Safety and Tolerability of Ruxolitinib Cream in Adolescents with Mild-to-Moderate Atopic Dermatitis: Results From a 1-Year, Phase III, Open-Label Study

Conflicts of interest/competing interests

Joel C. Joyce has served as a consultant for Incyte Corporation, Pfizer, Regeneron, and Sanofi; a speaker for AbbVie and Sanofi; and an investigator for AbbVie, Aclaris Therapeutics, Amgen, Apogee, CorEvitas, Eli Lilly, Galderma, Incyte Corporation, Janssen, Novartis, Organon, Pfizer, Sanofi, and Verrica. H. Chih-ho Hong has served as a speaker, advisor, consultant, and/or investigator for AbbVie, Amgen, Arcutis, ASLAN, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Cutanea, Dermira, Dermavant, DS Biopharma, Eli Lilly, Evelo Biosciences, Galderma, GlaxoSmithKline, Incyte Corporation, InmageneBio, IQVIA, JAMP, Janssen, LEO Pharma, Medimmune, Merck, Mirimar, Novartis, Organon, Oruka, Pfizer, Regeneron, Roche, Sanofi-Genzyme, Takeda, and UCB. Dareen D. Siri has received research grants from AbbVie, Amgen, Apogee, Biorasi, Dermira (Eli Lilly), Galderma, Incyte Corporation, Pfizer, Q32, Regeneron, Sanofi, and UCB and was a speaker or advisor for AbbVie, Arcutis, Dermavant, Incyte Corporation, Pfizer, Regeneron, and Sanofi. Darryl Toth has served as an investigator for AbbVie, Arcutis, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermavant, Dermira, DS Biopharma, Eli Lilly, Galderma, Incyte Corporation, Janssen, Kymab, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, Reistone Biopharma, Sanofi, Sun Pharma, Takeda, UCB, and Zai Lab. Howard Kallender, YuTzu Kuo, and Diana Stefani-Hunyady are employees and shareholders of Incyte Corporation. Kim A. Papp has received honoraria and/or grants as a consultant, speaker, investigator, or scientific officer from AbbVie, Acelyrin, Akros, Alumis, Amgen, Arcutis, Bausch Health/Valeant, Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite Biopharma, Celltrion, Concert Pharmaceuticals, Dermavant, Dermira, DiCE Pharmaceuticals, DiCE Therapeutics, Eli Lilly and Company, Evelo Biosciences, Forbion, Galderma, Horizon Therapeutics, Incyte Corporation, Janssen, Kymab, Kyowa Hakko Kirin, LEO Pharma, Meiji Seika Pharma, Mitsubishi Pharma, Nimbus Therapeutics, Novartis, Pfizer, Reistone, Sanofi-Aventis/Genzyme, Sandoz, Sun Pharma, Takeda, Tarsus Pharmaceuticals, UCB Pharma, and Zai Lab.

Ethics approval

These studies were conducted in accordance with Good Clinical Practice guidelines, provisions of the Declaration of Helsinki, and applicable regulations. Study protocols were approved by each site’s institutional review board.

Consent to participate

Written informed consent was obtained from all patients before any study-related procedures were conducted.

Consent for publication

Not applicable.

Code availability

Not applicable.

Availability of data and material

Incyte Corporation 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 Corporation for the purpose of conducting legitimate scientific research. Researchers may request anonymized datasets from any interventional study (except phase I 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, European Union, Japan). Data will be available for request after the primary publication or 2 years after the study has ended. Information on Incyte Corporation’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.

Authors’ contributions

JCJ, HCH, DDS, DT, DS-H, and KAP contributed to data collection and interpretation. HK, YK, and DS-H contributed to data analysis and interpretation. All authors contributed to draft development and critical appraisal of the manuscript. All authors approved the final version of the manuscript for submission and reviewed and approved subsequent revisions leading to the final version.

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