A recent multicenter observational cohort study has demonstrated the sustained effectiveness and safety of Mepolizumab in treating chronic rhinosinusitis with nasal polyps (CRSwNP) in a real-world setting. The study, conducted across three University Hospitals, enrolled 67 patients and tracked their progress over a year, providing valuable insights into the long-term benefits of Mepolizumab in managing this challenging condition.
The research, published in ScienceDirect, addresses a gap in real-world evidence for Mepolizumab, which was approved for CRSwNP treatment in 2021. CRSwNP is characterized by type 2 inflammation, and Mepolizumab, an anti-IL-5 monoclonal antibody, targets this inflammatory pathway. The study aimed to evaluate the drug's effectiveness and safety profile during the first year of treatment.
Key Findings
The study revealed statistically significant improvements in several key metrics. Specifically, the Sinonasal Outcome Test 22 (SNOT-22) and Nasal Polyp Score (NPS) showed significant reductions at both the 6-month and 12-month marks compared to baseline (p < 0.001 for both comparisons). These improvements indicate a substantial enhancement in patients' quality of life and a reduction in the size and severity of nasal polyps.
Furthermore, the Sniffin' sticks test, used to assess olfactory function, demonstrated a statistically significant increase at 6 and 12 months compared to baseline (p < 0.001). This finding is particularly important as loss of smell is a common and debilitating symptom of CRSwNP.
Clinical Implications
"The results of this study underscore the clinical benefit of Mepolizumab in patients with CRSwNP," said the lead investigator. "The sustained improvements in SNOT-22, NPS, and olfactory function highlight the drug's potential to significantly improve the lives of these patients."
At the 12-month follow-up, all patients were considered to remain on Mepolizumab treatment, according to EUFOREA (European Forum for Research and Education in Allergy and Airways diseases) indications. This continuation was driven by a reduced NPS, improved quality of life, and a decreased need for systemic corticosteroids, indicating a positive long-term treatment response.
Study Details
The study enrolled patients in the Otorhinolaryngology Units of three University Hospitals. Data collected included demographics, smoking habits, previous corticosteroid use, history of endoscopic sinus surgery, concomitant asthma, allergic conditions, IgE levels, NSAID allergy, Aspirin Exacerbated Respiratory Disease (AERD), other comorbidities, blood eosinophils, NPS, SNOT-22, Sniffin' sticks test results, and Mepolizumab-related adverse events. Statistical analysis was performed using the Wilcoxon test for dependent samples, with statistical significance set at p < 0.05.
