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12.03.2024 | Review

Multidisciplinary Decision-Making—ITAlian Consensus After Two Years of Real Practice on the Management of Severe Uncontrolled CRSwNP by Biologics (ITACA Study)

verfasst von: Eugenio De Corso, Carlotta Pipolo, Marco Caminati, Elena Cantone, Veronica Seccia, Lorenzo Cecchi, Eustachio Nettis, Massimiliano Garzaro, Giancarlo Ottaviano, Matteo Gelardi, Carlo Cavaliere, Enrico Heffler, Fabio Pagella, Ernesto Pasquini, Matteo Trimarchi, Stefania Gallo, Ignazio La Mantia, Sara Torretta, Davide Mattavelli, Cristiano Caruso, Andrea Matucci, Alessandra Vultaggio, Gianluca Bellocchi, Matteo Alicandri Ciufelli, Passali FM, Gianenrico Senna

Erschienen in: Current Allergy and Asthma Reports | Ausgabe 3/2024

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Abstract

Purpose of Review

We aimed to reach an Italian multidisciplinary consensus on some crucial aspects of treatment decision making in CRSwNP, following 2 years of clinical experience in order to support specialists in the management of CRSwNP in clinical practice. We addressed issues relating to therapeutic decision-making and shared criteria for the treatment choice, as well as appropriate timing and criteria for evaluating treatment response, and highlighted the need for repeated multidisciplinary assessments.

Recent Findings

A national survey has been conducted recently to understand how rhinology practice has changed in Italy with the advent of biologics and how this affects patients with uncontrolled, severe CRSwNP. Despite the many published consensus documents, practical recommendations, and protocols on the use of biologics in CRSwNP, heterogenous behaviors in practice are still observed mainly conditioned by the novelty of the topic.

Summary

The consensus procedure followed a modified Delphi approach. The scientific board included 18 otorhinolaryngologists and 8 allergists, who selected the 4 main topics to be addressed and developed overall 20 statements. Consensus on these statements was sought by a larger group of 48 additional experts, through two rounds of voting, the first web-based, the second in presence with discussion and possible refinement of the statements. The statements reaching an average score ≥ 7 at the second voting round were approved. Five statements were proposed for each of the following topics: baseline evaluation of patients eligible for biologic therapy; choice between different therapeutic options; assessment of the response to biologic treatment; multidisciplinary management. At the first voting round, 19 out of the 20 statements reached a mean score ≥ 7. Following the discussion and a few consequent amendments, at the second round of voting all the 20 statements were approved.

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Langdon C, Mullol J. Nasal polyps in patients with asthma: prevalence, impact, and management challenges. J Asthma Allergy. 2016;9:45–53. https://doi.org/10.2147/JAA.S86251.CrossRefPubMedPubMedCentral

Lin DC, Chandra RK, Tan BK, et al. Association between severity of asthma and degree of chronic rhinosinusitis. Am J Rhinol Allergy. 2011;25(4):205–8. https://doi.org/10.2500/ajra.2011.25.3613.CrossRefPubMed

Philpott CM, Erskine S, Hopkins C, et al. Prevalence of asthma, aspirin sensitivity and allergy in chronic rhinosinusitis: data from the UK National Chronic Rhinosinusitis Epidemiology Study. Respir Res. 2018;19(1):129. https://doi.org/10.1186/s12931-018-0823-y.CrossRefPubMedPubMedCentral

Wu D, Bleier BS, Li L, et al. Clinical phenotypes of nasal polyps and comorbid asthma based on cluster analysis of disease history. J Allergy Clin Immunol Pract. 2018;6(4):1297-305.e1. https://doi.org/10.1016/j.jaip.2017.09.020.CrossRefPubMed

•• Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, et al. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020;58:1–464. https://doi.org/10.4193/Rhin20.600. First international guideline which emphasizes the role of the endotype as an essential prerequisite for precision medicine, providing the essential foundation for the start of the use of biologics in normal clinical practice.CrossRefPubMed

Bachert C, Marple B, Schlosser RJ, Hopkins C, Schleimer RP, Lambrecht BN, et al. Adult chronic rhinosinusitis. Nat Rev Dis Primers. 2020;6(1):86. https://doi.org/10.1038/s41572-020-00218-1.CrossRefPubMed

