Benralizumab efficacy by atopy status and serum immunoglobulin E for patients with severe, uncontrolled asthma

Publication date: Available online 1 February 2018
Source:Annals of Allergy, Asthma & Immunology
Author(s): Bradley E. Chipps, Paul Newbold, Ian Hirsch, Frank Trudo, Mitchell Goldman
BackgroundPatients with severe asthma can have eosinophilic inflammation and/or allergen sensitization. Benralizumab is an anti-eosinophilic monoclonal antibody being developed for patients with severe, uncontrolled asthma with eosinophilic inflammation.ObjectiveTo investigate the efficacy of benralizumab by atopic status and serum immunoglobulin E (IgE) concentrations.MethodsWe analyzed pooled results from the SIROCCO (NCT01928771) and CALIMA (NCT01914757) Phase III studies. Patients aged 12-75 years with severe, uncontrolled asthma on high-dosage inhaled corticosteroids plus long-acting β2-agonists received subcutaneous benralizumab 30 mg every 4 weeks (Q4W) or every 8 weeks (first three doses Q4W), or placebo Q4W. The analysis stratified patients who met/did not meet similar omalizumab-qualifying criteria of atopy and serum IgE 30-700 kU/L. Patients were also categorized as serum IgE-high (≥150 kU/L) or IgE-low (<150 kU/L) and atopic/nonatopic. Efficacy outcomes were for all patients and by blood eosinophil counts and included annual exacerbation rate (AER) ratio and prebronchodilator FEV1 change at treatment end relative to placebo.ResultsBenralizumab Q8W reduced exacerbations by 46% (95% CI, 26 to 61%, p=0.0002) and increased FEV1 by 0.125 L (95% CI, 0.018 to 0.232 L; p=0.0218) vs. placebo for patients with ≥300 eosinophils/L who met the atopy/IgE criteria. For eosinophilic patients with high or low IgE, treatment with benralizumab Q8W resulted in 42% and 43% reductions in exacerbation rate (p≤0.0004) and 0.123- and 0.138-L FEV1 increases (p≤0.0041) vs. placebo, respectively.ConclusionBenralizumab treatment reduced exacerbations and improved lung function for patients with severe, uncontrolled eosinophillic asthma regardless of serum IgE concentrations and atopy status.



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