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

ABSTRACT:

Objectives

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.

Methods

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

SUBMITTER: Fujieda S 

PROVIDER: S-EPMC12706541 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature