Dupilumab sustains lung function improvements in patients with moderate-to-severe asthma

Abstract

Background: TRAVERSE (NCT02134028), a phase 3 open-label extension study, assessed dupilumab safety and efficacy in patients with asthma aged ≥12 years who completed a previous dupilumab asthma study. This analysis evaluated changes in multiple lung function parameters in patients with moderate-to-severe asthma with elevated type 2 biomarkers (baseline eosinophils ≥150 cells·μL^-1 or fractional exhaled nitric oxide ≥25 ppb) who completed QUEST (parent study) and 2 years of dupilumab treatment in TRAVERSE.

Methods: Endpoints analyzed included: pre-bronchodilator forced expiratory volume in 1 s (FEV₁), forced vital capacity (FVC), forced expiratory flow (FEF_{25-75 %}), and pre- and post-bronchodilator FEV₁/FVC at parent study baseline (PSBL) at Weeks 0, 2, 48, and 96 in TRAVERSE, as well as pre- and post-bronchodilator FEV₁ slopes in QUEST and TRAVERSE. Statistical analyses were descriptive.

Results: Dupilumab improved pre-bronchodilator FEV₁, FVC, and FEF_{25-75 %} in QUEST; these improvements were sustained in TRAVERSE. In QUEST patients who received placebo, dupilumab initiation in TRAVERSE resulted in rapid lung function improvements. Mean (standard deviation) changes from PSBL at TRAVERSE Weeks 48 and 96 in pre-bronchodilator FEV₁ were 0.52 (0.59) and 0.45 (0.49) L in the dupilumab/dupilumab group and 0.47 (0.42) and 0.44 L (0.45) in the placebo/dupilumab group, respectively. Similar trends were observed for FVC and FEF_{25-75 %}. Dupilumab also improved FEV₁ slopes in QUEST and TRAVERSE.

Conclusion: Dupilumab demonstrated sustained improvements across multiple spirometric lung function measurements for up to 3 years; patients who received placebo in QUEST experienced rapid lung function improvement upon initiation of dupilumab in TRAVERSE.

Keywords: Dupilumab; Lung function; Moderate-to-severe asthma; Type 2 inflammation.