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作者信息

Klimek L, Förster-Ruhrmann U, Olze H, Beule A G, Chaker A M, Hagemann J, Huppertz T, Hoffmann T K, Dazert S, Deitmer T, Strieth S, Wrede H, Schlenter W, Welkoborsky H J, Wollenberg B, Becker S, Klimek F, Sperl A, Casper I, Zuberbier J, Rudack C, Cuevas M, Hintschich C A, Guntinas-Lichius O, Stöver T, Bergmann C, Pfaar O, Gosepath J, Gröger M, Beutner C, Laudien M, Weber R K, Hildenbrand T, Hoffmann A S, Bachert C

机构信息

Zentrum für Rhinologie und Allergologie, Wiesbaden.

Klinik für Hals-, Nasen- und Ohrenheilkunde, Charité-Universitätsmedizin Berlin.

出版信息

Laryngorhinootologie. 2022 Nov;101(11):855-865. doi: 10.1055/a-1908-3074. Epub 2022 Sep 23.

Abstract

BACKGROUND

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a multifactorial inflammatory disease of the nasal and paranasal mucosa. A Type-2 inflammation is described as the most common endotype. Since October 2019 the anti-IL-4/-IL-13 antibody dupilumab has been approved in Germany as an add-on therapy to intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyps, when systemic corticosteroids alone or surgery do not provide adequate disease control. While recommendations for the use of dupilumab in CRSwNP exist at both national and international levels, until now it has not been adequately established, how therapy should be monitored and when it should be discontinued in the German Health Care System.

METHODS

A literature search was performed analyzing previous data on the treatment of CRSwNP with dupilumab 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 05/2022 were included.

RESULTS

Based on international literature and previous experience, recommendations are given by an expert panel for follow-up and possible therapy breaks, therapy intervals or termination of therapy when using dupilumab for the indication CRSwNP in the German health care system based on a documentation form.

CONCLUSIONS

Understanding the immunological basis of CRSwNP opens new non-surgical therapy approaches with biologics for patients with severe courses. The authors give recommendations for follow-up, possible therapy breaks, therapy intervals and a termination for dupilumab treatment as add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP that cannot be adequately controlled with systemic corticosteroids and/or surgical intervention.

摘要

背景

伴鼻息肉的慢性鼻-鼻窦炎(CRSwNP)是一种鼻和鼻窦黏膜的多因素炎症性疾病。2型炎症被认为是最常见的内型。自2019年10月起,抗白细胞介素-4/白细胞介素-13抗体度普利尤单抗在德国被批准作为鼻内皮质类固醇的附加疗法,用于治疗患有严重慢性鼻-鼻窦炎伴鼻息肉的成人患者,当单独使用全身皮质类固醇或手术无法充分控制疾病时。虽然在国家和国际层面都存在关于度普利尤单抗在CRSwNP中使用的建议,但到目前为止,在德国医疗保健系统中,尚未充分确定应如何监测治疗以及何时应停止治疗。

方法

进行文献检索,分析先前关于度普利尤单抗治疗CRSwNP的数据,并通过检索Medline、Pubmed、国家和国际试验及指南登记处以及Cochrane图书馆来确定现有证据。纳入截至2022年5月发表的人体研究。

结果

基于国际文献和先前经验,一个专家小组根据一份文件表格,就德国医疗保健系统中使用度普利尤单抗治疗CRSwNP适应症时的随访、可能的治疗中断、治疗间隔或治疗终止给出了建议。

结论

了解CRSwNP的免疫基础为重症患者开辟了新的生物制剂非手术治疗方法。作者给出了关于随访、可能的治疗中断、治疗间隔以及度普利尤单抗作为鼻内皮质类固醇附加疗法治疗严重CRSwNP成年患者的治疗终止的建议,这些患者无法通过全身皮质类固醇和/或手术干预得到充分控制。

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