Use of CompEx in eosinophilic patients with severe, uncontrolled asthma on benralizumab

Abstract

CompEx Asthma, a composite endpoint for asthma exacerbations, captures clinically relevant, diary-based acute worsening events (AWEs, defined as deterioration in daily peak expiratory flow concurrent with deterioration in asthma symptoms and/or rescue therapy use) and severe exacerbation events (SevEx, defined by ATS/ERS guidelines). We hypothesised that CompEx and SevEx would show similar benralizumab treatment effects and correlations to blood eosinophil counts (BECs) in patients with severe asthma.Thispost-hocanalysis of pooled 12-month data from two Phase III studies included patients aged ≥16 years with severe, uncontrolled asthma who were randomised to benralizumab 30 mg or placebo. Annualised event rates (AERs) were analysed using a negative binomial model. The impact of BEC on treatment effect was assessed.Among patients with BEC ≥300 cells/µL (n=913), benralizumab reduced AERsversusplacebo for CompEx (1.57versus2.57; risk ratio [RR] 0.61; 95% confidence interval [CI] 0.53–0.70; p<0.001), SevEx (0.94versus1.55; RR 0.60; 95% CI 0.52–0.70; p<0.001) and AWE (0.92versus1.57; RR 0.59; 95% CI 0.48–0.72; p<0.001), with greater treatment effects observed for higher BECs. In patients with BEC ≥300 cells/µL, benralizumab was associated with shorter median event duration (CompEx: 10.5versus17.0 days; SevEx: 10.0versus15.0 days; AWE: 5.0versus6.0 days).Benralizumab reduced the risk of CompEx events with treatment effects similar to those for SevEx and AWEs across a range of BECs. Use of CompEx supports the evaluation of benralizumab and other novel drugs in clinical studies.