Effectiveness and safety of benralizumab for severe asthma in clinical practice (J-BEST): a prospective study

Background: Benralizumab is a humanized, fucosylated, monoclonal antibody that targets the interleukin 5 (IL-5) a receptor. Several phase III trials have shown that benralizumab can significantly reduce the incidence of acute exacerbations and improve lung function in patients with severe asthma. However, there is a paucity of data from clinical practice. In this prospective study, we evaluated the effectiveness and safety of benralizumab for severe asthma in clinical practice. Methods: This was a prospective, open-label, single-arm, single-center study in patients with severe asthma in clinical practice (UMIN000031951). Haematological, clinical, functional, and pharmacotherapeutic parameters were evaluated at baseline and at weeks 4 and 12 after initiation of benralizumab. Results: Twenty-six patients were enrolled between May 2018 and March 2019. Both asthma quality of life questionnaire (AQLQ) score and asthma control test (ACT) score showed significant improvement over the study period. Forced expiratory volume in 1.0 second (FEV1) showed a significant increase at week 12 (baseline: 1.57 L; week 12: 1.75 L). Blood eosinophil and basophil counts were significantly decreased at week 12 compared to baseline. At week 12, the dose of regular oral corticosteroids (OCS) was significantly decreased from baseline as was the number of patients on need-based OCS. Benralizumab had no significant effect on fractional exhaled nitric oxide (FeNO) levels and total immunoglobulin E levels. Only one patient experienced mild headache during benralizumab therapy. Conclusions: In this study, benralizumab conferred clinically significant benefits in patients with severe asthma with no short-term severe adverse events.