Bansal, Ashish http://orcid.org/0000-0002-7371-6486
Simpson, Eric L.
Paller, Amy S.
Siegfried, Elaine C.
Blauvelt, Andrew
de Bruin-Weller, Marjolein
Corren, Jonathan
Sher, Lawrence
Guttman-Yassky, Emma
Chen, Zhen
Daizadeh, Nadia
Kamal, Mohamed A.
Shumel, Brad
Mina-Osorio, Paola
Mannent, Leda
Patel, Naimish
Graham, Neil M. H.
Khokhar, Faisal A.
Ardeleanu, Marius
Clinical trials referenced in this document:
Documents that mention this clinical trial
Responder Threshold for Patient-Oriented Eczema Measure (POEM) and Children’s Dermatology Life Quality Index (CDLQI) in Adolescents with Atopic Dermatitis
https://doi.org/10.1007/s13555-019-00333-2
Conjunctivitis in Dupilumab Clinical Trials for Adolescents with Atopic Dermatitis or Asthma
https://doi.org/10.1007/s40257-020-00577-1
Documents that mention this clinical trial
Dupilumab Safety and Efficacy in a Phase III Open-Label Extension Trial in Children 6–11 Years of Age with Severe Atopic Dermatitis
https://doi.org/10.1007/s13555-023-01016-9
161 52-Week Laboratory Safety Findings From an Open-Label Extension Study of Dupilumab in Adolescent Patients With Atopic Dermatitis (LIBERTY AD PED-OLE)
https://doi.org/10.1136/archdischild-2021-europaediatrics.161
Conjunctivitis in Dupilumab Clinical Trials for Adolescents with Atopic Dermatitis or Asthma
https://doi.org/10.1007/s40257-020-00577-1
Documents that mention this clinical trial
S49 Dupilumab improves lung function across baseline disease characteristics in patients with evidence of type 2 inflammation at baseline: the LIBERTY ASTHMA QUEST study
https://doi.org/10.1136/thorax-2019-btsabstracts2019.55
S86 Long-term assessment of exacerbations and lung function in the LIBERTY ASTHMA TRAVERSE study, stratified by lung function improvements at the end of the phase 3 LIBERTY ASTHMA QUEST parent study
https://doi.org/10.1136/thorax-2021-btsabstracts.92
S118 Dupilumab efficacy is not affected by prior asthma exacerbation status in LIBERTY ASTHMA TRAVERSE open-label extension study
https://doi.org/10.1136/thorax-2023-btsabstracts.124
Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial
https://doi.org/10.1016/s0140-6736(16)30307-5
P44 Dupilumab reduces exacerbations and improves lung function in uncontrolled, moderate-to-severe asthma patients regardless of prior exacerbation history in the phase 3 LIBERTY ASTHMA QUEST study
https://doi.org/10.1136/thorax-2018-212555.202
S78 Dupilumab reduces risk of severe exacerbations and improves FEV1 regardless of baseline disease severity in patients with uncontrolled, moderate-to-severe asthma: data from the phase 3 LIBERTY ASTHMA QUEST study
https://doi.org/10.1136/thorax-2018-212555.84
S31 Dupilumab reduces severe exacerbations across baseline disease characteristics in patients with elevated baseline type 2 biomarkers: the LIBERTY ASTHMA QUEST study
https://doi.org/10.1136/thorax-2019-btsabstracts2019.37
S127 Relation between change in type 2 biomarker levels and efficacy outcomes in patients with asthma treated with dupilumab
https://doi.org/10.1136/thorax-2022-btsabstracts.133
Liberty Asthma QUEST: Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Dupilumab Efficacy/Safety in Patients with Uncontrolled, Moderate-to-Severe Asthma
https://doi.org/10.1007/s12325-018-0702-4
S128 Baseline characteristics of patients with asthma treated with dupilumab in a real-world setting: results from the RAPID registry
https://doi.org/10.1136/thorax-2022-btsabstracts.134
P124 Stability of fractional exhaled nitric oxide levels as a biomarker in patients with uncontrolled asthma
https://doi.org/10.1136/thorax-2023-btsabstracts.276
S135 Dupilumab efficacy vs standard of care in patients with uncontrolled, persistent asthma – a meta analysis
https://doi.org/10.1136/thorax-2020-btsabstracts.140
S84 Long-term efficacy of dupilumab: 3-year data of QUEST patients with moderate-to-severe asthma enrolled in LIBERTY ASTHMA TRAVERSE
https://doi.org/10.1136/thorax-2021-btsabstracts.90
Conjunctivitis in Dupilumab Clinical Trials for Adolescents with Atopic Dermatitis or Asthma
https://doi.org/10.1007/s40257-020-00577-1
Funding for this research was provided by:
Sanofi
Regeneron Pharmaceuticals
Article History
First Online: 22 January 2021
Declarations
:
: Research was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. Medical writing and editorial support were provided by Vicki Schwartz, PhD, of Excerpta Medica, funded by Sanofi Genzyme and Regeneron Pharmaceuticals, Inc. Open access was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc.
