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Data Sheet 1_Benralizumab for adults with rare and off-label eosinophilic disorders: a 52-week prospective, single-center study.docx

Title: Data Sheet 1_Benralizumab for adults with rare and off-label eosinophilic disorders: a 52-week prospective, single-center study.docx
Authors: Aviv Talmon; Oded Shamriz; Limor Rubin; Yaarit Ribak; Iris Aynor; Adam Nevo; Anna Elia; Meitav Ben Sion; Esther Forkosh; Alon Y. Hershko; Yuval Tal
Publication Year: 2025
Collection: Frontiers: Figshare
Subject Terms: Genetic Immunology; benralizumab; IL-5; eosinophilic disorders; basket trial; eosinophil
Description: Background Rare eosinophilic disorders are challenging to manage due to their heterogeneity and lack of targeted therapies. Benralizumab, an anti-IL-5 receptor monoclonal antibody approved for the treatment of severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA), has not been systematically studied in other eosinophilic conditions. Objective To assess the efficacy and safety of benralizumab in adults with rare, non-asthmatic eosinophilic disorders over 52 weeks. Methods In this single-center, prospective, open-label study, 17 adults with diverse eosinophilic diseases received benralizumab 30 mg every 4 weeks for 24 weeks; responders continued up to 52 weeks. The primary endpoint was ≥50% reduction in peripheral eosinophil counts or tissue infiltration. Secondary outcomes included symptom improvement, reduced exacerbations, corticosteroid withdrawal, and safety. Results Of the 19 enrolled patients, 17 initiated treatment. Sixteen achieved clinical resolution, and all showed complete peripheral eosinophil depletion. Corticosteroids were discontinued in all completers. One patient had a partial response, and one discontinued due to mild, unrelated liver enzyme elevation. No serious adverse events occurred. Relapses were observed after treatment cessation. Efficacy was demonstrated across heterogeneous conditions, including eosinophilic leukemia, folliculitis, vaginitis, and IgG4-related disease. Conclusion Benralizumab is safe, well-tolerated, and effective in diverse rare eosinophilic disorders, enabling corticosteroid discontinuation and symptom control. These findings support its broader therapeutic potential and warrant further investigation.
Document Type: dataset
Language: unknown
DOI: 10.3389/fimmu.2025.1702989.s001
Availability: https://doi.org/10.3389/fimmu.2025.1702989.s001; https://figshare.com/articles/dataset/Data_Sheet_1_Benralizumab_for_adults_with_rare_and_off-label_eosinophilic_disorders_a_52-week_prospective_single-center_study_docx/30428023
Rights: CC BY 4.0
Accession Number: edsbas.3B451048
Database: BASE