Potential new drug to treat severe, uncontrolled asthma

person getting a vaccination shot

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.

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  1. Drugby

    Asthma is not a single disease entity. Phenotypes and subphenotypes exist, like eosinophilic asthma. The focus of current management is on control of the disease. Patients with frequent exacerbations may benefit from addition of biologic agent targeting the interleukin-5 pathway or immunoglobulin E. Roughly one in 20 people with asthma have a severe and often uncontrolled version of the condition with an eosinophilic phenotype, despite maximum therapy, good adherence and optimal device technique. IL-5 MABs like benralizumab, reslizumab and mepolizumab are exciting additions to omalizumab, an anti-IgE drug available now in Australia. But before patients get too excited and request info on these new drugs, pharmacists can make a critical difference by assessing device technique at every dispensing and talk to patients about the benefits on ICSs and ICA/LABAs to improve adherence.

    • Simon O'Halloran

      Great points Debbie, and completely agree regarding your points assessment of inhaler technique and optimising the management of existing therapies.

    • Karalyn Huxhagen

      absolutely agree. I recently attended a Lung Foundation training that was delivered to all allied health including exercise physiologists, social workers etc. The people sitting around me found the hands on device training and the Lung Foundation nurse’s presentation of great worth. The very next day I received a phone call about a patient who was massacring his Ultibro capsules by presssing the device at least 8 times before inhaling. The EPs stated they needed to be included more often in these events so they know what to look for when assessing functionality. They work closely with me and were blown away by how compliance and good technique made such a difference. Well done Lung Foundation on providing such a great awakening within HPs. I know we were supposed to be focusing more on COPD but the night covered both areas and was one of the best events I have attended on this subject.

      • Karalyn Huxhagen

        the night also featured Miss Deb in the lung foundation videos on technique. These videos are well worth downloading and using with patients in the phcy or HMRs

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