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DOI: 10.1055/s-0042-1746974
The prevalence of type 2 inflammatory signatures in patients with chronic rhinosinusitis with nasal polyps from two phase 3 clinical trials, SINUS-24 and SINUS-52
Introduction
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a disease of the nasal cavity and paranasal sinuses characterized by type 2 inflammation. Recent publications described algorithms for identification of type 2 inflammation in CRSwNP without tissue analysis. We used these algorithms to assess the prevalence of type 2 inflammation in patients with severe CRSwNP from two phase 3 studies (SINUS-24/SINUS-52 [NCT02912468/NCT02898454]).
Materials and Methods
Type 2 inflammation was assessed at baseline (pooled SINUS-24/SINUS-52 [N=724]) according to: 1. EPOS consensus guidelines (eosinophils ≥250 cells/μL or IgE ≥100 IU/mL); 2. EUFOREA 2020 position paper (comorbid asthma or eosinophils ≥300 cells/µL); 3. GINA threshold for airway inflammation (eosinophils ≥150 cells/µL); 4. eosinophils ≥150 cells/μL or IgE ≥100 IU/mL; 5. any coexisting type 2 condition (atopic dermatitis/asthma/nonsteroidal anti-inflammatory drug-exacerbated respiratory disease); 6. eosinophils ≥150 cells/μL or IgE ≥100 IU/mL or type 2 comorbidity.
Results
The proportions of patients with type 2 inflammation by each definition were: 1. 83.4%; 2. 76.4%; 3. 85.8%; 4. 92.3%; 5. 64.2%; and 6. 95.3%. In patients without comorbid asthma (n=296) the proportions were, 1. 75.0%; 3. 79.1%; 4. 87.8%; and 6. 88.5%, and in patients from Japan/Asia (n=49) the proportions were, 1. 87.8%; 2. 83.7%; 3. 83.7%; 4. 93.9%; 5. 67.3%; 6. 93.9%.
Conclusions
Up to 95% of patients with CRSwNP displayed a type 2 inflammatory signature based on these algorithms and prevalence was similar in patients without coexisting asthma and those from Japan/Asia.
Conflict of InterestDer Erstautor weist auf folgenden Interessenkonflikt hinC. Bachert: ALK, AstraZeneca, GlaxoSmithKline, Mylan, Novartis, Sanofi, Stallergenes Greer – advisory board member and speakers’ fees.S.E. Lee: GlaxoSmithKline, Sanofi, AstraZeneca, Genentech – clinical trial funding, advisory board member.C. Hopkins: GSK, OptiNose, Sanofi Genzyme, Smith & Nephew – advisory board member.A.T. Peters: Regeneron Pharmaceuticals, Inc., Sanofi – advisory board member; AstraZeneca – research support and advisory board member; Optinose – consultant and research support.W. Fokkens: BioInspire Technologies, GlaxoSmithKline, Meda Pharmaceuticals, Sanofi – research grants.A.H. Khan, A. Praestgaard, J.A. Jacob-Nara, P.J. Rowe: Sanofi − employees, may hold stock and/or stock options in the company.S. Siddiqui, S. Nash, Y. Deniz: Regeneron Pharmaceuticals, Inc. – employees, may hold stock and/or stock options in the company.
Conflict of Interest
The author declares that there is no conflict of interest.
Publication History
Article published online:
24 May 2022
© 2022. 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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