Funding

This study was funded by Incyte Corporation (Wilmington, DE).

Conflict of interest

LFE has served as a consultant, speaker, advisory board member, or investigator for AbbVie, Amgen, Arcutis, Aslan, Bristol-Myers Squibb, Castle Biosciences, Dermavant, Eli Lilly, Forte, Galderma, Incyte, Janssen, Johnson & Johnson, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi–Genzyme, Target RWE, and UCB. ELS is an investigator for AbbVie, Eli Lilly, Galderma, Kyowa Hakko Kirin, LEO Pharma, Merck, Pfizer, and Regeneron and is a consultant with honorarium for AbbVie, Eli Lilly, Forte, Galderma, Incyte, LEO Pharma, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi Genzyme, and Valeant. KP has received honoraria or clinical research grants as a consultant, speaker, scientific officer, advisory board member, and/or steering committee member for AbbVie, Akros, Amgen, Anacor, Arcutis, Astellas, Bausch Health/Valeant, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite, Celgene, Coherus, Dermira, Dow Pharmaceuticals, Eli Lilly, Galderma, Gilead, GlaxoSmithKline, Incyte, InflaRx, Janssen, Kyowa Hakko Kirin, LEO Pharma, Meiji Seika Pharma, Merck (MSD), Merck Serono, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi-Aventis/Genzyme, Sun Pharmaceuticals, Takeda, and UCB. JCS has served as an advisor for AbbVie, LEO Pharma, Menlo Therapeutics, Novartis, Pierre Fabre, and Trevi; has received speaker honoraria from AbbVie, Eli Lilly, Janssen-Cilag, LEO Pharma, Novartis, Sanofi-Genzyme, and Sun Pharma; and has received clinical trial funding from AbbVie, Almirall, Amgen, Galapagos, Holm, Incyte, InflaRX, Janssen-Cilag, Menlo Therapeutics, Merck, Novartis, Pfizer, Regeneron, Trevi, and UCB. AB has served as a speaker (received honoraria) for AbbVie, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, Regeneron, and Sanofi; served as a scientific adviser (received honoraria) for AbbVie, Abcentra, Affibody, Aligos, Almirall, Alumis, Amgen, Anaptysbio, Arcutis, Arena, Aslan, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, Dermavant, EcoR1, Eli Lilly and Company, Escient, Evelo, Evommune, Forte, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, Leo, Merck, Novartis, Pfizer, Rani, Rapt, Regeneron, Sanofi–Genzyme, Spherix Global Insights, Sun Pharma, TLL Pharmaceutical, TrialSpark, UCB Pharma, Vibliome, and Xencor; and has acted as a clinical study investigator (institution has received clinical study funds) for AbbVie, Acelyrin, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Concert, Dermavant, Eli Lilly and Company, Evelo, Evommune, Galderma, Incyte, Janssen, Leo, Merck, Novartis, Pfizer, Regeneron, Sun Pharma, and UCB Pharma. LK has served as an investigator, consultant, or speaker for AbbVie, Amgen, Anaptys, Arcutis, Dermavant, Eli Lilly, Glenmark, Incyte, Kamedis, LEO Pharma, L’Oreal, Menlo Therapeutics, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi, Sun Pharma, and Taro. JIS received honoraria for advisory board, speaker, and consultant services from AbbVie, Asana, Bluefin, Boehringer Ingelheim, Celgene, Dermavant, Dermira, Eli Lilly, Galderma, GlaxoSmithKline, Glenmark, Incyte, Kiniksa, LEO Pharma, Menlo, Novartis, Pfizer, Realm, Regeneron, and Sanofi and research grants for investigator services from GlaxoSmithKline and Galderma. ECS has received consulting fees from AbbVie, Boehringer Ingelheim, Incyte, LEO Pharma, Novan, Novartis, Pfizer, Pierre Fabre, Regeneron, Sanofi Genzyme, UCB, and Verrica; has served as a contract researcher for AI Therapeutics; has received grant funding from Pfizer; has served as an investigator for Janssen; has received institutional funding related to clinical trial sponsorship from Janssen, Lilly, Pierre Fabre, Regeneron, and Verrica; and has served as a data safety monitoring board member for LEO Pharma, Novan, Pfizer, and UCB. MEK and MEV were employees of Incyte at the time of the study. HK and HR are employees and shareholders of Incyte. ASP has served as an investigator, speaker, or data safety monitoring board member for AbbVie, Abeona, Aegerion Pharma, Azitra, BioCryst, Boehringer Ingelheim, Bristol Myers Squibb, Castle Creek, Catawba, Dermavant, Eli Lilly, Galderma, InMed, Janssen, Krystal, LEO Pharma, Novartis, Regeneron, Sanofi/Genzyme, Seanergy, TWI Biotechnology, and UCB.

Availability of Data and Materials

Incyte Corporation (Wilmington, DE) is committed to data sharing that advances science and medicine while protecting patient privacy. Qualified external scientific researchers may request anonymized datasets owned by Incyte for the purpose of conducting legitimate scientific research. Researchers may request anonymized datasets from any interventional study (except phase 1 studies) for which the product and indication have been approved on or after 1 January 2020 in at least one major market (e.g., USA, Europe Union, and Japan). Data will be available for request after the primary publication or 2 years after the study has ended. Information on Incyte’s clinical trial data sharing policy and instructions for submitting clinical trial data requests are available at: https://www.incyte.com/Portals/0/Assets/Compliance%20and%20Transparency/clinical-trial-data-sharing.pdf?ver=2020-05-21-132838-960

Ethics Approval

This study was conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki. The protocols were approved by the relevant institutional review board or ethics committee at each study site.

Consent to Participate

Written informed consent/assent was provided by all patients before enrollment.

Consent for Publication

Not applicable.

Code Availability

Not applicable.

Author Contributions

LFE, MEK, and MEV made substantial contributions to the conception and design of the work. LFE, ELS, KP, JCS, AB, and LK all made substantial contributions to the acquisition of data. HR made substantial contributions to the analysis of the data; all authors made substantial contributions to the interpretation of data. All authors drafted the work and revised it critically for important intellectual content, approved the version to be published, and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.