Clinical Effectiveness Over 2 Years of Benralizumab Treatment in Patients with Severe Eosinophilic Asthma and Concomitant Nasal Polyposis; Analysis from the BPAP Study

Abstract

Introduction and Objectives Benralizumab is an anti-interleukin- 5 receptor alpha monoclonal antibody indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma (SEA). Herein we present real-world data from the Benralizumab Patient Access Programme (BPAP) for a subgroup of patients with SEA and concomitant nasal polyposis (SEAwNP) after 2 years of treatment with benralizumab for SEA. Methods The BPAP study is a multi-centre, retrospective, observational study of patients with SEA from eight UK centres. Data were collected from the medical records of patients receiving their first benralizumab dose between April 2018 and November 2019. Outcomes were assessed using descriptive statistics, with patients censored when treatment was discontinued. Results Within the BPAP cohort of 276 patients, 57 (21%) patients had SEAwNP and were included in this subgroup analysis. The mean age was 50.9 (standard deviation SD] 13.5); 46% (26/57) were female; mean BMI was 30.2 (SD 5.7); 61% (35/57) of patients were receiving maintenance oral corticosteroids (mOCS) at baseline. Clinical outcomes for the overall BPAP cohort and SEAwNP subgroup are shown in the table 1. Patients with SEAwNP had a mean annualised exacerbation rate (AER) of 3.8 (95% confidence interval CI] 3.1-4.5) at baseline (n=56), decreasing to 0.8 (95% CI 0.5-1.1) at Year 2 (n=48); a relative reduction of 79%, with 44% of patients being exacerbation free over 2 years. For patients with SEAwNP on mOCS at baseline, 57% were off mOCS for asthma after 2 years, with 77% achieving a dose reduction of >=50%. At baseline, mean asthma control questionnaire (ACQ-6) score was 2.9 (SD 1.5, n=55); this reduced to 1.3 (SD 1.5. n=30) at 2 years. The proportion of patients with SEAwNP achieving an improvement of >=0.5 was 71% (20/28); 63% (19/30) had an ACQ-6 score of <1.5. Clinical outcomes in the overall BPAP cohort and SEAwNP subgroup were comparable (table 1). Conclusions This analysis in a subgroup of patients with SEAwNP shows that patients who were treated with benralizumab had clinically relevant and sustained improvements in clinical outcomes comparable to the overall cohort, including improved exacerbation rates, mOCS use and asthma symptom control.