Biologics in severe uncontrolled chronic rhinosinusitis with nasal polyps: A bicentric experience

Biologics in severe uncontrolled chronic rhinosinusitis with nasal polyps: A bicentric experience

Authors

  • Gianluca Bellocchi Department of Otolaryngology, San Camillo Forlanini Hospital, Rome, Italy https://orcid.org/0000-0001-5341-3309
  • Antonella Loperfido Department of Otolaryngology, San Camillo Forlanini Hospital, Rome, Italy https://orcid.org/0000-0002-7174-8126
  • Francesco Maria Passali Department of Clinical Sciences and Translational Medicine, Otorhinolaryngology Unit, Tor Vergata University of Rome, Italy. https://orcid.org/0000-0003-4032-8230
  • Stefano Millarelli Department of Otolaryngology, San Camillo Forlanini Hospital, Rome, Italy
  • Gianluca Velletrani Department of Clinical Sciences and Translational Medicine, Otorhinolaryngology Unit, Tor Vergata University of Rome, Italy. https://orcid.org/0000-0002-0822-6587
  • Marco Perla Department of Clinical Sciences and Translational Medicine, Otorhinolaryngology Unit, Tor Vergata University of Rome, Italy.
  • Loreta Di Michele Department of Pulmonary Interstitial Diseases, San Camillo Forlanini Hospital, Rome, Italy https://orcid.org/0000-0002-1907-5470
  • Stefano Di Girolamo Department of Clinical Sciences and Translational Medicine, Otorhinolaryngology Unit, Tor Vergata University of Rome, Italy. https://orcid.org/0000-0002-6419-9704

Keywords:

Chronic rhinosinusitis with nasal polyps, Type 2 inflammation, Quality of life, Biologics, Dupilumab

Abstract

Background and aim: The introduction of biologics in the management of chronic rhinosinusitis with nasal polyposis (CRSwNP) has allowed new therapeutic options and Dupilumab represents the first approved biological agent. Aim of this paper is to provide a multicentric study in a real-life setting of treatment with Dupilumab for severe uncontrolled CRSwNP in Italy.

Methods: A retrospective data collection was performed from the departments of Otolaryngology of two major health institutions in Rome: San Camillo Forlanini Hospital and Tor Vergata University. Both centres contributed to the study providing information about patients affected by severe uncontrolled CRSwNP and treated with Dupilumab.

Results: A total of 83 patients were included in the study (43 males; 40 females; mean age: 55.8 years). Monitoring our patients, we observed improvement in reduction of nasal polyposis and nasal obstruction, respectively measured through NPS and PNIF. Concerning the CRSwNP symptoms and their impact on quality of life, we found an improvement in the olfaction, as measured respectively by SSIT-16 and SNOT-22.

Conclusions: Dupilumab has demonstrated broad efficacy in CRSwNP management. Further studies are needed to confirm our results and to establish biomarkers to identify endotypes and predict response to biologics treatment in CRSwNP.

References

La Mantia I, Ciprandi G, Varricchio A, Ragusa M, Cipolla F, Andaloro C. When rhinosinusitis is not just rhinosinusitis: Clinical characteristics and phenotypes of patients with type 2 chronic rhinosinusitis with nasal polyps. Acta Biomed. 2022;93(4):e2022240. doi: 10.23750/abm.v93i4.12561.

Ciprandi G, Passali D, Bellussi LM, Passali FM. Rhinosinusitis: clinical-based phenotyping. Acta Biomed. 2022;93(5):e2022211. doi: 10.23750/abm.v93i5.12633.

Wang M, Bu X, Luan G, et al. Distinct type 2-high inflammation associated molecular signatures of chronic rhinosinusitis with nasal polyps with comorbid asthma. Clin Transl Allergy. 2020;3:10-26. doi: 10.1186/s13601-020-00332-z.

Passali D, Damiani V, Passali GC, Cassano P, Piemonte M, Ciprandi G. The impact of rhinosinusitis in clinical practice: an Italian Survey. Acta Biomed. 2020;91(1-S):28-35. doi: 10.23750/abm.v91i1-S.9247.

Busse WW, Maspero JF, Lu Y, et al. Efficacy of dupilumab on clinical outcomes in patients with asthma and perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2020;125:565-576. doi: 10.1016/j.anai.2020.05.026.

Passali D, Bellussi LM, Damiani V, Tosca MA, Motta G, Ciprandi G. Chronic rhinosinusitis with nasal polyposis: the role of personalized and integrated medicine. Acta Biomed. 2020;91(1-S):11-18. doi: 10.23750/abm.v91i1-S.9243.

