Galletti Cosimo, Ragusa Martina, Sireci Federico, Ciodaro Francesco, Barbieri Maria Antonietta, Giunta Giorgia, Grigaliute Egle, Immordino Angelo, Lorusso Francesco, Dispenza Francesco, Freni Francesco, Galletti Francesco, Gallina Salvatore, La Mantia Igo, Galletti Bruno
Department of Adult and Development Age Human Pathology "Gaetano Barresi", Unit of Otorhinolaryngology, University of Messina, Via Consolare Valeria 1, 98125 Messina, ME, Italy.
Department of Medical-Surgical Sciences and Advanced Technologies, E.N.T. Unit, P.O. "G. Rodolico", University of Catania, Catania, Italy.
Am J Otolaryngol. 2024 Jan-Feb;45(1):104106. doi: 10.1016/j.amjoto.2023.104106. Epub 2023 Nov 5.
This study aimed to evaluate the effectiveness and safety of dupilumab during the first year of treatment in a real-life setting, focusing on improvement in nasal polyp score (NPS) as well as specific symptoms, quality of life and olfactory function.
METHODOLOGY/PRINCIPAL: A multicentric observational cohort study was carried out. A total of 170 patients were enrolled in the Otorhinolaryngology Unit of the three University Hospitals and considered for dupilumab therapy. All recorder characteristics were age (at the first dupilumab application visit), sex, smoke habits, previous local and systemic corticosteroid therapy, history of endoscopic sinus surgery, number of previous endoscopic sinus surgery, concomitant asthma, history of an allergic condition, immunoglobulin E (IgE), allergy to nonsteroidal anti-inflammatory drugs (NSAIDs), Aspirin Exacerbated Respiratory Disease (AERD), other comorbidities associated, blood eosinophils, nasal polyp score, sinonasal outcome test 22 (SNOT 22), sniffin' stick test, the start date of dupilumab therapy and number of doses of dupilumab and eventually, Dupilumab's adverse events related to administration. The Wilcoxon test for dependent samples was performed to compare variables. Statistical significance was assumed for p values < 0.05.
A statistically significant reduction in SNOT-22 and NPS was shown at the 6th and 12th month compared to baseline values (p < 0.001 for both comparisons). A statistically significant increase value at the Sniffin' sticks test was shown in the 6th and 12th month compared to baseline values (p < 0.001 for both comparisons). At the 12-month follow-up, according to EUFOREA indications, all patients were considered to remain in treatment with dupilumab and continued the treatment because of a reduced NPS, improved quality of life and a reduced need for system corticosteroids. Dupilumab seemed to be well tolerated by all patients. Any adverse effect of the drug led to the quit of biological treatment.
This multi-centric real-life study supported the effectiveness of dupilumab as an add-on therapy to intranasal corticosteroids in patients with severe uncontrolled CRSwNP in improvement of quality of life, severity of symptoms, polyp size reduction and smell function. Furthermore, our data support the safety profile of monoclonal therapy with dupilumab.
本研究旨在评估度普利尤单抗在真实临床环境中治疗第一年的有效性和安全性，重点关注鼻息肉评分（NPS）的改善情况以及特定症状、生活质量和嗅觉功能。
方法/主要内容：开展了一项多中心观察性队列研究。三家大学医院的耳鼻喉科共纳入了170例患者并考虑给予度普利尤单抗治疗。记录的所有特征包括年龄（首次应用度普利尤单抗就诊时）、性别、吸烟习惯、既往局部和全身糖皮质激素治疗情况、鼻窦内窥镜手术史、既往鼻窦内窥镜手术次数、合并哮喘情况、过敏史、免疫球蛋白E（IgE）、对非甾体抗炎药（NSAIDs）过敏情况、阿司匹林加重性呼吸系统疾病（AERD）、其他合并症、血液嗜酸性粒细胞、鼻息肉评分、鼻窦结局测试22（SNOT 22）、嗅觉棒测试、度普利尤单抗治疗开始日期和度普利尤单抗剂量，以及最终度普利尤单抗给药相关的不良事件。采用配对样本的Wilcoxon检验比较变量。p值<0.05时具有统计学意义。
与基线值相比，在第6个月和第12个月时，SNOT - 22和NPS有统计学意义的降低（两次比较p均<0.001）。与基线值相比，在第6个月和第12个月时，嗅觉棒测试有统计学意义的增加（两次比较p均<0.001）。在12个月的随访中，根据欧洲鼻科学会鼻息肉和鼻窦炎工作组（EUFOREA）的指征，所有患者因NPS降低、生活质量改善以及全身糖皮质激素需求减少而被认为继续接受度普利尤单抗治疗。所有患者对度普利尤单抗的耐受性似乎良好。药物的任何不良反应均未导致生物治疗中断。
这项多中心真实临床研究支持度普利尤单抗作为鼻内糖皮质激素的附加疗法，用于治疗严重未控制的慢性鼻 - 鼻窦炎伴鼻息肉（CRSwNP）患者，可改善生活质量、减轻症状严重程度、缩小息肉大小以及改善嗅觉功能。此外，我们的数据支持度普利尤单抗单克隆治疗的安全性。
