CC BY-NC-ND 4.0 · Laryngorhinootologie 2019; 98(S 02): S176
DOI: 10.1055/s-0039-1686710
Abstracts
Rhinology

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

C Bachert
1   Faculty of Medicine, Ghent University, Gent, Belgien
,
M Desrosiers
2   Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Montréal, QC, Canada
,
J Mullol
3   Hospital Clínic, IDIBAPS, Universitat de Barcelona, CIBERES, Barcelona, Spain
,
JF Maspero
4   Allergy and Respiratory Research Unit, Fundación CIDEA, Buenos Aires, Argentina
,
M Wagenmann
5   Department of Otorhinolaryngology, Düsseldorf University Hospital (UKD), Düsseldorf
,
I Niemann
6   Sanofi Genzyme, Berlin
,
A Khan
7   Sanofi, Chilly-Mazarin, France
,
S Kamat
8   Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA
,
N Amin
9   Regeneron Pharmaceuticals, Inc., Tarrytown, USA
,
LP Mannent
7   Sanofi, Chilly-Mazarin, France
› Author AffiliationsResearch sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ClinicalTrials.gov Identifier: NCT02898454. Medical writing/editorial assistance provided by Sinéad Holland, PhD, of Excerpta Medica, funded by Sanofi Genzyme and Regeneron Pharmaceuticals, Inc.
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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/).

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