Efficacy of omalizumab in moderate chronic rhinosinusitis with nasal polyps and IgE-mediated asthma.

BACKGROUND

Biologic therapies are recommended for severe, uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP), but evidence in moderate disease remains limited.

OBJECTIVE

To evaluate the effectiveness of omalizumab in patients with moderate CRSwNP and mild-to-moderate IgE-mediated asthma without prior sinus surgery.

METHODS

In this randomized, controlled, open-label study, adult patients were recruited through integrated otolaryngology and allergy clinics; 59 patients were randomized (3:2) to omalizumab plus standard therapy (n = 36) or standard therapy alone (n = 23) and followed for 12 months. The primary end point was change in Nasal Polyp Score. Secondary end points included nasal obstruction, asthma control, exacerbations, systemic corticosteroid use, and biomarkers of type 2 inflammation.

RESULTS

Omalizumab significantly reduced Nasal Polyp Score, improved nasal obstruction and asthma control, reduced asthma exacerbations and systemic corticosteroid exposure, and improved biomarkers of type 2 inflammation compared with controls.

CONCLUSION

Omalizumab is effective in patients with moderate CRSwNP and mild-to-moderate asthma and may have a role earlier in the treatment algorithm for selected patients, pending confirmation in larger, multicenter studies.