Clinical Evidence of the Use of Mepolizumab in the Treatment of Chronic Rhinosinusitis with Nasal Polyps: A Prospective Observational Study.

IF 2.7 4区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Healthcare Pub Date : 2025-02-15 DOI:10.3390/healthcare13040419
Antonio Moffa, Francesco Iafrati, Lucrezia Giorgi, Domiziana Nardelli, Luca Carnuccio, Peter Baptista, Ewa Olszewska, Manuele Casale
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Abstract

Background/Objectives: 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. Methods: 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. Results: 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; p < 0.05), and nasal obstruction and rhinorrhea (p < 0.05), while no significant improvements were seen in olfactory function (p < 0.05). Eosinophil levels also significantly decreased (p < 0.05). Conclusions: Mepolizumab effectively manages severe CRSwNP, showing improvements in symptom control and quality of life with an acceptable safety profile.

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Mepolizumab治疗慢性鼻窦炎伴鼻息肉的临床证据:一项前瞻性观察研究。
背景/目的:慢性鼻窦炎伴鼻息肉(CRSwNP)的治疗面临重大挑战。Mepolizumab是一种抗白细胞介素-5单克隆抗体,它的引入为严重、不受控制的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Mepolizumab治疗意大利严重CRSwNP的有效性和安全性。方法:单中心前瞻性观察研究,在现实生活中与本中心的患者进行。在入组之前,每个患者都进行了跨学科评估,必要时由肺病专家和过敏症专家进行评估。所有根据AIFA指南和EPOS/EUFOREA更新推荐使用Mepolizumab治疗的患者都被纳入研究人群:(1)年龄超过18岁的受试者,(2)患有严重CRSwNP的受试者,(3)单独使用标准治疗无法成功治疗的受试者,以及(4)血液嗜酸性粒细胞计数大于150细胞/mL的患者。除了标准治疗外,Mepolizumab每四周皮下注射一次100毫克。结果: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(SNOT-22;P < 0.05),鼻塞和鼻漏(P < 0.05),而嗅觉功能无显著改善(P < 0.05)。嗜酸性粒细胞水平也显著降低(p < 0.05)。结论:Mepolizumab有效地治疗严重的CRSwNP,在症状控制和生活质量方面表现出改善,并具有可接受的安全性。
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来源期刊
Healthcare
Healthcare Medicine-Health Policy
CiteScore
3.50
自引率
7.10%
发文量
0
审稿时长
47 days
期刊介绍: Healthcare (ISSN 2227-9032) is an international, peer-reviewed, open access journal (free for readers), which publishes original theoretical and empirical work in the interdisciplinary area of all aspects of medicine and health care research. Healthcare publishes Original Research Articles, Reviews, Case Reports, Research Notes and Short Communications. We encourage researchers to publish their experimental and theoretical results in as much detail as possible. For theoretical papers, full details of proofs must be provided so that the results can be checked; for experimental papers, full experimental details must be provided so that the results can be reproduced. Additionally, electronic files or software regarding the full details of the calculations, experimental procedure, etc., can be deposited along with the publication as “Supplementary Material”.
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