@article{f5a938e16dba44f8ac029a2c509e6cca,
title = "Dupilumab Efficacy in Steroid-Dependent Severe Asthma by Baseline Oral Corticosteroid Dose",
abstract = "Background: Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4/-13, key and central drivers of type 2 inflammation in multiple diseases. In the phase 3 LIBERTY ASTHMA VENTURE (VENTURE) study (NCT02528214), dupilumab versus placebo reduced oral corticosteroid (OCS) dose and improved clinical outcomes in patients with OCS-dependent severe asthma. Dupilumab efficacy in patients with varying disease burden (defined by baseline OCS dose) has not been assessed. Objective: This post hoc analysis of VENTURE evaluated dupilumab efficacy across subgroups defined by baseline OCS dose. Methods: The OCS dose, proportion no longer needing OCS at week 24, annualized severe exacerbation rate, and least squares mean change from baseline in pre- and post-bronchodilator forced expiratory volume in 1 second at week 24 were evaluated in VENTURE patients with OCS-dependent severe asthma receiving dupilumab 300 mg every 2 weeks versus placebo, categorized by a baseline OCS dose of less than 10 mg/d or 10 or more mg/d. Results: Dupilumab reduced daily OCS dose from baseline at week 24 in both dose groups. In dupilumab-/placebo-treated patients with a baseline OCS dose of less than 10 mg/d and 10 or more mg/d, 72%/42% and 37%/23% stopped OCS by week 24 (P < .01/P < .05), respectively. Dupilumab significantly reduced the annualized severe exacerbation rate by 71% and 48% (P < .01/P < .05). At week 24, dupilumab improved pre- and post-bronchodilator forced expiratory volume in 1 second in patients in both dose groups. Conclusions: In patients with OCS-dependent severe asthma receiving lower or higher baseline OCS doses, dupilumab significantly reduced the OCS dose and improved the likelihood of no longer requiring OCS while also reducing exacerbations and improving lung function.",
keywords = "Asthma, Chronic oral corticosteroids, Dupilumab, Exacerbation, Interleukin-13, Interleukin-4, Lung function",
author = "Christian Domingo and Maspero, {Jorge F.} and Mario Castro and Hanania, {Nicola A.} and Ford, {Linda B.} and Halpin, {David M.G.} and Jackson, {David J.} and Nadia Daizadeh and Michel Djandji and Mitchell, {Colin P.} and Nora Crikelair and Jacob-Nara, {Juby A.} and Yamo Deniz and Rowe, {Paul J.} and Benjamin Ortiz",
note = "Funding Information: Research sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ClinicalTrials.gov Identifier: NCT02528214. Medical writing/editorial assistance was funded by Sanofi Genzyme and Regeneron Pharmaceuticals, Inc., according to the Good Publication Practice guideline.Conflicts of interest: C. Domingo reports travel and speaker fees from ALK, Allergy Therapeutics, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Esteve, Ferrer Pharma, GlaxoSmithKline, HAL Allergy, ImmunoTek, Menarini, Novartis, Pfizer, Sanofi-Aventis, Stallergenes Greer, Takeda, and Teva. J. F. Maspero is a consultant for AstraZeneca and Sanofi; has received speaker fees from GlaxoSmithKline, Menarini, Novartis, and Uriach; and has received research grants from Novartis. M. Castro reports research support from American Lung Association, AstraZeneca, GlaxoSmithKline, National Institutes of Health (NIH), Novartis, PCORI, Pulmatrix, Sanofi-Aventis, and Shionogi; is a consultant for Genentech, Novartis, Sanofi-Aventis, and Teva; reports speaker fees from AstraZeneca, Genentech, GlaxoSmithKline, Regeneron Pharmaceuticals, Inc., Sanofi, and Teva; and reports royalties from Elsevier. N. A. Hanania reports research support from AstraZeneca, Boehringer Ingelheim, and GlaxoSmithKline; and is a consultant for AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Regeneron Pharmaceuticals, Inc., and Sanofi. L. B. Ford reports grant support through institution from 3M, Aimmune Therapeutics, AstraZeneca, DBV Technologies, Genentech, GlaxoSmithKline, Glenmark, Hoffmann-La Roche, Novartis, Pearl Pharmaceuticals, Sanofi, and Teva; and is a national consultant for Sanofi. D. M. G. Halpin is an advisory board member and has received speaker