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哮喘新药:再生元的Dupixent能够迅速改善儿童的肺功能

2021-05-19 Allan MedSci原创

VOYAGE试验评估了Dupixent联合标准护理(SoC)在408例中度至重度哮喘不受控制的患儿中的安全性和有效性。

哮喘是常见的气道慢性炎症疾病,主要特征是多变和复发的症状、可逆性气流阻塞,和支气管痉挛。常见症状表现为喘息、咳嗽、胸腔紧迫、胸闷和呼吸困难。普遍认为哮喘是因为基因和环境因素共同导致的。环境因素通常包含:暴露于空气污染和过敏原,其他可能的诱发因子包含阿司匹林和β受体阻断药之类的药物。 

根据一项III期试验的详细结果,赛诺菲和Regeneron的Dupixent可显著降低6至11岁患有中度至重度哮喘不受控制的儿童的严重哮喘发作,并迅速改善其肺功能。

此外,在VOYAGE试验中,发现Dupixent(dupilumab)可改善总体哮喘控制并减少呼出气一氧化氮(FeNO)的含量,FeNO是2型炎症的气道生物标志物,在哮喘中起关键作用。

图1. Dupixent(dupilumab)的作用机制

该试验的主要研究者Leonard Bacharier说:“患有不受控制的中度至重度哮喘的儿童会经历严重且持续的症状,这些症状可能影响他们生活的许多方面,包括学习、睡眠和运动”。

他补充说:“试验结果表明,将dupilumab加入标准的护理治疗后,可显著减少哮喘发作,迅速改善肺功能并改善哮喘控制,这对于这些患儿是尤其重要的”。

VOYAGE试验评估了Dupixent联合标准护理(SoC)在408例中度至重度哮喘不受控制的患儿中的安全性和有效性。这项研究的主要结果(先前于2020年10月报道)发现,与安慰剂相比,Dupixent联合SoC治疗组患者的严重哮喘发作率显著降低(一年平均降低65% vs. 59%)。病人的肺功能也有所改善,最早可在两周内观察到并持续长达52周。

 

原始出处:

http://www.pharmatimes.com/news/sanofis_dupixent_rapidly_improves_lung_function_in_children_1370186

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    2021-11-19 廉润庆

    受益匪浅

    0

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    2021-10-27 星晓

    结果令人鼓舞

    0

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    2021-05-20 老大208

    学习了

    0

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    2021-05-19 ms3000000364740662

    很好

    0

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过敏性哮喘是一种持续或间歇性接触过敏原而引起的炎症性疾病,过敏性鼻炎可成为哮喘的诱发因素。这些疾病的主要机制是过敏反应和免疫反应失调。辅酶Q10是线粒体中的一种酶辅助因子,能够控制哮喘和过敏性鼻炎症状

NEJM:TSLP单抗Tezepelumab治疗严重不受控制哮喘III期临床研究获得成功

对于严重、不受控制的哮喘患者,TSLP单抗Tezepelumab在降低恶化风险,改善肺功能、哮喘控制和健康相关生活质量方面显著优于安慰剂

撸猫有风险!抗体鸡尾酒REGN1908-1909治疗猫过敏性轻度哮喘,II期研究取得阳性结果

该试验达到了预防早期哮喘反应的主要终点(EAR,定义为一秒钟内强制呼气量下降≥20%[FEV1])。

Eur Respir J:哮喘与COPD共存:危险因素、临床病史和肺功能轨迹

与单纯COPD相比,哮喘和COPD之间的共存似乎起源于生命的早期。这些结果表明,预防这种严重的疾病(在老年人中很常见)应该从儿童期开始。

新冠疫苗 VS 哮喘,我们做何选择?

 根据卫健委3月颁布的《新冠病毒疫苗接种技术指南(第一版)》明确:支气管哮喘不是接种新冠疫苗的禁忌症;年龄在18周岁以上的哮喘患者,处于哮喘缓解期且健康情况较好时可以预约接种新冠疫苗。

拓展阅读

赛诺菲/再生元的Dupixent在第二次慢性自发性荨麻疹研究中表现欠佳

赛诺菲和再生元制药本周五表示,基于预先指定的中期分析,Dupixent (dupilumab) 用于慢性自发性荨麻疹 (CSU) 患者的 III 期研究将因无效而停止。

幼儿哮喘患者的福音,CHMP批准Dupixent用于患有哮喘的幼儿患者

Dupilumab是一种人IgG4抗体,能够抗IL-4受体 (IL-4R) α亚基,可阻断由IL-4和IL-13诱导的IL-4R信号传导,下调驱动2型炎症性疾病的分子途径。

赛诺菲、再生元的Dupixent在慢性自发性荨麻疹中取得积极成果

慢性自发性荨麻疹(CSU)也称慢性特发性荨麻疹,定义为一周内大多数时间存在荨麻疹并且这种情况持续6周或以上。大约40%的患者伴发血管性水肿。

Dupixent在欧盟获得批准用于儿童特应性皮炎

欧盟委员会已批准赛诺菲和再生元的生物制剂Dupixent,允许其用于治疗6至11岁的儿童特应性皮炎。

赛诺菲/再生元Dupixent获FDA突破性疗法认定

据外媒报道,昨日,美国FDA授予了赛诺菲/再生元Dupixent(dupilumab,度普利尤单抗)突破性治疗指定,用于治疗12岁及以上的嗜酸性粒细胞性食管炎(EoE)患者。此次认定基于对EoE患者进

慢性皮肤病及呼吸道疾病患者的福音:FDA批准Dupixent(dupilumab)300mg预填充笔

近日,美国FDA已批准Dupixent(dupilumab)300mg单剂量预填充笔,用于12岁及以上患者的所有Dupixent适应症。

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