N Engl J Med

ATS 2024: Dupilumab associated with better lung function than placebo

May 23, 2024

Results from the NOTUS trial, presented at the annual American Thoracic Society meeting, show that in patients with COPD and type 2 inflammation, dupilumab was associated with fewer exacerbations and better lung function than placebo.

• In a phase 3, double-blind, randomized trial, investigators assigned patients with COPD who had a blood eosinophil count of 300 cells per microliter or higher to receive subcutaneous dupilumab (n=470) or placebo (n=465) every 2 weeks. The primary end point was the annualized rate of moderate or severe exacerbations. Key secondary end points included changes from baseline in the prebronchodilator forced expiratory volume in 1 second (FEV₁) at weeks 12 and 52 and in the St. George's Respiratory Questionnaire (SGRQ).
• The annualized rate of moderate or severe exacerbations was 0.86 (95% confidence interval [CI], 0.70 to 1.06) with dupilumab and 1.30 (95% CI, 1.05 to 1.60) with placebo; the rate ratio as compared with placebo was 0.66 (95% CI, 0.54 to 0.82; P<0.001).
• The prebronchiodilator FEV₁ increased from baseline to week 12 with dupilumab (least-squares mean change, 139 ml [95% CI, 105 to 173]) as compared with placebo (least-squares mean change, 57 ml [95% CI, 23 to 91]), with a significant least-squares mean difference at week 12 of 82 ml (P<0.001) and at week 52 of 62 ml (P = 0.02).
• No significant between-group difference was observed in the change in SGRQ scores from baseline to 52 weeks. The incidence of adverse events was similar in the two groups and consistent with the established profile of dupilumab.

Source:

Bhatt SP, et al; NOTUS Study Investigators. (2024, May 20). N Engl J Med. Dupilumab for COPD with Blood Eosinophil Evidence of Type 2 Inflammation. https://pubmed.ncbi.nlm.nih.gov/38767614/