Benralizumab, a humanized, afucosylated anti- IL-5Rα monoclonal antibody, does not appear to impair seasonal virus vaccination antibody response in young asthmatic patients, according to the results of a Phase 3b randomized controlled trial (ALIZE).
The trial analyzed the antibody response to the seasonal influenza vaccine among 103 asthma patients. Patients included in the study were 12 to 21 years old, had moderate to severe asthma, and were receiving medium- or high-dose inhaled corticosteroids/long-acting β2-agonists.
During the study, patients received either benralizumab 30mg (N=51) or placebo (N=52) at weeks 0, 4, and 8. Additionally, at week 8, the quadrivalent influenza vaccine was administered. Strain-specific antibody responses were assessed at week 12 for 4 influenza antigens using hemagglutination inhibition (HAI) and microneutralization (MN) assays.
Results of the study found no significant differences in either the HAI or MN antibody responses between the benralizumab and placebo groups at week 12. “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,” the study authors reported. They added, “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.” Additionally, at week 12, 78.0%-100% of patients receiving benralizumab achieved a ≥40 HAI antibody titer, compared with 79.6%-100% of patients receiving placebo. No significant safety findings were reported.
For young patients with moderate to severe asthma, antibody response to seasonal influenza vaccination does not seem to be impaired by the use of benralizumab.
Zeitlin, PL et al. Benralizumab does not impair antibody response to seasonal influenza vaccination in adolescent and young adult patients with moderate to severe asthma: results from the Phase IIIb ALIZE trial. Journal of Asthma and Allergy. https://doi.org/10.2147/JAA.S172338