Long-Term Effectiveness of Dupilumab in Severe Uncontrolled Chronic Rhinosinusitis with Nasal Polyps: A Multicenter Retrospective Study.

Abstract

Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a complex immunological disease associated with significant morbidity and reduced health-related quality of life. Dupilumab is an anti-T2-inflammatory biological drug registered for chronic rhinosinusitis with nasal polyps, indicated by integrated care pathways when optimal medico-surgical treatment yields insufficient control of sinonasal symptoms.

Objective: The purpose of this study was to confirm the long-term efficacy of dupilumab in the treatment of severe uncontrolled CRSwNP.

Methods: Multicentric data collection of patients with severe uncontrolled CRSwNP treated with Dupilumab was retrospectively performed. Mixed Model Anova test was used to evaluate the effect of the biological therapy in the improvement of nasal polyp score and quality of life measured with Sinonasal Outcome Test-22 (SNOT-22) and visual analog scale (VAS) scores.

Results: The study showed a statistically significant and progressive improvement in the Nasal Polyp Score with a decrease from a median baseline value of 6 (IQR 5-6) to 0 (IQR 0-2) at 24 months. Furtherly, optimal results were found for SNOT-22 scores from baseline (62 ± 19) to 6 months (15± 11), with further variations on each successive timepoint remaining below the minimal clinically important difference. VAS scores of nasal obstruction, rhinorrhea, sleep disorders, and craniofacial pain, demonstrated consistent and significant improvements over time until one year of treatment, confirming substantial relief for the most pertinent symptoms of the condition.

Conclusions: The results of this study show high therapeutic efficacy and safety of dupilumab for severe CRswNP particularly in the first 6-12 months, with sustained benefits up to 24 months.