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

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

doi:10.5414/ALX02460E

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

Allergol Select. 2024 Mar 21:8:26-39. doi: 10.5414/ALX02460E. eCollection 2024.

Authors

Ludger Klimek¹, Ulrike Förster-Ruhrmann², Heidi Olze², Achim G Beule^{3

4}, Adam M Chaker^{5

6}, Jan Hagemann⁷, Tilman Huppertz⁷, Thomas K Hoffmann⁸, Stefan Dazert⁹, Thomas Deitmer¹⁰, Sebastian Strieth¹¹, Holger Wrede¹², Wolfgang W Schlenter¹³, Hans-Jürgen Welkoborsky¹⁴, Barbara Wollenberg⁵, Sven Becker¹⁵, Fredericke Bärhold¹⁵, Felix Klimek¹, Ingrid Casper¹, Jaron Zuberbier², Claudia Rudack³, Mandy Cuevas¹⁶, Constantin A Hintschich¹⁷, Orlando Guntinas-Lichius¹⁸, Timo Stöver¹⁹, Christoph Bergmann²⁰, Pascal Werminghaus²¹, Oliver Pfaar²², Jan Gosepath²³, Moritz Gröger²⁴, Caroline Beutner²⁵, Martin Laudien²⁶, Rainer K Weber²⁷, Tanja Hildebrand²⁸, Anna S Hoffmann²⁹, Claus Bachert³⁰

Affiliations

¹ Center for Rhinology and Allergology, Wiesbaden.
² HNO-University Clinic Charité, Berlin.
³ Clinic for Otorhinolaryngology, Münster University Hospital.
⁴ Clinic for Otorhinolaryngology, Head and Neck Surgery at Greifswald University Medical Center.
⁵ Department of Otolaryngology - Head and Neck Surgery, Klinikum rechts der Isar, Technical University of Munich, Munich.
⁶ Center of Allergy and Environment (ZAUM) of the Technical University of Munich.
⁷ Clinic and Polyclinic for Otolaryngology, University Medical Center Mainz, Mainz.
⁸ Department of Otorhinolaryngology, Head and Neck Surgery, University of Ulm, Ulm.
⁹ Clinic for Otorhinolaryngology, Head and Neck Surgery, Ruhr University Bochum, St. Elisabeth Hospital.
¹⁰ German Society for Otorhinolaryngology, Head and Neck Surgery, Bonn.
¹¹ Clinic and Polyclinic for Otorhinolaryngology, University Hospital Bonn.
¹² Ear, nose and throat specialist, Herford.
¹³ Medical Association of German Allergists, Wiesbaden.
¹⁴ Clinic for Ear, Nose and Throat Medicine, Head and Neck Surgery, Nordstadt Clinic of the KRH, Hannover.
¹⁵ HNO-University Clinic Tübingen.
¹⁶ Clinic and Polyclinic for Otolaryngology, University Hospital Carl Gustav Carus, TU Dresden, Dresden.
¹⁷ Clinic and Polyclinic for Ear, Nose and Throat Medicine, University Hospital Regensburg, Regensburg.
¹⁸ Clinic for Otorhinolaryngology, Jena University Hospital.
¹⁹ Otorhinolaryngology University Clinic Frankfurt am Main.
²⁰ HNO RKM740 Interdisciplinary Specialist Clinic, Düsseldorf, Germany.
²¹ Praxis für Hals-, Nasen-, Ohrenheilkunde und Allergologie, Düsseldorf.
²² Clinic for Ear, Nose and Throat Medicine, University Hospital Giessen and Marburg GmbH, Marburg site, Philipps University Marburg, Marburg.
²³ Clinic for Otorhinolaryngology, HSK Wiesbaden.
²⁴ Clinic and Polyclinic for Otorhinolaryngology, University Hospital LMU Munich.
²⁵ Department of Dermatology, Venereology and Allergology, University Medical Center Göttingen, Germany Klinik für Dermatologie, Venerologie und Allergologie, Universitätsmedizin Göttingen.
²⁶ Department of Otorhinolaryngology, Head and Neck Surgery, Kiel University, University Medical Centre Schleswig-Holstein, Kiel.
²⁷ Clinic for Otorhinolaryngology, Karlsruhe Municipal Hospital.
²⁸ Department of Ear, Nose and Throat Medicine, Freiburg University Medical Center.
²⁹ Clinic for Ear, Nose and Throat Medicine, University Medical Center Hamburg-Eppendorf.
³⁰ Upper Airways Research Laboratory and Department of Oto-Rhino-Laryngology, Ghent University and Ghent, University Hospital, Ghent, Belgium.

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.

Keywords: CRSwNP; biologicals; chronic rhinosinusitis; eosinophilic inflammation; mepolizumab.

Publication types

Review