Biologics for chronic rhinosinusitis with nasal polyps: a real-world prospective cohort study

Monoclonal antibody therapies targeting type 2 inflammation for chronic rhinosinusitis with nasal polyps (CRSwNP) have shown efficacy in randomized controlled trials (RCTs), however prospective real-world comparative data across all appro-ved biologics remain limited. We aimed to evaluate the real-world effectiveness of omalizumab, mepolizumab, and dupilumab in patients with severe CRSwNP.

A prospective, multicentre, real-world phase IV study in Belgium, enrolling 360 patients with severe CRSwNP initiating treatment with omalizumab (n=65), mepolizumab (n=242), or dupilumab (n=53) between March 2022 and April 2025. Clinical data were collected at baseline and after 6 months. The therapeutic response was evaluated based on EUFOREA criteria.

After 6 months, nasal polyp score (NPS), olfactory function, and patient-reported outcomes improved across all biologics, with concurrent improvements in asthma control within each treatment group. A good-to-excellent multidomain therapeutic response was achieved in 51% of patients, and treatment continuation beyond 6 months was observed in 74% of omalizumab-, 81% of mepolizumab-, and 92% of dupilumab-treated patients. No severe adverse events were reported.

In this real-world cohort, the three registered biologics provided significant clinical benefit in severe CRSwNP, with numerically larger improvements observed in patients treated with dupilumab.