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.

Bachert C: Actobiotics, ALK, ASIT Biotech, AstraZeneca, Novartis, Sanofi, Stallergenes – advisory board member. Desrosiers M: AstraZeneca, GSK, Probionase Therapies, Sanofi – clinical trial funding; Regeneron Pharmaceuticals, Inc., Sanofi – advisory board member; Probionase Therapies – equity holder. Mullol J: ALK-Abelló, Allakos, FAES, Genentech, Glenmark, GSK, Meda Pharmaceuticals, Menarini, MSD, Novartis, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, UCB, Uriach – member of national and international scientific advisory boards (consulting), fees for lectures, grants for research projects. Maspero JF: AstraZeneca, GSK, Novartis, Sanofi, Teva – consultant; Boehringer Ingelheim, Menarini, Novartis, Uriach – speaker fees; AstraZeneca, Novartis, Sanofi – research grants. Wagenmann M: ALK-Abelló, Allakos, AstraZeneca, GSK, HAL, Meda Pharmaceuticals, Novartis, Otonomy, Roche, sanofi-aventis, Stallergenes, Strekin, Teva – member of national and international scientific advisory boards (consulting), fees for lectures, grants for research projects. Niemann I, Khan A, Mannent LP: Sanofi – employees, may hold stock and/or stock options in the company. Kamat S, Amin N: Regeneron Pharmaceuticals, Inc. – employees and shareholders.

Prof. Dr. med. Claus Bachert

Faculty of Medicine, Gent University,

De Pintelaan 185, 9000

Gent, Belgien

eMail: [e-mail]

Publikationsverlauf

Publikationsdatum:
23. April 2019 (online)