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Effectiveness and rapidity on olfatory fuction recovery in CRS patients treated with Dupilumab: a real life prospective controlled study

  • Rhinology
  • Published:
European Archives of Oto-Rhino-Laryngology Aims and scope Submit manuscript

Abstract

Background

Recovery of olfactory function plays a prominent role in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). While rates and timing of such recovery vary, monoclonal antibodies might yield better results which we aimed at evaluating with this study.

Methodology

A prospective controlled study was conducted at our tertiary otolaryngological center from April 1, 2021, to October 1, 2022, in CRSwNP patients. We included an active group (n = 60 patients) performing dupilumab treatment and a control group (n = 60 patients) treated with intranasal and oral corticosteroids. Primary endpoints were changes in smell visual analogical scale (VAS) and SS-I (Sniffin' Sticks-identification) scores, and olfactory recovery rate. The secondary efficacy endpoints were nasal obstruction, rhinorrhea, headache, SNOT-22, and nasal congestion score (NCS).

Results

At 6 months, the active group demonstrated better outcomes than control in SS-I scores (10.23 ± 4.21 vs.3.68 ± 3.08; p < 0.001). No significant differences were found in blood eosinophil count, SNOT-22, and NPS (p > 0.05 for all). Olfactory function in the treatment arm improved in 86.66% (52/60 cases), with normal scores in 48.33% (29/60), while the control group reported a lower recovery rate (3/60; 5%), with no normal olfaction cases. Log-rank comparison for Kaplan–Meier functions was statistically significant (p < 0.001), but no differences were found in subanalysis in the active group based on blood eosinophil count at baseline, SNOT-22, and NPS scores.

Conclusions

Patients who receive dupilumab treatment may experience a faster recovery of olfactory function compared to those receiving corticosteroid therapy. This result would be maintained regardless of the severity of type 2 CRSwNP inflammation, the volume of the polyps, or the patient's subjective symptomatology.

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Data availability

The data that support the findings of this study are available from the corresponding author upon reasonable request.

References

  1. Fokkens WJ, Lund VJ, Hopkins C et al (2020) European position paper on rhinosinusitis and nasal polyps. Rhinology 58(29):1–464. https://doi.org/10.4193/Rhin20.600

    Article  PubMed  Google Scholar 

  2. Epperson MV, McCann AC, Phillips KM, Caradonna DS, Gray ST, Sedaghat AR (2021) Unbiased measure of general quality of life in chronic rhinosinusitis reveals disease modifiers. Laryngoscope 131(6):1206–1211. https://doi.org/10.1002/lary.29139

    Article  PubMed  Google Scholar 

  3. Banoub RG, Hoehle LP, Phillips KM et al (2018) Depressed mood modulates impact of chronic rhinosinusitis symptoms on quality of life. J Allergy Clin Immunol Pract 6(6):2098–2105. https://doi.org/10.1016/j.jaip.2018.04.034

    Article  PubMed  Google Scholar 

  4. Smith TL, Schlosser RJ, Soler ZM et al (2021) Olfactory cleft mucus inflammatory proteins in CRS: a case-control study. Int Forum Allergy Rhinol 11(9):1321–1335. https://doi.org/10.1002/alr.22770

    Article  PubMed  PubMed Central  Google Scholar 

  5. Soler ZM, Yoo F, Schlosser RJ et al (2020) Correlation of mucus inflammatory proteins and olfaction in chronic rhinosinusitis. Int Forum Allergy Rhinol 10(3):343–355. https://doi.org/10.1002/alr.22499

    Article  PubMed  Google Scholar 

  6. Migneault-Bouchard C, Hsieh JW, Hugentobler M, Frasnelli J, Landis BN (2020) Chemosensory decrease in different forms of olfactory dysfunction. J Neurol 267(1):138–143. https://doi.org/10.1007/s00415-019-09564-x

    Article  PubMed  CAS  Google Scholar 

  7. Ahmed OG, Rowan NR (2020) Olfactory dysfunction and chronic rhinosinusitis. Immunol Allergy Clin North Am 40(2):223–232. https://doi.org/10.1016/j.iac.2019.12.013

