Abstract Rationale In September 2024, dupilumab received approval in the United States as an add-on maintenance therapy for adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic endotype. Since approval, real-world evidence on the characteristics and treatment history of patients receiving dupilumab for COPD is lacking. We aimed to examine the profiles of early dupilumab users for COPD management. Methods This observational analysis utilized data from the Komodo administrative claims database. Eligibility criteria included patients aged ≥40 years, who initiated dupilumab between September 27, 2024, and March 31, 2025 (index=first dupilumab dispensation), 1-year of continuous enrollment prior to index (baseline period), a COPD diagnosis in the 90 days prior to index, no previous dupilumab exposure, and prescription of dupilumab by specialties relevant to COPD care. Demographic and clinical characteristics of patients along with prior COPD treatment history were evaluated during the baseline period. Results A total of 1,078 COPD patients treated with dupilumab were identified (median age: 69 years (interquartile range IQR: 62-76), 53.1% female), with prevalent comorbid type 2 inflammatory conditions, including asthma (38.8%), atopic dermatitis (7.0%), and chronic rhinosinusitis with nasal polyps (2.6%). Additional comorbidities included atherosclerotic cardiovascular disease (41.2%), heart failure (26.4%), obstructive sleep apnea (30.4%), anxiety (32.1%), and depression (29.0%). Before dupilumab initiation, 64.8% of patients received triple therapy (inhaled corticosteroids ICS/long-acting beta agonist LABA/long-acting muscarinic antagonist LAMA), while 22.1% and 13.6% received dual therapies of ICS/LABA and LAMA/LABA, respectively, with potential overlap between therapies. Frequent use of rescue inhalers was observed, with 69.5% of patients receiving ≥3 dispensations of short-acting beta agonists during the baseline period. Patients exhibited frequent COPD exacerbations before dupilumab initiation, with 29.4% of patients having ≥1 severe exacerbation leading to hospitalization with a median cumulative length of stay of 6 days (IQR: 2-12) during the baseline period. Among patients with severe exacerbation, 42.6% experienced multiple severe exacerbations. Additionally, 58.3% of the study cohort had ≥1 moderate exacerbation defined as a COPD-related outpatient visit plus dispensation of antibiotics and/or systemic corticosteroids. Conclusions Early initiators of dupilumab for COPD had a high burden of respiratory and systemic comorbidities, experienced frequent exacerbations including repeated severe exacerbations, and had extensive use of triple inhaler therapy. These findings are consistent with profiles of patients with uncontrolled advanced COPD, highlighting the unmet need of this population. Novel approaches to therapy, such as dupilumab, may offer additional options to address these challenges. This abstract is funded by: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc.
Bon et al. (Fri,) studied this question.