Ruxolitinib Cream Monotherapy Improved Symptoms and Quality of Life in Adults and Adolescents with Mild-to-Moderate Atopic Dermatitis: Patient-Reported Outcomes from Two Phase III Studies

Funding

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

Competing Interests

ELS has served as an investigator for AbbVie, Eli Lilly, Galderma, Kyowa Hakko Kirin, LEO Pharma, Merck, Pfizer, and Regeneron and as a consultant with honoraria for AbbVie, Eli Lilly, Forte, Galderma, Incyte Corporation, LEO Pharma, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi, and Valeant. MA has served as a consultant, researcher, and/or has received research grants from AbbVie, Almirall, Amgen, Bayer, Beiersdorf, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Centocor, Dermira, Eli Lilly, Galderma, Genzyme, GlaxoSmithKline, Hexal, Incyte Corporation, Janssen, LEO Pharma, Medac, Menlo Therapeutics, MSD, Novartis, Pfizer, Regeneron, Sandoz, Sanofi, Stallergenes, Takeda, Trevi, and UCB. DT has served as an investigator and/or consultant/advisor for AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Eli Lilly, Galderma, Incyte Corporation, Janssen-Cilag, Kyowa Kirin, LEO Pharma, New Bridge, Novartis, Pfizer, Regeneron, Samsung, Sanofi, Target-RWE, and UCB and has received grants from AbbVie, LEO Pharma, and Novartis. LM has served as an investigator, consultant, and/or advisor for AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galderma, Incyte Corporation, Janssen-Cilag, LEO Pharma, Menlo Therapeutics, Novartis, Pfizer, and Sanofi. AWA has served as a research investigator and/or scientific advisor to AbbVie, Bristol Myers Squibb, Dermavant, Dermira, Incyte Corporation, Janssen, LEO Pharma, Lilly, Modmed, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB. AB has served as a speaker (received honoraria) for Eli Lilly and Company and UCB; served as a scientific advisor (received honoraria) for AbbVie, Abcentra, Aclaris, Affibody, Aligos, Almirall, Alumis, Amgen, AnaptysBio, Apogee, Arcutis, Arena, Aslan, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Celldex, CTI BioPharma, Dermavant, EcoR1, Eli Lilly and Company, Escient, Evelo, Evommune, Forte, Galderma, HighlightII Pharma, Incyte Corporation, InnoventBio, Janssen, Landos, LEO Pharma, Lipidio, Microbion, Merck, Monte Rosa Therapeutics, Nektar, Novartis, Overtone Therapeutics, Paragon, Pfizer, Q32 Bio, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB Pharma, Union, Ventyx, Vibliome, and Xencor; acted as a clinical study investigator (institution has received clinical study funds) for AbbVie, Acelyrin, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Concert, Dermavant, DermBiont, Eli Lilly and Company, Evelo, Evommune, Galderma, Incyte Corporation, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, Takeda, UCB Pharma, and Ventyx; and owns stock in Lipidio and Oruka. KAP has received honoraria and/or grants 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. JCS has served as an advisor for AbbVie, LEO Pharma, Novartis, Pierre Fabre, Trevi, and UCB; has received speaker honoraria from AbbVie, Eli Lilly, Janssen-Cilag, LEO Pharma, Novartis, Pfizer, and Sanofi Genzyme; and has received clinical trial funding from AbbVie, Almirall, Amgen, Galapagos, Holm, Incyte Corporation, InflaRX, Janssen-Cilag, Menlo Therapeutics, Merck, Novartis, Pfizer, Regeneron, Trevi, and UCB. MB has served as an investigator for Incyte Corporation, Regeneron, and Sanofi and has served as an advisor for AbbVie, Amgen, Dermavant, Eli Lilly, Incyte Corporation, Janssen, LEO Pharma, Pfizer, Regeneron, and Sanofi Genzyme. SGK has served as an advisory board member or consultant for AbbVie, Celldex Therapeutics, Galderma, Incyte Corporation, Johnson & Johnson, Kiniksa Pharmaceuticals, Novartis, Pfizer, Regeneron, and Sanofi and has served as an investigator for Galderma, Pfizer, and Sanofi. HK, DS, and HR are employees and shareholders of Incyte Corporation. LK has served as an investigator, consultant, or speaker for AbbVie, Amgen, AnaptysBio, Arcutis, Dermavant, Eli Lilly, Glenmark, Incyte Corporation, Kamedis, LEO Pharma, L’Oreal, Menlo Therapeutics, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi, Sun Pharma, and Taro.

Ethics Approval

These studies were conducted in accordance with Good Clinical Practice guidelines, provisions of the Declaration of Helsinki, and applicable regulations. Both study protocols were approved by all relevant institutional review boards or ethics committees.

Consent to Participate

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

Consent to Publish

Not applicable.

Availability of Data and Materials

Incyte Corporation (Wilmington, DE, USA) 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 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., US, EU, JPN). 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.

Code Availability

Not applicable.

Authors’ Contributions

ELS, MA, DT, LM, AWA, AB, KAP, JCS, SGK, and LK contributed to data collection and interpretation. MB, HK, and DS contributed to data interpretation. HR contributed to data analysis and reporting. All authors contributed to draft development and critical appraisal of the manuscript and approved the final version for submission.

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