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

Autor:	Klimek L; Center for Rhinology and Allergology, Wiesbaden., Förster-Ruhrmann U; HNO-University Clinic Charité, Berlin., Olze H; HNO-University Clinic Charité, Berlin., Beule AG; Clinic for Otorhinolaryngology, Münster University Hospital.; Clinic for Otorhinolaryngology, Head and Neck Surgery at Greifswald University Medical Center., Chaker AM; Department of Otolaryngology - Head and Neck Surgery, Klinikum rechts der Isar, Technical University of Munich, Munich.; Center of Allergy and Environment (ZAUM) of the Technical University of Munich., Hagemann J; Clinic and Polyclinic for Otolaryngology, University Medical Center Mainz, Mainz., Huppertz T; Clinic and Polyclinic for Otolaryngology, University Medical Center Mainz, Mainz., Hoffmann TK; Department of Otorhinolaryngology, Head and Neck Surgery, University of Ulm, Ulm., Dazert S; Clinic for Otorhinolaryngology, Head and Neck Surgery, Ruhr University Bochum, St. Elisabeth Hospital., Deitmer T; German Society for Otorhinolaryngology, Head and Neck Surgery, Bonn., Strieth S; Clinic and Polyclinic for Otorhinolaryngology, University Hospital Bonn., Wrede H; Ear, nose and throat specialist, Herford., Schlenter WW; Medical Association of German Allergists, Wiesbaden., Welkoborsky HJ; Clinic for Ear, Nose and Throat Medicine, Head and Neck Surgery, Nordstadt Clinic of the KRH, Hannover., Wollenberg B; Department of Otolaryngology - Head and Neck Surgery, Klinikum rechts der Isar, Technical University of Munich, Munich., Becker S; HNO-University Clinic Tübingen., Bärhold F; HNO-University Clinic Tübingen., Klimek F; Center for Rhinology and Allergology, Wiesbaden., Casper I; Center for Rhinology and Allergology, Wiesbaden., Zuberbier J; HNO-University Clinic Charité, Berlin., Rudack C; Clinic for Otorhinolaryngology, Münster University Hospital., Cuevas M; Clinic and Polyclinic for Otolaryngology, University Hospital Carl Gustav Carus, TU Dresden, Dresden., Hintschich CA; Clinic and Polyclinic for Ear, Nose and Throat Medicine, University Hospital Regensburg, Regensburg., Guntinas-Lichius O; Clinic for Otorhinolaryngology, Jena University Hospital., Stöver T; Otorhinolaryngology University Clinic Frankfurt am Main., Bergmann C; HNO RKM740 Interdisciplinary Specialist Clinic, Düsseldorf, Germany., Werminghaus P; Praxis für Hals-, Nasen-, Ohrenheilkunde und Allergologie, Düsseldorf., Pfaar O; Clinic for Ear, Nose and Throat Medicine, University Hospital Giessen and Marburg GmbH, Marburg site, Philipps University Marburg, Marburg., Gosepath J; Clinic for Otorhinolaryngology, HSK Wiesbaden., Gröger M; Clinic and Polyclinic for Otorhinolaryngology, University Hospital LMU Munich., Beutner C; Department of Dermatology, Venereology and Allergology, University Medical Center Göttingen, Germany Klinik für Dermatologie, Venerologie und Allergologie, Universitätsmedizin Göttingen., Laudien M; Department of Otorhinolaryngology, Head and Neck Surgery, Kiel University, University Medical Centre Schleswig-Holstein, Kiel., Weber RK; Clinic for Otorhinolaryngology, Karlsruhe Municipal Hospital., Hildebrand T; Department of Ear, Nose and Throat Medicine, Freiburg University Medical Center., Hoffmann AS; Clinic for Ear, Nose and Throat Medicine, University Medical Center Hamburg-Eppendorf., Bachert C; Upper Airways Research Laboratory and Department of Oto-Rhino-Laryngology, Ghent University and Ghent, University Hospital, Ghent, Belgium.
Jazyk:	angličtina
Zdroj:	Allergologie select [Allergol Select] 2024 Mar 21; Vol. 8, pp. 26-39. Date of Electronic Publication: 2024 Mar 21 (Print Publication: 2024).
