Long-Term Adherence to Benralizumab and Sustained Clinical Benefits in Patients with Severe Eosinophilic Asthma: Insights from GALERNA, a Retrospective Real-World Study in Spain

Abstract

Background: The GALERNA study is a retrospective real-world observational study conducted across 21 hospitals in Spain, aiming to evaluate long-term clinical benefits and adherence to benralizumab in 255 adult patients with severe eosinophilic asthma (SEA) over a follow-up period of up to 144 weeks. Objectives: Primary objectives focused on assessing adherence to benralizumab, while secondary objectives included the description of severe asthma exacerbation rates, systemic corticosteroid (SCS) use, persistence to benralizumab, lung function, asthma control, and the proportion of patients achieving super-response or clinical remission. Data were collected at baseline (48 weeks prior to benralizumab initiation/index date), follow-up 1 (FUP1) (0-48 weeks), FUP2 (49-96 weeks), and FUP3 (97-144 weeks) after the index date. Results: At baseline, patients demonstrated a substantial disease burden characterised by impaired lung function, poorly controlled asthma, and frequent severe exacerbations. The results indicated high adherence rates to benralizumab, with 92.9% of patients receiving each of the prescribed doses of benralizumab at week 48 and 70.6% at week 144. Patients showed substantial and sustained clinical improvements, with a reduction in the proportion of individuals presenting at least one severe exacerbation from baseline to FUP3 and a 74% decrease in SCS use for the same period. Lung function also improved, with the proportion of patients achieving pre-bronchodilator FEV(1) ? 80% rising to 52% at 144 weeks. Furthermore, mean Asthma Control Test (ACT) scores increased to 20.5, with 68.5% of patients achieving well-controlled asthma (ACT ? 20). By the end of the study, 63.6% of patients achieved super-response and 39.1% showed clinical remission, with an overall benralizumab persistence of 79.8% during all follow-up periods. Conclusions: The GALERNA study provides compelling real-world evidence that benralizumab affords marked and sustained clinical benefits together with high long-term adherence in Spanish SEA patients, reinforcing its usefulness as a long-term therapeutic option in routine clinical practice.