Benralizumab Outcomes in Patients with Severe Eosinophilic Asthma Treated in Real-Life Settings: Results of the BREEZE Study in 5 Countries From Central Eastern Europe and Baltics.

Purpose: To describe real-world clinical characteristics, treatment patterns and outcomes of severe eosinophilic asthma (SEA) patients initiated on benralizumab after treatment authorization in Central Eastern Europe and Baltic Area.

Patients and methods: BREEZE was a retrospective, medical chart review with a pre-post design conducted in 42 clinical centers from Bulgaria, Czech Republic, Hungary, Lithuania and Romania. Eligibility included diagnosis of SEA and at least one dose of benralizumab administered in real-life settings. Descriptive statistics were used in the full analysis set and key subgroups stratified by blood eosinophils (bEOS) number, maintenance oral corticosteroids (mOCS) use and prior biologics exposure and included calculation of the annualized exacerbation rate (AER) at baseline, and weeks (W) 16 and 48.

Results: Of 381 patients included, 66% were female with overall mean age 56 ±12 years at benralizumab start. At baseline: median bEOS 580 cells/μL (74% bEOS>400), forced expiratory volume in 1 second (FEV₁) 1660 mL, mOCS use in 25% of patients (10 mg/day prednisone equivalent, 68% >5 mg/day), AER 3.05 (95% CI 2.9-3.2), and poorly controlled asthma (Asthma Control Test [ACT] <16) in 63% of patients. Median duration of exposure to benralizumab was 11.5 (95% CI 7.7-12.3) months, and discontinuation rate was 1.3% (95% CI 0.4%-3.0%). Median bEOS decreased to 0 at W16 and maintained thereafter; FEV₁ increases of +240 mL at W16 and +335 mL at W48 were reported (p <0.001 for both). Overall relative reduction in AER at W16 and W48 was 92% and 93%, respectively, and 82-94% across key subgroups. mOCS dose reduction was 50%, and proportion of patients requiring >5 mg/day decreased constantly (25% at W16, 28% at W48). ACT scores increased from W16 to W56 (p <0.001 for all).

Conclusion: Our findings indicate clinically meaningful benefits of benralizumab across multiple geographies and various subgroups of patients with SEA.