TABLE 2

Post-bronchodilator forced expiratory volume in 1 s (FEV1) slope during the 52-week treatment period (after week 4) across different patient subgroups

1.14mL/200mg every 2weeks2mL/300mg every 2weeks
PlaceboDupilumabPlaceboDupilumab
ITT population317631321633
 Subjects311622319626
 Post-bronchodilator FEV1 slope after week 4# L·year−1−0.038±0.4530.001±0.393−0.075±0.7370.009±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 placebo0.040.04
Patients with ≥150 blood eosinophils·µL−1 at baseline232437237452
 Subjects228432235447
 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±0.020.00±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 placebo0.080.18
Patients with ≥300 blood eosinophils·µL−1 at baseline148264142277
 Subjects146261142274
 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 placebo0.370.09
Patients with ≥25ppb FeNO at baseline162299172310
 Subjects159295171306
 Post-bronchodilator FEV1 slope after week 4# L·year−1−0.019±0.5300.016±0.446−0.098±0.958−0.007±0.405
 Estimated post-bronchodilator FEV1 slope ±se−0.02±0.030.00±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 placebo0.420.14
Patients with ≥150 blood eosinophils·µL−1 and ≥25ppb FeNO at baseline134248142258
 Subjects132245141255
 Post-bronchodilator FEV1 slope after week 4# L·year−1−0.002±0.5620.008±0.347−0.102±1.043−0.014±0.413
 Estimated post-bronchodilator FEV1 slope ±se−0.01±0.030.00±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 placebo0.710.36

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.