Galletti Cosimo, Giammona Indaco Federica, Portelli Daniele, Laterra Giulia, Zambito Patrizia, Ferrisi Maria Grazia, Freni Leonard, Ciodaro Francesco, Freni Francesco, Maira Salvatore, Galletti Bruno
Otorhinolaryngology Unit, "Ospedale Umberto I" Enna, Faculty of Medicine and Surgery, Università degli Studi di Enna "Kore", Contrada Ferrante, 94100 Enna, Italy.
Otorhinolaryngology Unit, Ospedale "Umberto I" Enna, Contrada Ferrante, 94100 Enna, Italy.
Medicina (Kaunas). 2025 Aug 15;61(8):1471. doi: 10.3390/medicina61081471.
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. 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. : 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 ( < 0.0001). The SNOT-22 showed a substantial decline from a median of 77.6 (IQR: 19.0) to 21.5 (IQR: 13.4), < 0.0001. Visual Analog Scale (VAS) scores for nasal congestion improved significantly from 8.4 (IQR: 1.1) to 1.7 (IQR: 1.2), < 0.0001. Tympanogram scores improved from Tympanogram type "B" to Tympanogram type "A" ( = 0.018). COMOT-15 scale decreased from a median of 51.3 (IQR: 8.4) to 19.2 (IQR: 5.0) ( < 0.0001). Peripheral eosinophil counts remained unchanged or increased (baseline 0.80 vs. 0.84 cells/μL at six months, ( = 0.834)). : 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.
伴鼻息肉的慢性鼻-鼻窦炎(CRSwNP)和嗜酸性粒细胞性中耳炎(EOM)是常见的与2型炎症相关的共存嗜酸性粒细胞性疾病,严重影响患者的生活质量。度普利尤单抗是一种靶向白细胞介素-4受体α和抗白细胞介素-13的单克隆抗体,已在CRSwNP治疗中显示出有前景的疗效和安全性;然而,其在合并EOM和CRSwNP中的作用在文献中仍然有限。本研究旨在评估度普利尤单抗在伴CRSwNP和EOM患者中为期6个月的观察期内的临床疗效。对22例年龄在18 - 75岁、患有严重未控制的CRSwNP且确诊为难治性EOM的患者进行了为期6个月的回顾性观察队列研究,这些患者接受度普利尤单抗治疗(每两周300 mg)。收集了人口统计学数据,结局指标包括鼻息肉评分(NPS)、鼻窦结局测试(SNOT - 22)、鼻充血视觉模拟量表(VAS)、鼓室图分类以及慢性中耳炎结局测试(COMOT - 15),在基线和6个月时进行评估。:在6个月的治疗期内,合并CRSwNP和嗜酸性粒细胞性中耳炎的患者在多项经过验证的临床和患者报告的结局指标上均有显著改善。鼻息肉评分(NPS)从基线时的中位数5.7(四分位间距:1.2)显著降至6个月时的1.5(四分位间距:I.3)(<0.0001)。SNOT - 22从中位数77.6(四分位间距:19.0)大幅降至21.5(四分位间距:13.4),<0.0001。鼻充血视觉模拟量表(VAS)评分从8.4(四分位间距:1.1)显著改善至1.7(四分位间距:1.2),<0.0001。鼓室图评分从鼓室图B型改善为鼓室图A型(P = 0.018)。COMOT - 15量表从中位数51.3(四分位间距:8.4)降至19.2(四分位间距:5.0)(<0.0001)。外周嗜酸性粒细胞计数保持不变或增加(基线时为0.80,6个月时为0.84细胞/μL,(P = 0.834))。:度普利尤单抗治疗CRSwNP和EOM患者6个月后,鼻窦症状、中耳功能和生活质量有显著临床改善,外周嗜酸性粒细胞增多无显著变化。