@article{aa7b04dc9f5a465d8f6f20207e637906,
title = "Dupilumab reduces systemic corticosteroid use and sinonasal surgery rate in CRSwNP",
abstract = "BACKGROUND: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a type 2 inflammatory disease with a high symptom burden and poor quality of life. Treatment options include recurrent surgeries and/or frequent systemic corticosteroids (SCS). Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and interleukin-13, key drivers of type 2-mediated inflammation. We report results of pooled analyses from 2 randomised, double-blind, placebo-controlled phase 3 studies (SINUS 24 [NCT02912468]; SINUS-52 [NCT02898454]) to evaluate dupilumab effect versus placebo in adults with CRSwNP with/without SCS use and sinonasal surgery. METHODOLOGY: SINUS-24 patients were randomised 1:1 to subcutaneous dupilumab 300 mg (n=143) or placebo (n=133) every 2 weeks (q2w) for 24 weeks. SINUS-52 patients were randomised 1:1:1 to 52 weeks of subcutaneous dupilumab 300 mg q2w (n=150), 24 weeks q2w followed by 28 weeks of dupilumab 300 mg every 4 weeks (n=145) or 52 weeks of placebo q2w (n=153). RESULTS: Dupilumab reduced the number of patients undergoing sinonasal surgery (82.6%), the need for in-study SCS use (73.9%), and SCS courses (75.3%). Significant improvements were observed with dupilumab vs placebo regardless of prior sinonasal surgery or SCS use in nasal polyp, nasal congestion, Lund-MacKay, and Sinonasal Outcome Test (22-items) scores, and the University of Pennsylvania Smell Identification Test. CONCLUSIONS: Dupilumab demonstrated significant improvements in disease signs and symptoms and reduced the need for sino-nasal surgery and SCS use versus placebo in patients with severe CRSwNP, regardless of SCS use in the previous 2 years, or prior sinonasal surgery.",
keywords = "Nasal polyps, Paranasal sinus diseases, Rhinitis, Sinusitis",
author = "M. Desrosiers and Mannent, {L. P.} and N. Amin and Canonica, {G. W.} and Hellings, {P. W.} and P. Gevaert and J. Mullol and Lee, {S. E.} and S. Fujieda and Han, {J. K.} and C. Hopkins and W. Fokkens and R. Jankowski and Cho, {S. H.} and X. Mao and M. Zhang and Rice, {M. S.} and Khan, {A. H.} and S. Kamat and N. Patel and Graham, {N. M. H.} and M. Ruddy and C. Bachert",
note = "Funding Information: This research was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. ClinicalTrials.gov Identifiers: NCT02912468 (SINUS-24) and NCT02898454 (SINUS-52). Funding Information: board member; Kyorin Pharmaceuticals – speaker fees. Han JK: Sanofi – advisory board member. Hopkins C: GlaxoSmithKline, Optinose, Sanofi Genzyme, Smith and Nephew – advisory board member. Fokkens W: BioInspire Technologies, GlaxoSmithKline, Meda Pharmaceuticals, Sanofi – research grants. Jankowski R: ALK, Laboratoire de la Mer, Regeneron Pharmaceuticals, Inc., Sa-nofi – advisory board member. Cho SH: Regeneron Pharmaceuticals, Inc., Sanofi – research grant. Bachert C: ALK, AstraZeneca, GlaxoSmithKline, Mylan, Novartis, Sanofi, Stallergenes Greer – advisory board member and speakers{\textquoteright}fees. Funding Information: The authors thank the patients and their families for their participation in the studies; their colleagues for their support; Nora Crikelair (Regeneron Pharmaceuticals, Inc.) and Dianne Barry and Nadia Daizadeh (Sanofi) for their contributions, and J{\'e}r{\^o}me Msihid (Sanofi) for statistical analyses. Writing/editorial support in the preparation of this manuscript was provided by Sin{\'e}ad Holland, PhD, of Excerpta Medica, funded by Sanofi Genzyme and Regeneron Pharmaceuticals, Inc. Publisher Copyright: {\textcopyright} 2021, International Rhinologic Society. All rights reserved. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",
year = "2021",
month = jun,
day = "1",
doi = "https://doi.org/10.4193/Rhin20.415",
language = "English",
volume = "59",
pages = "301--311",
journal = "Rhinology",
issn = "0300-0729",
publisher = "University Hospital Utrecht",
number = "3",
}