Nicola Hanania, MD, MS

Early Lung Function Gains With Dupilumab Linked to Long-Term Asthma Outcomes, With Nicola Hanania, MD, MS

The treatment landscape for chronic obstructive pulmonary disease (COPD) has long centered on preventing exacerbations and slowing the relentless progression of lung function decline. While current inhaled therapies and biologics have improved patient outcomes, clinicians remain challenged by the variability of disease expression and the difficulty of predicting long-term benefit from new treatments. Recent data with dupilumab, an IL-4/IL-13 pathway–targeting biologic, offer important insight into how early improvements in lung function may translate into sustained outcomes, including reduced exacerbation rates and improved quality of life.

In a new post hoc analysis of the phase 3 NOTUS and BOREAS trials presented at the European Respiratory Society (ERS) Congress 2025, held September 27 to October 1 in Amsterdam, Netherlands, investigators examined whether lung function gains seen as early as 4 weeks after treatment initiation could predict reductions in exacerbations over 1 year, as well as improvements in patient-reported outcomes. 

 spoke with Nicola A. Hanania, MD, MS, professor of medicine and director of the Asthma Clinical Research Center at Baylor College of Medicine, who has been at the forefront of research into dupilumab’s role in COPD management and served as study investigator on the trials. The findings showed that early lung function improvement was modestly but significantly correlated with both reduced exacerbation risk and enhanced quality-of-life scores, offering a potential new tool for clinicians in monitoring treatment response.

For physicians, this analysis highlights an important shift. COPD management has often relied on retrospective markers, such as exacerbation history, to guide therapy escalation. If early, objective measures like forced expiratory volume can serve as reliable indicators of long-term benefit, clinicians may be better equipped to identify responders sooner, optimize biologic use, and personalize treatment strategies. In this interview, Hanania discussed the rationale for investigating early lung function improvements, the implications for clinical practice, and what these findings may mean for the broader goal of improving outcomes in COPD.

"Post hoc analyses have to always be looked at with a grain of salt, but it's an important addition to what we know. It also reinforces the knowledge that lung function improvement is an important thing to to work for to improve in the management of COPD... we sometimes say these patients have fixed airway obstruction. We can't move the needle. That's not true. We can improve lung function, and indeed, in our analysis, it sounds like those who have improvement lung function as early as 4 weeks had also reduction exacerbation and improvement in symptoms," Hanania said.

Hanania's disclosures include Sanofi, Genzyme, Regeneron, GSK, AstraZeneca, Regeneron, Genentech, and Merck.

Media Update: ERS: new data across Sanofi’s immunology pipeline reinforce leadership in respiratory diseases. News release. Sanofi. September 4, 2025. https://www.sanofi.com/en/media-room/press-releases/2025/2025-09-04-05-30-00-3144180

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Hanania discussed the rationale and findings of the BOREAS and NOTUS studies.

Early Lung Function Gains With Dupilumab Linked to Long-Term COPD Outcomes, With Nicola Hanania, MD, MS

Prioritizing Long-Term Control and Steroid Reduction in COPD

Engaging patients in understanding the importance of long-term COPD control and the risks of frequent oral corticosteroid use remains a significant challenge. It is critical to inform not only patients but also health care providers and families about the serious consequences of repeated steroid exposure, including increased exacerbations, hospitalizations, and even mortality. Beyond well-known adverse effects like weight gain, osteoporosis, and diabetes, steroids are also linked to mental health issues such as depression and anxiety, as well as cardiovascular risks. Effective communication strategies, including leveraging electronic medical records to flag exacerbations early, may enable timely interventions and better patient outcomes.

A major difficulty lies in patients who feel well between exacerbations and therefore may not perceive the need for intensified treatment or steroid-sparing therapies. Many patients appreciate the immediate relief steroids provide during flare-ups, making it harder to convey the cumulative harm of repeated short courses over time. Personalizing education by discussing patients’ own experiences with steroid adverse effects—such as skin thinning or blood sugar issues—and framing treatment as prevention of future complications can help increase awareness. Emphasizing the goal of avoiding long-term damage may motivate patients to adhere more closely to maintenance therapies.

In closing, the panel expressed optimism about recent advances in COPD treatment, particularly the availability of new biologics that reduce exacerbations and steroid use. Although personalized approaches are still evolving, these therapies offer hope for patients who have struggled with frequent flare-ups. The clinicians highlighted the rewarding nature of seeing real improvements in patient lives and emphasized the importance of ongoing research to refine treatment selection. Overall, it is an exciting era for COPD care, marked by new tools and a growing understanding of the disease’s underlying biology.

