Exploring the New COPD Era: Biologics, Guidelines, and Real-World Barriers

Over the past decade, chronic obstructive pulmonary disease (COPD) management has undergone a quiet but meaningful shift. Where treatment once revolved almost entirely around inhaled bronchodilators and corticosteroids, clinicians are now navigating a broader, more biologically informed landscape. The increasing recognition that COPD is not a singular disease but instead a collection of phenotypes and inflammatory patterns, has pushed the field toward more patient-specific assessment, improved diagnostic rigor, and the early use of biomarkers to guide therapy.

This evolution has been accelerated by the arrival of targeted biologic options for a subset of patients with eosinophilic COPD. For many clinicians, the 2024 approval of dupilumab for eosinophilic COPD marked the first truly novel therapeutic pathway in years, opening doors for patients who continue to struggle with exacerbations despite optimal inhaled regimens.1 This approval was followed up by that of mepolizumab in 2025 and investigations into new therapies continue to grow.2 As enthusiasm grows, so too do practical questions around patient selection, real-world efficacy, fluctuating biomarkers, and navigating payer barriers to ensure appropriate access.

Against this backdrop, experts led by MeiLan K. Han, MD, MS, Henry Sewall Professor of Medicine, Professor of Internal Medicine and Section Head, Division of Pulmonary and Critical Care Medicine, University of Michigan Medical School, convened at a recent clinical forum convened by HCPLive to capture front-line perspectives on how pulmonologists and severe-airways specialists are incorporating biologics into COPD care. The conversation explored the realities of diagnosing complex airway disease, evaluating eosinophil thresholds in practice, distinguishing asthma–COPD overlap from pure COPD, and reframing management around treatable traits rather than rigid step-up protocols. The discussion reveals a field in transition, one still anchored in foundational therapies but increasingly empowered by precision tools that promise to reshape outcomes for the right patients.

Across the forum, clinicians highlighted how COPD management continues to be challenged by misdiagnosis, delayed referral, inhaler misuse, and inconsistent adherence, issues that predate new therapies but directly influence how well patients respond to them.

"There are some of us do use dupilumab in patients where we haven't documented [high eosinophils currently], because of the use of steroids... And I don't want to leave those out," a panelist said.

A recurring theme was the need for deeper phenotyping at the point of care, including careful interpretation of eosinophils, exacerbation patterns, imaging findings, and symptom profiles to determine whether a patient reflects true COPD, asthma–COPD overlap, or a mixed inflammatory state. Participants emphasized that eosinophils should guide but not dictate decisions, noting their variability over time and the importance of assessing broader clinical context.

"The data would really suggest it's your super frequent exacerbators that benefit the most. I will say one of the challenges that I personally have with roflumilast, I don't have many patients who are able to tolerate it," one panelist said while discussing roflumilast as a potential treatment choice.

The group also explored how biologics are being deployed in real-world practice, with clinicians describing their criteria for initiating therapy in patients who remain highly symptomatic or are frequent exacerbators despite optimized triple therapy. They discussed the operational barriers that accompany biologics, such as documentation, insurance approvals, infusion logistics, and the importance of aligning pulmonologists, primary care physicians, pharmacists, and payers.

"Our primary care physicians, they have a lack of training on COPD. They sit on those patients with exacerbations for too long. They give them parenteral steroids very often. So, a broader education campaign to teach the front lines on when to recognize and when promptly refer patients to somebody who can treat these patients, I think, will be essential to change [the trajectory of] disease," another said.

Ultimately, the take-home message centered on a more individualized, treatable-traits–driven model of COPD care: one that leverages biologics where appropriate but remains grounded in foundational elements such as inhaler technique, pulmonary rehabilitation, risk-factor modification, and longitudinal patient engagement.

References

1. Dupixent® (dupilumab) Approved in the U.S. as the First-ever Biologic Medicine for Patients with COPD. Regeneron Pharmaceuticals, Inc. September 27, 2024. https://www.globenewswire.com/news-release/2024/09/27/2954552/0/en/Dupixent-dupilumab-Approved-in-the-U-S-as-the-First-ever-Biologic-Medicine-for-Patients-with-COPD.html.

2. Johnson V. FDA Approves Mepolizumab for Eosinophilic COPD. News release. Article. HCPLive. https://www.hcplive.com/view/personalized-copd-treatment-lessons-biologic-trials-clinical-practice