Wallace DV. Treatment options for chronic rhinosinusitis with nasal polyps. Allergy Asthma Proc. 2021;42(6):450–60. https://doi.org/10.2500/aap.2021.42.210080.CrossRefPubMed

• De Corso E, Bellocchi G, De Benedetto M, Lombardo N, Macchi A, Malvezzi L, et al. Biologics for severe uncontrolled chronic rhinosinusitis with nasal polyps: a change management approach. Consensus of the Joint Committee of Italian Society of Otorhinolaryngology on biologics in rhinology. Acta Otorhinolaryngol Ital. 2022;42(1):1–16. https://doi.org/10.14639/0392-100X-N1614. First Italian position paper published after the approval of biologics in Italy in which the value of multidisciplinarity is greatly stressed.

De Corso E, Pipolo C, Cantone E, Ottaviano G, Gallo S, Canevari FRM, et al. Survey on Use of Local and Systemic Corticosteroids in the Management of Chronic Rhinosinusitis with Nasal Polyps: Identification of Unmet Clinical Needs. J Pers Med. 2022;12(6):897. https://doi.org/10.3390/jpm12060897.CrossRefPubMedPubMedCentral

10.

Bachert C, Han JK, Wagenmann M, et al. EUFOREA expert board meeting on uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics: definitions and management. J Allergy Clin Immunol. 2021;147(1):29–36.CrossRefPubMed

11.

• De Corso E, Ottaviano G, Pipolo C, Cantone E, Mattavelli D, Alicandri-Ciufelli M, et al. Chronic Rhinosinusitis with Nasal Polyps: A Survey on Routine Management and Evaluation of Disease Control in Practice. J Pers Med. 2023;13(11):1531. https://doi.org/10.3390/jpm13111531. Italian survey from which the need for a clinical definition of disease control in clinical practice and for specific tools to measure it clearly emerges.CrossRefPubMedPubMedCentral

12.

Tomassen P, Vandeplas G, Van Zele T, Cardell LO, Arebro J, Olze H, et al. Inflammatory endotypes of chronic rhinosinusitis based on cluster analysis of biomarkers. J Allergy Clin Immunol. 2016;137(5):1449-56.e4. https://doi.org/10.1016/j.jaci.2015.12.1324.CrossRefPubMed

13.

Bachert C, Zhang N, Hellings PW, Bousquet J. Endotype-driven care pathways in patients with chronic rhinosinusitis. J Allergy Clin Immunol. 2018;141(5):1543–51. https://doi.org/10.1016/j.jaci.2018.03.004.CrossRefPubMed

14.

De Greve G, Hellings PW, Fokkens WJ, Pugin B, Steelant B, Seys SF. Endotype-driven treatment in chronic upper airway diseases. Clin Transl Allergy. 2017;7:22. https://doi.org/10.1186/s13601-017-0157-8.CrossRefPubMedPubMedCentral

15.

Bachert C, Han JK, Desrosiers M, Hellings PW, Amin N, Lee SE, et al. Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials. Lancet. 2019;394:1638–50. https://doi.org/10.1016/S0140-6736(19)31881-1.CrossRefPubMed

16.

van der Lans RJL, Fokkens WJ, Adriaensen GFJPM, Hoven DR, Drubbel JJ, Reitsma S. Real-life observational cohort verifies high efficacy of dupilumab for chronic rhinosinusitis with nasal polyps. Allergy 2022;77:670–4. https://doi.org/10.1111/all.15134.

17.

Gevaert P, Omachi TA, Corren J, Mullol J, Han J, Lee SE, et al. Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials. J Allergy Clin Immunol. 2020;146(3):595–605. https://doi.org/10.1016/j.jaci.2020.05.032.CrossRefPubMed

18.

Gevaert P, Saenz R, Corren J, Han JK, Mullol J, Lee SE, et al. Long-term efficacy and safety of omalizumab for nasal polyposis in an open-label extension study. J Allergy Clin Immunol. 2022;149(3):957-65.e3. https://doi.org/10.1016/j.jaci.2021.07.045.CrossRefPubMed

19.