Senna G, Micheletto C, Piacentini G, et al. Multidisciplinary management of type 2 inflammatory diseases. Multidiscip Respir Med. 2022;17:813. doi: 10.4081/mrm.2022.813.

De Corso E, Bellocchi G, De Benedetto M, 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;42:1-16. doi: 10.14639/0392-100X-N1614.

Fokkens WJ, Lund VJ, Hopkins C, et al. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020;58:1-464. doi: 10.4193/Rhin20.600.

Fokkens WJ, Viskens AS, Backer V, et al. EPOS/EUFOREA update on indication and evaluation of Biologics in Chronic Rhinosinusitis with Nasal Polyps 2023. Rhinology. 2023. doi: 10.4193/Rhin22.489.

https://www.gazzettaufficiale.it/atto/serie_generale/caricaArticolo?art.versione=1&art.idGruppo=0&art.flagTipoArticolo=1&art.codiceRedazionale=22A05434&art.idArticolo=1&art.idSottoArticolo=1&art.idSottoArticolo1=10&art.dataPubblicazioneGazzetta=2022-09-30&art.progressivo=0 Accessed May 13th 2023.

Meltzer EO, Hamilos DL, Hadley JA, et al. Rhinosinusitis initiative. rhinosinusitis: developing guidance for clinical trials. J Allergy Clin Immunol. 2006;118:S17-61. doi: 10.1016/j.jaci.2006.09.005.

Lourijsen ES, de Borgie CA, Vleming M, et al. Endoscopic sinus surgery in adult patients with chronic rhinosinusitis with nasal polyps (PolypESS): study protocol for a randomised controlled trial. Trials. 2017;18:39. doi: 10.1186/s13063-016-1728-z.

Gallo S, Russo F, Mozzanica F, et al. Prognostic value of the Sinonasal Outcome Test 22 (SNOT-22) in chronic rhinosinusitis. Acta Otorhinolaryngol Ital. 2020;40:113-121. doi: 10.14639/0392-100X-N0364.

Hummel T, Whitcroft KL, Andrews P, et al. Position paper on olfactory dysfunction. Rhinology. 2016;56:1-30. doi: 10.4193/Rhino16.248.

Scadding G, Hellings P, Alobid I, et al. Diagnostic tools in Rhinology EAACI position paper. Clin Transl Allergy. 2011;1:2. doi: 10.1186/2045-7022-1-2.

Vinciguerra A, Rampi A, Yacoub MR, et al. Hypereosinophilia management in patients with type 2 chronic rhinosinusitis treated with dupilumab: preliminary results. Eur Arch Otorhinolaryngol. 2022;279:5231-5238. doi: 10.1007/s00405-022-07389-5.

Benjamin MR, Stevens WW, Li N, et al. Clinical characteristics of patients with chronic rhinosinusitis without nasal polyps in an academic setting. J Allergy Clin Immunol Pract. 2019;7:1010-1016. doi: 10.1016/j.jaip.2018.10.014.

Håkansson K, Bachert C, Konge L, et al. Airway inflammation in chronic rhinosinusitis with nasal polyps and asthma: the united airways concept further supported. PLoS One. 2015;10:e0127228. doi: 10.1371/journal.pone.0127228.

Mullol J, Maldonado M, Castillo JA, et al. Management of united airway disease focused on patients with asthma and chronic rhinosinusitis with nasal polyps: a systematic review. J Allergy Clin Immunol Pract. 2022;10:2438-2447.e9. doi: 10.1016/j.jaip.2022.04.039.

DelGaudio JM, Loftus PA, Hamizan AW et al. Central compartment atopic disease. American J of Rhinology & Allergy. 2017;31:228-234. doi: 10.2500/ajra.2017.31.4443.

Cantone E, Gallo S, Torretta S, et al. the role of allergen-specific immunotherapy in ent diseases: a systematic review. J Pers Med. 2022;12:946. doi: 10.3390/jpm12060946.

Seccia V, D'Amato M, Scioscia G, et al. Management of patients with severe asthma and chronic rhinosinusitis with nasal polyps: a multidisciplinary shared approach. J Pers Med. 2022;12:1096. doi: 10.3390/jpm12071096.

Hellings PW, Akdis CA, Bachert C, et al. EUFOREA Rhinology Research Forum 2016: report of the brainstorming sessions on needs and priorities in rhinitis and rhinosinusitis. Rhinology. 2017;55:202-210. doi: 10.4193/Rhin17.028.

Millarelli S, Loperfido A, Mammarella F, et al. A practical clinical protocol for monitoring patients with severe uncontrolled chronic rhinosinusitis with nasal polyposis treated with biologics. Allergy Rhinol (Providence). 2022;13:21526567221074335. doi: 10.1177/21526567221074335.

