A Phase 3 trial of benralizumab showed that by adding the treatment to standard of care, patients with severe, uncontrolled eosinophilic asthma had a median reduction in oral corticosteroid (OCS) use of 75% versus 25% in a placebo group.
Benralizumab, an anti-eosinophil monoclonal antibody, was evaluated in the 28-week, Phase 3 ‘ZONDA’ trial. A total of 220 adult patients with severe, uncontrolled asthma who had been receiving high-dose inhaled corticosteroid/long-acting beta2 (LABA) and OCS, were enrolled. They were randomized to receive either 30mg of benralizumab subcutaneously every 4- or 8-weeks, or placebo. The primary endpoint was the percentage change in OCS dose from baseline to week 28, in both dose regimens.
The primary endpoint was met with 75% of the benralizumab group reducing their OCS doses compared to 25% in the placebo group. Additionally, 52% of the benralizumab group who had optimized baseline OCS doses of ≤12.5mg/d were able to completely stop OCS use.
“Benralizumab showed an impressive clinical efficacy by reducing exacerbations rate by up to 70% at the same time enabling patients with severe asthma to significantly lower their prednisone dose and maintain their lung function,” said Dr. Parameswaran Nair, professor at McMaster University, Canada, and lead author of the study.
Common cold, worsening asthma and bronchitis were the most common adverse events (≥10%) reported in the benralizumab group. Overall the benralizumab related adverse event occurrence was similar to placebo. Dependence on OCS can result in a number of comorbities including weight gain, diabetes, osteoporosis, glaucoma, and depression.
Data from ZONDA was included in the New Drug Application (NDA) currently under review by the Food and Drug Administration.
For more information visit Nejm.org.