Desrosiers M, Diamant Z, Castelnuovo P, Hellings PW, Han JK, Peters AT, et al. Sustained efficacy of mepolizumab in patients with severe chronic rhinosinusitis with nasal polyps: SYNAPSE 24-week treatment-free follow-up. Int Forum Allergy Rhinol. 2023;14(1):18–31. https://doi.org/10.1002/alr.23219.CrossRefPubMed

20.

Hopkins C, Han JK, Lund VJ, Bachert C, Fokkens WJ, Diamant Z, et al. Evaluating treatment response to mepolizumab in patients with severe CRSwNP. Rhinology. 2023;61(2):108–17. https://doi.org/10.4193/Rhin22.200.CrossRefPubMed

21.

• De Corso E, Pipolo C, Cantone E, Ottaviano G, Gallo S, Trimarchi M, et al. Practical recommendations for managing severe chronic rhinosinusitis with nasal polyps in the era of biologics. Acta Otorhinolaryngol Ital. 2023;43(5):324–40. https://doi.org/10.14639/0392-100X-N2422 . Italian position paper which highlights through a survey the needs that emerge from the daily use of biologics in normal clinical practice.

22.

•• Fokkens WJ, Lund V, Bachert C, Mullol J, Bjermer L, Bousquet J, et al. EUFOREA consensus on biologics for CRSwNP with or without asthma. Allergy. 2019;74:2312–9. https://doi.org/10.1111/all.13875. First paper in which the criteria for the indication of CRSwNPs to biological drugs are defined.CrossRefPubMed

23.

De Corso E, Bilò MB, Matucci A, Seccia V, Braido F, Gelardi M, et al. Personalized Management of Patients with Chronic Rhinosinusitis with Nasal Polyps in Clinical Practice: A Multidisciplinary Consensus Statement. J Pers Med. 2022;12(5):846. https://doi.org/10.3390/jpm12050846.CrossRefPubMedPubMedCentral

24.

Lombardi C, Asero R, Bagnasco D, Blasi F, Bonini M, Bussi M, et al. ARIA-ITALY multidisciplinary consensus on nasal polyposis and biological treatments. World Allergy Organ J. 2021;14: 100592. https://doi.org/10.1016/j.waojou.2021.100592.CrossRefPubMedPubMedCentral

25.

Hopkins C, McKenzie JL, Anari S, Carrie S, Ramakrishnan Y, Kara N, et al. British Rhinological Society consensus guidance on the use of biological therapies for chronic rhinosinusitis with nasal polyps. Clin Otolaryngol. 2021;46:1037–43. https://doi.org/10.1111/coa.13779.CrossRefPubMed

26.

•• Fokkens WJ, De Corso E, Backer V, Bernal-Sprekelsen M, Bjermer L, von Buchwald C, et al. EPOS2020/EUFOREA expert opinion on defining disease states and therapeutic goals in CRSwNP. Rhinology. 2024 Jan 13. https://doi.org/10.4193/Rhin23.415. Epub ahead of print. PMID: 38217529. Expert opinion including new definitions such as Control of disease and Remission.

27.

Thamboo A, Kilty S, Witterick I, Chan Y, Chin CJ, Janjua A, et al. Canadian Rhinology Working Group consensus statement: biologic therapies for chronic rhinosinusitis. Otolaryngol Head Neck Surg. 2021;50:15. https://doi.org/10.1186/s40463-021-00493-2.CrossRef

28.

Loblaw DA, Prestrud AA, Somerfield MR, Oliver TK, Brouwers MC, Nam RK, et al. American Society of Clinical Oncology Clinical Practice Guidelines: formal systematic review-based consensus methodology. J Clin Oncol. 2012;30(25):3136–40. https://doi.org/10.1200/JCO.2012.42.0489.CrossRefPubMed

29.

Humphrey-Murto S, Varpio L, Wood TJ, Gonsalves C, Ufholz LA, Mascioli K, et al. The Use of the Delphi and Other Consensus Group Methods in Medical Education Research: A Review. Acad Med. 2017;92(10):1491–8. https://doi.org/10.1097/ACM.0000000000001812.CrossRefPubMed

30.