    Article  PubMed  Google Scholar 

  8. Thomas AJ, Mace JC, Ramakrishnan VR et al (2020) Quality-of-life and olfaction changes observed with short-term medical management of chronic rhinosinusitis. Int Forum Allergy Rhinol 10(5):656–664. https://doi.org/10.1002/alr.22532

    Article  PubMed  PubMed Central  Google Scholar 

  9. Mattos JL, Soler ZM, Schlosser RJ et al (2021) Olfactory function after surgical treatment of CRS: a comparison of CRS patients to healthy controls. Am J Rhinol Allergy 35(3):391–398. https://doi.org/10.1177/1945892420960671

    Article  PubMed  Google Scholar 

  10. De Corso E, Pipolo C, Cantone E et al (2022) 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 12(6):897. https://doi.org/10.3390/jpm120608972

    Article  PubMed  PubMed Central  Google Scholar 

  11. Mullol J, Bachert C, Amin N et al (2022) Olfactory outcomes with dupilumab in chronic rhinosinusitis with nasal polyps. J Allergy Clin Immunol Pract 10(4):1086-1095.e5. https://doi.org/10.1016/j.jaip.2021.09.037

    Article  PubMed  CAS  Google Scholar 

  12. Lee SE, Hopkins C, Mullol J et al (2022) dupilumab improves health related quality of life: results from the phase 3 SINUS studies. Allergy 77(7):2211–2221. https://doi.org/10.1111/all.15222

    Article  PubMed  CAS  Google Scholar 

  13. Bachert C, Han JK, Desrosiers M et al (2019) 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 394(10209):1638–1650. https://doi.org/10.1016/S0140-6736(19)31881-1

    Article  PubMed  CAS  Google Scholar 

  14. Boscke R, Heidemann M, Bruchhage KL (2023) Dupilumab for chronic rhinosinusitis with nasal polyps: real-life retrospective 12-month effectiveness data. Rhinology 61(3):203–213. https://doi.org/10.4193/Rhin22.469

    Article  PubMed  CAS  Google Scholar 

  15. De Corso E, Settimi S, Montuori C et al (2022) 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 11(10):2684. https://doi.org/10.3390/jcm11102684

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  16. van der Lans RJL, Fokkens WJ, Adriaensen GFJPM, Hoven DR, Drubbel JJ, Reitsma S (2022) Real-life observational cohort verifies high efficacy of dupilumab for chronic rhinosinusitis with nasal polyps. Allergy 77(2):670–674. https://doi.org/10.1111/all.15134

    Article  PubMed  CAS  Google Scholar 

  17. Haxel BR, Hummel T, Fruth K et al (2022) Real-world-effectiveness of biological treatment for severe chronic rhinosinusitis with nasal polyps. Rhinology 60(6):435–443. https://doi.org/10.4193/Rhin22.129

    Article  PubMed  CAS  Google Scholar 

  18. von Elm E, Altman DG, Egger M et al (2014) The strengthening the reporting of observational studies in epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg 12(12):1495–1499. https://doi.org/10.1016/j.ijsu.2014.07.013

    Article  Google Scholar 

  19. Reddel HK, Bacharier LB, Bateman ED et al (2021) Global initiative for asthma strategy 2021: executive summary and rationale for key changes. Eur Respir J 59(1):2102730. https://doi.org/10.1183/13993003.02730-2021

    Article  PubMed  CAS  Google Scholar 

  20. Meltzer EO, Hamilos DL, Hadley JA et al (2006) Rhinosinusitis: developing guidance for clinical trials. J Allergy Clin Immunol 118(5 Suppl):S17–S61. https://doi.org/10.1016/j.jaci.2006.09.005

    Article  PubMed  Google Scholar 

  21. Hummel T, Sekinger B, Wolf SR, Pauli E, Kobal G (1997) “Sniffin” sticks’: olfactory performance assessed by the combined testing of odor identification, odor discrimination and olfactory threshold. Chem Senses 22(1):39–52. https://doi.org/10.1093/chemse/22.1.39

    Article  PubMed  CAS  Google Scholar 

  22. Gudziol V, Lötsch J, Hähner A, Zahnert T, Hummel T (2006) Clinical significance of results from olfactory testing. Laryngoscope 116(10):1858–1863. https://doi.org/10.1097/01.mlg.0000234915.51189.cb

