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<p>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 <i>FIP1L1::PDGFRA</i>-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, <i>P</i> = 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: <a href="http://clinicaltrials.gov/ct2/show/NCT04191304">NCT04191304</a>.</p>

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Benralizumab versus placebo for hypereosinophilic syndrome: a randomized, placebo-controlled phase 3 trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月31日

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  • 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

摘要

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.