贝那利珠单抗对比安慰剂治疗高嗜酸粒细胞综合征：一项随机、安慰剂对照的Ⅲ期临床试验
2026/04/28
摘要
背景：贝那利珠单抗是一种耗竭嗜酸性粒细胞的抗IL-5受体α单克隆抗体，已在重症嗜酸粒细胞性哮喘及嗜酸粒细胞性肉芽肿性多血管炎中证实有效，并在高嗜酸粒细胞综合征（HES）中显示出有前景的疗效。
目的：NATRON研究是一项随机、双盲、安慰剂对照的Ⅲ期临床试验，旨在评估贝那利珠单抗在FIP1L1::PDGFRA基因融合阴性HES患者中的疗效与安全性。主要终点为首次HES急性发作时间。
方法：共133例患者（中位年龄51岁（范围14-87岁），62%为女性）按1:1随机分组，在背景治疗基础上分别接受贝那利珠单抗（30 mg，每4周一次）或安慰剂治疗24周。
结果：与安慰剂相比，贝那利珠单抗显著降低了首次急性发作风险（风险比0.35，95%置信区间0.18-0.69，P=0.0024）。贝那利珠单抗组与安慰剂组的不良事件发生率分别为64.2%和66.7%。贝那利珠单抗的安全性与其已知特征一致。
结论：上述结果证实了贝那利珠单抗作为添加疗法治疗HES的有效性与安全性。
Benralizumab versus placebo for hypereosinophilic syndrome: a randomized, placebo-controlled phase 3 trial.
Princess U, Ogbogu; Florence,
Abstrast
BACKGROUND: 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).
OBJECTIVES: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: These results demonstrate the efficacy and safety of add-on benralizumab in the treatment of HES.
背景：贝那利珠单抗是一种耗竭嗜酸性粒细胞的抗IL-5受体α单克隆抗体，已在重症嗜酸粒细胞性哮喘及嗜酸粒细胞性肉芽肿性多血管炎中证实有效，并在高嗜酸粒细胞综合征（HES）中显示出有前景的疗效。
目的：NATRON研究是一项随机、双盲、安慰剂对照的Ⅲ期临床试验，旨在评估贝那利珠单抗在FIP1L1::PDGFRA基因融合阴性HES患者中的疗效与安全性。主要终点为首次HES急性发作时间。
方法：共133例患者（中位年龄51岁（范围14-87岁），62%为女性）按1:1随机分组，在背景治疗基础上分别接受贝那利珠单抗（30 mg，每4周一次）或安慰剂治疗24周。
结果：与安慰剂相比，贝那利珠单抗显著降低了首次急性发作风险（风险比0.35，95%置信区间0.18-0.69，P=0.0024）。贝那利珠单抗组与安慰剂组的不良事件发生率分别为64.2%和66.7%。贝那利珠单抗的安全性与其已知特征一致。
结论：上述结果证实了贝那利珠单抗作为添加疗法治疗HES的有效性与安全性。
（中日友好医院呼吸与危重症医学科 万静萱 摘译 林江涛 审校）
（Nat Med 2026 Mar 31;(0).DOI:10.1038/s41591-026-04315-8. IF: 36.13）
（Nat Med 2026 Mar 31;(0).DOI:10.1038/s41591-026-04315-8. IF: 36.13）
Benralizumab versus placebo for hypereosinophilic syndrome: a randomized, placebo-controlled phase 3 trial.
Princess U, Ogbogu; Florence,
Abstrast
BACKGROUND: 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).
OBJECTIVES: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: These results demonstrate the efficacy and safety of add-on benralizumab in the treatment of HES.
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