A clinical trial led by UBC and Vancouver Coastal Health Research Institute shows that injections of a new monoclonal antibody to standard-of-care asthma medicine significantly reduced exacerbations and improved lung function and symptoms in severe asthma patients with high levels of eosinophils in their blood and airways.
Mark FitzGerald, Head of the Division of Respiratory Medicine and Director of the Centre for Heart and Lung Health at the Vancouver Coastal Health Research Institute, led the Phase III trial, which evaluated the effect of two dosing regimens of benralizumab administered in 4-week and 8-week regimens as add-on therapy to standard-of-care medicine across primary and key secondary endpoints.
Benralizumab, made by AstraZeneca, is an anti-eosinophil antibody that induces direct, rapid and near-complete depletion of eosinophils, a type of white blood cell that control the mechanism associated with allergy and asthma. Many patients with severe, uncontrolled asthma have high levels of eosinophils in the blood and airways (known as eosinophilia) which is associated with frequent asthma exacerbations, high symptom burden and impaired lung function.
• Reductions in the annual rate of asthma exacerbations (up to 51 per cent)
• Improvement in lung function, which was seen at four weeks after the first benralizumab dose and sustained throughout the treatment period
• Improvement in asthma symptoms, such as wheeze, cough, chest tightness and shortness of breath.
The outcomes, published in The Lancet, were demonstrated for the 8-week dosing regimen, with no additional benefit observed with 4-week dosing, which may support less-frequent dosing. In addition, post-hoc analysis showed greater improvements in exacerbation rate reduction, lung function and total asthma symptom scores in patients with a history of more frequent asthma exacerbations.
“Statistics show that up to 250,000 Canadians suffer from severe asthma, and new treatment options are needed to help this patient population regain control of their disease and reduce exacerbations,” Dr. FitzGerald said. “This study demonstrates that the anti-eosinophil effect of benralizumab within the appropriate patient population improved outcomes for patients whose severe asthma is driven by eosinophilic inflammation.”
Severe uncontrolled asthma is a debilitating and potentially fatal form of the disease, where patients experience frequent exacerbations every year and have significant limitations on lung function and quality of life. Uncontrolled asthma can lead to a dependence on oral corticosteroids, with systemic steroid exposure leading to serious and irreversible adverse effects.
The data will be included in regulatory submissions for benralizumab that are planned for the U.S. and E.U. later in 2016.