在NAVIGATOR中,在患有重症,不受控制的喘患者和并发性鼻的患者中,Tezepelumab的有效性
Tanya M Laidlaw1,2, Andrew Menzies-Gow3, Scott Caveney4
1Jeff and Penny Vinik Center for Allergic Diseases Research, Division of Allergy and Clinical Immunology, Brigham and Women's Hospital, Boston, MA, USA.
Journal of asthma and allergy
|September 11, 2023
概括
在重度喘患者中,Tezepelumab显著降低了喘恶化,改善了肺功能和症状,包括那些鼻息肉患者. 这种生物疗法为难以控制的喘提供了一种新的治疗选择.
科学领域:
- 免疫学 免疫学 免疫学
- 肺部病理学 肺部病理学
- 过敏和临床免疫学
背景情况:
- 严重的喘影响了大量患者,治疗选择有限.
- 胸膜层淋巴蛋白 (TSLP) 是严重喘中呼吸道炎症的关键驱动因素.
- 德泽佩卢马布针对TSLP,提供了一个潜在的新疗法方法.
研究的目的:
- 评价tezepelumab在患有严重,不受控制的喘患者的疗效,特别关注具有和没有鼻息肉 (NP) 的子组.
- 评估tzepelumab对年度喘恶化率 (AAER),肺功能和症状控制的影响.
主要方法:
- 一项3期,随机,双盲,安慰剂对照研究 (NAVIGATOR) 涉及1059名患有严重喘的患者.
- 患者在52周内每4周接受皮下注射特泽佩卢马布 (210毫克) 或安慰剂.
- 探索性分析评估了NP子组中的AAER,肺功能 (FEV1),中鼻结局测试 (SNOT) -22分数,以及生物标志物 (FeNO,血液中乙烯基蛋白,IgE,IL-5,IL-13).
主要成果:
- 与安慰剂相比,Tezepelumab在52周内在患有NP的患者中减少了85%的AAER,在没有NP的患者中减少了51%的AAER.
- 在两组NP小组中都观察到肺功能,喘控制和与健康相关的生活质量 (HRQoL) 的显著改善.
- 在患有NP的患者中,Tezepelumab证明了鼻腔症状 (SNOT-22分数) 的降低,并且降低了FeNO和血中乙氨基酸细胞计数等生物标志物.
结论:
- 在严重的喘患者中,Tezepelumab在减少恶化和改善喘控制和HRQoL方面提供了显著的临床益处,无论鼻的息肉状况如何.
- 该药物还显示出有效性,改善了同病性NP患者的鼻腔症状.
- 捷佩卢马布是治疗严重喘的一种有前途的生物疗法,它可以治疗TSLP驱动的炎症.
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