Moffa Antonio, Iafrati Francesco, Giorgi Lucrezia, Nardelli Domiziana, Carnuccio Luca, Baptista Peter, Olszewska Ewa, Casale Manuele
School of Medicine, Università Campus Bio-Medico di Roma, 00128 Rome, Italy.
Integrated Therapies in Otolaryngology, Fondazione Policlinico Universitario Campus Bio-Medico, 00128 Rome, Italy.
Healthcare (Basel). 2025 Feb 15;13(4):419. doi: 10.3390/healthcare13040419.
: Chronic rhinosinusitis with nasal polyps (CRSwNP) poses significant therapeutic challenges. The introduction of Mepolizumab, an anti-interleukin-5 monoclonal antibody, offers a new therapeutic option for patients with severe, uncontrolled CRSwNP. This prospective observational study aims to assess the efficacy and safety of Mepolizumab for treating severe CRSwNP in Italy. : A single-center prospective observational study conducted in real-life settings with the patients of our center. Prior to enrollment, each patient underwent an interdisciplinary evaluation involving a pulmonologist and an allergologist if deemed necessary. All patients who were referred for treatment with Mepolizumab in compliance with the AIFA guidelines and the EPOS/EUFOREA update were included in the study population: (1) subjects who were over the age of 18, (2) who had severe CRSwNP, (3) whose condition was not successfully managed with standard therapies alone, and (4) whose blood eosinophil counts were greater than 150 cells/mL. Mepolizumab was administered subcutaneously through a 100 mg injection once every four weeks in addition to the standard-of-care therapy. : At the end of the enrollment process, 20 patients with severe CRSwNP were enrolled. Significant improvements were observed in Nasal Polyp Score, quality of life (SNOT-22; < 0.05), and nasal obstruction and rhinorrhea ( < 0.05), while no significant improvements were seen in olfactory function ( < 0.05). Eosinophil levels also significantly decreased ( < 0.05). : Mepolizumab effectively manages severe CRSwNP, showing improvements in symptom control and quality of life with an acceptable safety profile.
伴有鼻息肉的慢性鼻-鼻窦炎（CRSwNP）带来了重大的治疗挑战。抗白细胞介素-5单克隆抗体美泊利单抗的引入为重度、未得到控制的CRSwNP患者提供了一种新的治疗选择。这项前瞻性观察性研究旨在评估美泊利单抗在意大利治疗重度CRSwNP的疗效和安全性。：在现实环境中对我们中心的患者进行的单中心前瞻性观察性研究。在入组前，如有必要，每位患者都接受了包括肺科医生和过敏症专科医生在内的多学科评估。所有按照意大利药品管理局（AIFA）指南以及欧洲鼻窦炎和鼻息肉立场文件（EPOS）/欧洲鼻科学会和欧洲过敏与临床免疫学会（EUFOREA）更新版被转诊接受美泊利单抗治疗的患者被纳入研究人群：（1）年龄超过18岁的受试者，（2）患有重度CRSwNP的受试者，（3）仅采用标准疗法病情未得到成功控制的受试者，以及（4）血液嗜酸性粒细胞计数大于150个细胞/毫升的受试者。除了标准治疗外，美泊利单抗通过100毫克注射剂皮下给药，每四周一次。：在入组过程结束时，20例重度CRSwNP患者入组。鼻息肉评分、生活质量（鼻窦鼻相关生活质量问卷-22项[SNOT-22]；P<0.05）以及鼻塞和流涕（P<0.05）均有显著改善，而嗅觉功能无显著改善（P<0.05）。嗜酸性粒细胞水平也显著下降（P<0.05）。：美泊利单抗能有效治疗重度CRSwNP，在症状控制和生活质量方面有改善，且安全性可接受。
