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ORIGINAL RESEARCH article

Front. Immunol.

Sec. Inflammation

Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1702989

This article is part of the Research TopicEvolving paradigms: IL-5's role in eosinophilic pathologies and targeted treatmentsView all articles

Benralizumab for Adults with Rare and Off-Label Eosinophilic disorders: a 52-week Prospective, Single-Center Study

Provisionally accepted
Aviv  TalmonAviv TalmonOded  ShamrizOded ShamrizLimor  RubinLimor RubinYaarit  RibakYaarit RibakIris  AynorIris AynorAdam  NevoAdam NevoAnna  EliaAnna EliaMeitav  Ben SionMeitav Ben SionEsther  ForkoshEsther ForkoshAlon  HershkoAlon HershkoYuval  TalYuval Tal*
  • Hadassah Medical Center, Jerusalem, Israel

The final, formatted version of the article will be published soon.

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 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 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 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 was 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.

Keywords: benralizumab, IL-5, Eosinophilic disorders, Basket trial, Eosinophi

Received: 10 Sep 2025; Accepted: 06 Oct 2025.

Copyright: © 2025 Talmon, Shamriz, Rubin, Ribak, Aynor, Nevo, Elia, Ben Sion, Forkosh, Hershko and Tal. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Yuval Tal, yuvalt@hadassah.org.il

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