fees from AstraZeneca, Boehringer Ingelheim, Chiesi, CSL Behring, GlaxoSmithKline, Novartis, Pfizer, Sandoz, and Sanofi. D. J. Jackson reports advisory board fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Sanofi, and Teva. N. Daizadeh is a former employee of Sanofi and may hold stock and/or stock options in the company. M. Djandji, C. P. Mitchell, J. A. Jacob-Nara, and P. J. Rowe are employees of Sanofi and may hold stock and/or stock options in the company. N. Crikelair and Y. Deniz are employees and shareholders of Regeneron Pharmaceuticals, Inc. B. Ortiz is a former employee and shareholder of Regeneron Pharmaceuticals, Inc.This research was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ClinicalTrials.gov Identifier: NCT02528214. Medical writing/editorial assistance was provided by Erin McClure Carroll, PhD, of Excerpta Medica, and was funded by Sanofi Genzyme and Regeneron Pharmaceuticals, Inc., according to the Good Publication Practice guideline. Funding Information: Research sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ClinicalTrials.gov Identifier: NCT02528214 . Medical writing/editorial assistance was funded by Sanofi Genzyme and Regeneron Pharmaceuticals, Inc. , according to the Good Publication Practice guideline. Funding Information: Conflicts of interest: C. Domingo reports travel and speaker fees from ALK, Allergy Therapeutics, Almirall, AstraZeneca , Boehringer Ingelheim , Chiesi, Esteve, Ferrer Pharma, GlaxoSmithKline , HAL Allergy, ImmunoTek, Menarini, Novartis , Pfizer , Sanofi-Aventis, Stallergenes Greer, Takeda , and Teva. J. F. Maspero is a consultant for AstraZeneca and Sanofi; has received speaker fees from GlaxoSmithKline , Menarini, Novartis , and Uriach; and has received research grants from Novartis . M. Castro reports research support from American Lung Association , AstraZeneca , GlaxoSmithKline , National Institutes of Health (NIH), Novartis , PCORI , Pulmatrix, Sanofi-Aventis, and Shionogi; is a consultant for Genentech , Novartis , Sanofi-Aventis, and Teva; reports speaker fees from AstraZeneca , Genentech , GlaxoSmithKline , Regeneron Pharmaceuticals, Inc. , Sanofi , and Teva; and reports royalties from Elsevier. N. A. Hanania reports research support from AstraZeneca , Boehringer Ingelheim , and GlaxoSmithKline; and is a consultant for AstraZeneca , Boehringer Ingelheim , GlaxoSmithKline , Novartis , Regeneron Pharmaceuticals, Inc. , and Sanofi . L. B. Ford reports grant support through institution from 3M, Aimmune Therapeutics , AstraZeneca , DBV Technologies, Genentech , GlaxoSmithKline , Glenmark, Hoffmann-La Roche , Novartis , Pearl Pharmaceuticals, Sanofi , and Teva; and is a national consultant for Sanofi . D. M. G. Halpin is an advisory board member and has received speaker fees from AstraZeneca , Boehringer Ingelheim , Chiesi, CSL Behring , GlaxoSmithKline , Novartis , Pfizer , Sandoz, and Sanofi . D. J. Jackson reports advisory board fees from AstraZeneca , Boehringer Ingelheim , GlaxoSmithKline , Novartis , Sanofi , and Teva. N. Daizadeh is a former employee of Sanofi and may hold stock and/or stock options in the company. M. Djandji, C. P. Mitchell, J. A. Jacob-Nara, and P. J. Rowe are employees of Sanofi and may hold stock and/or stock options in the company. N. Crikelair and Y. Deniz are employees and shareholders of Regeneron Pharmaceuticals, Inc. B. Ortiz is a former employee and shareholder of Regeneron Pharmaceuticals, Inc. Funding Information: This research was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ClinicalTrials.gov Identifier: NCT02528214 . Medical writing/editorial assistance was provided by Erin McClure Carroll, PhD, of Excerpta Medica, and was funded by Sanofi Genzyme and Regeneron Pharmaceuticals, Inc. , according to the Good Publication Practice guideline. Publisher Copyright: {\textcopyright} 2022 The Authors",
year = "2022",
month = jul,
doi = "10.1016/j.jaip.2022.03.020",
language = "English",
volume = "10",
pages = "1835--1843",
journal = "The Journal of Allergy and Clinical Immunology: In Practice",
issn = "2213-2198",
publisher = "Elsevier",
number = "7",
}
