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Expanding treatments for COPD management

Melanie Krongold, MD; Farrukh Abbas, MD, FCCP; Diego Maselli, MD, FCCP

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2 minutes
Airways Disorders Network, Asthma and COPD Section
Melanie Krongold, MD
Melanie Krongold, MD

COPD is one of the leading causes of death in the United States. There has been a rapidly growing focus on advancing COPD therapies to reduce disease progression, symptom burden, exacerbations, and patient quality of life. In the last year, the FDA has approved two new therapies for COPD management—dupilumab and ensifentrine.

Farrukh Abbas, MD
Farrukh Abbas, MD

Dupilumab, a monoclonal antibody that targets the interleukin (IL)-4 receptor and blocks the signaling of both IL-4 and IL-13, is the first biologic therapy approved in the US to treat patients with COPD with type 2 inflammation. Two large phase III double-blinded randomized clinical trials, BOREAS and NOTUS, were performed in patients with COPD who had an absolute blood eosinophil count of ≥300 cells/mcl, chronic bronchitis, and a history of exacerbation. Dupilumab, when added to triple therapy, was associated with fewer exacerbations, improved lung function based on FEV1, and quality of life based on the St. George’s Respiratory Questionnaire, after 52 weeks. Dupilumab has been added to the GOLD 2025 treatment algorithm for patients with COPD with a history of exacerbations, chronic bronchitis, and an eosinophilic phenotype.

Diego Maselli, MD, FCCP
Diego Maselli, MD, FCCP

Ensifentrine is a novel nebulized dual phosphodiesterase 3 and 4 inhibitor showing significant anti-inflammatory and bronchodilator activity. The ENHANCE-1 and ENHANCE-2 trials, two phase III multicenter and randomized, double-blind studies were conducted among patients aged 40 to 80 years with symptomatic COPD. Both trials showed ensifentrine significantly improved average FEV1 over 12 weeks and respiratory symptoms. In these trials, about 55% to 69% of patients were concurrently taking background maintenance therapy, with only about 1% to 23% of patients taking dual inhaled therapy prior to ensifentrine use. This therapy has been added to the GOLD 2025 treatment algorithm for dyspnea in patients with COPD.

There are multiple trials underway for biologics use in patients with COPD, particularly those with evidence of type 2 inflammation. With the new additions to the GOLD 2025 report, we can be hopeful that continuing research for novel COPD therapies will provide expanded options for symptom relief, quality of life, lung function improvement, and exacerbation reduction for patients with COPD.

References

  1. Anzueto A, Barjaktarevic IZ, Siler TM, et al. Ensifentrine, a novel phosphodiesterase 3 and 4 inhibitor for the treatment of chronic obstructive pulmonary disease: randomized, double-blind, placebo-controlled, multicenter phase III trials (the ENHANCE trials). Am J Respir Crit Care Med. 2023;208(4):406-416.
  2. Bhatt SP, Rabe KF, Hanania NA, et al. Dupilumab for COPD with blood eosinophil evidence of type 2 inflammation. N Engl J Med. 2024;390(24):2274-2283.
  3. Bhatt SP, Rabe KF, Hanania NA, et al. Dupilumab for COPD with type 2 inflammation indicated by eosinophil counts. N Engl J Med. 2023;389(3):205-214.
  4. Global Initiative for Chronic Obstructive Lung Disease 2025 Report. Overview of the evidence: Pharmacotherapy. In: Global Strategy for the Diagnosis, Management, and Prevention of COPD (2025 Report). PP 78-92 . https://goldcopd.org/2025-gold-report/

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