The authors would like to thank the patients and study investigators who participated in the study.
The study was sponsored by Eli Lilly and Company, under license from Incyte Corporation. The sponsor funded the journal’s Rapid Service fee.
All named 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.
Study conception and design: Fabio P. Nunes. Acquisition of data: Jamie Weisman. Analysis and interpretation of data: Mark Boguniewicz, Yuxin Ding, Meghan Feely, Fabio P. Nunes, Jonathan I. Silverberg, Eric L. Simpson, Lindsay Strowd, Luna Sun, and Jill Waibel.
Medical Writing, Editorial, and Other Assistance
Medical writing assistance in preparation of this article was provided by Nicole Byers of Eli Lilly and Company. Support for this assistance was funded by Eli Lilly and Company.
Jonathan I. Silverberg served as a consultant and/or advisory board member for AbbVie, Arena, Asana, Bluefin, Boehringer-Ingelheim, Dermavant, Dermira, Eli Lilly and Company, Galderma, GlaxoSmithKline, Glenmark, Incyte, Kiniksa, Leo, Luna, Novartis, Pfizer, RAPT, Regeneron, Sanofi, receiving honoraria; served as a speaker for Regeneron-Sanofi; and received research grants from Galderma. Mark Boguniewicz served as an investigator for Incyte and Regeneron and a consultant and/or advisory board member for AbbVie, Eli Lilly and Company, Janssen, LEO Pharma, Pfizer, Regeneron, and Sanofi-Genzyme. Jill Waibel served as a consultant and/or investigator for, and/or received personal fees from AbbVie, Allergan, Almirall, AstraZeneca, Avita Medical, Biofrontera, Candela, Cytrellis, Dermira, Dominion Aesthetics, Eli Lilly and Company, Michaelson Diagnostics, Novartis, Pfizer, and Sciton. Jamie Weisman served as a speaker and/or investigator and/or has received grants and/or honoraria from AbbVie, Amgen, Biogen, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, Stiefel, and Valeant Pharmaceuticals. Lindsay Strowd has received support from Actelion, Eli Lilly and Company, Galderma, Pfizer, Regeneron, and Sanofi. Luna Sun, Yuxin Ding, and Meghan Feely are employees and shareholders of Eli Lilly and Company. Meghan Feely is also a clinical instructor at Mount Sinai. Fabio P. Nunes is a former employee of Eli Lilly and Company and is a current employee and shareholder of Janssen Pharmaceuticals Companies of Johnson and Johnson. Eric L. Simpson received grants and fees for participation as a consultant and principal investigator from Eli Lilly and Company, LEO Pharma, Pfizer, and Regeneron; grants for participation as a principal investigator from Galderma and Merck & Co.; and fees for consultant services from AbbVie, Boehringer Ingelheim, Dermavant Incyte, Forte Bio, Pierre Fabre Dermo, and Sanofi Genzyme.
Compliance with Ethics Guidelines
This trial was conducted in accordance with the ethical principles of the Helsinki Declaration of 1964 and its later amendments and Good Clinical Practice guidelines and approved by the appropriate institutional review boards/ethics committees at each study site (Table S1), including the Quorum Review IRB (approval #33039). All patients provided written informed consent.
Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the US and EU and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at https://www.vivli.org.
This work was presented as an oral presentation at the 2020 Revolutionizing Atopic Dermatitis Virtual Congress.