The authors thank the patients and their families for their participation in this study; their colleagues for their support; and Linda Williams (Regeneron Pharmaceuticals, Inc.), and Adriana Mello and El-Bdaoui Haddad (Sanofi Genzyme) for their contributions.
Research sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ClinicalTrials.gov Identifier NCT02260986. The study sponsors have funded the Journal’s Rapid Service fee for this paper.
Medical Writing and Editorial Assistance
Medical writing/editorial assistance provided by Vicki Schwartz, PhD, of Excerpta Medica, funded by Sanofi Genzyme and Regeneron Pharmaceuticals, Inc.
Content included in this manuscript was previously accepted for a poster presentation at the Society for Investigative Dermatology (SID) 2020 Annual Meeting; May 13–16, 2020. However, the meeting was held virtually, and no posters were presented. The abstract was published in the SID 2020 Meeting Abstract Supplement of the Journal of Investigative Dermatology (J Invest Dermatol. 2020;140[7Suppl]:S53[Abstract 407]).
Jonathan Weyne, Zhen Chen, Brad Shumel are employees and shareholders of Regeneron Pharmaceuticals, Inc. Andrew Blauvelt is a scientific adviser, clinical study investigator for AbbVie, Aclaris, Almirall, Arena, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Dermira, Eli Lilly, Forte, Galderma, Janssen, LEO Pharma, Novartis, Ortho Derm, Pfizer, Rapt, Regeneron Pharmaceuticals, Inc., Sandoz, Sanofi Genzyme, Sun Pharma, UCB; and a paid speaker for AbbVie. Marjolein de Bruin-Weller is a Principal Investigator, advisory board member, consultant for Regeneron Pharmaceuticals, Inc., Sanofi Genzyme; Principal Investigator, advisory board member for AbbVie, Pfizer; and an advisory board member for Eli Lilly, and UCB. Errol Prens has received honoraria and/or research grants from AbbVie, Amgen, Celgene, Eli Lilly, Galderma, Janssen-Cilag, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Sandoz, Sanofi Genzyme, and UCB. Penny Asbell is an advisory board member and consultant for Regeneron Pharmaceuticals, Inc. Debra Sierka is an employee, and may hold stock and/or stock options in Sanofi Genzyme.
Compliance with Ethics Guidelines
The study was conducted in accordance with the provisions of the Declaration of Helsinki, the International Conference on Harmonisation Good Clinical Practice guideline, and applicable regulatory requirements. The protocol was reviewed and approved by institutional review boards/ethics committees at all study sites. An independent data monitoring committee monitored patient safety. All patients provided signed written informed consent.
All authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
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 manuscript. Individual anonymized participant data will be considered for sharing once the product and indication has been approved by major health authorities (e.g., FDA, EMA, PMDA, etc), if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification. Submit requests to https://vivli.org/.