BEHAVE: Benralizumab clinical efficacy, tolerability, and safety in real-world experience with home-based spirometry

Benralizumab is an IL-5Rα antibody indicated for severe eosinophilic asthma and reduces exacerbations, improves asthma control and lung function. In this prospective, observational, cohort study we investigated the clinical outcomes of benralizumab in real-world experience and feasibility and effectiveness of home spirometry measurements. We collected baseline data in 50 patients from 12- months prior to the first Benralizumab injection and up to 48 weeks on this therapy. We analysed improvements in asthma exacerbations (AE), asthma control and lung function. Data were analysed with t-test, Wilcoxon signed-rank test or Spearman correlation coefficient. Mean age of the patients was 56,17±11,56, 72% males, 50% never-smokers, BMI 27,25±5,03, mean pack-year count 23,05±13,23, median number of exacerbations in the last 12 months 3(2-5) and maintenance OCS 20% of the patients. Median blood eosinophil count was 306,66/µl (182,60-615,68), mean FeNO 42,31±31,15 ppb, FEV1 2,27±0,86l and mean ACQ-6 2,44±1,2. At week 24 there was a significant improvement in ACT(p=0.004), ACQ-6 and miniAQLQ (p<0.001). Comparing data at 48-weeks to baseline, we found a significant reduction AEs (p<0.001) and ACQ-6 (p=0.02) while FEV1 was improved by 170 ml (2,22 vs. 2,39l). Daily compliance rates for home-spirometry measurements were 40,72±29,73% and there was a correlation between office based and home spirometry measurements (= 0.88). No safety issues were reported. This study reaffirms benralizumab's effectiveness in reducing exacerbations, and enhancing asthma control, with no safety issues and provides a better understanding of its value for patients with severe eosinophilic asthma.