Santomasi C, Buonamico E, Dragonieri S, et al. Effects of benralizumab in a population of patients affected by severe eosinophilic asthma and chronic rhinosinusitis with nasal polyps: a real life study. Acta Biomed. 2023;94(1):e2023028. doi: 10.23750/abm.v94i1.13474.

De Corso E, Settimi S, Montuori C, et al. Effectiveness of dupilumab in the treatment of patients with severe uncontrolled CRSwNP: a "real-life" observational study in the first year of treatment. J Clin Med. 2022;11:2684. doi: 10.3390/jcm11102684.

Ottaviano G, Saccardo T, Roccuzzo G, et al. Effectiveness of dupilumab in the treatment of patients with uncontrolled severe CRSwNP: a "real-life" observational study in naïve and post-surgical patients. J Pers Med. 2022;12:1526. doi: 10.3390/jpm12091526.

van der Lans RJL, Fokkens WJ, Adriaensen GFJPM, et al. Real-life observational cohort verifies high efficacy of dupilumab for chronic rhinosinusitis with nasal polyps. Allergy. 2022;77:670-674. doi: 10.1111/all.15134.

Millarelli S, Loperfido A, Giorgione C, et al. Biologics in the management of chronic rhinosinusitis with nasal polyposis: a real-life experience. Otorhinolaryngology. 2023;73:1-7. doi: 10.23736/S2724-6302.22.02454-9.

Fokkens W, Van Der Lans R, Reitsma S. Dupilumab for the treatment of chronic rhinosinusitis with nasal polyposis. Expert Opin Biol Ther. 2021;21:575-585. doi: 10.1080/14712598.2021.1901881.

Popiela MZ, Barbara R, Turnbull AMJ, et al. Dupilumab-associated ocular surface disease: presentation, management and long-term sequelae. Eye. 2021; 35:3277–3284. doi: 10.1038/s41433-020-01379-9.

Maudinet A, Law-Koune S, Duretz C, et al. Ocular surface diseases induced by dupilumab in severe atopic dermatitis. Ophthalmol Ther. 2019;8:485-490. doi: 10.1007/s40123-019-0191-9.

Wechsler ME, Klion AD, Paggiaro P, et al. Effect of dupilumab on blood eosinophil counts in patients with asthma, chronic rhinosinusitis with nasal polyps, atopic dermatitis, or eosinophilic esophagitis. J Allergy Clin Immunol Pract. 2022;10:2695-2709. doi: 10.1016/j.jaip.2022.05.019.

De Corso E, Pasquini E, Trimarchi M, et al. Dupilumab in the treatment of severe uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP): a multicentric observational phase IV real-life study (DUPIREAL). Allergy. 2023. doi: 10.1111/all.15772.

Domínguez-Sosa MS, Cabrera-Ramírez MS, Marrero-Ramos MDC, et al. Real-Life Effectiveness of Mepolizumab in Refractory Chronic Rhinosinusitis with Nasal Polyps. Biomedicines. 2023;11:485. doi: 10.3390/biomedicines11020485.

Gallo S, Castelnuovo P, Spirito L, et al. Mepolizumab improves outcomes of chronic rhinosinusitis with nasal polyps in severe asthmatic patients: a multicentric real-life study. J Pers Med. 2022;12:1304. doi: 10.3390/jpm12081304.

Santomasi C, Buonamico E, Dragonieri S, et al. Effects of benralizumab in a population of patients affected by severe eosinophilic asthma and chronic rhinosinusitis with nasal polyps: a real life study. Acta Biomed. 2023;94:e2023028. doi: 10.23750/abm.v94i1.13474.

Cavaliere C, Segatto M, Ciofalo A, et al. Benralizumab reduces eosinophils and inflammatory markers in patients with severe eosinophilic asthma and chronic rhinosinusitis with nasal polyps: a pilot real-life study. Immunol Lett. 2022;248:70-77. doi: 10.1016/j.imlet.2022.06.009.

Morse JC, Miller C, Senior B. Management of chronic rhinosinusitis with nasal polyposis in the era of biologics. J Asthma Allergy. 2021;14:873-882. doi: 10.2147/JAA.S258438.

Downloads

Published

17-10-2023

Issue

Section

ORIGINAL CLINICAL RESEARCH

How to Cite

1.
Bellocchi G, Loperfido A, Passali FM, et al. Biologics in severe uncontrolled chronic rhinosinusitis with nasal polyps: A bicentric experience. Acta Biomed. 2023;94(5):e2023227. doi:10.23750/abm.v94i5.14745