| Design | Phase 3, double-blind, placebo-controlled RCT |
|---|---|
| Treatment | Dupilumab, added to background triple inhaled therapy |
| Control | Placebo |
| Population | 939 patients with COPD and type 2 inflammation indicated by elevated blood eosinophils |
| Follow-up | 52 weeks |
| Primary endpoint | Annualised rate of moderate or severe exacerbations |
| Result | 0.78 per year (95% CI 0.64 to 0.93) with dupilumab versus 1.10 (0.93 to 1.30) with placebo — rate ratio 0.70 (0.58 to 0.86, p<0.001). Prebronchodilator FEV1 at week 12 rose 160 mL versus 77 mL (difference 83 mL, p<0.001), sustained to week 52. SGRQ improved by -9.7 versus -6.4 (difference -3.4, p=0.002). Adverse events were balanced. |
| Secondary endpoints | Prebronchodilator FEV1, St George's Respiratory Questionnaire, E-RS symptom score |
Among patients with COPD who had type 2 inflammation as indicated by elevated blood eosinophil counts, those who received dupilumab had fewer exacerbations, better lung function and quality of life, and less severe respiratory symptoms than those who received placebo.
The trial authors, in the published abstract
The first clearly positive biologic trial in COPD, and the moment the eosinophil stopped being only a steroid-response marker and became a treatment target in its own right. MATINEE later showed a smaller but consistent effect with mepolizumab.
Bhatt SP, Rabe KF, Hanania NA, et al. Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts. N Engl J Med 2023 Jul 20;389(3):205-214.