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

 (COPD) with chronic bronchitis and type 2 inflammation, defined by blood eosinophil counts of 300 cells/µL or higher, in patients remaining uncontrolled on triple therapy. GOLD 2026, published just ahead of 

European Respiratory Society (ERS) International Congress, held in Barcelona from September 5-9

, added mepolizumab alongside dupilumab as a second biologic option for this same eosinophilic, exacerbation-prone phenotype.

A post hoc analysis of pooled BOREAS and NOTUS data assessed dupilumab versus placebo across all 4 seasons by exacerbation start date, since winter exacerbations are disproportionately infection-driven while type 2 inflammatory exacerbations are not. Dupilumab reduced exacerbation rates by 25.9% in winter, 33.4% in spring, 33.1% in summer, and 27.1% in fall (all P≤.005).

 Events requiring both systemic corticosteroids and antibiotics, the most resource-intensive category, were numerically lower with dupilumab in every season.

A separate pooled analysis stratified by smoking status found dupilumab reduced exacerbation rates by 32% in both current and former smokers, with a non-significant treatment-by-subgroup interaction (

 Current smokers are often excluded from or underrepresented in COPD biologic trials, and dupilumab carries no smoking cessation prerequisite for initiation.

Across the METREX, METREO, and MATINEE trials, mepolizumab reduced exacerbations by 18% to 21% without significant gains in lung function or quality of life, while dupilumab improved both alongside exacerbation reduction of 30% to 34% in its pivotal trials.

 Both analyses discussed here are post hoc rather than prespecified, so clinicians should weigh them as supportive context within approved labeling rather than as new indications.

Surya Bhatt, MD, MSPH, professor of medicine in the Division of Pulmonary, Allergy, and Critical Care Medicine at the University of Alabama at Birmingham, discussed these findings with 

 at the ERS Congress 2026 in Barcelona. In the following interview, Bhatt addresses what the seasonal and smoking status data add to choosing between dupilumab and mepolizumab in COPD.

HCPLive: What was the hypothesis behind this seasonal analysis, and what does the consistent exacerbation reduction across seasons suggest about dupilumab's mechanism?

The goal of this analysis was to understand how dupilumab performs across seasons regardless of the presence of specific exacerbation triggers within a particular season. Given type 2 inflammation doesn't drive exacerbations only in response to specific triggers, we expected dupilumab to work similarly across seasons. Therefore, the results are consistent with our expectations, demonstrating that, regardless of season, dupilumab consistently and significantly reduced exacerbations.

HCPLive: Why is the reduction in exacerbations requiring both steroids and antibiotics particularly meaningful for frequent exacerbators?

 The decision to treat a particular patient with steroids alone, antibiotics alone, or with both is a clinical decision often made by clinicians based on clinical gestalt and prior response to these medications. Although individual events were not phenotyped for etiology, the broad efficacy of dupilumab for all types of events raises confidence that the efficacy is not confined to steroid-responsive type 2 inflammation-related exacerbations only.

HCPLive: Should smoking cessation remain a prerequisite before initiating dupilumab in a patient who meets the eosinophil threshold?

Dupilumab is already approved for eligible patients with COPD, including both current and former smokers, so smoking cessation is not a requirement to initiate dupilumab. This analysis confirms that dupilumab not only significantly reduces exacerbations in current or former smokers, but also led to improvements in other key outcomes in both populations, including improvements in lung function, health-related quality of life, and reduction in symptom burden compared to placebo.

HCPLive: How should clinicians weigh post hoc subgroup findings when making treatment decisions for dupilumab in COPD?

Clinicians should continue to prescribe dupilumab in accordance with local regulatory guidelines in alignment with approved labeling. However, post hoc analyses like these provide additional information on the potential outcomes across patient populations or other specific variables when prescribing dupilumab. These two post hoc analyses, for example, can provide clinicians more confidence in administering dupilumab regardless of smoking status and across seasons.

HCPLive: With 2 biologics now in the GOLD algorithm, how should clinicians choose between dupilumab and mepolizumab for individual patients?

Dupilumab is currently the only approved biologic for COPD that has demonstrated improved outcomes across exacerbations, lung function, and health-related quality of life. Dupilumab is already approved for eligible patients regardless of smoking status and can be used in any season, but the results from these post hoc analyses provide additional data that could give healthcare providers a more holistic understanding of the outcomes their patients might see while on dupilumab.

Editor's Note: This transcript has been edited for grammar and clarity using artificial intelligence tools. Bhatt’s disclosures include Sanofi, Regeneron, Apreo, Boehringer Ingelheim, GSK, Genentech, Merck, and others.

Criner G, Wilkinson T, Sciurba F, et al. Dupilumab reduces exacerbations regardless of season in patients with chronic obstructive pulmonary disease. Presented at: ERS Congress 2026; September 5-9, 2026; Barcelona, Spain.

Bhatt S, et al. Dupilumab is efficacious in chronic obstructive pulmonary disease with type 2 inflammation regardless of smoking status. Presented at: ERS Congress 2026; September 5-9, 2026; Barcelona, Spain. Abstract PA2555.

Cazzola M, Bajpai J, Calzetta L, Matera MG, Rogliani P. GOLD 2026: transforming COPD management with early intervention, multi-dimensional assessment, and personalized care. Drugs. 2026;86(5):581-597. doi:10.1007/s40265-026-02303-3

Articles

Dupilumab is approved for exacerbation-prone COPD with chronic bronchitis and type 2 inflammation (blood eosinophils ≥300/µL) despite triple therapy, and GOLD 2026 now lists mepolizumab as an additional biologic option. Post hoc pooled BOREAS/NOTUS analyses showed dupilumab significantly reduced exacerbations across all seasons, including winter, and numerically lowered events requiring both systemic corticosteroids and antibiotics. Another pooled analysis demonstrated comparable exacerbation reduction in current and former smokers with no interaction signal. These findings support use within labeling, acknowledging post hoc limitations.

Bhatt also discusses how these findings inform the choice between dupilumab and mepolizumab under GOLD 2026.

Dupilumab Cuts COPD Exacerbations Across Seasons, Smoking Status: Surya Bhatt, MD

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

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