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特泽布尔单抗治疗未控制的重度哮喘。

Tezepelumab in the Treatment of Uncontrolled Severe Asthma.

机构信息

Wayne State University, Eugene Applebaum College of Pharmacy and Health Sciences, Detroit, MI, USA.

Wayne State University, Eugene Applebaum College of Pharmacy and Health Sciences and Ascension St. John Hospital and Medical Center, Detroit, MI, USA.

出版信息

Ann Pharmacother. 2023 Jan;57(1):62-70. doi: 10.1177/10600280221095540. Epub 2022 May 10.

Abstract

OBJECTIVE

To review the pharmacology, efficacy, and safety of subcutaneous tezepelumab in the treatment of severe uncontrolled asthma.

DATA SOURCES

The PubMed database and ClinicalTrials.gov were searched using the following terms: , , , and .

STUDY SELECTION AND DATA EXTRACTION

Articles published in English between January 2000 and March 2022 related to pharmacology, safety, and clinical trials were assessed.

DATA SYNTHESIS

In a phase 2 trial, tezepelumab at low, medium, and high doses reduced the annualized asthma exacerbation rate by 62%, 71%, and 66%, respectively, when compared with placebo ( < 0.001). In addition to significant reduction of asthma exacerbation rate in the overall treatment population, a phase 3 trial showed significant reduction of asthma exacerbation across all subgroups analyzed regardless of serum eosinophil count (EOS), fractionated exhaled nitric oxide (FeNO) level, or allergic status as determined by IgE sensitivity.

RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE

Tezepelumab is indicated to treat nonallergic and noneosinophilic severe uncontrolled asthma phenotypes in addition to type 2 inflammatory asthma. When selecting the most appropriate biologic agent, consider the risks, benefits, and costs. There is a paucity of data on the efficacy of tezepelumab in patients with comorbid conditions. In the case of a patient presenting with uncontrolled severe asthma with such comorbid conditions, it may be prudent to consider a biologic therapy that can target both.

CONCLUSION

Tezepelumab has shown clinical utility in severe uncontrolled asthma regardless of phenotype, fulfilling the need for treatment options in individuals with severe, uncontrolled, noneosinophilic, and nonallergic asthma.

摘要

目的

综述皮下注射特泽鲁单抗治疗重度未控制哮喘的药理学、疗效和安全性。

资料来源

使用以下术语在 PubMed 数据库和 ClinicalTrials.gov 中进行搜索:,,, 和.

研究选择和数据提取

评估了 2000 年 1 月至 2022 年 3 月期间发表的与药理学、安全性和临床试验相关的英语文章。

数据综合

在一项 2 期试验中,与安慰剂相比,低、中、高剂量的特泽鲁单抗分别使年化哮喘加重率降低 62%、71%和 66%(<0.001)。除了在整个治疗人群中显著降低哮喘加重率外,3 期试验还显示无论血清嗜酸性粒细胞计数(EOS)、呼出气一氧化氮分数(FeNO)水平或 IgE 敏感性确定的过敏状态如何,所有分析亚组的哮喘加重率均显著降低。

与患者护理和临床实践的相关性

特泽鲁单抗除了 2 型炎症性哮喘外,还可用于治疗非过敏性和非嗜酸性粒细胞重度未控制哮喘表型。在选择最合适的生物制剂时,应考虑风险、获益和成本。特泽鲁单抗在合并症患者中的疗效数据有限。对于患有合并症的未控制的重度哮喘患者,考虑使用可同时针对两种疾病的生物疗法可能是谨慎的。

结论

特泽鲁单抗在重度未控制哮喘中具有临床实用性,无论表型如何,满足了对重度、未控制、非嗜酸性粒细胞和非过敏性哮喘患者的治疗选择需求。

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