Severe Asthma Research - October 2016
Christina E Ciaccio, MD, MSc
Assistant Professor of Pediatrics
University of Chicago Medicine
Comer Children’s Hospital
Chicago, Illinois, United States
Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial
Benralizumab is a novel anti-IL5Rα that results in eosinophilic depletion as opposed to the reduction seen with other anti-IL5 molecules such as reslizumab and mepolizumab. A previous phase IIb study demonstrated benralizumab’s efficacy in uncontrolled asthma despite treatment with medium or high dose inhaled corticosteroids plus long-acting beta agonists when dosed at 100mg every 8 weeks. In this phase III study, benralizumab was studied at a dose of 30mg. This randomized, double-blind, parallel group, placebo-controlled, multicenter study included patients aged 12-75 who had asthma not controlled with medium or high dose inhaled corticosteroids plus a long-acting beta agonist. Patients were randomized to either receive subcutaneous benralizumab 30mg once every 4 weeks, 30mg once every 8 weeks or placebo. Over an 18 month period, 1205 patients were randomized and 1069 completed the study. Both benralizumab groups showed significant improvement in annual exacerbation rates as well as FEV1. The benralizumab group that received treatment every 8 weeks also had improvement in asthma symptoms and ED visits. Side effects were similar in all three groups. This industry-funded study demonstrates another potentially effective biologic treatment for asthma which may benefit patients by decreasing the number of visits required for therapy.
Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. The Lancet 2016; published online ahead of print, September 2. (doi:10.1016/S0140-6736(16)31324-1).