Real-World Effectiveness Following Benralizumab Use in Patients with Severe Eosinophilic Asthma in Romania: A Retrospective Cohort Study (BREEZE)

<b>Background/Objectives</b>: The outcomes of biologics in severe eosinophilic asthma (SEA) in real-world settings are less known. We describe the SEA population, treatment patterns, and outcomes following benralizumab authorization in Romania. <b>Methods</b>: BREEZE was a retrospective chart review study with a pre-post design conducted in five Central Eastern European and Baltic countries, including Romania (July 2022-January 2023). Adult SEA patients receiving ≥1 benralizumab dose in routine care were enrolled with up to 56 weeks (W) follow-up after benralizumab initiation. Using a funnel approach, the number of patients decreased throughout the follow-up; changes from baseline were tested in patients with available data. <b>Results</b>: The Romanian cohort included 131 patients (mean age: 54.4 years at benralizumab initiation; 66% females). Half of patients (53%) received 8 benralizumab doses; only 3 discontinued treatment. At benralizumab initiation, 15% were on maintenance oral corticosteroids (mOCS, median dose: 12.5 mg/day prednisone-equivalent; 17/20 patients > 5 mg/day). At W48, 11.4% of 70 patients with available data continued using mOCS (median dose: 5 mg/day; 3/8 > 5 mg/day). The annualized exacerbation rate was 2.61 (95%CI: 2.28-2.98) at baseline, reducing by 89% at W16 and 90% at W48. Blood eosinophils decreased early from a median of 620 cells/μL (94/120 > 400 cells/μL) at baseline to 1 cell/μL at W16 (<i>n</i> = 36; <i>p</i> < 0.001). FEV₁ increased from 1.8 L at baseline to 2.06 L at W16 (<i>n</i> = 59; <i>p</i> < 0.001), 2.15 L at W24 (<i>n</i> = 51; <i>p</i> < 0.001), and 1.96 L at W48 (<i>n</i> = 31; <i>p</i> = 0.002). Most patients had poorly controlled asthma (103 with ACT < 16) at baseline; score increased >9 points at W16 (<i>n</i> = 81; <i>p</i> < 0.001), W24 (<i>n</i> = 80; <i>p</i> < 0.001), and W48 (<i>n</i> = 55; <i>p</i> = 0.002). <b>Conclusions</b>: Our national cohort contributes to the increasing evidence on the meaningful results of benralizumab in SEA patients treated in routine practice.