Benralizumab eliminates oral corticosteroid use in certain patients with severe asthma
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Benralizumab eliminated the use of maintenance oral corticosteroids in oral corticosteroid-dependent patients with severe asthma with a broad range of blood eosinophil counts, according to high-level results of the phase 3b PONENTE trial.
The phase 3b, open-label, single-arm PONENTE trial investigated the efficacy and safety of benralizumab (Fasenra, AstraZeneca) for reducing daily oral corticosteroid use in 600 patients with severe asthma in Europe, North America, South America and Taiwan, according to a press release.
Results showed that 62% of patients with severe asthma met the primary endpoint of achieving complete elimination of daily oral corticosteroid use. For the second primary endpoint, 81% of patients with severe asthma achieved complete elimination or reduced their daily oral corticosteroid dose to 5 mg or less. Both endpoints were sustained for at least 4 weeks while maintaining asthma control, according to the release.
Results from the PONENTE trial will be presented at a future medical meeting, according to the release.
“These exciting results demonstrate Fasenra’s impact in eliminating or reducing oral corticosteroid use,” Andrew Menzies-Gow, MD, principal investigator of the PONENTE trial and director of the lung division at Royal Brompton Hospital, London, said in the release. “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.”
The trial enrolled patients who had been on a maintenance oral corticosteroid dose of 5 mg or more of prednisone for at least 3 months and had a baseline peripheral blood eosinophil count of 150 cells/µL or higher, or baseline eosinophils below 150 cells/µL with a documented eosinophil count of 300 cells/µL or higher in the past 12 months. The treatment period consisted of a 4-week induction phase with no oral corticosteroid adjustments, a variable oral corticosteroid tapering phase and an ongoing 24- to 32-week maintenance phase, according to the release.
The PONENTE trial expands upon oral corticosteroid-sparing data from the ZONDA phase 3 trial with a longer maintenance phase of 24 to 32 weeks. The PONENTE trial showed a more durable oral corticosteroid reduction and asthma control than in ZONDA or other published biologic medication trials, according to the release.
“These data should inform severe asthma treatment guidelines and strengthen physicians’ confidence to more safely eliminate chronic oral corticosteroid use in their patients,” Menzies-Gow said.
Benralizumab is currently approved as an add-on maintenance treatment for severe eosinophilic asthma and for self-administration. Benralizumab is currently being evaluated in eight eosinophil-driven diseases other than severe asthma, according to the release.