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

TL;DR

This study shows that benralizumab significantly improves outcomes for patients with severe eosinophilic asthma in Romania.

Contribution

The study provides real-world evidence of benralizumab's effectiveness in treating severe eosinophilic asthma in Romania.

Findings

Benralizumab reduced annualized exacerbation rates by 89% at 16 weeks and 90% at 48 weeks.

Blood eosinophils decreased significantly from baseline to 16 weeks.

FEV1 and asthma control scores improved significantly within 16 weeks of treatment.

Abstract

Background/Objectives: 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. Methods: 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. Results: 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 (n = 36; p < 0.001). FEV1 increased from 1.8 L at baseline to 2.06 L at W16 (n = 59; p < 0.001), 2.15 L at W24 (n = 51; p < 0.001), and 1.96 L at W48 (n = 31; p = 0.002). Most patients had poorly controlled asthma (103 with ACT < 16) at baseline; score increased >9 points at W16 (n = 81; p < 0.001), W24 (n = 80; p < 0.001), and W48 (n = 55; p = 0.002). Conclusions: Our national cohort contributes to the increasing evidence on the meaningful results of benralizumab in SEA patients treated in routine practice.

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