Findings from a phase 3b trial showed that a majority of patients with severe eosinophilic asthma treated with benralizumab (Fasenra; AstraZeneca), an interleukin-5 antagonist, were able to eliminate or reduce oral corticosteroid (OCS) use.
The open-label, single-arm PONENTE trial assessed the efficacy and safety of reducing OCS use after initiating treatment with benralizumab in nearly 600 adults with severe eosinophilic asthma. The trial included patients who were on high-dose inhaled corticosteroids plus a long-acting beta2-agonist, in addition to long-term OCS therapy of 5mg or greater with or without additional asthma controller(s).
The trial consisted of a 4-week induction phase with no OCS adjustments, a variable OCS tapering phase and an ongoing 24 to 32 week maintenance phase. The co-primary end points were the proportion of patients achieving a 100% reduction in daily OCS dose and the proportion of patients achieving a 100% reduction or a daily OCS dose of less than or equal to 5mg if further OCS reduction was not possible.
Results demonstrated that 62% of patients achieved complete elimination of daily OCS use, and 81% of patients achieved complete elimination or reduced their daily OCS use to 5mg or less. These treatment effects were sustained for at least 4 weeks while maintaining asthma control. As for safety, benralizumab was found to be consistent with its known profile.
“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,” said Professor Andrew Menzies-Gow, Director of the Lung Division, Royal Brompton Hospital, London, UK, the principal investigator of the PONENTE trial. “These data should inform severe asthma treatment guidelines and strengthen physicians’ confidence to more safely eliminate chronic oral corticosteroid use in their patients.”
Benralizumab is marketed under the brand name Fasenra and is currently indicated for use as add-on maintenance treatment of severe asthma in patients 12 years and older, and with an eosinophilic phenotype.
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Fasenra eliminated oral corticosteroid use in a majority of OCS-dependent patients with asthma in PONENTE Phase IIIb trial. [press release]. Wilmington, DE: AstraZeneca; October 29, 2020.