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

Annals of Allergy, Asthma, and Immunology Apr 11, 2018

Chipps BE, et al. - Benralizumab's effectiveness was tested based on atopic status and serum immunoglobulin E (IgE) concentrations of patients with severe, uncontrolled asthma. Regardless of serum IgE concentrations and atopy status, reduction in exacerbations and improvement in lung function were achieved with benralizumab treatment in patients with severe, uncontrolled eosinophillic asthma.

Methods
  • Researchers analyzed pooled results from the SIROCCO (NCT01928771) and CALIMA (NCT01914757) Phase III studies.
  • Subcutaneous benralizumab 30 mg every 4 weeks (Q4W) or every 8 weeks (first three doses Q4W), or placebo Q4W were administered in patients aged 12-75 years with severe, uncontrolled asthma on high-dosage inhaled corticosteroids plus long-acting β2-agonists.
  • Stratification of patients who met/did not meet similar omalizumab-qualifying criteria of atopy and serum IgE 30-700 kU/L was carried out and patients were grouped 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.

Results
  • With benralizumab Q8W in patients with ≥300 eosinophils/L who met the atopy/IgE criteria, reduction in 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) were noted relative to placebo.
  • Researchers found that 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.
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