•• Fokkens WJ, Viskens AS, Backer V, Conti D, De Corso E, Gevaert P, et al. EPOS/EUFOREA update on indication and evaluation of Biologics in Chronic Rhinosinusitis with Nasal Polyps 2023. Rhinology. 2023;61(3):194–202. https://doi.org/10.4193/Rhin22.489. Important update on indications for biologics and evaluation of success.CrossRefPubMed

31.

Khoury P, Akuthota P, Kwon N, Steinfeld J, Roufosse F. HES and EGPA: Two Sides of the Same Coin. Mayo Clin Proc. 2023;98(7):1054–70. https://doi.org/10.1016/j.mayocp.2023.02.013.CrossRefPubMed

32.

Cantone E, De Corso E, Ricciardiello F, Di Nola C, Grimaldi G, Allocca V, et al. Olfaction recovery following dupilumab is independent of nasal polyp reduction in CRSwNP. J Pers Med. 2022;12:1215. https://doi.org/10.2174/1570159X20666220420113513.CrossRefPubMedPubMedCentral

33.

Wu Q, Zhang Y, Kong W, Wang X, Yuan L, Zheng R, et al. Which Is the Best Biologic for Nasal Polyps: Dupilumab, Omalizumab, or Mepolizumab? A Network Meta-Analysis. Int Arch Allergy Immunol. 2022;183(3):279–88. https://doi.org/10.1159/000519228.CrossRefPubMed

34.

Shen Y, Ke X, Hong S, Yang Y. Adverse events for biologics in patients with CRSwNP: A meta-analysis. Clin Transl Allergy. 2022;12(6): e12169. https://doi.org/10.1002/clt2.12169.CrossRefPubMedPubMedCentral

35.

Reitsma S, Adriaensen G, Cornet ME, van Haastert RM, Raftopulos MH, Fokkens WJ. The Amsterdam Classification of Completeness of Endoscopic Sinus Surgery (ACCESS): a new CT-based scoring system grading the extent of surgery. Rhinology. 2020;58(6):538–43. https://doi.org/10.4193/Rhin20.165.CrossRefPubMed

36.

Loftus CA, Soler ZM, Desiato VM, Koochakzadeh S, Yoo F, Storck KA, et al. Factors impacting revision surgery in patients with chronic rhinosinusitis with nasal polyposis. Int Forum Allergy Rhinol. 2020;10(3):289–302. https://doi.org/10.1002/alr.22505.CrossRefPubMed

37.

•• Sedaghat AR, Caradonna DS, Chandra RK, Franzese C, Gray ST, Halderman AA, et al. Determinants of physician assessment of chronic rhinosinusitis disease control using EPOS 2020 criteria and the importance of incorporating patient perspectives of disease control. Int Forum Allergy Rhinol. 2023;13(11):2004–17. https://doi.org/10.1002/alr.23168. Important article where for the first time the importance of the patient's perception in the definition of disease control is underlined by Delphi method.CrossRefPubMed

38.

Busse WW, Melén E, Menzies-Gow AN. Holy Grail: the journey towards disease modification in asthma. Eur Respir Rev. 2022;31(163): 210183. https://doi.org/10.1183/16000617.0183-2021.CrossRefPubMedPubMedCentral

39.

•• Caminati M, De Corso E, Ottaviano G, Pipolo C, Schiappoli M, Seccia V, et al. Remission in Type 2 Inflammatory Diseases: Current Evidence, Unmet Needs, and Suggestions for Defining Remission in Chronic Rhinosinusitis with Nasal Polyps. Curr Allergy Asthma Rep. 2024;24(1):11–23. https://doi.org/10.1007/s11882-023-01118-6. Systematic review on the need to define remission in nasal polyposis starting from the definitions of other type 2 diseases.CrossRefPubMed

40.

Saydy N, Moubayed SP, Bussières M, Janjua A, Kilty S, Lavigne F, et al. What is the optimal outcome after endoscopic sinus surgery in the treatment of chronic rhinosinusitis? A consultation of Canadian experts. J Otolaryngol Head Neck Surg. 2021;50(1):36. https://doi.org/10.1186/s40463-021-00519-9.CrossRefPubMedPubMedCentral

41.

