Abstract Rationale Up to 40% of patients with chronic obstructive pulmonary disease (COPD) have evidence of type 2 inflammation, which is associated with higher disease burden and worse COPD outcomes. The prevalence of diseases that share an underlying type 2 inflammation mechanism in patients with COPD, and their impact on COPD severity, are poorly understood. Here, we report the baseline characteristics of patients with COPD with or without a history of additional type 2 inflammatory disease and their adjusted annualized moderate or severe exacerbation rate. Methods BOREAS (NCT03930732) and NOTUS (NCT04456673) were two phase 3, randomized, placebo-controlled trials that enrolled patients (aged 40-85 years) with COPD, moderate-to-severe airflow limitation, and type 2 inflammation (blood eosinophil count ≥300 cells/µL at screening). Patients were randomized 1:1 to dupilumab 300 mg every 2 weeks or matched placebo for 52 weeks. In this post hoc analysis of the pooled placebo patients from BOREAS and NOTUS, placebo patients were stratified based on reported history of ≥ 1 additional type 2 inflammatory disease (including nasal polyps, chronic sinusitis, atopic dermatitis, allergic conjunctivitis, allergic rhinitis, hives, food allergy, eosinophilic esophagitis, and hypersensitivity to aspirin or nonsteroidal anti-inflammatory drugs). Reported history of asthma was an exclusion criterion for the BOREAS and NOTUS studies and hence patients with asthma are not included. Baseline characteristics and the adjusted annualized moderate or severe COPD exacerbation rates on placebo were assessed in patients with or without a history of type 2 inflammatory diseases. Results Of 936 patients randomized to placebo in BOREAS and NOTUS, 148 (15.8%) reported an additional history of type 2 disease. The most prevalent diseases reported among the type-2 co-existing patients were allergic rhinitis (82/148 55.4%), chronic sinusitis (33/148 22.3%), and food allergy history (16/148 (10.8% ). Baseline characteristics were broadly similar between patients with or without a history of additional type 2 disease (Table). Moderate or severe exacerbation rates were higher in patients with a history of type 2 inflammatory disease (estimate 1.49 95% CI: 1.09, 2.05) compared with those without (estimate 1.07 95% CI 0.91, 1.26). Conclusion Patients with COPD and a history of additional type 2 inflammatory diseases had higher moderate or severe exacerbation rates than those without, suggesting that additional type 2 inflammatory diseases are associated with greater disease burden in patients with COPD and type 2 inflammation. This abstract is funded by: Sanofi and Regeneron Pharmaceuticals Inc. ClinicalTrials.gov Identifiers: NCT03930732 and NCT04456673
Brusselle et al. (Fri,) studied this question.