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多种生物制剂时代:联合使用和换药是重度哮喘管理的一种选择吗?

The era of multiple biologics: Is combination and switching an option in the management of severe asthma?

作者信息

Okwuofu Emmanuel Oshiogwe, Yong Audrey Chee Hui, Lim Jonathan Chee Woei, Stanslas Johnson

机构信息

Pharmacotherapeutic Unit, Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, Malaysia.

Department of Medicinal Chemistry, Faculty of Pharmacy, MAHSA University, 42610, Jenjarom, Selangor, Malaysia.

出版信息

Pulm Pharmacol Ther. 2025 Sep;90:102375. doi: 10.1016/j.pupt.2025.102375. Epub 2025 Jun 19.

DOI:10.1016/j.pupt.2025.102375
PMID:40543758
Abstract

BACKGROUND AND OBJECTIVE

The introduction of biologics therapies targeting specific cytokines relevant to asthma pathophysiology has changed the landscape in the treatment of severe asthma in both adults and children. However, the availability of multiple agents, inclusion criteria for randomised control trials (RCTs), variation in national and international guidelines, instances of treatment failures, and the potential of switching or combining biologic therapies, highlight the need for real-world evidence. Data from real-world studies of biologics in severe asthma may complement efficacy data obtained from RCTs and provide important post-marketing safety information. Additionally, these studies may help inform the design of future clinical trials, characterise the natural history of the disease, and support important translational research. This review highlights current evidence for the combination and switching of biologics in severe asthma and comorbid diseases that may serve as pointers for optimal clinical outcomes.

METHOD

Pubmed, Scopus, and Web of Science were searched using specified search strategies.

RESULTS

Available evidence suggests that patients with severe asthma who received combination or switched biologics (omalizumab, benralizumab, reslizumab, mepolizumab, dupilumab, and Tezepelumab) in real-world settings experienced significant improvement in asthma control, exacerbation, and lung function. Although combining biologics is not currently a common practice, there are cases where biologic therapies were combined, discontinued, or switched.

CONCLUSION

Patients may benefit from the early and systematic consideration of combination and switching of biologic therapies in severe asthma.

摘要

背景与目的

针对与哮喘病理生理学相关的特定细胞因子的生物制剂疗法的引入,改变了成人和儿童重度哮喘的治疗格局。然而,多种药物的可获得性、随机对照试验(RCT)的纳入标准、国家和国际指南的差异、治疗失败的情况以及生物制剂疗法转换或联合使用的可能性,凸显了获取真实世界证据的必要性。重度哮喘生物制剂真实世界研究的数据可补充从RCT获得的疗效数据,并提供重要的上市后安全性信息。此外,这些研究可能有助于为未来临床试验的设计提供信息,描述疾病的自然史,并支持重要的转化研究。本综述强调了重度哮喘生物制剂联合使用和转换以及可能作为最佳临床结果指标的合并疾病的当前证据。

方法

使用特定的检索策略对PubMed、Scopus和Web of Science进行检索。

结果

现有证据表明,在真实世界中接受生物制剂联合使用或转换治疗(奥马珠单抗、贝那利珠单抗、瑞利珠单抗、美泊利珠单抗、度普利尤单抗和tezepelumab)的重度哮喘患者在哮喘控制、病情加重和肺功能方面有显著改善。虽然联合使用生物制剂目前并不常见,但存在生物制剂疗法联合使用、停用或转换的情况。

结论

重度哮喘患者可能从早期和系统地考虑生物制剂疗法的联合使用和转换中获益。

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