Abstract
BACKGROUND AND OBJECTIVES: Benralizumab is a humanized, afucosylated monoclonal antibody against the IL-5Rα. Initial monthly followed by every-other-month injections result in rapid and nearly complete eosinophil depletion. We evaluated whether three doses of benralizumab modifies antibody response to seasonal influenza vaccination for adolescent/young adult patients with moderate to severe asthma. METHODS: ALIZE (NCT02814643) was a Phase IIIb randomized controlled trial of patients aged 12-21 years receiving medium- to high-dosage inhaled corticosteroids/long-acting β(2)-agonists. Patients received benralizumab 30 mg or placebo at Weeks 0, 4, and 8, plus tetravalent influenza vaccination at Week 8. At Week 12, strain-specific antibody responses following vaccination were assessed for four influenza antigens by hemagglutination inhibition (HAI) and microneutralization (MN) assays. RESULTS: A total of 103 patients were randomized and received benralizumab (n=51) or placebo (n=52). There were no consistent differences in HAI or MN antibody responses at Week 12 between patients receiving benralizumab or placebo. HAI geometric mean fold rises (GMFRs) for all influenza strains tested were 3.3-4.2 for benralizumab vs 3.4-3.9 for placebo; MN GMFRs were 2.8-5.1 for benralizumab vs 3.2-4.4 for placebo. A ≥4-fold rise in HAI from Weeks 8 to 12 occurred in 44.0%-56.0% and 30.6%-49.0% of patients receiving benralizumab and placebo, respectively. At Week 12, 78.0%-100% vs 79.6%-100% of patients receiving benralizumab and placebo, respectively, achieved a ≥40 HAI antibody titer. There were no significant safety findings. CONCLUSION: Benralizumab did not impair the antibody response to seasonal virus vaccination in adolescents and young adult patients with moderate to severe asthma.