LATE-BREAKING ABSTRACT: Benralizumab provides significant improvements for patients with severe, uncontrolled asthma: SIROCCO Phase III results

Introduction: Benralizumab is a humanized monoclonal antibody that targets interleukin-5 receptor alpha subunit and induces direct, rapid, and nearly complete depletion of systemic and bronchial eosinophils via antibody-dependent cell-mediated cytotoxicity. Aims and Objectives: The efficacy and safety of benralizumab for the treatment of severe, uncontrolled asthma with (blood) eosinophilia were evaluated in the SIROCCO study (NCT01928771). Methods: In this randomized, placebo (PBO)-controlled trial, 1,204 patients (pts) (ages 12–75 years) with severe asthma uncontrolled on high-dosage inhaled corticosteroids and long-acting β 2 agonists were treated for 48 weeks with 30 mg SC benralizumab either every 4 weeks or every 8 weeks (first 3 doses every 4 weeks), or PBO every 4 weeks. Pts were stratified 2:1 based on blood eosinophil counts of ≥300 and Results: For the primary analysis, pts receiving benralizumab achieved significantly greater decreases in the annual exacerbation rate vs. PBO (table), and lung function and asthma symptom improvement at Week 48. Adverse events were similar between the benralizumab-treated groups and PBO. Conclusions: Benralizumab significantly reduced annual exacerbation rates, improved lung function, and reduced asthma symptoms, in patients with severe, eosinophilic asthma.