Responders to biologics in severe uncontrolled chronic rhinosinusitis with nasal polyps: a multicentric observational real-life study.

Background: Clinical trials have demonstrated the effectiveness of biologics in treating chronic rhinosinusitis with nasal polyps (CRSwNP). However, real-world evidence regarding patient outcomes and predictors of clinical response remains limited.

Methodology: In this multicentric 18-month follow-up study, 326 adult patients who initiated biologic therapy for severe uncontrolled CRSwNP were included. Patient characteristics, including clinical and inflammatory markers, and comorbidities were collected at baseline and at 3, 6, 12, and 18 months of follow-up. We examined success rates based on current guidelines and identified potential factors associated to clinical response at 6 months.

Results: We observed a significant decrease of Sino-Nasal Outcomes Test-22 (SNOT-22) from a median score (interquartile range) of 60.5 (47-74) at baseline to 26.0 (11-41) at 3 months. A significant decrease of nasal symptoms and endoscopic nasal polyp score was observed at 3 months. After 6 months of biologic treatment, 59% of patients were classified as excellent responders according to the EUFOREA-EPOS 2023 criteria. Multivariate analysis revealed a suggestive association between baseline eosinophil blood count, type of biologic and an excellent response at 6 months.

Conclusions: This real-world study confirms the effectiveness of biologics as an add-on therapy in patients with severe uncontrolled CRSwNP. Biologics lead to rapid and sustained improvement in clinical symptoms. A significant proportion of patients exhibit an excellent response, with no need for systemic corticosteroids.