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生物制剂的长期安全性、反应的持久性、停药及换药

Long-term safety, durability of response, cessation and switching of biologics.

作者信息

Mohan Arjun, Qiu Anna Y, Lugogo Njira

机构信息

Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, Michigan, USA.

Division of Pulmonary, and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

出版信息

Curr Opin Pulm Med. 2024 May 1;30(3):303-312. doi: 10.1097/MCP.0000000000001067. Epub 2024 Mar 1.

Abstract

PURPOSE OF REVIEW

Severe asthma patients suffer from decreased quality of life, and increased asthma symptoms, exacerbations, hospitalizations, and risk of death. Biologics have revolutionized treatment for severe asthma. However, with multiple biologic agents now available, clinicians must consider initial selection the long-term effectiveness of biologics. Additionally, patients have overlapping eligibilities and clinicians may consider switching between biologics for improved response. Finally, careful assessment of biologics cessation is needed for severe asthma patients who depend on these add-on therapies for asthma control.

RECENT FINDINGS

Evidence for long-term durability and safety varies by biologic agent. In general, initial benefits noted from these agents (ex. exacerbation reduction) is, at minimum, sustained with long term use. Rates of adverse events and serious adverse events, including those requiring cessation of a biologics are low with long term use. Further studies are needed to understand the development of antidrug antibodies but currently their prevalence rates are low. Adverse events and insufficient efficacy are common reasons for biologic cessation or switching. Discontinuation maybe associated with waning of benefits but can be considered in certain situations. Biologic switching can be associated with improved asthma control.

SUMMARY

Biologics are safe and effective long-term therapies for the management of asthma. Discontinuation must be carefully considered and if possible avoided. Reasons for insufficient efficacy must be evaluated and if needed, biologic switching should be considered.

摘要

综述目的

重度哮喘患者生活质量下降,哮喘症状、急性加重、住院次数增加,死亡风险升高。生物制剂彻底改变了重度哮喘的治疗方式。然而,由于现在有多种生物制剂可供选择,临床医生必须考虑生物制剂的初始选择及其长期疗效。此外,患者的入选标准存在重叠,临床医生可能会考虑在不同生物制剂之间切换以提高疗效。最后,对于依赖这些附加疗法控制哮喘的重度哮喘患者,需要仔细评估生物制剂的停用情况。

最新发现

不同生物制剂的长期疗效和安全性证据有所不同。一般来说,这些制剂最初带来的益处(如减少急性加重)至少在长期使用中得以维持。长期使用时,不良事件和严重不良事件(包括那些需要停用生物制剂的事件)的发生率较低。需要进一步研究以了解抗药抗体的产生情况,但目前其发生率较低。不良事件和疗效不佳是停用或更换生物制剂的常见原因。停用可能与益处减弱有关,但在某些情况下可以考虑。更换生物制剂可能与改善哮喘控制有关。

总结

生物制剂是治疗哮喘安全有效的长期疗法。必须谨慎考虑并尽可能避免停用。必须评估疗效不佳的原因,如有必要,应考虑更换生物制剂。

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