Dupilumab in chronic obstructive pulmonary disease: a pooled analysis of emergency department visits, hospital admissions, and systemic corticosteroid use.

Abstract

In chronic obstructive pulmonary disease (COPD), exacerbations drive morbidity, healthcare resource utilization, and mortality. Hospitalization and emergency department (ED) visits reflect acute clinical instability. Systemic corticosteroids are usually prescribed for exacerbations, but cumulative exposure is a concern. To evaluate the effect of dupilumab on ED visits/hospital admissions and systemic corticosteroid use in patients experiencing exacerbations. BOREAS and NOTUS, two phase 3, randomized, double-blind, placebo-controlled trials, enrolled patients (40-85 years) with COPD, moderate-to-severe airflow limitation, and type 2 inflammation (screening blood eosinophil count ≥300 cells/µL). Patients received dupilumab 300 mg (N = 938) or placebo (N = 936) for 52 weeks. Systemic corticosteroid use and annualized rate and time to first ED visit/hospital admission were assessed. Dupilumab versus placebo reduced ED visits/hospital admissions of any duration by 38% (rate ratio, 0.62 [95% CI, 0.43-0.90]; P = .0121), delayed time to first event, and reduced risk of a first event by 45% (hazard ratio, 0.55 [95% CI, 0.38-0.78]; P = .0010). Compared with placebo, systemic corticosteroid use was reduced in patients treated with dupilumab who experienced severe exacerbations by 42% (rate ratio, 0.58 [95% CI, 0.38-0.89]; P = .0126) and moderate exacerbations by 28% (rate ratio, 0.72 [95% CI, 0.60-0.87]; P = .0005). Dupilumab reduced ED visits/hospital admissions of any duration. Patients who experienced moderate and/or severe exacerbations required fewer systemic corticosteroids with dupilumab compared with placebo. ClinicalTrials.gov (NCT03930732, NCT04456673).