    Article  PubMed  Google Scholar 

  23. Oleszkiewicz A, Schriever VA, Croy I, Hähner A, Hummel T (2019) Updated Sniffin’ Sticks normative data based on an extended sample of 9139 subjects. Eur Arch Otorhinolaryngol 276(3):719–728. https://doi.org/10.1007/s00405-018-5248-1

    Article  PubMed  CAS  Google Scholar 

  24. Kennedy JL, Hubbard MA, Huyett P, Patrie JT, Borish L, Payne SC (2013) Sino-nasal outcome test (SNOT-22): a predictor of postsurgical improvement in patients with chronic sinusitis. Ann Allergy Asthma Immunol 111(4):246-251.e2. https://doi.org/10.1016/j.anai.2013.06.033

    Article  PubMed  PubMed Central  Google Scholar 

  25. Mattos JL, Rudmik L, Schlosser RJ et al (2019) Symptom importance, patient expectations, and satisfaction in chronic rhinosinusitis. Int Forum Allergy Rhinol 9(6):593–600

    Article  PubMed  PubMed Central  Google Scholar 

  26. Lin YT, Yeh TH (2022) Studies on clinical features, mechanisms, and management of olfactory dysfunction secondary to chronic rhinosinusitis. Front Allergy 3:835151

    Article  PubMed  PubMed Central  Google Scholar 

  27. Oka H, Tsuzuki K, Takebayashi H, Kojima Y, Daimon T, Sakagami M (2013) Olfactory changes after endoscopic sinus surgery in patients with chronic rhinosinusitis. Auris Nasus Larynx 40(5):452–457. https://doi.org/10.1016/j.anl.2012.12.001

    Article  PubMed  Google Scholar 

  28. Kobal G, Hummel T, Sekinger B, Barz S, Roscher S, Wolf S (1996) “Sniffin’ sticks”: screening of olfactory performance. Rhinology 34(4):222–226

    PubMed  CAS  Google Scholar 

  29. Kohli P, Naik AN, Farhood Z et al (2016) Olfactory outcomes after endoscopic sinus surgery for chronic rhinosinusitis: a meta-analysis. Otolaryngol Head Neck Surg 155(6):936–948. https://doi.org/10.1177/0194599816664879

    Article  PubMed  Google Scholar 

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Acknowledgements

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Funding

This research received no external funding.

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Authors and Affiliations

  1. Department of Medical and Surgical Sciences and Advanced Technologies “GF Ingrassia” ENT Section, University of Catania, 95123, Catania, Italy

    Ignazio La Mantia, Egle Grigaliute, Martina Ragusa, Salvatore Cocuzza & Antonino Maniaci

  2. ENT Surgeon, Department of Oto-Rhino-Laryngology Head and Neck Surgery, La Conception University Hospital, Aix-Marseille Univ, 147 Bd Baille, 13005, Marseille, France

    Thomas Radulesco, Nicolas Fakhry & Justin Michel

  3. Rhynology Study Group of the Young-Otolaryngologists of the International Federations of Oto-Rhino-Laryngological Societies (YO-IFOS), Paris, France

    Thomas Radulesco, Alberto Maria Saibene, Christian Calvo-Henriquez, Nicolas Fakhry & Antonino Maniaci

  4. Otolaryngology Unit, Santi Paolo E Carlo Hospital, Department of Health Sciences, Università Degli Studi Di Milano, Milan, Italy

    Alberto Maria Saibene

  5. Service of Otolaryngology, Hospital Complex of Santiago de Compostela, Santiago de Compostela, Spain

    Christian Calvo-Henriquez

  6. Faculty of Medicine and Surgery, University of Enna “Kore”, 94100, Enna, Italy

    Antonino Maniaci

Authors
  1. Ignazio La Mantia
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  2. Egle Grigaliute
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Correspondence to Antonino Maniaci.

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La Mantia, I., Grigaliute, E., Ragusa, M. et al. Effectiveness and rapidity on olfatory fuction recovery in CRS patients treated with Dupilumab: a real life prospective controlled study. Eur Arch Otorhinolaryngol 281, 219–226 (2024). https://doi.org/10.1007/s00405-023-08184-6

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