BOREAS
Trial question
What is the role of dupilumab in patients with COPD who had type 2 inflammation indicated by eosinophil counts?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
34.0% female
66.0% male
N = 939
939 patients (319 female, 620 male).
Inclusion criteria: patients with COPD who had a blood eosinophil count ≥ 300 cells/mL and an elevated exacerbation risk despite the use of standard triple therapy.
Key exclusion criteria: current diagnosis of asthma or a history of asthma.
Interventions
N=468 dupilumab (subcutaneous injection of 300 mg every 2 weeks).
N=471 placebo (matching placebo every 2 weeks).
Primary outcome
Annualized rate of moderate or severe exacerbations
0.78
1.1
1.1
0.8
0.6
0.3
0.0
Dupilumab
Placebo
Significant
decrease ▼
Significant decrease in annualized rate of moderate or severe exacerbations (0.78 vs. 1.1; RR 0.7, 95% CI 0.58 to 0.86).
Secondary outcomes
Significantly greater improvement in prebronchodilator FEV1 at week 12 (160 mL vs. 77 mL; LSMD 83, 95% CI 42 to 125).
Significantly lower reduction in St. George's Respiratory Questionnaire Score at week 52 (-9.7 points vs. -6.4 points; LSMD -3.4, 95% CI -5.5 to -1.3).
Significantly lower reduction in evaluating respiratory symptoms in COPD score (-2.7 points vs. -1.6 points; LSMD -1.1, 95% CI -1.8 to -0.4).
Safety outcomes
No significant differences in adverse events leading to discontinuation of trial drug, serious adverse events, and adverse events leading to death.
Conclusion
In patients with COPD who had a blood eosinophil count ≥ 300 cells/mL and an elevated exacerbation risk despite the use of standard triple therapy, dupilumab was superior to placebo with respect to annualized rate of moderate or severe exacerbations.
Reference
Surya P Bhatt, Klaus F Rabe, Nicola A Hanania et al. Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts. N Engl J Med. 2023 Jul 20;389(3):205-214.
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