• Citer

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

par Ogbogu, Princess U;Roufosse, Florence ;Akuthota, Praveen;Kuna, Piotr;Groh, Matthieu;Reiter, Andreas;Yokota, Akira;Siddiqui, Salman;Mutsaers, Pim P.G.N.J.;Li, Bing;Khoury, Paneez;Bahadori, Lila L.M.;Bednarczyk, Artur;Bouma, Gerben;Brooks, Laura ;Ferreira, Jorge;Grindebacke, Hanna;Ho, Calvin C.N.;Jain, Priya;Palmer, Rebecca R.L.;Jison, Maria;Klion, Amy
Référence Nature medicine, 32, 6, page (2319)
Publication Publié, 2026-06

Article révisé par les pairs

• Accès en ligne
• Détails
• Contenu
• Statistiques

Résumé :

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.