Effectiveness and Safety of Dupilumab Monotherapy in Japanese Patients With Chronic Rhinosinusitis With Nasal Polyps.

Abstract

The randomized, double-blind, placebo-controlled LIBERTY SINUS-24 and SINUS-52 studies demonstrated that dupilumab is effective for chronic rhinosinusitis with nasal polyps (CRSwNP) when used with an intranasal corticosteroid (INCS); however, INCSs are not approved for CRSwNP in Japan. The current study aimed to investigate the effectiveness and safety of dupilumab monotherapy in Japanese individuals with CRSwNP. This phase 4, open-label, single-arm, multicenter study enrolled adult individuals with CRSwNP inadequately controlled with standard care therapies, including systemic corticosteroids and/or surgery. Subcutaneous dupilumab 300 mg was administered every 2 weeks; in participants with stable disease at week 24 (improvement of ≥ 2 points in the Nasal Polyp Score [NPS] from baseline at weeks 16 and 24), the dosing interval could be modified to every 4 weeks. The primary endpoint was the proportion of responders at week 24. The study included 25 individuals with CRSwNP (mean ± standard deviation age of 53.4 ± 13.6 years; 60.0% male). At week 24, 23 participants (92.0%) were considered responders to dupilumab. Reductions from baseline to week 24 in bilateral endoscopic NPS (mean change -2.4), nasal congestion severity score (-1.58), and Lund-Mackay scores (-5.6) were observed with dupilumab. Dupilumab was well tolerated; over 52 weeks, 16 participants (69.6%) experienced a treatment-emergent adverse event (TEAE). Most TEAEs were mild in severity; moderate and severe TEAEs were reported in five (21.7%) and one (4.3%) participant, respectively. Dupilumab monotherapy was effective and well tolerated in Japanese individuals with symptomatic CRSwNP. ClinicalTrials.gov identifier: NCT05049122.