NOTUS TRIAL
Dupilumab for COPD with Blood Eosinophil Evidence of Type 2 Inflammation
A double-blind, placebo-controlled, randomized trial
Objective:
To assess the efficacy and safety of dupilumab in patients with moderate to severe COPD and evidence of type 2 inflammation.
935 Patients
Inclusion Criteria:
- Aged 40-85 years
- Moderate-to-severe COPD for at least 12 months
- Receiving background triple inhaler therapy for ≥ 3 months
- Documented history of high exacerbation risk
- Evidence of type 2 inflammation at first visit
Exclusion Criteria:
- Evidence of right cardiac failure
Groups
- Dupilumab S/C (300 mg every 2 weeks):
- n = 470
- Placebo:
- n = 465
Outcomes
Primary Outcome:
- Annualized rate of moderate or severe exacerbations (%)
- Dupilumab: 0.86
- Placebo: 1.30
- Rate Ratio: 0.66
- 95% CI: 0.54-0.82
- P < 0.001
Secondary Outcomes:
- Increase in prebronchodilator FEV1 from baseline to week 12 (mL):
- Dupilumab: 139 mL
- Placebo: 57 mL
- Difference: 82 mL
- 95% CI: 40-124
- P < 0.001
- Change in SGRQ score from baseline to week 52:
- Dupilumab: -9.8
- Placebo: -6.4
- Difference: -3.4
- 95% CI: -5.8 to -0.9
Conclusion:
In patients with COPD and type 2 inflammation as indicated by elevated blood eosinophil counts, dupilumab was associated with fewer exacerbations and better lung function than placebo.
Source:
- Bhatt SP et al. N Engl J Med 2024; doi:10.1056/NEJMoa2401304