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

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

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.