Efficacy of Dupilumab in Patients with Chronic Rhinosinusitis with Nasal Polyps and Eosinophilic Otitis Media: A Six-Month Observational Study

<i>Background and Objectives:</i> Chronic rhinosinusitis with nasal polyps (CRSwNP) and eosinophilic otitis media (EOM) are frequently co-existing eosinophilic disorders related to type 2 inflammation, which significantly impair the quality of life of patients. Dupilumab, a monoclonal antibody targeting the IL-4 receptor alpha and anti-IL-13, has demonstrated a promising profile of efficacy and safety in the treatment of CRSwNP; however, evidence on its role in concomitant EOM and CRSwNP remains limited in the literature. This study aims to evaluate the clinical efficacy of dupilumab in patients with concomitant CRSwNP and EOM over a six-month observational period. <i>Materials and Methods:</i> A retrospective observational cohort study was conducted on twenty-two patients (aged 18-75 years) over six months with severe uncontrolled CRSwNP and confirmed refractory EOM who were treated with dupilumab (300 mg every two weeks). Demographic data are collected, and outcome measures included Nasal Polyp Score (NPS), Sino-Nasal Outcome Test (SNOT-22), Visual Analog Scale for nasal congestion (VAS), tympanogram classification, and Chronic Otitis Media Outcome Test (COMOT-15), evaluated at baseline and 6 months. <i>Results</i>: Over the six-month treatment period, patients with coexisting CRSwNP and eosinophilic otitis media experienced significant improvements across the multiple validated clinical and patient-reported outcome measures. The Nasal Polyp Score (NPS) significantly decreased from a median of 5.7 (IQR: 1.2) at baseline to 1.5 (IQR: 1.3) at six months (<i>p</i> < 0.0001). The SNOT-22 showed a substantial decline from a median of 77.6 (IQR: 19.0) to 21.5 (IQR: 13.4), <i>p</i> < 0.0001. Visual Analog Scale (VAS) scores for nasal congestion improved significantly from 8.4 (IQR: 1.1) to 1.7 (IQR: 1.2), <i>p</i> < 0.0001. Tympanogram scores improved from Tympanogram type "B" to Tympanogram type "A" (<i>p</i> = 0.018). COMOT-15 scale decreased from a median of 51.3 (IQR: 8.4) to 19.2 (IQR: 5.0) (<i>p</i> < 0.0001). Peripheral eosinophil counts remained unchanged or increased (baseline 0.80 vs. 0.84 cells/μL at six months, (<i>p</i> = 0.834)). <i>Conclusions</i>: Dupilumab treatment in patients with CRSwNP and EOM led to significant clinical improvements in sinonasal symptoms, middle ear function, and quality of life over six months, with no significant change in peripheral eosinophilia.

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Journal
Medicina
Published
2025-08-15
DOI
https://doi.org/10.3390/medicina61081471
Citations
1
Primary Topic
Sinusitis and nasal conditions
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article
Field-Weighted Citation Impact
1.85
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article

Efficacy of Dupilumab in Patients with Chronic Rhinosinusitis with Nasal Polyps and Eosinophilic Otitis Media: A Six-Month Observational Study

Salvatore Maira, Francesco Freni, Giulia Laterra, Daniele Portelli et al.
1 citations
Medicina
Sinusitis and nasal conditions
1.85
article

Efficacy of Dupilumab in Patients with Chronic Rhinosinusitis with Nasal Polyps and Eosinophilic Otitis Media: A Six-Month Observational Study

Salvatore Maira, Francesco Freni, Giulia Laterra, Daniele Portelli, PETER E. ZAMBITO, Francesco Ciodaro, Bruno Galletti, Cosimo Galletti, Leonard Freni, Maria Grazia Ferrisi, Federica Giammona Indaco
article en
1 citations

Abstract

<i>Background and Objectives:</i> Chronic rhinosinusitis with nasal polyps (CRSwNP) and eosinophilic otitis media (EOM) are frequently co-existing eosinophilic disorders related to type 2 inflammation, which significantly impair the quality of life of patients. Dupilumab, a monoclonal antibody targeting the IL-4 receptor alpha and anti-IL-13, has demonstrated a promising profile of efficacy and safety in the treatment of CRSwNP; however, evidence on its role in concomitant EOM and CRSwNP remains limited in the literature. This study aims to evaluate the clinical efficacy of dupilumab in patients with concomitant CRSwNP and EOM over a six-month observational period. <i>Materials and Methods:</i> A retrospective observational cohort study was conducted on twenty-two patients (aged 18-75 years) over six months with severe uncontrolled CRSwNP and confirmed refractory EOM who were treated with dupilumab (300 mg every two weeks). Demographic data are collected, and outcome measures included Nasal Polyp Score (NPS), Sino-Nasal Outcome Test (SNOT-22), Visual Analog Scale for nasal congestion (VAS), tympanogram classification, and Chronic Otitis Media Outcome Test (COMOT-15), evaluated at baseline and 6 months. <i>Results</i>: Over the six-month treatment period, patients with coexisting CRSwNP and eosinophilic otitis media experienced significant improvements across the multiple validated clinical and patient-reported outcome measures. The Nasal Polyp Score (NPS) significantly decreased from a median of 5.7 (IQR: 1.2) at baseline to 1.5 (IQR: 1.3) at six months (<i>p</i> < 0.0001). The SNOT-22 showed a substantial decline from a median of 77.6 (IQR: 19.0) to 21.5 (IQR: 13.4), <i>p</i> < 0.0001. Visual Analog Scale (VAS) scores for nasal congestion improved significantly from 8.4 (IQR: 1.1) to 1.7 (IQR: 1.2), <i>p</i> < 0.0001. Tympanogram scores improved from Tympanogram type "B" to Tympanogram type "A" (<i>p</i> = 0.018). COMOT-15 scale decreased from a median of 51.3 (IQR: 8.4) to 19.2 (IQR: 5.0) (<i>p</i> < 0.0001). Peripheral eosinophil counts remained unchanged or increased (baseline 0.80 vs. 0.84 cells/μL at six months, (<i>p</i> = 0.834)). <i>Conclusions</i>: Dupilumab treatment in patients with CRSwNP and EOM led to significant clinical improvements in sinonasal symptoms, middle ear function, and quality of life over six months, with no significant change in peripheral eosinophilia.

MedicinaVol. 61(8)
University of Messina (IT), Università degli Studi di Enna Kore (IT), Ospedali Riuniti Umberto I (IT)
Openalex Percentile: Top 13%
Sinusitis and nasal conditions
1.85
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