Dupilumab for COPD: Current Evidence and Recommendations
Dupilumab (Dupixent) is FDA-approved for the treatment of inadequately controlled chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype, specifically as an add-on maintenance treatment in adult patients. 1
Indication and Patient Selection
Dupilumab is indicated for a specific subset of COPD patients with:
- Inadequately controlled COPD despite standard triple therapy (LAMA/LABA/ICS)
- Eosinophilic phenotype (blood eosinophil count ≥300 cells/μL)
- History of exacerbations despite optimal treatment
This targeted approach aligns with the growing understanding that COPD is heterogeneous, with different endotypes requiring personalized treatment approaches.
Efficacy Evidence
Recent high-quality evidence strongly supports dupilumab's efficacy in COPD patients with type 2 inflammation:
- Exacerbation reduction: Dupilumab reduced the annualized rate of moderate or severe exacerbations by 30% compared to placebo (rate ratio 0.70) 2
- Lung function improvement: Increased prebronchodilator FEV1 by 83 mL more than placebo at 12 weeks, with benefits sustained through 52 weeks 2
- Quality of life benefits: Improved St. George's Respiratory Questionnaire (SGRQ) scores by 3.4 points more than placebo 2
- Symptom reduction: Improved Evaluating Respiratory Symptoms in COPD (E-RS-COPD) scores by 1.1 points more than placebo 2
A pooled analysis of two phase 3 trials (BOREAS and NOTUS) confirmed these findings across a larger population of 1,874 patients, showing consistent benefits in exacerbation reduction (31.3% lower annualized rate) and prolonged time to first severe exacerbation 3.
Real-World Experience
Real-world data, though limited, supports clinical trial findings:
- 55% reduction in annualized exacerbation rates
- Decreased severe exacerbations
- Improved COPD assessment test scores
- Good tolerability with minimal side effects 4
Administration and Dosing
For COPD patients, dupilumab is administered as:
- Initial dose: 600 mg (two 300 mg injections)
- Maintenance: 300 mg subcutaneously every 2 weeks 1
Safety Considerations
Dupilumab has demonstrated a favorable safety profile in COPD patients:
- Similar rates of adverse events, serious adverse events, and treatment discontinuations compared to placebo 2
- No new safety signals specific to COPD patients 3
However, clinicians should be aware of potential adverse effects observed in other indications:
- Conjunctivitis and other ocular surface disorders (particularly in atopic dermatitis patients)
- Injection site reactions
- Rare cases of eosinophilia
Clinical Implications and Recommendations
Patient selection is critical: Target patients with:
- Blood eosinophil count ≥300 cells/μL
- Continued exacerbations despite triple therapy
- No history of asthma or other pulmonary diseases associated with elevated eosinophils
Consider dupilumab when:
- Standard triple therapy (LAMA/LABA/ICS) is inadequate
- Patient has had ≥2 moderate or ≥1 severe exacerbation in the previous year
- Quality of life is significantly impacted
Monitor for:
- Reduction in exacerbation frequency and severity
- Improvement in lung function and symptoms
- Ocular side effects (refer to ophthalmology if needed)
Vaccination considerations:
- Complete age-appropriate vaccinations prior to initiating treatment 1
Limitations and Considerations
- Dupilumab is not indicated for relief of acute bronchospasm 1
- Cost and need for repeated injections may limit accessibility for some patients 4
- Long-term efficacy and safety data beyond 52 weeks is still being collected
Dupilumab represents an important advancement in COPD management, offering a targeted biological therapy for patients with a specific inflammatory endotype who continue to experience exacerbations despite optimal standard therapy.