Trial results suggest treatment could be used as an add-on therapy for severely asthmatic patients
Two phase III, double-blind, randomised controlled trials including more than 2500 participants looked at the safety and efficacy of benralizumab injections as an add-on therapy for patients with severe, uncontrolled asthma.
Benralizumab targets the IL-5 receptor that drives the proliferation of eosinophils – white blood cells that are associated with allergy and asthma.
According to the trials, many patients with severe, uncontrolled asthma are found to have high levels of eosinophils in the blood and airways, which is associated with frequent asthma exacerbations and impaired lung function.
Published in The Lancet and presented at the European Respiratory Society meeting in London this week, the trial results found a year’s course of subcutaneous benralizumab injections can lead to a decrease in the frequency of asthma exacerbations by a third to a half, compared with placebo.
“Patients with severe, uncontrolled asthma have very few treatment options once they are already taking high-dose inhaled corticosteroids and long-acting beta agonists,” says Professor Eugene Bleecker from the Wake Forest School of Medicine and lead author of one of the trials.
“By targeting the IL-5 receptor, benralizumab depletes eosinophils directly, and our studies show that eosinophils counts were nearly completely depleted by week four of treatment,” says Prof Bleecker.
Professor J. Mark FitzGerald from the University of British Columbia and lead author of the second trial, says: “The results from both trials indicate that benralizumab treatment once every four or eight weeks decreased eosinophil counts, reduced asthma exacerbations, and improved lung function” in patients with high levels of eosinophils.
“Additional therapeutic options to control severe asthma are urgently needed, and our findings support the use of benralizumab as an add-on therapy.”
Adverse events related to treatment across both trials included: one case of uricaria, two cases of asthma and herpes zoster, one case of allergic granulomatous, one panic attack, and one paraethisia.
The authors note both trials indicate a strong placebo effect, as rates of exacerbations decreased significantly in the placebo group who had an injection, but did not receive the drug.
Benralizumab is a drug developed by AstraZeneca and both trials were funded by the pharmaceutical group.