Real-world evidence for the effectiveness and safety of dupilumab in patients with CRSwNP after 1 year of therapy

OBJECTIVES: For nearly 3 years, the monoclonal antibody dupilumab has been approved in Germany for the treatment of patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Although efficacy has been demonstrated in large double-blind, placebo-controlled clinical trials, few reports of real-world data on this therapy have been published to date. METHODS: Patients with an indication for treatment with dupilumab for CRSwNP were included in the study and followed up every 3 months for a period of 1 year. At the baseline visit, demographic data, medical history, comorbidities, nasal polyp score, disease-related quality of life (SNOT-22), nasal congestion, and sense of smell (VAS and Sniffiń Sticks test) were recorded. In addition, total blood eosinophil counts and serum total IgE were measured. During follow-up, all of the described parameters and possible adverse events were recorded. RESULTS: Eighty-one patients were enrolled in the study, of whom 68 patients were still receiving dupilumab after 1 year of follow-up. Eight patients discontinued therapy, with only 1 patient discontinuing due to severe side effects. The Polyp score decreased substantially during follow-up, and parameters for disease-related quality of life and sense of smell increased significantly. Total IgE levels decreased significantly, and eosinophils leveled off at baseline after an initial increase after three months of therapy. No clinical data could be identified to a priori predict a treatment response. CONCLUSIONS: Dupilumab shows effectiveness and safety in the treatment of CRSwNP under real-world conditions. More research on systemic biomarkers and clinical parameters to predict treatment response is necessary.