Benralizumab cuts steroid use in eosinophilic asthma patients: Study

November 6, 2020 0 By FM

Benralizumab (Fasenra; AstraZeneca) can eliminate or reduce oral corticosteroid (OCS) use in the majority of patients with severe eosinophilic asthma, reveals findings from PONENTE Phase IIIb trial.

Benralizumab is a monoclonal antibody that binds directly to interleukin-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of eosinophils via apoptosis (programmed cell death).

Severe asthma is an often-debilitating condition affecting approximately 34 million people worldwide. Around 13.5 million people with severe asthma currently rely on oral corticosteroids to control exacerbations and prevent hospitalizations, globally. However, over-reliance on oral corticosteroids can also cause significant health risks for patients, as well as additional strain on health systems.

Phase IIIb trial included nearly 600 patients from Europe, North America, South America, and Taiwan. The trial tested by administering 30 mg dose of benralizumab subcutaneously (SC) in adult patients with severe eosinophilic asthma on high-dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist (LABA) and long-term use of OCS therapy with or without additional asthma controller(s). According to the researchers, patients recruited into the study had been on maintenance OCS dose of ≥5 mg of prednisone for at least three months and had a baseline peripheral blood eosinophil count of ≥150 cells/μL or baseline eosinophils below 150 cells/μL with a documented eosinophil count of ≥300 cells/μL in the past 12 months.

According to the findings, 62% of patients achieved complete elimination of daily OCS use by the end of the study period of 24–32 weeks. On the second primary endpoint, 81% of patients achieved complete elimination or were able to reduce their daily OCS dose to 5mg or less when the further reduction was not possible due to adrenal insufficiency.

“These exciting results demonstrate benralizumab’s impact in eliminating or reducing oral corticosteroid use. The reductions achieved with the personalized oral corticosteroid tapering schedule are particularly important because adrenal insufficiency can be a barrier to safe and meaningful oral corticosteroid reduction. These data should inform severe asthma treatment guidelines and strengthen physicians’ confidence to more safely eliminate chronic oral corticosteroid use in their patients.” said Professor Andrew Menzies-Gow, Director of the Lung Division, Royal Brompton Hospital, London, UK, the principal investigator of the PONENTE trial.

These data further support the clinical profile of benralizumab in eliminating oral corticosteroid use across a broader population of severe asthma patients. Benralizumab can be used as an add-on maintenance therapy in patients with severe asthma, and those with an eosinophilic phenotype, said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D.