Benralizumab Continues to Show Efficacy, Safety in Phase 3 Trial

Of patients with a baseline blood eosinophil count of 300 cells per mL or more who were given benralizumab every 8 weeks, 75% were exacerbation-free during their second year of treatment.

William Busse, MD

In an extension trial examining the long-term efficacy of benralizumab (Fasenra), the medication was shown to remain safe and tolerable in asthma patients during an additional year of treatment.

Asthma affects over 300 million people around the world. Up to 10% have severe asthma that persists despite high doses of standard controller medicines, leading to chronic use of oral corticosteroids (OCS). Long-term use of OCS can cause additional health issues, including weight gain, diabetes, immunosuppression, and cardiovascular disease.

Developed by biopharmaceutical company AstraZeneca, benralizumab is a respiratory biologic approved as an add-on treatment in severe eosinophilic asthma in several countries, including the US.

High levels of eosinophils are observed in about half of patients with asthma, causing both airway inflammation and hyper-responsiveness. This results in increased asthma severity. Benralizumab binds to the interleukin (IL)-5a receptor on eosinophils, causing cell death, and reducing inflammation.

The BORA trial is 1 of 6 phase 3 trials in the benralizumab WINDWARD program, examining the long-term effectiveness of benralizumab. Patients from the SIROCCO and CALIMA phase 3 trials, who were taking 30 mg of benralizumab every 4 weeks or every 8 weeks, were eligible to continue their regimen in the BORA study for an additional year.

Of the patients included in the BORA study with a baseline blood eosinophil count of 300 cells per mL or more, who were given benralizumab continuously from SIROCCO or CALIMA every 8 weeks, 75% were exacerbation-free during their second year of treatment in BORA.

Previously, patients who were given benralizumab every 8 weeks in the SIROCCO and CALIMA studies, 65% and 60%, respectively, were exacerbation-free during their first year of treatment.

Lead BORA researcher William Busse, MD, professor of medicine, Division of Allergy, Pulmonary and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, told MD Magazine® because this is a new treatment, these findings are significant.

“In addition, subjects who had been on placebo in CALIMA and SIROCCO were given benralizumab either every 4 or 8 weeks, and the same outcomes were achieved as in the original studies,” Busse said. “These findings replicate previous data and help validate the beneficial outcomes: preventing exacerbations, improving lung function, and reducing symptoms.”

While the two-year safety data is reassuring, Busse said that most asthma patients will be on these medications for up to 5 years. As a result, longer treatment observations are required.

“Biologics, in general, are providing keen insight into the mechanisms of asthma, which had not been previously available in other studies,” Busse said.

The study results, "Long-term safety and efficacy of benralizumab in severe, uncontrolled asthma: first results of BORA, a randomized, Phase III extension study," were presented at the European Respiratory Society (ERS) International Congress 2018 in Paris, France.