Table 1.
Change from baseline to week 2 and week 52 in lung function parameters
| Lung function parameter | Week 2 | Week 52 | ||
|---|---|---|---|---|
| Tezepelumab 210 mg Q4W | Placebo | Tezepelumab 210 mg Q4W | Placebo | |
| Pre-bronchodilator FEV1, La | ||||
| Mean at baseline (SD) | 1.8 (0.7) | 1.9 (0.7) | 1.8 (0.7) | 1.9 (0.7) |
| n | 514 | 507 | 471 | 453 |
| LS mean change from baseline (SE) | 0.16 (0.02) | 0.05 (0.02) | 0.23 (0.02) | 0.10 (0.02) |
| LS mean difference (95% CI) | 0.11 (0.07, 0.15) | 0.13 (0.08, 0.18) | ||
| Pre-bronchodilator ppFEV1, % | ||||
| Mean at baseline (SD) | 62.8 (18.0) | 62.7 (18.0) | 62.8 (18.0) | 62.7 (18.0) |
| n | 514 | 507 | 471 | 453 |
| LS mean change from baseline (SE) | 5.71 (0.47) | 1.94 (0.47) | 7.86 (0.57) | 3.05 (0.58) |
| LS mean difference (95% CI) | 3.77 (2.46, 5.08) | 4.81 (3.22, 6.40) | ||
| Post-bronchodilator FEV1, Lb | ||||
| Mean at baseline (SD) | 2.1 (0.8) | 2.1 (0.8) | 2.1 (0.8) | 2.1 (0.8) |
| n | – | – | 480 | 460 |
| LS mean change from baseline (SE) | – | – | 0.15 (0.02) | 0.03 (0.02) |
| LS mean difference (95% CI) | – | 0.12 (0.07, 0.16) | ||
| Pre-bronchodilator FVC, L | ||||
| Mean at baseline (SD) | 2.9 (0.9) | 3.0 (0.9) | 2.9 (0.9) | 3.0 (0.9) |
| n | 514 | 507 | 471 | 453 |
| LS mean change from baseline (SE) | 0.16 (0.02) | 0.06 (0.02) | 0.24 (0.02) | 0.11 (0.02) |
| LS mean difference (95% CI) | 0.10 (0.05, 0.15) | 0.13 (0.07, 0.19) | ||
| Post-bronchodilator FVC, Lb | ||||
| Mean at baseline (SD) | 3.1 (1.0) | 3.2 (0.9) | 3.1 (1.0) | 3.2 (0.9) |
| n | – | – | 480 | 460 |
| LS mean change from baseline (SE) | – | – | 0.13 (0.02) | 0.04 (0.02) |
| LS mean difference (95% CI) | – | 0.09 (0.04, 0.14) | ||
| Pre-bronchodilator FEV1/FVC ratio, % | ||||
| Mean at baseline (SD) | 63.2 (13.3) | 62.5 (12.9) | 63.2 (13.3) | 62.5 (12.9) |
| n | 514 | 507 | 471 | 453 |
| LS mean change from baseline (SE) | 2.4 (0.3) | 0.5 (0.3) | 2.6 (0.3) | 0.5 (0.3) |
| LS mean difference (95% CI) | 1.89 (1.15, 2.63) | 2.06 (1.22, 2.90) | ||
| Post-bronchodilator FEV1/FVC ratio, %b | ||||
| Mean at baseline (SD) | 66.5 (13.7) | 66.1 (13.5) | 66.5 (13.7) | 66.1 (13.5) |
| n | – | – | 480 | 460 |
| LS mean change from baseline (SE) | – | – | 1.87 (0.3) | 0.08 (0.3) |
| LS mean difference (95% CI) | – | 1.78 (0.98, 2.59) | ||
| Pre-bronchodilator FEF25–75, L/s | ||||
| Mean at baseline (SD) | 1.1 (0.8) | 1.1 (0.9) | 1.1 (0.8) | 1.1 (0.9) |
| n | 514 | 507 | 471 | 453 |
| LS mean change from baseline (SE) | 0.16 (0.02) | 0.05 (0.02) | 0.21 (0.02) | 0.08 (0.02) |
| LS mean difference (95% CI) | 0.12 (0.06, 0.17) | 0.13 (0.07, 0.19) | ||
| Weekly mean morning PEF, L/min | ||||
| Mean at baseline (SD) | 261.7 (109.7) | 262.5 (105.8) | 261.7 (109.7) | 262.5 (105.8) |
| n | 519 | 519 | 414 | 391 |
| LS mean change from baseline (SE) | 20.3 (1.7) | 6.4 (1.7) | 34.6 (3.1) | 18.0 (3.1) |
| LS mean difference (95% CI) | 13.9 (9.15, 18.65) | 16.6 (8.07, 25.05) | ||
| Weekly mean evening PEF, L/min | ||||
| Mean at baseline (SD) | 276.9 (111.3) | 278.2 (106.9) | 276.9 (111.3) | 278.2 (106.9) |
| n | 517 | 519 | 405 | 390 |
| LS mean change from baseline (SE) | 17.4 (1.7) | 4.9 (1.7) | 23.9 (3.1) | 9.0 (3.1) |
| LS mean difference (95% CI) | 12.5 (7.69, 17.21) | 14.9 (6.31, 23.41) | ||
n is the number of patients with available data at the given time point. All patients who were randomized and received study treatment were included in the repeated measures model
CI confidence interval, FEF25–75 forced expiratory flow between 25 and 75% of vital capacity, FEV1 forced expiratory volume in 1 s, FVC forced vital capacity, LS least-squares, PEF peak expiratory flow, ppFEV1 percent predicted forced expiratory volume in 1 s, Q4W every 4 weeks, SD standard deviation, SE standard error
aFEV1 data have been published previously [18]
bPost-bronchodilator FEV1, post-bronchodilator FVC, and post-bronchodilator FEV1/FVC ratio were only assessed at week 24 and week 52