Efficacy of Dupilumab in Patients with Chronic Rhinosinusitis with Nasal Polyps and Eosinophilic Otitis Media: A Six-Month Observational Study
Abstract
1. Introduction
2. Materials and Methods
- SNOT-22: We used the validated Italian version of SNOT-22. Possible total score range: 0–110. A SNOT-22 score < 20 was suggestive of mild symptoms. During follow-up time, the minimal clinically important difference (MCID) in SNOT-22 scores was assumed for an 8.9-point increase as reported in previous studies.
- Nasal endoscopy (Nasal Polyp Score): Each side of the nasal cavity was separately evaluated and scored in a range from 0 to 4 (0 = no polyps; 1 = small polyps in the middle meatus not reaching below the inferior border of the middle turbinate; 2 = polyps reaching below the lower border of the middle turbinate; 3 = large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate; and 4 = large polyps causing complete obstruction of the inferior nasal cavity). The sum of the scores for both nasal cavities was recorded as the NPS value.
- VAS for symptoms: Intensity of symptoms was measured on a horizontal 10 cm line. A mean score for each symptom analyzed was obtained using the average scores assigned to all patients for the same symptom.
- Diagnostic Criteria of Eosinophilic Otitis Media (EOM): Major criteria: Otitis media with effusion or chronic otitis media with eosinophilic dominant effusion. Minor criteria: Highly viscous middle ear effusion, resistance to conventional treatment for OM, association with asthma, and association with CRSwNP. Definitive case: Positive for major criteria + two or more minor criteria. Exclusion criteria: Eosinophilic Granulomatosis with Polyangiitis (EGPA) [2].
- Tympanogram: “A”, “B” or “C”.
- Chronic otitis media outcome test (COMOT-15): We used the validated Italian version of COMOT-15. The COMOT-15 consists of three subscales, categorized as ear symptoms (questions 1–6), hearing function (questions 7–9), and mental health (questions 10–13), which form the overall score. In addition to questions 1 to 13, the COMOT-15 contains two other questions: a general evaluation of the impact of chronic otitis media on QoL (question 14) and a question on the frequency of ENT visits as a result of chronic otitis media in the previous 6 months (question 15). The possible total score range is 0–75 [COMOT] [13].
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Population Sample at the Baseline (n = 22) | |
---|---|
Mean Age, y | 55 ± 11.9 |
Male | 11 (50%) |
Smoking | 22 (31.8%) |
CCS | 22 (100%) |
OCS | 22 (100%) |
Previous ESS | 22 (100%) |
Asthma | 16 (72.7%) |
Allergy | 20 (90.9%) |
AERD | 9 (40.9%) |
ASA TRIAD | 9 (40.9%) |
Mean IgE | 108.8 ± 88.7 |
Outcome Measure | Baseline Median (IQR) | 6-Months Median (IQR) | p-Value (95% CI) | Test Used |
---|---|---|---|---|
Mean EOS (0.1 × 103/μL) | 0.80 ± 0.49 | 0.84 ± 0.58 | 0.834 (−0.38–0.31) | Wilcoxon signed-rank |
Mean NPS | 5.7 ± 1.2 | 1.5 ± 1.3 | <0.0001 (3.61–4.76) | Wilcoxon signed-rank |
Mean SNOT 22 | 77.6 ± 19.0 | 21.5 ± 13.4 | <0.0001 (45.13–66.96) | Wilcoxon signed-rank |
Mean VAS | 8.4 ± 1.1 | 1.7 ± 1.2 | <0.0001 (5.92–7.54) | Wilcoxon signed-rank |
Mean COMOT 15 | 51.3 ± 8.4 | 19.2 ± 5.0 | <0.0001 (28.90–35.28) | Wilcoxon signed-rank |
Mean EOS | 0.80 ± 0.49 | 0.84 ± 0.58 | 0.834 (−0.38–0.31) | Wilcoxon signed-rank |
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© 2025 by the authors. Published by MDPI on behalf of the Lithuanian University of Health Sciences. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
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Galletti, C.; Giammona Indaco, F.; Portelli, D.; Laterra, G.; Zambito, P.; Ferrisi, M.G.; Freni, L.; Ciodaro, F.; Freni, F.; Maira, S.; et al. Efficacy of Dupilumab in Patients with Chronic Rhinosinusitis with Nasal Polyps and Eosinophilic Otitis Media: A Six-Month Observational Study. Medicina 2025, 61, 1471. https://doi.org/10.3390/medicina61081471
Galletti C, Giammona Indaco F, Portelli D, Laterra G, Zambito P, Ferrisi MG, Freni L, Ciodaro F, Freni F, Maira S, et al. Efficacy of Dupilumab in Patients with Chronic Rhinosinusitis with Nasal Polyps and Eosinophilic Otitis Media: A Six-Month Observational Study. Medicina. 2025; 61(8):1471. https://doi.org/10.3390/medicina61081471
Chicago/Turabian StyleGalletti, Cosimo, Federica Giammona Indaco, Daniele Portelli, Giulia Laterra, Patrizia Zambito, Maria Grazia Ferrisi, Leonard Freni, Francesco Ciodaro, Francesco Freni, Salvatore Maira, and et al. 2025. "Efficacy of Dupilumab in Patients with Chronic Rhinosinusitis with Nasal Polyps and Eosinophilic Otitis Media: A Six-Month Observational Study" Medicina 61, no. 8: 1471. https://doi.org/10.3390/medicina61081471
APA StyleGalletti, C., Giammona Indaco, F., Portelli, D., Laterra, G., Zambito, P., Ferrisi, M. G., Freni, L., Ciodaro, F., Freni, F., Maira, S., & Galletti, B. (2025). Efficacy of Dupilumab in Patients with Chronic Rhinosinusitis with Nasal Polyps and Eosinophilic Otitis Media: A Six-Month Observational Study. Medicina, 61(8), 1471. https://doi.org/10.3390/medicina61081471