DOI:	10.5414/ALX02460E
Abstrakt:	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. Competing Interests: B. Wollenberg has received honoraria and/or research funding from MSD, Sanofi, AstraZeneca, Novartis, BMS Adboard outside the present work. J. Hagemann states that he has received payments for lectures and fees for advisory boards from the companies Sanofi Aventis, Novartis Pharma GmbH, and GlaxoSmithKline. A.M. Chaker provides consulting services (e.g., Advisory Boards, DSMBs), lectures, or other activities via the Technical University of Munich (TUM) or has conducted clinical studies or received research funding via TUM from: Allergopharma, ALK-Abello, AstraZenecaa, Bencard/Allergen Therapeutics, GSK, HAL Allergy, Immunotek, Novartis, SanofiGenzyme and Regeneron, Zeller AG, EIT Health, BMBF. AMC is also an officer of EUFOREA, EAACI, AeDA, and DGAKI. H. Olze has received honoraria and/or research funding from F. Hoffmann-La Roche Ltd., Sanofi-Aventis Deutschland GmbH, AstraZeneca GmbH, GlaxoSmithKline GmbH & Co KG, and Novartis Pharma GmbH. L. Klimek reports grants and/or honoraria from Allergopharma, MEDA/Mylan, HAL Allergie, ALK Abelló, LETI Pharma, Stallergenes, Quintiles, Sanofi, ASIT Biotech, Lofarma, Allergy Therapeut., AstraZeneca, GSK, Inmunotk, outside the submitted work; and membership in the following organizations: AeDA, DGHNO, German Academy for Allergology and Clinical Immunology, HNO-BV GPA, EAACI. U. Förster-Ruhrmann received honoraria for lectures from Novartis, AstraZeneca, Sanofi. and GSK outside the present work. S. Strieth reports grants from the German Research Foundation (DFG), Bonn, grants from the Head and Neck Tumor Research Foundation, Wiesbaden, grants and non-financial support from MED-EL AG, Innsbruck, personal fees from Auris Medical, Basel, personal fees from Merck Serono, Darmstadt, personal fees from Otonomy, Inc, San Diego (USA), personal fee Nordmark Arzneimittel, Uetersen, grant Andreas Fahl Medizintechnik-Vertrieb, Cologne, grant Atos Medical, Troisdorf, grant Tracoe Medical, Nieder-Olm, grants from Heimomed Heinze, Kerpen, grants from Bromepithetik, Heidelberg, grants from Fresenius Kabi, Bad Hersfeld, personnel fee from Sonofi Genzyme, Berlin, personal fee from ALK-Abelló Arzneimittel, Hamburg, outside the submitted work. M. Cuevas has received honoraria and/or non-financial support from Novartis, Sanovi-Aventis, Allergopharma, HAL Allergy, Leti Pharma, AstraZeneca, GlaxoSmithKline, ALK Abelló, Bencard Allergy, Stallergenes, and Roxall outside the submitted work and reports memberships with the following organizations: AeDA, DGHNO. A.G. Beule has received honoraria for lectures, consulting, or research activities from Allakos, AstraZenecaa, BMS, GSK, Medtronic, MSD, Novartis, Olympus, Pharmalog, Pohl Boskamp, and Sanofi Aventis outside the present work. O. Guntinas-Lichius has received honoraria from MED-EL, Merck, Novartis, MEDICE, and Merz outside the present work; and he is a member of the following organizations: DGHNO, BVHNO. T.K. Hoffmann participates in honorary advisory boards of the companies Merck, MSD, and BMS, but outside the scope of this work. C. Bachert received honoraria/research funding from the companies Sanofi, GSK, Novartis, Astra Zeneca, and ALK outside the present work. H. Wrede reports lecture fees from Allergopharma, MEDA/Mylan, HAL Allergie, LETI Pharma, Stallergenes, Sanofi, Lofarma, Allergy Therapeut., GSK outside the submitted work; and membership of the following organizations: AeDA, HNO-BV. T. Stöver has received research and study funding as well as fees for lectures and/or consultancy work from MED-EL Elektromedizinische Geräte Deutschland GmbH and Cochlear Deutschland GmbH & Co. KG outside the submitted work. He is a member of the DGHNO-KHC, the expert committee on medical devices and in-vitro diagnostics on behalf of the EU, the advisory board of the Hörzentrum Oldenburg GmbH, the task force ‘Living Practice Guidelines’, the advisory board of the Lower Saxony Center for Biomathematics, as chairman of the advisory board of the Friedberg Foundation for Hearing and Speech Promotion and as co-editor of the journal Laryngo-Rhino-Otology. C. Beutner