First outcomes of bio logical treatment for refractory chronic rhinosinusitis with nasal polyposis at Motol University Hospital

Czech version

Authors: A. Klobalová; Z. Balatková; M. Kaňa; Š. Novák; D. Kalfeřt; J. Plzák
Authors‘ workplace: Klinika otorinolaryngologie a chirurgie hlavy a krku 1. LF UK a FN v Motole, Praha
Published in: Otorinolaryngol Foniatr, 73, 2024, No. 4, pp. 227-232.
Category: Original Article
doi: https://doi.org/10.48095/ccorl2024227

Overview

Introduction: Patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP), meeting the EPOS 2020 criteria, are indicated for biological treatment. The pathogenesis of the disease significantly involves a type II immunopathological response. Treatment involves monoclonal antibodies that block the signaling of inflammatory cytokines. In the Czech Republic, three medications are approved –⁠ dupilumab, mepolizumab, and omalizumab. Methodology: A retrospective study was conducted, comprising of 26 patients treated with dupilumab at the Department of Otorhinolaryngology and Head and Neck Surgery at Motol University Hospital from November 2020 to December 2023. In the study cohort, we monitored the progression of nasal polyp score (NPS) scores, 22-item Sinonasal Outcome Test (SNOT-22), Odourized Markers Test (OMT), IgE levels, eosinophil count, and Asthma Control Test from the beginning of treatment and at week 16, 1 year, and 2 years into treatment. Results: According to the results, there is a statistically significant improvement not only in subjective symptoms but also in the objective findings of most variables. After 1 year of treatment, we observed a statistically significant improvement in NPS (from 6.15 ± 1.35 to 1.69 ± 1.76), SNOT-22 (from 58.83 ± 17.37 to 15.33 ± 16.80), OMT (from 1.52 ± 1.83 to 5.88 ± 3.5), and IgE levels (from 245 ± 251 kIU/l to 64 ± 68 kIU/l). In the study, the effectiveness of biologics was demonstrated in our patient cohort. Conclusion: The aim of this study is to report the initial outcomes of biologic treatment in patients with chronic rhinosinusitis with nasal polyposis treated at the Department of Otorhinolaryngology and Head and Neck Surgery, 1^st Faculty of Medicine, Motol University Hospital. Our study demonstrated a statistically significant improvement in SNOT-22, OMT, NPS, and serum IgE levels. The results were statistically significant when comparing baseline values with the 16-week follow-up, as well as when comparing baseline values with the 1-year follow up. No serious complications were encountered during the course of treatment.

Keywords:

biological treatment – dupilumab – CRSwNP

Sources

1. Fokkens WJ, Lund VJ, Hopkins C et al. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology 2020; 58 (Suppl S29): 1–464. Doi: 10.4193/Rhin20.600.

2. Balatková Z, Knížek Z, Vodička J et al. Biologická léčba chronické rinosinusitidy. Otorinolaryngol Foniatr 2021; 70 (2): 109–114. Doi: 10.48095/ccorl2021109.

3. Hirose K, Iwata A, Tamachi T et al. Allergic airway inflammation: key players beyond the Th2 cell pathway. Immunol Rev 2017; 278 (1): 145–161. Doi: 10.1111/imr.12540.

4. Gandhi NA, Bennett BL, Graham NM et al. Targeting key proximal drivers of type 2 inflammation in disease. Nat Rev Drug Discov 2016; 15 (1): 35–50. Doi: 10.1038/nrd4624.

5. Pundir V, Pundir J, Lancaster G et al. Role of corticosteroids in Functional Endoscopic Sinus Surgery –⁠ a systematic review and meta-analysis. Rhinology 2016; 54 (1): 3–19. Doi: 10.4193/Rhino15.079.

6. 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; 61 (3): 194–202. Doi: 10.4193/Rhin22.489.

7. Lund VJ, Mackay IS. Staging in rhinosinusitus. Rhinology 1993; 31 (4): 183–184.

8. Pinto JM, Mehta N, DiTineo M et al. A randomized, double-blind, placebo-controlled trial of anti-IgE for chronic rhinosinusitis. Rhinology 2010; 48 (3): 318–324. Doi: 10.4193/Rhino09. 144.

9. Han JK, Bachert C, Fokkens W et al. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med 2021; 9 (10): 1141–1153. Doi: 10.1016/ S2213-2600 (21) 00097-7.

10. Bachert C, Sousa AR, Lund VJ et al. Reduced need for surgery in severe nasal polyposis with mepolizumab: Randomized trial. J Allergy Clin Immunol 2017; 140 (4): 1024–1031 e1014. Doi: 10.1016/j.jaci.2017.05.044.

11. Jonstam K, Swanson BN, Mannent LP et al. Dupilumab reduces local type 2 pro-inflammatory biomarkers in chronic rhinosinusitis with nasal polyposis. Allergy 2019; 74 (4): 743–752. Doi: 10.1111/all.13685.

12. Bachert C, Han JK, Desrosiers M 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 (10209): 1638–1650. Doi: 10.1016/S0140-6736 (19) 31881-1.

13. Kilty SJ, Lasso A. Canadian real-world study of access and clinical results using dupilumab for chronic rhinosinusitis with polyps. J Otolaryngol Head Neck Surg 2022; 51 (1): 17. Doi: 10.1186/s40463-022-00570-0.

14. Schalek P, Otruba L, Hahn A. Quality of life in patients with chronic rhinosinusitis: a validation of the Czech version of SNOT-22 questionnaire. Eur Arch Otorhinolaryngol 2010; 267 (3): 473–475. doi: 10.1007/s00405-009-1180-8.

15. Vodicka J, Pellant A, Chrobok V. Screening of olfactory function using odourized markers. Rhinology 2007; 45 (2): 164–168.

ORCID autorů

Z. Balatková 0000-0003-1121-9836,

M. Kaňa 0000-0002-5530-6803,

Š. Novák 0000-0002-1174-0878,

D. Kalfeřt 0000-0003-4369-4113,

J. Plzák 0000-0003-3710-4455.

Přijato k recenzi: 29. 7. 2024

Přijato k tisku: 31. 10. 2024

MUDr. Aneta Klobalová

Klinika otorinolaryngologie a chirurgie hlavy a krku

1. LF UK a FN v Motole