Panelists discuss the ongoing challenge of engaging patients, providers, and families in understanding the long-term risks of frequent oral corticosteroid use in chronic obstructive pulmonary disease (COPD), emphasizing the importance of clear communication about serious adverse effects—including mental health and cardiovascular risks—and the role of electronic medical records in early intervention; they note that patients often feel well between exacerbations and may undervalue steroid-sparing strategies, so personalized education focusing on preventing future harm is key, and express optimism that new biologics offer promising options to reduce exacerbations and steroid dependence, highlighting the evolving, hopeful landscape of COPD care.

Selecting a Biologic in COPD Management

The introduction of 2 biologics for patients with COPD with high blood eosinophils and frequent exacerbations marks an exciting advancement in treatment. Both therapies have demonstrated reductions in exacerbation risk and the need for oral steroids, which is particularly important since steroids can cause serious adverse effects, especially in patients with multiple health issues. Having these biologic options provides clinicians with new tools to better manage patients who previously had limited choices, potentially improving outcomes by breaking the cycle of frequent exacerbations and steroid use.

When deciding between the 2 biologics, there are some differences to consider, although no definitive guidelines currently exist. Factors such as blood eosinophil levels, presence of certain inflammatory markers, lung function, and patient preference for dosing schedules (every 2 weeks vs every 4 weeks) may guide treatment selection. Cost and insurance coverage also play significant roles in real-world decision-making. Clinicians acknowledge that it can sometimes take trial and error to determine which biologic yields the best response for a given patient, highlighting the need for personalized approaches in the absence of clear-cut criteria.

Ultimately, shared decision-making with patients is crucial, especially when costs are comparable. Patients’ preferences about injection frequency and convenience, as well as their tolerance for potential adverse effects, should be factored in. The availability of 2 biologics offers flexibility, allowing providers to switch therapies if the first choice does not produce adequate results. This evolving landscape reflects progress in COPD care but also underscores the need for further research to better clarify the optimal use of these new treatment options.

Panelists discuss the introduction of 2 biologics for patients with chronic obstructive pulmonary disease (COPD) with high blood eosinophils and frequent exacerbations as a major advancement, highlighting their ability to reduce exacerbations and steroid use; they note differences in dosing schedules, inflammatory markers, and patient preferences that influence therapy choice, emphasize the role of shared decision-making amid cost and insurance challenges, and acknowledge that trial and error may be needed to personalize treatment while calling for more research to optimize biologic use.

Structuring Patient Visits to Ensure Timely COPD Management

Effective management of COPD requires early identification of patients at risk for exacerbations, which can be life-threatening. To achieve this, clinic visits are structured around targeted, probing questions that quickly assess recent exacerbation history. Asking about hospitalizations, emergency department visits, unscheduled doctor visits, and recent use of steroids or antibiotics helps uncover both major and minor flare-ups. Many patients may not recognize or report these events unless specifically asked, so these questions are essential to flag high-risk patients. Early identification allows clinicians to intervene sooner and break the cycle of repeated exacerbations and hospitalizations.

Another challenge is that patients often underestimate or do not fully understand what qualifies as an exacerbation, especially when symptoms are mild or treated outside of specialist care. Educating patients to report any flare-up, even those managed at urgent care or with a short course of steroids, improves communication and ensures timely adjustment of treatment. This is particularly important because many patients receive care from multiple providers and may not volunteer information unless prompted. Continuity of care is further complicated when events occur outside the primary health care system, making it difficult for specialists to stay informed.

Integration of electronic medical records across institutions is becoming a valuable tool to bridge communication gaps. Access to comprehensive records enables providers to see hospital admissions, prescriptions, and clinical notes even if care occurred elsewhere. This data allows for real-time monitoring of exacerbations and better risk stratification. Additionally, encouraging patients to use patient portals to report flare-ups or hospitalizations fosters ongoing engagement. Together, these strategies help clinicians recognize early signs of worsening disease and escalate therapy appropriately to improve patient outcomes.

Panelists discuss the importance of early identification of patients with chronic obstructive pulmonary disease (COPD) at risk for exacerbations through targeted clinical questioning about recent hospitalizations, emergency visits, and steroid or antibiotic use, noting that many patients underreport or misunderstand exacerbations; they emphasize patient education, improved communication across multiple providers, and the integration of electronic medical records and patient portals as key strategies to enhance monitoring, ensure timely treatment escalation, and ultimately reduce exacerbation frequency and severity.

Nicola Hanania, MD, MS

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