1.14 mL/200 mg every 2 weeks | 2 mL/300 mg every 2 weeks | |||
Placebo | Dupilumab | Placebo | Dupilumab | |
ITT population | 317 | 631 | 321 | 633 |
Subjects | 311 | 622 | 319 | 626 |
Post-bronchodilator FEV1 slope after week 4# L·year−1 | −0.038±0.453 | 0.001±0.393 | −0.075±0.737 | 0.009±0.442 |
Estimated post-bronchodilator FEV1 slope¶ ±se | −0.04±0.02 | −0.00±0.01 | −0.04±0.02 | −0.00±0.01 |
LS mean difference versus matched placebo (95% CI) | 0.04 (0.00–0.08) | 0.04 (0.00–0.08) | ||
p-value versus matched placebo | 0.04 | 0.04 | ||
Patients with ≥150 blood eosinophils·µL−1 at baseline | 232 | 437 | 237 | 452 |
Subjects | 228 | 432 | 235 | 447 |
Post-bronchodilator FEV1 slope after week 4# L·year−1 | −0.038±0.487 | −0.003±0.350 | −0.086±0.842 | −0.006±0.447 |
Estimated post-bronchodilator FEV1 slope¶ ±se | −0.04±0.02 | 0.00±0.01 | −0.04±0.02 | −0.01±0.01 |
LS mean difference versus matched placebo (95% CI) | 0.04 (−0.01–0.09) | 0.03 (−0.02–0.08) | ||
p-value versus matched placebo | 0.08 | 0.18 | ||
Patients with ≥300 blood eosinophils·µL−1 at baseline | 148 | 264 | 142 | 277 |
Subjects | 146 | 261 | 142 | 274 |
Post-bronchodilator FEV1 slope after week 4# L·year−1 | −0.025±0.525 | −0.008±0.355 | −0.160±1.006 | −0.012±0.533 |
Estimated post-bronchodilator FEV1 slope¶ ±se | −0.05±0.03 | −0.02±0.02 | −0.07±0.03 | −0.01±0.02 |
LS mean difference versus matched placebo (95% CI) | 0.03 (−0.03–0.09) | 0.06 (−0.01–0.12) | ||
p-value versus matched placebo | 0.37 | 0.09 | ||
Patients with ≥25 ppb FeNO at baseline | 162 | 299 | 172 | 310 |
Subjects | 159 | 295 | 171 | 306 |
Post-bronchodilator FEV1 slope after week 4# L·year−1 | −0.019±0.530 | 0.016±0.446 | −0.098±0.958 | −0.007±0.405 |
Estimated post-bronchodilator FEV1 slope¶ ±se | −0.02±0.03 | 0.00±0.02 | −0.06±0.03 | −0.01±0.02 |
LS mean difference versus matched placebo (95% CI) | 0.03 (−0.04–0.09) | 0.05 (−0.02–0.11) | ||
p-value versus matched placebo | 0.42 | 0.14 | ||
Patients with ≥150 blood eosinophils·µL−1 and ≥25 ppb FeNO at baseline | 134 | 248 | 142 | 258 |
Subjects | 132 | 245 | 141 | 255 |
Post-bronchodilator FEV1 slope after week 4# L·year−1 | −0.002±0.562 | 0.008±0.347 | −0.102±1.043 | −0.014±0.413 |
Estimated post-bronchodilator FEV1 slope¶ ±se | −0.01±0.03 | 0.00±0.02 | −0.05±0.03 | −0.02±0.02 |
LS mean difference versus matched placebo (95% CI) | 0.01 (−0.06–0.08) | 0.03 (−0.04–0.10) | ||
p-value versus matched placebo | 0.71 | 0.36 |
Data are presented as n or mean±sd, unless otherwise stated. ITT: intention-to-treat; LS: least squares; FeNO, fractional exhaled nitric oxide. #: individual post-bronchodilator FEV1 slope was calculated as the slope of a linear regression model with the post-bronchodilator FEV1 (L) at each visit as the response variable and the time since randomisation as the independent variable; ¶: estimated from a mixed-effects model with repeated measure with post-bronchodilator FEV1 as outcome, and treatment, age, sex, height, geographic region, baseline eosinophil strata, baseline inhaled corticosteroid dose level, time since randomisation and treatment-by-time interaction and baseline post-bronchodilator as variables.