Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) is characterized by a type 2 pattern of inflammation. Mepolizumab was approved for the treatment of CRSwNP in 2021. However, there is a lack of real-life studies.
Aim: This work aimed to evaluate the effectiveness and safety profile of Mepolizumab during the first year of treatment in a real-life setting.
Methods: A multicentric observational cohort study was carried out. A total of 67 patients were enrolled in the Otorhinolaryngology Unit of the three University Hospitals and considered for Mepolizumab therapy. All recorder characteristics were age (at the first Mepolizumab 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 Mepolizumab therapy and number of doses of Mepolizumab and eventually, Mepolizumab'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.
Results: A statistically significant reduction in SNOT-22 and NPS was shown in 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 Mepolizumab and continued the treatment because of a reduced NPS, improved quality of life, and a reduced need for system corticosteroids.
Conclusions: This multi-centric real-life study supported the effectiveness of Mepolizumab in patients with severe uncontrolled CRSwNP in the improvement of quality of life, the severity of symptoms, polyp size reduction, and smell function. Our data also support the safety profile of monoclonal therapy with Mepolizumab.
Keywords: Chronic rhinosinusitis with nasal polyps; Mepolizumab; Otorhinolaryngology; Real-word evidence; Safety profile.
Copyright © 2024. Published by Elsevier Inc.