Late Breaking Abstract - Characterizing responders to benralizumab for severe asthma: pooled analysis of the SIROCCO and CALIMA studies

Introduction: In Phase III studies, benralizumab, a humanized anti–interleukin-5 receptor α, anti-eosinophil (EOS) monoclonal antibody, significantly reduced asthma exacerbations and improved asthma control for patients (pts) with severe, uncontrolled asthma. Aims and Objectives: We evaluated the effect of baseline blood EOS counts and exacerbation history on benralizumab response. Methods: This was a post-hoc analysis of pooled data from SIROCCO (Lancet. 2016;388:2115–27; 48 weeks [N=1,204]) and CALIMA (Lancet. 2016;388:2128–41; 56 weeks [N=1,091]) of pts with severe, uncontrolled asthma receiving benralizumab 30 mg every 4 weeks (Q4W), every 8 weeks (Q8W, Q4W for the first 3 doses), or placebo. Pts had ≥2 exacerbations in the previous year. The primary endpoint was annual exacerbation rate (AER) by baseline blood EOS count and exacerbation history. Results: AER decreased with benralizumab vs. placebo at every EOS threshold, with a response/EOS threshold relationship for Q8W dosing (table). More exacerbations in the past year were associated with a greater response to benralizumab. Similar trends emerged for lung function and asthma symptom improvements. Conclusions: For pts with severe, uncontrolled asthma, greater baseline blood EOS counts and more frequent exacerbations were associated with greater treatment effects. These results should help refine patient selection for benralizumab treatment.