@article{a9326fdc00fb45b788bd2591f919e6a2,
title = "Dupilumab Demonstrates Rapid Onset of Response Across Three Type 2 Inflammatory Diseases",
abstract = "Background: Type 2 inflammatory diseases often coexist in patients. Dupilumab targets type 2 inflammation and has demonstrated treatment benefits in patients with atopic dermatitis (AD), asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP) with an acceptable safety profile. Objective: This post hoc analysis across five phase 3 studies in patients with moderate to severe AD or asthma, or severe CRSwNP, evaluated time of onset and duration of the treatment response. Methods: Patients received subcutaneous dupilumab 200/300 mg or placebo. Assessments included the Eczema Area and Severity Index, Peak Pruritus Numerical Rating Scale, and Dermatology Life Quality Index in AD; pre-bronchodilator FEV1, daily morning peak expiratory flow, and symptom scores in asthma; and University of Pennsylvania Smell Identification Test, daily nasal congestion, and loss of smell scores in CRSwNP. Results: At week 2 after the initiation of dupilumab versus placebo, 67.8% versus 36.5% of AD patients achieved a clinically meaningful benefit (Eczema Area and Severity Index: 50% or greater improvement; Peak Pruritus Numerical Rating Scale: 3 point or greater improvement; or Dermatology Life Quality Index: 4 point or greater improvement) (P < .001). Moreover, 61.6% versus 39.9% of asthma patients achieved improvements in pre-bronchodilator FEV1 of 100 mL or greater and 48.8% versus 26.3% achieved 200 mL or greater improvement (both P < .001); 33.2% versus 5.6% of CRSwNP patients regained a sense of smell (P < .001). Treatment effects further improved or were sustained to the end of treatment. Conclusions: Clinically meaningful responses were achieved rapidly after the first dupilumab dose in AD, asthma, or CRSwNP and were sustained throughout treatment (see Video in this article's Online Repository at www.jaci-inpractice.org).",
keywords = "Anti-IL-13, Anti-IL-4, Asthma, Dupilumab, Rapid onset",
author = "Canonica, {G. Walter} and Arnaud Bourdin and Peters, {Anju T.} and Martin Desrosiers and Claus Bachert and Stephan Weidinger and Simpson, {Eric L.} and Nadia Daizadeh and Zhen Chen and Siddhesh Kamat and Khan, {Asif H.} and Jingdong Chao and Graham, {Neil M.H.} and Elizabeth Laws and Rossi, {Ana B.} and Marius Ardeleanu and Mannent, {Leda P.} and Nikhil Amin and Benjamin Ortiz and Yamo Deniz and Michel Djandji and Rowe, {Paul J.}",
note = "Funding Information: This work was supported by Sanofi and Regeneron Pharmaceuticals, Inc.We thank the participating investigators and patients of the phase 3 LIBERTY AD SOLO-1 (NCT02277743), LIBERTY AD SOLO-2 (NCT02277769), LIBERTY ASTHMA QUEST (NCT02414854), LIBERTY NP SINUS-24 (NCT02912468), and LIBERTY NP SINUS-52 (NCT02898454) studies. We would also like to thank Nora Crikelair, Linda Williams, and Richa Attre at Regeneron Pharmaceuticals, Inc. and Colin Mitchell, Ledia Goga, and El-Bdaoui Haddad at Sanofi. Medical writing and editorial assistance were provided by Jennifer L.F. Port, PhD, of Excerpta Medica, and was funded by Sanofi and Regeneron Pharmaceuticals, Inc. according to the Good Publication Practice guideline. Conflicts of interest: G.W. Canonica reports speaker fees and serving as an advisory board member at ALK, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, HAL Allergy, Menarini, Mundipharma, Novartis, Regeneron Pharmaceuticals, Inc., Sanofi, and Stallergenes Greer. A. Bourdin reports other affiliations at Acceleron Pharma, Actelion, Galapagos, Merck Sharp & Dohme, Nuvaira, Pulmonx, United Therapeutics, and Vertex Pharmaceuticals; personal fees from AstraZeneca, Chiesi, GlaxoSmithKline, Regeneron Pharmaceuticals, Inc., and Sanofi; grants and personal fees from Boehringer Ingelheim; and nonfinancial support during the conduct of the study from GlaxoSmithKline. A.T. Peters reports research support from AstraZeneca; serving as a consultant at Optinose; and research support and serving as a consultant at Regeneron Pharmaceuticals, Inc., and Sanofi. M. Desrosiers reports clinical trial funding from AstraZeneca, GlaxoSmithKline, Probionase Therapies, and Sanofi; has served as an advisory board member at Regeneron Pharmaceuticals, Inc., and Sanofi; and is an equity holder at Probionase Therapies. C. Bachert reports serving as an advisory board member at ALK, AstraZeneca, Novartis, and Sanofi. S. Weidinger reports giving lectures at educational events for AbbVie, Galderma, LEO Pharma, Regeneron Pharmaceuticals, Inc., and Sanofi Genzyme; serving as a co-principal investigator at Treatment of Atopic Eczema (TREAT) Registry Taskforce Germany; serving as a consultant at Incyte, LEO Pharma, Novartis, Regeneron Pharmaceuticals, Inc., and Sanofi Genzyme; institutional research grants at LEO Pharma, L'Or{\'e}al, Novartis, and Pfizer; and conducting clinical trials for many pharmaceutical industries that manufacture drugs used for the treatment of psoriasis and atopic eczema. E.L. Simpson reports grants and research support from Amgen, Celgene, Chugai, Eli Lilly, Galderma, Genentech, MedImmune, Regeneron Pharmaceuticals, Inc., Sanofi, Tioga Pharmaceuticals, and Vanda Pharmaceuticals; and serving as a consultant at Anacor Pharmaceuticals, Celgene, Galderma, Genentech, Medicis Pharmaceutical, Merck, and Sanofi/Regeneron Pharmaceuticals, Inc. N. Daizadeh is a prior employee at Sanofi and may hold stock and/or stock options in the company. A.H. Khan, E. Laws, A.B. Rossi, L.P. Mannent, M. Djandji, and P.J. Rowe are employees at Sanofi and may hold stock and/or stock options in the company. Z. Chen, S. Kamat, J.D. Chao, M. Ardeleanu, and Y. Deniz are employees and shareholders at Regeneron Pharmaceuticals, Inc. N.M.H. Graham, N. Amin, and B. Ortiz are prior employees and shareholders at Regeneron Pharmaceuticals, Inc. Funding Information: This work was supported by Sanofi and Regeneron Pharmaceuticals , Inc. Publisher Copyright: {\textcopyright} 2022 The Authors",
year = "2022",
month = jun,
doi = "10.1016/j.jaip.2022.02.026",
language = "English (US)",
volume = "10",
pages = "1515--1526",
journal = "Journal of Allergy and Clinical Immunology: In Practice",
issn = "2213-2198",
publisher = "Elsevier",
number = "6",
}