No Effect of Benralizumab Treatment on Antibody Response to Seasonal Influenza Vaccination in Adolescent and Young Adult Patients With Moderate to Severe Asthma: Results From the Phase IIIb ALIZE Trial

RATIONALE: Benralizumab is a humanized, afucosylated monoclonal antibody against the interleukin-5 receptor α that results in rapid and nearly complete eosinophil depletion. Eosinophil depletion might impact vaccine immune response, therefore this trial evaluated whether benralizumab modifies the antibody response after influenza vaccination in adolescent/young adult patients with moderate/severe asthma.

METHODS: ALIZE (NCT02814643) was a Phase IIIb randomized controlled trial conducted in patients aged 12–21 years receiving medium- to high-dosage ICS/LABA. Patients received benralizumab 30 mg SC or placebo at Weeks 0, 4, and 8, plus tetravalent influenza vaccination given at Week 8. At Week 12, strain-specific antibody responses following vaccination were assessed by hemagglutinin inhibition (HAI) and microneutralization (MN) assays.

RESULTS: 103 patients were randomized and treated (benralizumab, n=51; placebo, n=52). There were no consistent differences in HAI or MN antibody responses at Week 12 between benralizumab and placebo patients. HAI geometric mean fold rises (GMFRs) for all influenza strains tested ranged from 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. Percentages of patients who had a ≥4-fold rise in HAI from Weeks 8 to 12 were 44.0–56.0% and 30.6–49.0% for benralizumab- and placebo-treated patients, respectively. At Week 12, 78.0–100% vs. 79.6–100% of benralizumab- and placebo-treated patients, respectively, achieved a ≥40 HAI antibody titer. There were no significant safety issues in the study.

CONCLUSIONS: Benralizumab had no apparent effect on antibody responses to seasonal influenza virus vaccination in adolescent and young adult patients with moderate/severe asthma.