Abstract
BACKGROUND: Dupilumab has demonstrated efficacy in type 2 severe asthma in clinical trials. Real-world data, particularly from Spain and including patients with prior biologic failure, remains limited. This study evaluated the effectiveness and safety of dupilumab in a Spanish cohort with type 2 severe asthma over 12 months. METHODS: Retrospective, multicenter observational study in adult and adolescent patients (≥12 years) with type 2 severe asthma treated with dupilumab for at least six months. Clinical data, including exacerbations, lung function (FEV(1)), Asthma Control Test (ACT), quality of life (Mini-AQLQ), systemic corticosteroid use, and biomarkers (total IgE, eosinophil count, FeNO), were collected at baseline, 6, and 12 months. The EXACTO scale was used to assess response in non-oral corticosteroid (OCS)-dependent patients at 12 months. Subgroup analyses included chronic rhinosinusitis with nasal polyps (CRSwNP) and OCS-dependent patients at baseline. RESULTS: A total of 156 patients were included; 54.5% had received prior biologic therapies. Significant improvements (p<0.005) from baseline to 12 months were observed in exacerbations (1.43 to 0.20 per year), FEV(1) (2530.10 to 2824.59 mL), ACT (15.84 to 21.31), and Mini-AQLQ (27.24 to 74.27). Total IgE and FeNO significantly decreased whereas blood eosinophilia increased. In non-OCS-dependent patients (n=78), 56.4% were good or super-responders according to the EXACTO scale. CRSwNP patients (n=66) significantly improved in asthma and nasal symptoms. Among OCS-dependent patients (n=35), 68.6% discontinued OCS by 6 months. Comparable clinical improvements in exacerbation rates, lung function and overall response were observed in biologic-naïve and biologic-pretreated patients, consistent with similar EXACTO scores (4.92 ± 1.29 vs. 4.55 ± 1.37, respectively; p=0.166). No new safety signals were identified. CONCLUSION: This Spanish real-world study confirms sustained effectiveness and acceptable safety of dupilumab in type 2 severe asthma, including patients with prior biologic failure and comorbid CRSwNP, supporting its use in routine clinical practice.