1205 randomised patients with severe uncontrolled asthma; 809 with blood eosinophils of at least 300 cells/µL formed the primary analysis population
Follow-up
48 weeks
Primary endpoint
Annual asthma exacerbation rate in patients with eosinophils at least 300 cells/µL
Result
Compared with placebo, benralizumab reduced the annual exacerbation rate over 48 weeks when given every 4 weeks (rate ratio 0.55, 95% CI 0.42 to 0.71, p<0.0001) and every 8 weeks (rate ratio 0.49).
Secondary endpoints
FEV1, asthma symptom score, safety
These results confirm the efficacy and safety of benralizumab for patients with severe asthma and elevated eosinophils, which are uncontrolled by high-dosage ICS plus LABA, and provide support for benralizumab to be an additional option to treat this disease in this patient population.
The trial authors, in the published abstract
How it has aged
Depletes eosinophils outright by targeting the IL-5 receptor rather than the cytokine, which gives near-complete eosinophil ablation. The eight-weekly schedule was as effective as four-weekly, foreshadowing the dosing-interval question that SWIFT pushed to six months. Its later use in acute exacerbations (ABRA) is a different idea entirely.
Publications
Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β(2)-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial
Bleecker ER, FitzGerald JM, Chanez P, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β(2)-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet 2016 Oct 29;388(10056):2115-2127.
45% reduction in annual exacerbation rate with 4-weekly dosing
51% reduction with 8-weekly dosing
Benefit confined to patients with eosinophils of at least 300 cells/µL