: Ashish Bansal, Zhen Chen, Mohamed A. Kamal, Brad Shumel, Paola Mina-Osorio, Neil M. H. Graham, Faisal A. Khokhar, and Marius Ardeleanu are employees and shareholders of Regeneron Pharmaceuticals, Inc. Eric L. Simpson reports grants from AbbVie, Celgene, Eli Lilly, Galderma, Kyowa Hakko Kirin, LEO Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., and Tioga; and personal fees from AbbVie, Boehringer-Ingelheim, Dermavant, Dermira, Eli Lilly, Forte Bio, Incyte, LEO Pharma, MedImmune, Menlo Therapeutics, Ortho Dermatologics, Pfizer, Pierre Fabre Dermo Cosmetique, Regeneron Pharmaceuticals, Inc., Sanofi, and Valeant. Amy S. Paller has served as a scientific adviser and/or clinical study investigator for Almirall, Amgen, Asana, Boehringer-Ingelheim, Castle Creek, Celgene, Dermavant, Dermira, Eli Lilly, Forte, Galderma, Incyte, Janssen, Lenus, LEO Pharma, Life Max, MEDACorp, Meiji Sieka, Novan, Novartis, Pierre Fabre, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, Sol Gel, and Verrica. Elaine C. Siegfried has served as a scientific adviser and/or clinical study investigator for Eli Lilly, Janssen, Novartis, Novan, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, UCB Pharma, and Verrica; as a paid speaker for Regeneron Pharmaceuticals, Inc.; and as a DSMB member for GSK, LEO Pharma, Novan, Pfizer, and UCB. Andrew Blauvelt has served as a scientific adviser and/or clinical study investigator for AbbVie, Aclaris, Almirall, Arena, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Dermira, Eli Lilly and Company, Forte, Galderma, Janssen, LEO Pharma, Novartis, Ortho, Pfizer, Rapt, Regeneron Pharmaceuticals, Inc., Sandoz, Sanofi Genzyme, Sun Pharma, and UCB Pharma; and as a paid speaker for AbbVie. Marjolein de Bruin-Weller has served as a principal investigator, consultant, and advisory board member for AbbVie; principal investigator, advisory board member, and consultant for Regeneron Pharmaceuticals, Inc. and Sanofi Genzyme; an advisory board member and consultant for Eli Lilly; a principal investigator, consultant, and advisory board member for LEO Pharma; a principal investigator, consultant, and advisory board member for Pfizer; and an advisory board member for UCB. Jonathan Corren has served as a speaker for AstraZeneca, Genentech, Novartis, Regeneron Pharmaceuticals, Inc., and Sanofi; has received consulting fees from AstraZeneca, Genentech, Novartis, Regeneron Pharmaceuticals, Inc., and Sanofi; has received research funds from AstraZeneca, Genentech, Novartis, Regeneron Pharmaceuticals, Inc., and Sanofi; and has served as an advisory board member for AstraZeneca, Genentech, Novartis, Regeneron Pharmaceuticals, Inc., and Sanofi. Lawrence Sher has served as an advisory board member for Aimmune, Optinose, Regeneron Pharmaceuticals, Inc., and Sanofi Genzyme; as a speaker for Aimmune, Regeneron Pharmaceuticals, Inc., and Sanofi Genzyme; and as a principal investigator for Aimmune, Amgen, AstraZeneca, Circassia, DBV Technologies, Galderma, GSK, Merck, Mylan, Novartis, Optinose, Pearl, Pfizer, Sanofi, and Teva; and has received grants from Glenmark, Genzyme, and Sanofi Genzyme. Emma Guttman-Yassky is an employee of Mount Sinai and has received research funds (grants paid to the institution) from AbbVie, Almirall, Amgen, AnaptysBio, Asana Biosciences, AstraZeneca, Boehringer-Ingelheim, Celgene, Dermavant, DS