A biological research may reduce the need for adults with severe asthma to take an oral corticosteroid to control their asthma, according to a randomized controlled trial presented at the ATS 2017 International Conference. The results of the study are reported simultaneously online, prior to printing in the New England Journal of Medicine.
The biologic is benralizumab, a monoclonal antibody to the anti-interleukin-5 receptor, which when administered subcutaneously, rapidly depletes eosinophils, cells that at high concentrations in the blood and airways lead to frequent exacerbations of asthma. Benralizumab was evaluated for patients whose asthma is poorly controlled by high doses of standard inhaled corticosteroid and long-acting β2-agonist therapies and therefore prescribed oral corticosteroids (prednisone) on a regular basis to increase control .
“Frequent or long-term use of systemic corticosteroids can lead to life-threatening complications, including osteoporosis, diabetes, cardiovascular disease and suprarenal suppression,” said lead author Parameswaran Nair, MD, PhD, a professor of medicine at the Firestone Institute for Respiratory Health , At McMaster University in Hamilton, Canada. “We need new and safe therapies that replace the need for systemic corticosteroids for patients with severe asthma.”
According to the authors, about 5 to 10 percent of people with asthma have a severe form of the disease, and studies have shown that 32 to 45 percent of these people require frequent oral or maintenance corticosteroids.
220 patients, 18- to 75-year-olds, were randomly assigned to three arms: those receiving ben- zolumab every four weeks, who were treated with ZONDA (called dry and warm wind from the Andes). Received benralizumab every eight weeks (after three initial doses of four weeks) and those given a placebo.
At the end of the 28 weeks, the researchers found:
- The odds of reducing the use of Prednisone were more than four times higher for patients enrolled in either benralizumab arm than placebo.
- The annual exacerbation rates of patients enrolled in either benralizumab arm were estimated to be 55 to 70 percent lower than placebo, despite a reduction in the use of Prednisone.
- More than one-third of patients enrolled in the arms of benralizumab were able to reduce their Prednisone doses by ≥90 percent.
- FEV1, the measure of how much air a person can exhale in a second, was not significantly different between the study groups of benralizumab and placebo at the end of the study. However, FEV1 did not decrease compared with baseline, despite a significant reduction in Prednisone dose.
There were no major adverse events related to the use of benralizumab.
The researchers said that approximately 20 percent of patients did not respond to benralizumab and that future studies would be needed to determine which patients would benefit from the biological. “It is possible that the asthma of these patients does not critically depend on eosinophils or have not had significant activity of eosinophils in the airways,” said Nair, who added that “it is necessary to conduct long-term studies of patients with Prednisone dependent asthma Before definitive conclusions can be drawn about the long-term efficacy and safety of benralizumab and the depletion of eosinophils. ”
Benralizumab is under regulatory review in the United States, the European Union, Japan and several other countries.