europeanpharmaceuticalreviewMay 31, 2017
Tag: oral steroid , Asthma
The results of the trial demonstrate that patients treated with a potential new medicine and antibody, called benralizumab, were more than four times likely to reduce their usage of oral corticosteroids than those taking a placebo.
"The data is very impressive," said Dr Parameswaran Nair, the study’s lead investigator, professor of medicine at McMaster University, staff respirologist at St. Joseph’s Healthcare Hamilton and an AllerGen NCE Investigator.
"In the trial, patients were able to reduce their prednisone dose by as much as 75% yet they had 70% less exacerbations and 93% less emergency room visits or hospitalisations, while maintaining their lung function."
Supporting trial
The phase three ZONDA trial of 220 patients from 12 countries evaluated the effect of benralizumab 30 mg, a monoclonal antibody against the interleukin-5 receptor, on either an eight- or four-week sub-cutaneous dosing regimen for 28 weeks in adult patients with severe asthma receiving a high-dose inhaled corticosteroid and prednisone.
Benralizumab is not an approved medication, but is under regulatory review in several countries, including the United States.
"Benralizumab almost completely removes a white blood cell called eosinophil from the circulation and from lung tissue. Longer term studies with this drug are necessary to be absolutely certain of the safety of this treatment strategy," Nair said.
"However, the results are promising and would likely provide physicians with a useful strategy to treat patients with severe asthma and avoid the dreadful long-term adverse effects of corticosteroids."
Asthma affects 315 million people worldwide. Nearly 10% of asthma patients have severe asthma, which may be uncontrolled despite high doses of standard-of-care asthma medicines and can require the use of chronic oral corticosteroids.
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