Monitoring mepolizumab treatment in chronic rhinosinusitis with nasal polyps (CRSwNP): Discontinue, change, continue therapy?

Allergologie select Pub Date : 2024-03-21 eCollection Date: 2024-01-01 DOI:10.5414/ALX02460E
Ludger Klimek, Ulrike Förster-Ruhrmann, Heidi Olze, Achim G Beule, Adam M Chaker, Jan Hagemann, Tilman Huppertz, Thomas K Hoffmann, Stefan Dazert, Thomas Deitmer, Sebastian Strieth, Holger Wrede, Wolfgang W Schlenter, Hans-Jürgen Welkoborsky, Barbara Wollenberg, Sven Becker, Fredericke Bärhold, Felix Klimek, Ingrid Casper, Jaron Zuberbier, Claudia Rudack, Mandy Cuevas, Constantin A Hintschich, Orlando Guntinas-Lichius, Timo Stöver, Christoph Bergmann, Pascal Werminghaus, Oliver Pfaar, Jan Gosepath, Moritz Gröger, Caroline Beutner, Martin Laudien, Rainer K Weber, Tanja Hildebrand, Anna S Hoffmann, Claus Bachert
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Abstract

Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a multifactorial inflammatory disease of the mucous membranes of the nose and sinuses. Eosinophilic inflammation is described as a common endotype. The anti-IL-5 antibody mepolizumab was approved in November 2021 as an add-on therapy to intranasal glucocorticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyps when systemic glucocorticosteroids or surgery do not provide adequate disease control. While national and international recommendations exist for the use of mepolizumab in CRSwNP, it has not yet been adequately specified how this therapy should be monitored, what follow-up documentation is necessary, and when it should be discontinued if necessary.

Materials and methods: A literature search was performed to analyze previous data on the treatment of CRSwNP with mepolizumab and to determine the available evidence by searching Medline, Pubmed, the national and international trial and guideline registries, and the Cochrane Library. Human studies published in the period up to and including 10/2022 were considered.

Results: Based on the international literature and previous experience by an expert panel, recommendations for follow-up, adherence to therapy intervals, and possible therapy breaks as well as discontinuation of therapy when using mepolizumab for the indication CRSwNP in the German healthcare system are given on the basis of a documentation sheet.

Conclusion: Understanding the immunological basis of CRSwNP opens up new non-surgical therapeutic approaches with biologics for patients with severe, uncontrolled courses. Here, we provide recommendations for follow-up, adherence to therapy intervals, possible therapy pauses, or discontinuation of therapy when mepolizumab is used as add-on therapy with intranasal glucocorticosteroids to treat adult patients with severe CRSwNP that cannot be adequately controlled with systemic glucocorticosteroids and/or surgical intervention.

监测伴有鼻息肉的慢性鼻炎(CRSwNP)患者的美妥珠单抗治疗:停止、改变还是继续治疗?
背景:慢性鼻窦炎伴鼻息肉(CRSwNP)是鼻腔和鼻窦粘膜的一种多因素炎症性疾病。嗜酸性粒细胞炎症被描述为一种常见的内型。抗IL-5抗体mepolizumab于2021年11月获批作为鼻内糖皮质激素的附加疗法,用于治疗伴有鼻息肉的严重慢性鼻窦炎成人患者,当全身糖皮质激素或手术不能充分控制疾病时。虽然国内和国际上都有关于在 CRSwNP 中使用甲泼尼单抗的建议,但尚未充分说明应如何监测这种疗法、需要哪些随访文件以及必要时应何时停药:通过检索 Medline、Pubmed、国内和国际试验与指南登记处以及 Cochrane 图书馆,进行了文献检索,以分析以往使用甲泼尼珠单抗治疗 CRSwNP 的数据并确定可用证据。研究考虑了截至 2022 年 10 月(含 2022 年 10 月)期间发表的人类研究:结果:根据国际文献和专家小组以往的经验,在德国医疗保健系统中使用甲泼尼单抗治疗CRSwNP时,根据文件表给出了随访、坚持治疗间隔、可能的治疗中断以及停止治疗的建议:结论:了解了 CRSwNP 的免疫学基础,就能为病情严重、无法控制的患者开辟新的生物制剂非手术治疗方法。在此,我们提供了有关随访、坚持治疗间隔、可能的治疗暂停或停止治疗的建议,这些建议是在使用mepolizumab作为鼻内糖皮质激素的附加疗法来治疗无法通过全身糖皮质激素和/或手术干预得到充分控制的严重CRSwNP成年患者时提出的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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