Positive results from the MANDARA Phase III trial for FASENRA® (benralizumab) in patients with eosinophilic granulomatosis with polyangiitis (EGPA) have been published in the New England Journal of Medicine. As the first head-to-head trial of biologics in patients with EGPA, the MANDARA trial demonstrated that more than half of the patients achieved remission with eosinophil-targeting biologic therapies, allowing them to taper off oral corticosteroids (OCS) while preventing relapses.
In the trial, benralizumab was compared to mepolizumab, another biologic treatment, and the study met its primary endpoint, showing non-inferior rates of remission compared to mepolizumab. Specifically, 59% of patients treated with benralizumab attained remission, defined as a Birmingham Vasculitis Activity Score (BVAS) of 0 and an OCS dose of 4 mg/day or less. Additionally, 41% of the benralizumab-treated patients could fully taper off OCS in the latter weeks of the study, compared to 26% in the mepolizumab arm.
These study results were also presented at the AAAAI Annual Meeting. Dr. Michael Wechsler, Coordinating Investigator of the MANDARA trial, noted the significance of the findings. Patients with EGPA often rely on long-term, high-dose OCS, which come with serious side effects and challenges in tapering off. The trial results confirm that eosinophil-targeting biologic therapies like FASENRA can help patients achieve remission and reduce chronic OCS use.
Sharon Barr from AstraZeneca emphasized the importance of the trial for the EGPA community, highlighting the convenience of FASENRA as a single, monthly subcutaneous injection that helps patients achieve remission and manage their disease.
Elevated eosinophil levels are central to EGPA pathophysiology, with all patients experiencing high eosinophil levels at some disease stage. Approximately half of the EGPA patients also have severe eosinophilic asthma and often exhibit sinus and nasal symptoms.
FASENRA’s mode of action involves almost complete depletion of eosinophils, leading to greater improvements in patients’ ability to achieve remission and reduce reliance on OCS. These findings represent a significant advancement in EGPA management, providing patients with a potentially impactful treatment option that may address the challenges of this debilitating condition.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.
