
| Female, n (%) | 243 (62.6) | 234 (59.4) | 477 (61.0) | 179 (64.6) | 197 (71.6) | 376 (68.1) |
| Former smoker, n (%) | 88 (22.7) | 89 (22.6) | 177 (22.6) | 45 (16.2) | 37 (13.5) | 82 (14.9) |
| Pack-years among former smokers, mean±sd | 4.3±3.0 | 4.6±3.3 | 4.5±3.1 | 3.6±2.9 | 3.9±2.9 | 3.8±2.9 |
| Age at asthma onset years, n (%) | ||||||
| <18 | 121 (31.2) | 116 (29.4) | 237 (30.3) | 106 (38.3) | 107 (38.9) | 213 (38.6) |
| 18–40 | 140 (36.1) | 148 (37.6) | 288 (36.8) | 83 (30.0) | 95 (34.5) | 178 (32.2) |
| >40 | 127 (32.7) | 130 (33.0) | 257 (32.9) | 88 (31.8) | 73 (26.5) | 161 (29.2) |
| Time since asthma diagnosis years, mean±sd | 24.5±16.9 | 23.1±16.0 | 23.8±16.5 | 16.9±13.3 | 18.1±13.7 | 17.5±13.5 |
| BMI kg·m−2, mean±sd | 28.5±6.6 | 28.3±6.1 | 28.4±6.4 | 28.9±6.8 | 28.4±7.3 | 28.6±7.1 |
| ICS dose, n (%)# | ||||||
| Medium | 97 (25.0) | 111 (28.2) | 208 (26.6) | 104 (37.5) | 94 (34.2) | 198 (35.9) |
| High | 291 (75.0) | 282 (71.6) | 573 (73.3) | 173 (62.5) | 181 (65.8) | 354 (64.1) |
| Additional maintenance treatments (in addition to ICS), n (%) | ||||||
| LABA | 215 (55.4) | 215 (54.6) | 430 (55.0) | 144 (52.0) | 149 (54.2) | 293 (53.1) |
| LABA+LAMA | 44 (11.3) | 41 (10.4) | 85 (10.9) | 21 (7.6) | 27 (9.8) | 48 (8.7) |
| LABA+LAMA+LTRA | 47 (12.1) | 39 (9.9) | 86 (11.0) | 29 (10.5) | 23 (8.4) | 52 (9.4) |
| LABA+LTRA | 79 (20.4) | 93 (23.6) | 172 (22.0) | 80 (28.9) | 73 (26.5) | 153 (27.7) |
| OCS use, n (%) | 40 (10.3) | 45 (11.4) | 85 (10.9) | 18 (6.5) | 19 (6.9) | 37 (6.7) |
| Number of exacerbations in the past 12 months, per patient | ||||||
| Mean±sd | 2.8±1.5 | 2.8±1.5 | 2.8±1.5 | 2.6±1.2 | 2.5±1.0 | 2.6±1.1 |
| Median (min, max) | 2 (1, 15) | 2 (1, 11) | 2 (1, 15) | 2 (1, 10) | 2 (1, 8) | 2 (1, 10) |
| Pre-bronchodilator FEV1 L, mean±sd | 1.55±0.53 | 1.58±0.55 | 1.57±0.54 | 2.23±0.70 | 2.22±0.68 | 2.22±0.69 |
| Post-bronchodilator FEV1 L, mean±sd | 1.79±0.61 | 1.84±0.63 | 1.81±0.62 | 2.53±0.77 | 2.54±0.71 | 2.53±0.74 |
| % predicted pre-bronchodilator FEV1, mean±sd | 53.98±13.99 | 54.32±14.36 | 54.15±14.17 | 73.21±14.45 | 73.39±14.40 | 73.30±14.42 |
| Pre-bronchodilator FVC L, mean±sd | 2.84±0.90 | 2.91±0.96 | 2.87±0.93 | 3.01±0.94 | 3.01±0.85 | 3.01±0.90 |
| Post-bronchodilator FVC L, mean±sd | 3.13±0.96 | 3.20±1.01 | 3.16±0.98 | 3.21±0.96 | 3.22±0.85 | 3.21±0.91 |
| Pre-bronchodilator FEV1/FVC %, mean±sd | 54.84±9.45 | 54.90±9.02 | 54.87±9.23 | 74.32±8.34 | 73.85±8.30 | 74.09±8.32 |
| Post-bronchodilator FEV1/FVC %, mean±sd | 57.48±9.28 | 57.50±8.91 | 57.49±9.09 | 79.07±6.66 | 78.74±6.85 | 78.91±6.75 |
| FEV1 % reversibility, mean±sd | 17.0±16.0 | 17.1±16.5 | 17.1±16.3 | 15.1±17.1 | 15.9±16.1 | 15.5±16.6 |
| FEV1 % reversibility, n (%) | ||||||
| <12 | 167 (43.0) | 173 (43.9) | 340 (43.5) | 151 (54.5) | 142 (51.6) | 293 (53.1) |
| ≥12 to <15 | 30 (7.7) | 40 (10.2) | 70 (9.0) | 26 (9.4) | 21 (7.6) | 47 (8.5) |
| ≥15 | 191 (49.2) | 181 (45.9) | 372 (47.6) | 100 (36.1) | 112 (40.7) | 212 (38.4) |
| Serum total IgE IU·mL−1, median (min, max) | 192 (2, 12 823) | 180 (2, 11 860) | 185 (2, 12 823) | 167 (2, 3665) | 187 (2, 9741) | 174 (2, 9741) |
| FEIA positive for any perennial aeroallergen, n (%)¶ | 223 (57.5) | 231 (58.6) | 454 (58.1) | 187 (67.5) | 174 (63.3) | 361 (65.4) |
| BEC cells·µL−1, median (IQR) | 280 (170–470) | 280 (150–480) | 280 (160–480) | 220 (120–380) | 230 (130–390) | 220 (130–380) |
| FENO ppb, median (min, max) | 29.0 (4.0, 198.0) | 29.0 (5.0, 276.3) | 29.0 (4.0, 276.3) | 28.0 (5.0, 235.0) | 24.0 (3.5, 265.0) | 26.5 (3.5, 265.0) |
PAO: persistent airflow obstruction; Q4W: every 4 weeks; BMI: body mass index; ICS: inhaled corticosteroid; LABA: long-acting β-agonist; LAMA: long-acting muscarinic antagonist; LTRA: leukotriene receptor antagonist; 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).