Biopharma, Eli Lilly, Galderma, Glenmark/Ichnos Sciences, Innovaderm, Janssen, Kiniska, Kyowa Kirin, LEO Pharma, Novan, Novartis, Pfizer, Ralexar, Regeneron Pharmaceuticals, Inc., Sienna Biopharma, UCB, and Union Therapeutics/Antibiotx; and is a consultant for AbbVie, Aditum Bio, Almirall, Alpine, Amgen, Arena, Asana Biosciences, AstraZeneca, Bluefin Biomedicine, Boehringer-Ingelheim, Boston Pharmaceuticals, Botanix, Bristol-Myers Squibb, Cara Therapeutics, Celgene, Clinical Outcome Solutions, DBV, Dermavent, Dermira, Douglas Pharmaceutical, DS Biopharma, Eli Lilly, EMD Serono, Evelo Bioscience, Evidera, FIDE, Galderma, GSK, Haus Bioceuticals, Ichnos Sciences, Incyte, Kyowa Kirin, Larrk Bio, LEO Pharma, Medicxi, Medscape, Neuralstem, Noble Insights, Novan, Novartix, Okava Pharmaceuticals, Pandion Therapeutics, Pfizer, Principia Biopharma, RAPT Therapeutics, Realm, Regeneron Pharmaceuticals, Inc., Sanofi, SATO Pharmaceutical, Sienna Biopharma, Seanegy Dermatology, Seelos Therapeutics, Serpin Pharma, Siolta Therapeutics, Sonoma Biotherapeutics, Sun Pharma, Target PharmaSolutions and Union Therapeutics/AntibioTx, Vanda Pharmaceuticals, Ventyx Biosciences, and Vimalan. Nadia Daizadeh, Leda Mannent, and Naimish Patel are employees of and may hold stock and/or stock options in Sanofi.
: All trials were conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and with the International Council for Harmonisation guidelines for good clinical practice and applicable regulatory requirements. The studies were approved by the appropriate institutional ethics committees at each participating institution.
: All patients provided written consent/assent, and at least one parent or guardian for each adolescent patient provided written informed consent.
: Not applicable.
: For LIBERTY AD ADOL (R668-AD-1526; NCT03054428) and LIBERTY AD PED-OLE (R668-AD-1434; NCT02612454): qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in this article. Individual anonymized participant data will be considered for sharing once the product and indication has been approved by major health authorities (e.g., US Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency), if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification. Submit requests to ExternalRef removed. For LIBERTY ASTHMA QUEST (EFC13579; NCT02414854): qualified researchers may request access to patient-level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient-level data will be anonymized and study documents will be redacted to protect the privacy of our trial participants. Further details on Sanofi’s data sharing criteria, eligible studies, and process for requesting access can be found at: ExternalRef removed.
: Not applicable.
: Ashish Bansal, Mohamed A. Kamal, Brad Shumel, Neil M. H. Graham, Faisal A. Khokar, and Marius Ardeleanu contributed to the study concept and design. Eric L. Simpson, Amy S. Paller, Elaine C. Siegfried, Andrew Blauvelt, Marjolein de Bruin-Weller, Jonathan Corren, Lawrence Sher, and Emma Guttman-Yassky acquired the data. Zhen Chen and Nadia Daizadeh conducted the statistical analyses on the data. Ashish Bansal and Brad Shumel drafted the manuscript with the medical writer. All authors interpreted the data, provided critical feedback on the manuscript, approved the final manuscript for submission, and were accountable for the accuracy and integrity of the article.