Dupilumab Reduces COPD Exacerbations in Patients With Type 2 Inflammation

Patients with chronic obstructive pulmonary disease (COPD) and suspected type 2 inflammation had fewer exacerbations and better lung function with dupilumab than placebo, according to results from a phase 3 trial published online ahead of print in the New England Journal of Medicine.

“In some patients with COPD, type 2 inflammation may increase exacerbation risk and may be indicated by elevated blood eosinophil counts,” wrote first author Surya P Bhatt, MD, MSPH, of the University of Alabama at Birmingham, and study coauthors. “Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and interleukin-13, key drivers of type 2 inflammation.”

The double-blind trial included a total 939 patients with COPD, a blood eosinophil count of at least 300 per microliter, and elevated exacerbation risk despite using standard triple therapy. Among participants, 468 were randomized to receive 300 mg of dupilumab and 471 to receive placebo subcutaneously every 2 weeks.

The annualized rate of moderate or severe exacerbations of COPD, the study’s primary endpoint, was 0.78 with dupilumab and 1.10 with placebo, researchers reported.

Additionally, by week 12 forced expiratory volume in 1 second (FEV1) increased a least-squares (LS) mean of 160 mL with dupilumab compared to 77 mL with placebo, and the difference held through week 52, according to the study. Quality of life scores per the St. George’s Respiratory Questionnaire improved an LS mean of 9.7 points with dupilumab and 6.4 points with placebo, and symptom scores per the Evaluating Respiratory Symptoms in COPD improved by an LS mean 2.7 points with dupilumab and 1.6 with placebo by week 52.

The dupilumab and placebo groups were balanced when it came to the number of patients who experienced adverse events that led to discontinuation, serious adverse events, and adverse events that led to death, the study showed.

Reference: 
Bhatt SP, Rabe KF, Hanania NA, et al. Dupilumab for COPD with type 2 inflammation indicated by eosinophil counts. N Engl J Med. Published online May 21, 2023. doi:10.1056/NEJMoa2303951