Abstract
To characterize the clinical phenotypes of severe eosinophilic asthma based on early responsiveness to benralizumab in terms of forced expiratory volume in 1 second (FEV1) improvement. Sixty-four participants diagnosed with severe eosinophilic asthma and who had completed 4 months of benralizumab treatment were included in this analysis. Pre-treatment clinical factors were compared between responders and non-responders according to improvements in ACT or FEV1. Correlations between the sums of increased Type 2-related inflammatory parameters and changes of ACT or FEV1 were also evaluated before and after the 4-month treatment. A two-step cluster analysis was performed to identify distinct phenotypes related to benralizumab responsiveness in terms of FEV1. At the 4-month timepoint, all parameters, except for FeNO, were significantly improved after benralizumab treatment. FEV1 responders were associated with higher levels of Type 2-related inflammatory parameters. An improvement in FEV1 but not in ACT was clearly associated with increases in the sums of increased type 2-related inflammation parameters (p = 0.0001). The cluster analysis identified 5 distinct phenotypes of severe eosinophilic asthma according to the variable FEV1 responsiveness to benralizumab. The greatest response was found in the distinct phenotype of severe eosinophilic asthma, which was characterized by modest increase in total IgE and FeNO relative to blood eosinophils with least exposure to smoking. This study, to the best of our knowledge, is the first cluster analysis to report distinct phenotypes related to clinical benralizumab response in a real-world population with severe eosinophilic asthma. These results may help to predict responsiveness to benralizumab in patients with severe eosinophilic asthma.
Highlights
In recent years, several new biologics, such as benralizumab, have been developed to treat patients suffering from asthma poorly controlled by high-dose ICS and long-acting bronchodilators
The greatest response was found in the distinct phenotype of severe eosinophilic asthma, which was characterized by modest increase in total IgE and fractional exhaled nitric oxide (FeNO) relative to blood eosinophils with least exposure to smoking
This study, to the best of our knowledge, is the first cluster analysis to report distinct phenotypes related to clinical benralizumab response in a real-world population with severe eosinophilic asthma
Summary
Several new biologics, such as benralizumab, have been developed to treat patients suffering from asthma poorly controlled by high-dose ICS and long-acting bronchodilators. It has been reported to significantly improve clinical symptoms in patients with eosinophil counts above 150-300/μl in several international phase III trials, the optimal biologic for treatment of severe asthma varies based on each patient’s individual pathophysiology and a key unmet clinical need is a lack of clinically available biomarkers to guide treatment [3]. Traditional double-blind randomized controlled trials often result in a more homogenous patient population regarding demographics and disease characteristics than patients treated in everyday practice and it is necessary to obtain data on real-world outcomes to complement clinical trials and guide treatment-related decisions. Based on the hypothesis that even severe eosinophilic asthma does not represent a single phenotype of asthma, this multi-center, non-interventional, retrospective observational study in a real-world setting sought to characterize the clinical phenotypes of severe eosinophilic asthma based on early responsiveness to benralizumab in terms of forced expiratory volume in 1 second (FEV1) improvement
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