Dupilumab Improves Lung Function in Patients with COPD, Type 2 Inflammation

New research is shedding light on dupilumab’s sustained impact on lung function parameters in patients with chronic obstructive pulmonary disease (COPD) and type 2 inflammation.1

Pooled data from the phase 3 BOREAS and NOTUS trials were presented at the American Thoracic Society (ATS) International Conference 2025 by Meilan Han, MD, MS, a professor of medicine and chief of the division of pulmonary and critical care at the University of Michigan Health.1

A fully human monoclonal antibody, dupilumab blocks the shared receptor component for interleukin (IL)-4 and IL-13, key and central drivers of type 2 inflammation. It was approved the the US Food and Drug Administration for the treatment of COPD in September 2024 based on data from the BOREAS and NOTUS trials.1,2

In BOREAS and NOTUS, patients with COPD, moderate-to-severe airflow limitation, and type 2 inflammation, defined as ≥300 cells/µL blood eosinophils at screening, on background triple therapy received dupilumab 300 mg every 2 weeks or placebo for 52 weeks. In both trials, patients on dupilumab experienced a statistically significant reduction in exacerbations and improved lung function, and safety was consistent with the known profile.1

The analysis presented at ATS examined multiple lung function parameters in the pooled population and current and former smokers from both trials. Specifically, investigators looked at change in pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1), post-bronchodilator FEV1/forced vital capacity (FVC) ratio, and post-bronchodilator forced expiratory flow 25-75% of vital capacity (FEF25-75%) over time.1

In the intention-to-treat (ITT) population, patients received dupilumab (n = 938) or placebo (n = 936); 830 patients from each group had the opportunity to reach week 52. Investigators used the ITT population for subgroup analysis to compare current and former smokers.1

In the pooled ITT population who had the opportunity to reach week 52, the baseline mean pre-bronchodilator FEV1 was 1.32 (standard deviation [SD], 0.47) and 1.35 (SD, 0.48) L while post-bronchodilator FEV1 was 1.41 (SD, 0.47) and 1.44 (SD, 0.49) L. Post-bronchodilator FEV1/FVC ratio was 0.49 (SD, 0.12) and 0.49 (SD, 0.12), and post-bronchodilator FEF25-75% was 0.56 (SD, 0.33) and 0.56 (SD, 0.33) L/s for dupilumab and placebo, respectively.1

By week 12, compared with placebo, dupilumab improved pre-bronchodilator FEV1 (least squares [LS] mean difference, 83; 95% CI, 51-114] mL), post-bronchodilator FEV1 (LS mean difference, 72; 95% CI, 40-105 mL), post-bronchodilator FEV1/FVC (LS mean difference, 16; 95% CI, 9-23), and post-bronchodilator FEF25-75% (LS mean difference, 80; 95% CI, 44-116 mL/s). Investigators noted improvements were sustained up to week 52.1

In the ITT population, the LS mean difference vs placebo in pre-bronchodilator FEV1 at week 12 was 89 (95% CI, 52, 127) in former smokers (n = 661 dupilumab; n = 654 placebo) and 64 (95% CI, 20-109) mL in current smokers (n = 275 dupilumab; n = 282 placebo).1

“In 2 pivotal phase 3 trials in patients with COPD and type 2 inflammation, dupilumab improved lung function by Week 12 and sustained the improvement throughout the study period,” investigators concluded.1

References

1. Han MK, Sciurba FC, Anzueto A, et al. Dupilumab Improves Lung Function in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation: A Pooled Analysis From the Phase 3 NOTUS and BOREAS Trials [abstract]. Am J Respir Crit Care Med 2025;211:A1369. https://doi.org/10.1164/ajrccm.2025.211.Abstracts.A1369

2. Smith T. FDA Approves Dupilumab (Dupixent) for Treatment of COPD. HCPLive. September 27, 2024. Accessed May 23, 2025. https://www.hcplive.com/view/fda-approves-dupilumab-dupixent-for-treatment-of-copd