Exploring the New COPD Era: Biologics, Guidelines, and Real-World Barriers
The management of chronic obstructive pulmonary disease (COPD) has undergone a significant transformation over the past decade, shifting from a narrow focus on inhaled bronchodilators and corticosteroids to a more comprehensive, biologically-informed approach. This evolution is driven by the recognition that COPD encompasses a diverse range of phenotypes and inflammatory patterns, necessitating a more patient-centric assessment, rigorous diagnostics, and the early utilization of biomarkers to guide treatment. The introduction of targeted biologic therapies for eosinophilic COPD has further accelerated this shift, offering novel treatment options for patients who have not responded adequately to traditional inhaled therapies.
The 2024 approval of dupilumab for eosinophilic COPD marked a pivotal moment, introducing a groundbreaking therapeutic pathway for patients with persistent exacerbations despite optimal inhaled regimens. This milestone was followed by the approval of mepolizumab in 2025, and ongoing research into new therapies continues to expand. As enthusiasm for these biologic treatments grows, so do practical considerations regarding patient selection, real-world efficacy, biomarker fluctuations, and navigating payer barriers to ensure equitable access.
In response to these developments, experts gathered at a clinical forum hosted by HCPLive to share front-line insights on how pulmonologists and severe-airways specialists are integrating biologics into COPD care. The discussion delved into the complexities of diagnosing airway diseases, evaluating eosinophil thresholds in clinical practice, distinguishing asthma-COPD overlap from pure COPD, and redefining management strategies around treatable traits rather than rigid step-up protocols.
Clinicians emphasized the need for deeper phenotyping at the point of care, involving careful interpretation of eosinophils, exacerbation patterns, imaging findings, and symptom profiles to accurately classify patients as having true COPD, asthma-COPD overlap, or a mixed inflammatory state. They stressed that eosinophils should guide decisions but not dictate them, considering their variability over time and the importance of contextual assessment.
One panelist highlighted the challenge of managing patients with frequent exacerbations, noting that roflumilast, a potential treatment option, is not well-tolerated by many patients. This underscores the importance of personalized treatment approaches based on patient characteristics and response to therapy.
The forum also explored the practical deployment of biologics in real-world settings. Clinicians described their criteria for initiating therapy in patients with persistent symptoms or frequent exacerbations despite optimized triple therapy. They discussed operational barriers associated with biologics, such as documentation, insurance approvals, infusion logistics, and the need for collaboration among pulmonologists, primary care physicians, pharmacists, and payers.
One participant emphasized the importance of educating primary care physicians on COPD management, as they often lack the necessary training and may inadvertently prolong exacerbations by prescribing parenteral steroids. A comprehensive education campaign targeting front-line healthcare providers is proposed to improve disease recognition and timely referrals to specialists.
In conclusion, the consensus among experts is that COPD care should be more individualized and focused on treatable traits. This approach leverages biologics when appropriate while maintaining a foundation in essential elements such as inhaler technique, pulmonary rehabilitation, risk-factor modification, and ongoing 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