on fees from GSK, Sanofi and Novartis, ALK Abello outside the present work. M. Laudien supported and received support, lecture, and consulting fees in the last 5 years from: Olympus Deutschland GmbH, Olympus Europa SE & CO. KG, Novartis Pharma GmbH, Sanofi-Aventis Deutschland GmbH, Brainlab Sales GmbH, GlaxoSmithKline GmbH & Co KG and the John Grube Foundation outside the present work. M. Gröger reports grants and lecture fees from Sanofi, Novartis, AstraZeneca, and GSK outside the submitted work. C. Bergmann reports on grants and fees from GlaxoSmithKline (GSK), Sanofi Aventis, Bencard Allergy GmbH/Allergy Therapeutics, HAL Allergie GmbH/HAL Allergy Holding BV outside the present work. O. Pfaar receives honoraria and/or study funding from ALK-Abelló, Altamira, Allergopharma, Stallergenes Greer, HAL Allergy Holding B.V./HAL Allergie, AAAAI, Bencard Allergy/Allergy Therapeutics, Lofarma, Biomay, Circassia, ASIT Biotech Tools S.A., Danish Consultation, Laboratorios LETI/LETI Pharma, MEDA Pharma/MYLAN, Anergis S.A., Mobile Chamber Experts, Indoor Biotechnologies, GlaxoSmithKline, Astellas Pharma Global, EUFOREA, ROXALL, Novartis, Sanofi-Aventis and Sanofi-Genzyme, Med Update Europe, streamedup!, Pohl-Boskamp, Inmunotek S.L., Wiley and Sons, Paul Martini Foundation, Regeneron Pharmaceuticals Inc, RG Aerztefortbildung, Firma Meinhardt, PneumoLIVE, Institut für Disease Management, Deutsche Forschungsgesellschaft, Springer, Thieme, AstraZeneca, Deutsche Allergie-Liga, AeDA, IQVIA Commercial, Ingress Health, Wort&Bild Verlag, Verlag ME, Procter&Gamble, Alfried-Krupp Krankenhaus, all outside the present work; and he is a member of the board/excom of the EAACI and a member of the extended board of the DGAKI. He is also the main author or co-author of various guidelines and position papers in allergology and rhinology. A.S. Hoffmann has received honoraria from GSK, Sanofi, and Novartis for lectures and advisory boards outside this work. T. Hildenbrand reports on lecture fees from AstraZeneca and Novartis outside the present work. R. Weber has received fees for lecturing and consulting activities from GSK, Infectopharm, KARL STORZ SE & Co KG, NMP, Sanofi, Sidroga-Pharma, and Stryker. W. Schlenter, S. Becker, F. Bärhold, T. Deitmer, H.J. Welkoborsky, S. Dazert, T. Huppertz, C.A. Hintschich, J. Zuberbier, C. Rudack, J. Gosepath, P. Werminghaus, F. Klimek and I. Casper have no conflicts of interest in connection with the present work. Figure 1Documentation form for the German healthcare system. Table 1.Objectifiable parameters for a response to mepolizumab therapy after 6 months (at least 1 parameter should be fulfilled) (modified from [6]). Nasal obstruction: improvement of the nasal congestion score (0 – 3) by > 0.5 or improvement of objective tests (e.g., increase in nasal inspiratory peak flow or nasal volume flow in active anterior rhinomanometry by > 20 L/min, reduction in resistance)Nasal polyp score (NPS): Reduction of the endoscopically determined NPS (0 – 8) by > 1 score point compared to the initial valueSNOT-22/quality of life: reduction in SNOT-22 score (0 – 110) by > 8.9 (validated minimum clinically relevant difference)Symptomatology in visual analog scale (VAS): reduction in total VAS symptoms (0 – 10 score points) by > 2Smelling ability: improvement in the 16-point Sniffin‘ Sticks identification test by > 3 points (validated minimum clinically relevant difference) Table 2.Objectifiable parameters for an evaluation of long-term mepolizumab therapy (> 12 months) (modified from [6]). All symptoms are only moderately pronounced or at least improved compared to the status before the start of therapyTotal nasal polyp score < 4 (added on both sides)Nasal congestion score < 2 (the nasal passage allows almost normal breathing at rest)Visual analog scale total symptoms < 5SNOT-22 value < 30Chronic rhinosinusitis with nasal polys (CRSwNP) should not currently require the administration of systemic glucocorticosteroids or surgery for CRSwNP (except surgery to remove mechanical obstructions such as synechiae, mucoceles, etc.). (© Dustri-Verlag Dr. K. Feistle.)
Databáze:	MEDLINE
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