Evaluation of ongoing mepolizumab treatment in chronic rhinosinusitis with nasal polyps
Ludger Klimek , Ulrike Förster-Ruhrmann , Heidi Olze , Achim G. Beule , Adam M. Chaker , Jan Hagemann , Tilmann Huppertz , Thomas K. Hoffmann , Stefan Dazert , Thomas Deitmer , Sebastian Strieth , Holger Wrede , Wolfgang Schlenter , Hans-Jürgen Welkoborsky , Barbara Wollenberg , Sven Becker , Frederike 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 Hildenbrand , Anna-Sophie Hoffmann , Claus Bachert
Exploration of Asthma & Allergy ›› 2024, Vol. 2 ›› Issue (1) : 33 -48.
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a multifactorial inflammatory disease of the mucous membranes of the nose and paranasal sinuses. Eosinophilic inflammation is described as a common endotype. The anti-interleukin-5 (IL-5) antibody mepolizumab was approved in November 2021 as an add-on therapy to intranasal glucocorticosteroids for the treatment of adults with severe CRSwNP when systemic glucocorticosteroids or surgery do not provide adequate disease control. While national and international recommendations exist for the use of mepolizumab in CRSwNP, therapy monitoring and follow-up documentation are required, and therapy discontinuation has not been adequately established yet. In this paper, recommendations for monitoring the course and efficacy of therapy as well as for reviewing the duration and possible termination of therapy are provided. For this purpose, 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, and the national and international trial and guideline registries and the Cochrane Library. Human studies published in the period up to and including October 2022 were considered. Based on the international literature and previous experience, recommendations for follow-up, adherence to therapy intervals and possible therapy breaks, as well as termination of therapy when using mepolizumab for the indication CRSwNP in the German health care system are given by an expert panel on the basis of a documentation sheet.
Chronic rhinosinusitis / chronic rhinosinusitis with nasal polyps / biologics / eosinophilic inflammation / mepolizumab
| [1] |
|
| [2] |
|
| [3] |
|
| [4] |
|
| [5] |
|
| [6] |
|
| [7] |
|
| [8] |
|
| [9] |
|
| [10] |
|
| [11] |
|
| [12] |
|
| [13] |
|
| [14] |
|
| [15] |
|
| [16] |
|
| [17] |
|
| [18] |
|
| [19] |
|
| [20] |
|
| [21] |
|
| [22] |
|
| [23] |
|
| [24] |
|
| [25] |
|
| [26] |
|
| [27] |
|
| [28] |
|
| [29] |
|
| [30] |
|
| [31] |
|
| [32] |
|
| [33] |
|
| [34] |
|
| [35] |
|
| [36] |
|
| [37] |
|
| [38] |
|
| [39] |
|
| [40] |
|
| [41] |
|
| [42] |
|
| [43] |
|
| [44] |
|
| [45] |
|
| [46] |
|
| [47] |
|
| [48] |
|
| [49] |
|
| [50] |
Highlights of prescribing information [Internet]. GlaxoSmithKline; [cited 2022 Mar 11]. Available from: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Nucala/pdf/NUCALA—PI—PIL—IFU—COMBINED.PDF |
| [51] |
Annex I: summary of product characteristics [Internet]. GlaxoSmithKline; [cited 2022 Mar 11]. Available from: https://www.ema.europa.eu/en/documents/product—information/nucala—epar—product—information_en.pdf |
| [52] |
Effect of mepolizumab in severe bilateral nasal polyps [Internet]. GlaxoSmithKline; [cited 2022 Mar 11]. Available from: https://clinicaltrials.gov/ct2/show/NCT03085797 |
| [53] |
|
| [54] |
|
| [55] |
|
| [56] |
|
| [57] |
|
| [58] |
|
| [59] |
|
| [60] |
|
| [61] |
Highlights of prescribing information [Internet]. GlaxoSmithKline; [cited 2022 Nov 24]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761122s006,125526s018lbl.pdf |
| [62] |
Nucala — gebrauchsinformation für anwender — 100 mg injektionslösung im fertigpen [Internet]. GlaxoSmithKline; [cited 2022 Nov 24]. Available from: https://gskpro.com/content/dam/global/hcpportal/de_DE/produktinformationen/nucala/GI_Nucala_Fertigpen_102022.pdf |
| [63] |
|
| [64] |
Fachinformation: nucala 100 mg injektionslösung im fertigpen/in einer fertigspritze; nucala 40 mg injektionslösung in einer fertigspritze [Internet]. GlaxoSmithKline; [cited 2022 Nov 24]. Available from: https://gskpro.com/content/dam/global/hcpportal/de_DE/produktinformationen/nucala/FI_Nucala_Injektionsl%C3%B6sung_im_Fertigpen_in_einer_Fertigspritze_100%20mg_40%20mg_102022.pdf |
| [65] |
|
| [66] |
|
| [67] |
|
| [68] |
|
| [69] |
|
| [70] |
Tragende gründe: zum beschlussdes Gemeinsamen Bundesausschusses über eine änderung der arzneimittel—richtlinie: anlage XII — nutzenbewertung von arzneimitteln mit neuen wirkstoffen nach § 35a des fünften buches sozialgesetzbuch (SGB V) mepolizumab (neues anwendungsgebiet: chronische rhinosinusitis mit nasenpolypen) [Internet]. Berlin: Gemeinsamen Bundesausschusses; [cited 2022 My 19]. Available from: https://www.g—ba.de/downloads/40—268—8516/2022—05—19_AM—RL—XII_Mepolizumab_D—746_TrG.pdf |
| [71] |
|
| [72] |
|
| [73] |
|
| [74] |
|
| [75] |
|
| [76] |
|
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|
〉 |