Blauvelt, Andrew
Guttman-Yassky, Emma
Paller, Amy S.
Simpson, Eric L.
Cork, Michael J.
Weisman, Jamie
Browning, John
Soong, Weily
Sun, Xian
Chen, Zhen
Kosloski, Matthew P.
Kamal, Mohamed A.
Delevry, Dimittri
Chuang, Chien-Chia
O’Malley, John T.
Bansal, Ashish http://orcid.org/0000-0002-7371-6486
Funding for this research was provided by:
Sanofi and Regeneron Pharmaceuticals, Inc.
Article History
Accepted: 7 March 2022
First Online: 14 May 2022
Change Date: 20 May 2022
Change Type: Update
Change Details: The original publication was revised due to update of video caption.
Declarations
:
: This research was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. (ClinicalTrials.gov identifier: NCT03345914). The study sponsors participated in the study design; the collection, analysis, and interpretation of the data; the writing of the report; and the decision to submit the article for publication. Medical writing/editorial assistance was provided by Ekaterina Semenova, PhD, of Excerpta Medica, funded by Sanofi Genzyme and Regeneron Pharmaceuticals, Inc., according to the Good Publication Practice Guideline.
: Andrew Blauvelt is a scientific advisor and clinical study investigator for AbbVie, Abcentra, Aligos, Almirall, Amgen, Arcutis, Arena, Aslan, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly and Company, Evommune, Forte, Galderma, Incyte, Janssen, Landos, LEO Pharma, Novartis, Pfizer, Rapt, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, Sun Pharma, UCB Pharma, and Vibliome. Emma Guttman-Yassky has received personal fees from AbbVie, Allergan, Amgen, Asana BioSciences, Celgene, Concert, Dermavant, Dermira, DS Biopharma, Eli Lilly and Company, Escalier BioSciences, Galderma, Glenmark, Kyowa Kirin, LEO Pharma, Mitsubishi Tanabe, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., and Sanofi; and has received grants paid to the institution from AbbVie, Asana Biosciences, Celgene, Concert, Dermavant, Dermira, DS Biopharma, Galderma, Glenmark, Innovaderm, LEO Pharma, Novan, Novartis, Pfizer, Ralexar Therapeutics, and Regeneron Pharmaceuticals, Inc. Amy S. Paller has served as a scientific advisor, clinical study investigator, and/or data safety monitoring board member for AbbVie, Arena, Bausch, Bristol Myers Squibb, Dermavant, Eli Lilly and Company, Forte, Incyte, Janssen, LEO Pharma, Lifemax, Novartis, Pfizer, Rapt, Regeneron Pharmaceuticals, Inc., Sanofi, and UCB. Eric L. Simpson has received personal fees from AbbVie, Boehringer Ingelheim, Collective Acumen LLC, Eli Lilly and Company, Forte Bio, Incyte, Janssen, Kyowa Hakko Kirin, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Pierre Fabre Dermo Cosmetique, Regeneron Pharmaceuticals, Inc., Roivant, Sanofi, and Valeant; and grants (or undertaken a principal investigator role) from AbbVie, Eli Lilly and Company, Incyte, Kyowa Hakko Kirin, LEO Pharma, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, Tioga, and Vanda. Michael J. Cork has been a consultant and/or advisory board member for and/or received research grants from Astellas Pharma, Atopix, Boots, Dermavant, Eli Lilly and Company, Galapagos, Galderma, Hyphens Pharma, Johnson & Johnson, Kymab, L’Oréal, LEO Pharma, Menlo, Novartis, Oxagen, Perrigo (ACO Nordic), Pfizer, Procter & Gamble, Reckitt Benckiser, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, UCB Pharma, and the National Eczema Society, UK. Jamie Weisman has been an advisory board member or participated in a speaker’s bureau for AbbVie, Eli Lilly and Company, Janssen, Regeneron Pharmaceuticals, Inc., and UCB and received research grants from AbbVie, Allergan, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Dermira, Eli Lilly and Company, Galderma, GlaxoSmithKline, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., and UCB. John Browning has been an investigator for Amryt Pharma, Arcutis Biotherapeutics, Bristol Myers Squibb, Brickell Biotech, ChemoCentryx, Eli Lilly and Company, Galderma, Incyte, Lenus Pharma, LEO Pharma, Mayne Pharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., and Valeant; has been an advisor for Dermavant and LEO Pharma; and has been a speaker for Dermira, Pfizer, and Regeneron Pharmaceuticals, Inc. Weily Soong has received research funding from AbbVie, AstraZeneca, Cara, Galderma, Genentech, GlaxoSmithKline, Glenmark, Innovaderm, LEO Pharma, Mandala, Menlo, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Relaxar, Sanofi, Symbio, Teva, and Vanda Pharmaceuticals; has received speaker fees from AstraZeneca, GlaxoSmithKline, Optinose, Regeneron Pharmaceuticals, Inc., and Sanofi; and has received consulting fees from AbbVie, Genentech, and Regeneron Pharmaceuticals, Inc. Xian Sun, Zhen Chen, Matthew P. Kosloski, Mohamed A. Kamal, Dimittri Delevry, and Ashish Bansal are employees and shareholder of Regeneron Pharmaceuticals, Inc. Chien-Chia Chuang and John T. O’Malley are employees of and may hold stock and/or stock options in Sanofi.
: Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, and statistical analysis plan) that support the methods and findings reported in this manuscript. Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, 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.
: The study was conducted following the ethical principles derived from the Declaration of Helsinki, the International Conference on Harmonisation guidelines, Good Clinical Practice, and local applicable regulatory requirements. Written informed consent was obtained from all patients and the patients’ parents/guardians prior to commencement of any study treatment.
: All patients provided written consent/assent, and at least one parent or guardian for each adolescent patient provided written informed consent. All people named in the Acknowledgements section gave written permission to be named in the manuscript.
: Not applicable.
: Andrew Blauvelt and Ashish Bansal contributed to the study concept and design. Andrew Blauvelt, Emma Guttman-Yassky, Amy S. Paller, Eric L. Simpson, Michael J. Cork, Jamie Weisman, John Browning, and Weily Soong acquired data. Xian Sun and Zhen Chen conducted the statistical analyses of the data. All authors interpreted the data, provided critical feedback on the manuscript, approved the final manuscript for submission, and are accountable for the accuracy and integrity of the manuscript.