Baseline Characteristics of Patients With Chronic Rhinosinusitis With Nasal Polyps (With and Without Asthma) Enrolled in SINUS-52, a Randomized, Double-Blind, Phase 3 Study of Dupilumab

Introduction: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2-mediated inflammatory disease associated with a high symptom burden and poor health-related quality of life. Dupilumab, a human IL-4Rα mAb inhibiting IL-4 and IL-13, key drivers of type 2-mediated inflammation, is approved for uncontrolled moderate-to-severe atopic dermatitis in adults, and in the USA for patients (pts) aged ≥12 years with moderate-to-severe eosinophilic or oral corticosteroid-dependent asthma. In a phase 2a study, dupilumab improved endoscopic, radiologic, clinical, patient-reported sinonasal, and asthma outcomes in CRSwNP. We present baseline characteristics of CRSwNP pts on daily intranasal mometasone furoate from a dupilumab phase 3 study (SINUS-52; NCT02898454). Methods: Pts were randomized 1: 1: 1 to subcutaneous placebo every 2 weeks (q2w) for 52 weeks, dupilumab 300 mg q2w for 52 weeks, or dupilumab 300 mg q2w (first 24 weeks) followed by every 4 weeks (last 28 weeks). Results: Of 448 pts, 37.7% were female (mean [SD] age 52.0 [12.5] years). Mean CRSwNP duration was 10.9 [9.6] years, 58.3% pts had ≥1 prior sinonasal surgery, 80.1% received systemic corticosteroids in the 2 years prior. 82.4% of pts had a type 2 comorbidity history, including asthma (59.6%) and N-ERD (26.8%). Mean [SD] scores at baseline were: nasal polyp, 6.1 [1.2]; nasal congestion, 2.4 [0.6]; SNOT-22, 51.9 [20.9]; UPSIT, 13.6 [8.0]; CT Lund-Mackay, 18.0 [3.8]; visual analogue scale for symptom severity, 8.0 [2.1]. Conclusions: Overall baseline disease characteristics in the SINUS-52 study demonstrate a population with severe CRSwNP inadequately controlled with standard of care, highlighting a need for additional therapeutic options. Most pts had asthma or other type 2 comorbidities. Publication History Publication Date: 23 April 2019 (online) © 2019. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/). Georg Thieme Verlag KG Stuttgart · New York