Benralizumab versus placebo for hypereosinophilic syndrome: a randomized, placebo-controlled phase 3 trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Benralizumab, an eosinophil-depleting anti-IL-5 receptor α antibody, has demonstrated efficacy in severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis and shown promising results in hypereosinophilic syndrome (HES). NATRON was a randomized, double-blind placebo-controlled phase 3 study evaluating the efficacy and safety of benralizumab in FIP1L1::PDGFRA-negative HES. The primary endpoint was time to first HES flare. In total, 133 patients (median (range) age 51 (14-87) years, 62% female) were randomized (1:1) to receive benralizumab 30 mg every 4 weeks or placebo for 24 weeks, in addition to background therapy. Benralizumab significantly reduced the risk of first flare versus placebo (hazard ratio 0.35, 95% CI 0.18 to 0.69, P = 0.0024). Adverse events occurred in 64.2% and 66.7% of benralizumab- and placebo-treated patients, respectively. Benralizumab's safety was consistent with its known profile. These results demonstrate the efficacy and safety of add-on benralizumab in the treatment of HES. ClinicalTrials.gov identifier: NCT04191304 .
Source: Nature Medicine
Authors: Princess U. Ogbogu, Florence Roufosse, Praveen Akuthota, Piotr Kuna, Matthieu Groh, Andreas Reiter, Akira Yokota, Salman H. Siddiqui, Pim G. N. J. Mutsaers, Bing Li, Paneez Khoury, Lila M. Bahadori, Artur Bednarczyk, Gerben Bouma, Laura G. Brooks, Jorge Ferreira, Hanna Grindebacke, Calvin N. Ho, Priya Jain, Rebecca L. Palmer, Maria L. Jison, Amy D. Klion, on behalf of NATRON study group
Institutions: Rainbow Babies & Children's Hospital, Case Western Reserve University, Université Libre de Bruxelles, Erasmus Hospital, University of California San Diego, Medical University of Lodz, Université de Versailles Saint-Quentin-en-Yvelines, Hôpital Foch, Heidelberg University, University Medical Centre Mannheim, Chiba Aoba Municipal Hospital, Royal Brompton Hospital, NIHR Imperial Biomedical Research Centre, Imperial College London, Erasmus MC, Chinese Academy of Medical Sciences & Peking Union Medical College, Institute of Hematology & Blood Diseases Hospital, State Key Laboratory of Experimental Hematology, National Institutes of Health, National Institute of Allergy and Infectious Diseases, AstraZeneca (United States), AstraZeneca (Poland), AstraZeneca (United Kingdom), AstraZeneca (Sweden)
Language: English
Subfield: Rheumatology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $12,690
Award: G9000053808
OpenAlex ID: W7144056573