Burden of severe asthma in Italy: Patients treated with versus eligible for monoclonal antibodies in a large real-world study.

ObjectiveTo describe patients with severe asthma treated with or eligible for monoclonal antibodies, assessing the health and economic burden using the Italian National Healthcare Service (SSN) administrative data.MethodsFrom 4.6 million inhabitants, among patients with asthma from 1 January to 31 December 2022, those with severe asthma were identified by monoclonal antibody dispensation (cohort A) and by eligibility for monoclonal antibodies, defined as continuous treatment with medium- or high-dose inhaled corticosteroids and long-acting beta agonists and the occurrence of exacerbations (cohort B-narrow and cohort B-broad according to "narrow" and" broad" definitions, respectively). One-year exacerbations, healthcare utilization, and direct costs were assessed.ResultsOf the 128,621 patients with asthma (51.8% women; mean age, 54 years), patients with severe asthma were identified as follows: cohort A (n = 3046; 2.4%), cohort B-narrow (n = 3517; 2.7%), and cohort B-broad (n = 7621; 5.6%). Compared with cohort A, patients in cohorts B-narrow and B-broad were older, had more comorbidities, experienced more moderate/severe exacerbations (70.9%-57.3% vs. 46.7%), and had higher hospitalization rates and greater drug use but fewer specialist visits. The annual SSN costs averaged €7512 for cohort A versus €2911-€2351 for cohorts B-narrow and B-broad. Cohort A incurred higher costs for asthma drugs, whereas cohorts B-narrow and B-broad incurred higher costs for concomitant drugs, hospitalizations, and specialist care.ConclusionsA significant disease burden exists in patients with uncontrolled severe asthma who are potentially eligible for monoclonal antibodies in Italy.