Chan Y, Thamboo AV, Han JK, Desrosiers M. Remission: does it already exist in chronic rhinosinusitis with nasal polyposis? J Otolaryngol Head Neck Surg. 2023;52(1):50. https://doi.org/10.1186/s40463-023-00657-2.CrossRefPubMedPubMedCentral

42.

De Corso E, Settimi S, Montuori C, Cantiani A, Corbò M, Di Bella GA, et al. How to manage recurrences after surgery in CRSwNP patients in the biologic era: a narrative review. Acta Otorhinolaryngol Ital. 2023;43(Suppl. 1):S3-S13. https://doi.org/10.14639/0392-100X-suppl.1-43-2023-01 .

43.

Jarvis D, Newson R, Lotvall J, Hastan D, Tomassen P, Keil T, et al. Asthma in adults and its association with chronic rhinosinusitis: The GA2LEN survey in Europe. Allergy. 2012;67:91–8. https://doi.org/10.1111/j.1398-9995.2011.02709.x.CrossRefPubMed

44.

Seccia V, D’Amato M, Scioscia G, Bagnasco D, Di Marco F, Fadda G, et al. Management of Patients with Severe Asthma and Chronic Rhinosinusitis with Nasal Polyps: A Multidisciplinary Shared Approach. J Pers Med. 2022;12(7):1096. https://doi.org/10.3390/jpm12071096.CrossRefPubMedPubMedCentral

45.

Laidlaw TM, Mullol J, Woessner KM, Amin N, Mannent LP. Chronic Rhinosinusitis with Nasal Polyps and Asthma. J Allergy Clin Immunol Pract. 2021;9(3):1133–41. https://doi.org/10.1016/j.jaip.2020.09.063.CrossRefPubMed

46.

Castro M, Corren J, Pavord ID, Maspero J, Wenzel S, Rabe KF, et al. Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma. N Engl J Med. 2018;378(26):2486–96. https://doi.org/10.1056/NEJMoa1804092.CrossRefPubMed

47.

Pavord ID, Hanania NA, Corren J. Controversies in allergy: choosing a biologic for patients with severe asthma. J Allergy Clin Immunol Pract. 2022;10(2):410–9. https://doi.org/10.1016/j.jaip.2021.12.014.CrossRefPubMed

48.

Otten J, van der Lans R, de Corso E, Dziadziulia K, Hilvering B, Weersink E, et al. Evaluation of switching or simultaneous use of biologic treatment in patients with severe chronic rhinosinusitis with nasal polyps and severe asthma. Considerations in clinical decision making. Expert Rev Clin Immunol. 2023;19(8):1041–9. https://doi.org/10.1080/1744666X.2023.2218617.

Titel: Multidisciplinary Decision-Making—ITAlian Consensus After Two Years of Real Practice on the Management of Severe Uncontrolled CRSwNP by Biologics (ITACA Study)
verfasst von: Eugenio De Corso
Carlotta Pipolo
Marco Caminati
Elena Cantone
Veronica Seccia
Lorenzo Cecchi
Eustachio Nettis
Massimiliano Garzaro
Giancarlo Ottaviano
Matteo Gelardi
Carlo Cavaliere
Enrico Heffler
Fabio Pagella
Ernesto Pasquini
Matteo Trimarchi
Stefania Gallo
Ignazio La Mantia
Sara Torretta
Davide Mattavelli
Cristiano Caruso
Andrea Matucci
Alessandra Vultaggio
Gianluca Bellocchi
Matteo Alicandri Ciufelli
Passali FM
Gianenrico Senna
Publikationsdatum: 12.03.2024
Verlag: Springer US
Erschienen in: Current Allergy and Asthma Reports / Ausgabe 3/2024
Print ISSN: 1529-7322
Elektronische ISSN: 1534-6315
DOI: https://doi.org/10.1007/s11882-024-01135-z

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Multidisciplinary Decision-Making—ITAlian Consensus After Two Years of Real Practice on the Management of Severe Uncontrolled CRSwNP by Biologics (ITACA Study)