Abstract Rationale In chronic obstructive pulmonary disease, exacerbations drive morbidity, healthcare resource utilization, and mortality. Hospitalization and emergency department visits reflect acute clinical instability. Systemic corticosteroids are usually prescribed for exacerbations, but cumulative exposure is a concern. Objectives To evaluate the effect of dupilumab on emergency department visits/hospital admissions and systemic corticosteroid use in patients experiencing exacerbations. Methods BOREAS and NOTUS, two phase 3, randomized, double-blind, placebo-controlled trials, enrolled patients (40-85 years) with chronic obstructive pulmonary disease, 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 emergency department visit/hospital admission were assessed. Measurements and Main Results Dupilumab versus placebo reduced emergency department visits/hospital admissions of any duration by 38% (relative risk: 0.62 95% confidence interval: 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% confidence interval: 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% (relative risk: 0.58 95% confidence interval: 0.38-0.89; P = .0126) and moderate exacerbations by 28% (relative risk: 0.72 95% confidence interval: 0.60-0.87; P = .0005). Conclusions Dupilumab reduced emergency department visits/hospital admissions of any duration. Patients who experienced moderate and/or severe exacerbations required fewer systemic corticosteroids with dupilumab compared with placebo.
Bhatt et al. (Wed,) studied this question.