Clinical Remission in Patients with Severe Eosinophilic Asthma - A Single-Arm Observational Study with Benralizumab.

Purpose: To evaluate clinical remission rates and its individual components in patients with severe eosinophilic asthma treated with benralizumab, and to explore predictors of clinical remission using subgroup analyses by blood eosinophils, prior exacerbations, and previous biologic treatment. Patients and Methods: Data from a prospective, observational, non-interventional study (BEEPS, NCT03907137) of patients with severe eosinophilic asthma (SEA) in Switzerland were analysed post-hoc. Benralizumab 30 mg was administered at weeks 0 (baseline), 4, and 8, followed by an 8-weekly regimen until week 56. Clinical remission was defined as meeting all four of the following criteria: Asthma Control Questionnaire (ACQ-5) scores < 1.5 or ≤ 0.75, no oral corticosteroid (OCS) use, no exacerbations, and a stable lung function. Patients were categorised into three pre-planned subgroups: (1) Blood eosinophils at baseline: 300-400 cells/μL and > 400 cells/μL; (2) exacerbations in the last 12 months: <4 and ≥4 exacerbations; (3) prior biologic treatment: naïve and experienced patients. Results: At baseline, no patients met all four criteria for clinical remission. After 56 weeks of benralizumab treatment, 58.1% of patients achieved all criteria when using ACQ-5 < 1.5, and 51.6% did so with ACQ-5 ≤ 0.75. Throughout the study, each individual remission criterion improved consistently over time. Across all subgroups, asthma symptoms and annualized exacerbation rates (AER) continuously decreased over the course of treatment. Conclusion: More than 50% of patients with SEA achieved clinical remission on treatment with benralizumab. Furthermore, benralizumab demonstrated consistent clinical efficacy across all patient subgroups, providing deeper insight into the characteristics and needs of these specific populations.