Abstract Rationale The 2025 Global Initiative for Asthma (GINA) Strategy recommends add-on biologics for patients with severe asthma uncontrolled despite being on maximal therapy. Dupilumab is approved for moderate-to-severe eosinophilic or corticosteroid-dependent asthma, but the optimal timing of initiation after severe exacerbation remains unclear. This study examines patient characteristics associated with timely versus delayed dupilumab initiation. Methods In this retrospective observational study of Optum’s All-Payer Claims Database, data of patients ≥ 6 years old with evidence of asthma diagnosis (ICD-code), moderate-to-severe asthma based on ICS treatment, and classified as GINA 3-5, who had a severe asthma exacerbation episode between 10/2018-12/2023 were examined. Eligible patients were biologic naïve, had dupilumab initiation within 12 months of first observed severe asthma exacerbation (index date), and had ≥12 months of data prior to and after index. The timely cohort (TC) initiated dupilumab 0-90 days after index; delayed cohort (DC) initiated dupilumab 91-365 days after index. Baseline characteristics were assessed including patient demographics, disease characteristics, and asthma treatment. Results A total of 1,483 patients met eligibility criteria. Of these, 449 (30.3%) were in the TC and 1,034 (69.7%) in the DC. Mean age was similar between the TC and DC (40.5 years vs 39.5 years), as was proportion of males (40.8% vs 40.0%). Fewer patients in the TC had Managed Medicaid coverage (28.3% vs 33.8%). Of the fall exacerbators, there were fewer in TC (27.0% vs 35.4%), while more patients in TC experienced their index exacerbation in the summer (22.3% vs 12.9%). At baseline, the prevalence of type 2 inflammatory conditions was higher in the TC than the DC (83.3% vs 81.8%), with significantly more patients in TC diagnosed with coexisting CRSwNP (19.2% vs 14.4%). In addition, inhaled albuterol-containing rescue medication fills were lower in the TC compared to DC (4.31 vs 5.30). However, the proportion of patients with triple therapy fills were higher in the TC than DC (6.5% vs 3.9%) (Table 1). Conclusion In this real-world analysis, almost 70% of patients initiated dupilumab as add on therapy to maintenance controlled medications ≥90 days after severe asthma exacerbation. Most baseline characteristics were largely similar between cohorts, however patients in the TC cohort had a significantly higher frequency of co-existing CRSwNP and triple therapy fills, while those in the DC had a higher frequency of Medicaid and albuterol-containing medication refills per patient. Management approaches that improve access to timely dupilumab should be explored. This abstract is funded by: Sanofi and Regeneron Pharmaceuticals Inc.
Peters et al. (Fri,) studied this question.