Dupilumab Shows Efficacy and Safety in COPD With Type 2 Inflammation: AAAAI 2025

A pooled analysis of two phase 3 clinical trials indicated that add-on dupilumab 300 mg every 2 weeks significantly reduces moderate or severe exacerbations and improves lung function in patients with chronic obstructive pulmonary disease (COPD) and type 2 inflammation.¹

The analysis was presented March 3, 2025, during a poster session at the American Academy of Allergy, Asthma and Immunology 2025 conference. It was also published in the Journal of Allergy and Clinical Immunology.¹

Both trials, BOREAS (NCT03930732) and NOTUS (NCT04456673), enrolled adults with moderate-to-severe airflow limitation, defined as blood eosinophil count ≥300 cells/μL, who were on triple therapy of inhaled corticosteroid/long-acting β2-agonist/long-acting muscarinic antagonist. Participants were randomized to receive either placebo or dupilumab for 52 weeks.¹

The primary endpoint of annualized moderate or severe exacerbation rate showed a 31% reduction with dupilumab versus placebo (nominal P<.0001). Lung function measurements indicated that the change from baseline in prebronchodilator FEV₁ at Week 12 was greater with dupilumab (least squares mean difference, 83 mL; nominal P<.0001) and remained consistent through Week 52 (73 mL; nominal P<.0001). Annualized total courses of systemic corticosteroids for exacerbations were lower with dupilumab compared with placebo (0.639 vs 0.966).¹

Safety outcomes were similar between treatment arms, with dupilumab showing a tolerability profile consistent with previous studies. Investigators concluded that dupilumab reduced exacerbation rates, improved lung function, and decreased systemic corticosteroid use in patients with COPD driven by type 2 inflammation.¹

Dupilumab, marketed as Dupixent, was approved in September 2024 by the U.S. Food and Drug Administration as add-on maintenance therapy for adults with inadequately controlled COPD and evidence of an eosinophilic phenotype. Dupilumab was the first biologic agent approved in the US to treat the chronic lung disease and the first new treatment approach for COPD in more than a decade.²

References

1. Robinson L, Bhatt S, Rabe K, et al. Efficacy and safety of dupilumab in patients with chronic obstructive pulmonary disease and type 2 inflammation: pooled analysis of BOREAS and NOTUS trials. J Allergy Clin Immunol. Published online. Accessed March 6, 2025. https://www.jacionline.org/article/S0091-6749(24)02231-0/fulltext
2. Halsey, Grace. Dupilumab becomes first biologic approved in the US as targeted therapy for adults with COPD. PatientCareOnline website. Published September 27, 2024. Accessed March 6, 2025. https://www.patientcareonline.com/view/dupilumab-becomes-first-biologic-approved-in-the-us-as-targeted-therapy-for-adults-with-copd