Navigating the New COPD Era: Biologics, Guidelines, and Clinical Challenges

Dupilumab has emerged as a practice-changing option for patients with eosinophilic COPD, offering targeted anti–type 2 pathway therapy for those who continue to have frequent exacerbations despite optimized inhaled regimens; this development expands treatment choices for a high-risk subgroup and shifts attention to phenotype-driven care delivery.

Regulatory approval of dupilumab covers patients with recurrent exacerbations despite optimized inhaled therapy. This approval is based on pivotal randomized, placebo-controlled trials that reported reductions in exacerbation frequency and improvements in severe-exacerbation–related outcomes.

Integrating COPD biologics into practice requires clear selection criteria (commonly used eosinophil thresholds around ≥150–300 cells/µL plus exacerbation history), defined administration logistics (subcutaneous dosing with specialty-pharmacy or clinic-delivery options), and monitoring plans for response and safety. Payer authorization, documentation of prior inhaled optimization, and coordinated workflows among pulmonology, primary care, and pharmacy frequently determine uptake. Clinics will need stepwise escalation algorithms and administrative pathways to deliver biologic care reliably.

Updated COPD guidance increasingly endorses individualized, trait-driven management that centers biomarker use and phenotyping rather than blanket escalation of inhaled therapies. Clinicians will weigh eosinophil trends, exacerbation clustering, and overlap features when deciding whether to move beyond inhaled optimization. The clearest beneficiaries are frequent exacerbators with persistent eosinophilic inflammation despite optimized inhaled regimens.

Real-world barriers—misdiagnosis or failure to recognize an eosinophilic phenotype, delayed specialty referral, poor inhaler adherence, and payer or access hurdles—remain the principal threats to realizing population-level gains from biologics. These gaps blunt expected improvements in exacerbation burden and health-resource use.

Standardized, referral-triggered pathways combined with targeted adherence checks can help ensure eligible patients reach specialty assessment and biologic initiation promptly.

Key Takeaways:

• Dupilumab’s approval for eosinophilic COPD formalizes a biologic option for patients with recurrent exacerbations and an eosinophilic signature, adding a mechanism-targeted therapy to the COPD treatment sequence.
• Frequent-exacerbator patients with persistent eosinophilic inflammation despite optimized inhaled regimens are the primary beneficiaries and now have a validated biologic pathway to consider for exacerbation reduction.
• Clinics should operationalize phenotype-driven screening, streamline payer and pharmacy workflows, and create referral and monitoring pathways so eligible patients can access biologics efficiently and outcomes can be tracked over time.