Director, Center for Lung Analytics and Imaging Research (CLAIR), Endowed Professor of Airways Disease at the University of Alabama at Birmingham School of Medicine

Surya P. Bhatt, MD

Credit: University of Alabama at Birmingham

Until recently, the treatment landscape of chronic obstructive pulmonary disease (COPD) had few targeted therapies addressing its inflammatory mechanisms, with treatment largely focused on bronchodilators and systemic corticosteroids (SCS). The United States Food and Drug Administration (FDA) approval of Sanofi and Regeneron's 

, under the name Dupixent, in 2024 represented the first biologic option for patients with COPD and evidence of type 2 inflammation—a subset of patients prone to frequent exacerbations and progressive lung function decline.

Data on dupilumab's benefit for COPD continue to be generated, with some of the latest findings coming out of the 2025 European Respiratory Society (ERS) Congress. In an interview with 

, Surya P. Bhatt, MD, professor of medicine in the Division of Pulmonary, Allergy, and Critical Care Medicine at the University of Alabama at Birmingham, discussed new analyses from the pivotal BOREAS and NOTUS trials, which continue to define dupilumab’s clinical impact in COPD driven by type 2 inflammation.

The new ERS data build on that foundation, highlighting dupilumab’s ability to meaningfully reduce the risk of severe exacerbations, emergency department (ED) visits, and SCS use over 52 weeks compared to placebo. These findings reinforce the biologic’s potential not just to modify disease course but to alleviate the clinical and economic burden tied to COPD flare-ups.

In the conversation, Bhatt emphasized that clinically meaningful reductions, including 39% in time-to-first severe exacerbation and 45% in time-to-first severe exacerbation or emergency department visit, further validate dupilumab’s role in improving long-term outcomes. He also discussed how the data strengthen confidence in reducing dependence on systemic corticosteroids, a major goal in managing older, comorbidity-burdened COPD populations.

Were there any notable or surprising findings from the analysis that you’d like to highlight?

This is the first analysis to show dupilumab significantly (nominal 

= .0160) reduced the risk of severe exacerbations compared to placebo. As severe exacerbations in COPD are known to increase healthcare resource utilization, morbidity and mortality risk, these data further demonstrate the ability of dupilumab reduce a key clinical measure of disease that can have broader impacts for patients.

How do these findings build upon the primary outcomes already reported in BOREAS and NOTUS?

These findings are in line with our expectations based on the primary analyses of BOREAS and NOTUS, which demonstrated dupilumab significantly reduced moderate or severe exacerbations and improved lung function compared to placebo. In addition to the risk reduction related to severe exacerbations, this new analysis also emphasizes the ability of dupilumab to reduce other disease impacts that add to a patients overall burden, such as emergency department visits and systemic corticosteroid use.

How significant were the reductions in severe exacerbations and ED visits, and what does this mean for clinical practice?

At 52 weeks, dupilumab significantly reduced risk of the time-to-first severe exacerbation event by 39% (nominal 

= .0160) and the risk of time-to-first severe exacerbation event and/or ED visit by 45% (nominal 

= .0010). Additionally, dupilumab also significantly reduced overall severe exacerbation rates and/or ED visits (nominal 

= .0121). These results emphasize the ability of dupilumab to not only reduce disease burden, but also healthcare resource utilization.

What did the data show about systemic corticosteroid use, and how might dupilumab change the way clinicians rely on SCS for exacerbation management?

The data demonstrate that in patients who had at least one severe exacerbation, dupilumab resulted in significantly fewer days (nominal 

= .0126) requiring systemic corticosteroid use compared to placebo. The results give clinicians confidence that using dupilumab for eligible patients can reduce the need for systemic corticosteroids, treatments that can add to a patient’s overall burden because they are associated with safety risks when used long term.

Given the known safety concerns with chronic SCS use, how meaningful is it that dupilumab both reduced exacerbations and lowered cumulative steroid exposure?

Lowering systemic corticosteroid is particularly important in patients with COPD, who tend to be older, making them more vulnerable to the immunosuppressive impacts of these medicines. Systemic corticosteroid reduction along with severe exacerbation reduction emphasizes the ability of dupilumab to reduce a key clinical outcome and the need for additional treatments, which, together, reduce disease and treatment burden for patients.

From your perspective, how might these results influence treatment guidelines for patients with COPD and type 2 inflammation moving forward?

Dupilumab is already recommended by GOLD for the treatment of eligible patients with COPD. These results provide a fuller picture of the potential impacts that dupilumab can have on key clinical outcomes and healthcare resource utilization, and they can be captured in future guideline updates as appropriate.

We will continue to conduct subgroup analyses of the pivotal BOREAS and NOTUS trials to further understand its impact on additional clinical outcomes and in patient subgroups of interest.

Transcript has been edited for clarity. Bhatt's disclosures include Nuvaira, Sanofi, and Genentench.

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

Bafadhel M, Bhatt SP, Satia I, et al. Dupilumab Reduces the Risk of Severe Exacerbations in Patients With Chronic Obstructive Pulmonary Disease: Results From BOREAS and NOTUS. Presented at: ERS Congress 2025; September 27-October 1, 2025; Amsterdam, Netherlands. Poster #PA4778

Articles

Bhatt discussed the latest data from a post-hoc analysis of the BOREAS and NOTUS trials.