Positionspapier: Empfehlungen zur Anwendung von Mepolizumab bei chronischer Rhinosinusitis mit Polyposis nasi (CRSwNP) im deutschen Gesundheitssystem – Empfehlungen des Ärzteverbandes Deutscher Allergologen (AeDA) und der AGs Klinische Immunologie, Allergologie und Umweltmedizin und Rhinologie und Rhinochirurgie der Deutschen Gesellschaft für HNO-Heilkunde, Kopf- und Hals-Chirurgie (DGHNO-KHC)

Zusammenfassung

Hintergrund Die chronische Rhinosinusitis mit Nasenpolypen (CRSwNP) ist eine multifaktorielle entzündliche Erkrankung der paranasalen Schleimhäute, der als häufigstem Endotyp eine eosinophile Inflammation zugrunde liegt. Der Anti-IL-5-Antikörper Mepolizumab wurde im November 2021 für die Therapie der schweren CRSwNP zugelassen.

Methoden In einer Literatursuche wurde die Immunologie der CRSwNP analysiert und die vorhandene Evidenz ermittelt durch Recherchen in Medline, PubMed sowie den nationalen und internationalen Studien- und Leitlinien-Registern und der Cochrane Library. Es wurden Humanstudien berücksichtigt, die bis einschließlich 12/2021 publiziert wurden und in denen die Wirkung von Mepolizumab bei CRSwNP untersucht wurde.

Ergebnis Basierend auf der internationalen Literatur und bisherigen Erfahrungen werden von einem Expertengremium Empfehlungen für die Anwendung von Mepolizumab bei CRSwNP im deutschen Gesundheitssystem auf der Grundlage eines Dokumentationsbogens gegeben.

Schlussfolgerungen Das Verständnis über die immunologischen Grundlagen der CRSwNP eröffnet neue nichtoperative Therapieansätze mit Biologika für Patienten mit schweren Verlaufsformen. Mepolizumab ist seit November 2021 zugelassen zur Zusatztherapie mit intranasalen Kortikosteroiden zur Behandlung von erwachsenen Patienten mit schwerer CRSwNP, die mit systemischen Kortikosteroiden und/oder chirurgischem Eingriff nicht ausreichend kontrolliert werden können.

Abstract

Background Chronic rhinosinusitis with nasal polyps (CRSwNP) is a multifactorial inflammatory disease of the paranasal sinus mucosa with eosinophilic inflammation as the most common endotype. The anti-IL5 antibody mepolizumab was approved for the treatment of severe CRSwNP in the EU in November 2021.

Methods A literature search was performed to analyze the immunology of CRSwNP and determine the available evidence by searching Medline, Pubmed, and the German national and international trial and guideline registries and the Cochrane Library. Human studies published in the period up to and including 12/2021 that investigated the effect of mepolizumab in CRSwNP were considered.

Results Based on the international literature and previous experience, recommendations for the use of mepolizumab in CRSwNP in the German health care system are given by an expert panel on the basis of a documentation form.

Conclusions Understanding about the immunological basis of CRSwNP opens new non-surgical therapeutic approaches with biologics for patients with severe courses. Mepolizumab is approved since November 2021 for add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP who cannot be adequately controlled with systemic corticosteroids and/or surgical intervention.

Schlüsselwörter

CRS - CRSwNP - Eosinophilie - Sinusitis - T2-Inflammation - Mepolizumab

Publikationsverlauf

Artikel online veröffentlicht:
15. Februar 2022

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