We thank the patients, their families, the study sites, and the study personnel who participated in the BREEZE-AD1, BREEZE-AD2, and BREEZE-AD7 studies.

Funding

This study was sponsored by Eli Lilly and Company, under license from Incyte Corporation. The journal’s Rapid Service Fee was funded by Eli Lilly and Company.

Authorship

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.

Author’s Contributions

Amy DeLozier and Marta Casillas conceived and designed the study and analysis. Timo Buhl and Pablo Fernandez-Peñas were investigators and collected the data. Sherry Chen and Na Lu conducted the statistical analyses. Jacob P. Thyssen, Kenji Kabashima, and Sonja Ständer interpreted the data. All the authors had full access to all the data reported in the study and were involved in critically revising the manuscript for important intellectual content.

Medical Writing, Editorial, and Other Assistance

Catherine Lynch, a full-time employee of Eli Lilly and Company, assisted with manuscript preparation and process support.

Disclosures

Jacob P. Thyssen has served on advisory boards, acted as a speaker, or acted as an investigator for AbbVie, Eli Lilly and Company, LEO Pharma, Pfizer, Regeneron, and Sanofi-Genzyme; and has received grants/research support from Regeneron and Sanofi-Genzyme. Timo Buhl has received honoraria for lectures and advisory boards from ALK Abello, AstraZeneca, Eli Lilly and Company, Janssen, MEDA, Novartis, and Sanofi; and has received research grants from Eli Lilly and Company, Kiniksa, Philips, and Thermo Fisher. Pablo Fernández-Peñas has received grants/clinical trial contracts from AbbVie, AstraZeneca, BMS, CSL, Eli Lilly and Company, Eisai, Galderma, Janssen, Jiansu Hengrui, miRagen, Novartis, Oncosec, Pfizer, Sun Pharma, and UCB; received honoraria or consultation fees from AbbVie, Amgen, BI, BMS, Eli Lilly and Company, Janssen, Leo, Merck-Serono, MSD, Novartis, Pfizer, Sanofi, and UCB; and received compassionate supply of medication from AbbVie, Eli Lilly and Company, Janssen, and Novartis. Kenji Kabashima has received consulting fees, honoraria, grant support, and lecturing fees from Japan Tobacco, LEO Pharma, Maruho, Mitsubishi Tanabe, Ono Pharmaceutical, Procter & Gamble, Sanofi, Taiho, and Torii Pharmaceutical. Sherry Chen is a full-time employee of Tigermed. Na Lu is a consultant of IQVIA. Amy DeLozier and Marta Casillas are full-time employees, and own stock in, Eli Lilly and Company. Sonja Ständer has acted as an investigator for Dermasence, Galderma, Kiniksa Pharmaceuticals, Menlo Therapeutics, Trevi Therapeutics, Novartis, Sanofi, and Vanda Pharmaceuticals Inc.; and has acted as a consultant, speaker, and/or served on advisory boards for Almirall, Bayer, Beiersdorf, Bellus Health, Bionorica, Cara Therapeutics, Celgene, Clexio Biosciences, DS Biopharma, Eli Lilly and Company, Galderma, Menlo Therapeutics, Novartis, Perrigo, and Trevi Therapeutics.

Compliance with Ethics Guidelines

The studies were approved by all institutions. Details of the institutions and their ethics committees have been previously published [6, 15]. The studies were performed in accordance with the Helsinki Declaration of 1964, and its later amendments. All subjects provided informed consent to participate in the study.

Data Availability

Eli 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 USA 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, and 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 www.vivli.org.

Prior Presentation

These data were previously presented in part at the European Academy of Dermatology and Venereology (EADV) Congress; Madrid, Spain; 9–13 October 2019 (Silverberg J, et al. EADV 2019. FC07.03) and EADV Congress, Vienna, Austria (virtual event), 28 October–1 November 2020 (Buhl T, et al. EADV 2020. Virtual Meeting. P0231).