King, Brett
Maari, Catherine
Lain, Edward
Silverberg, Jonathan I.
Issa, Maher
Holzwarth, Katrin
Brinker, Dennis
Cardillo, Tracy
Nunes, Fabio P.
Simpson, Eric L.
Clinical trials referenced in this document:
Documents that mention this clinical trial
Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials
https://doi.org/10.1007/s13555-022-00828-5
Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials
https://doi.org/10.1007/s40257-021-00602-x
Documents that mention this clinical trial
Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials
https://doi.org/10.1007/s13555-022-00828-5
Baricitinib Rapidly Improves Skin Pain Resulting in Improved Quality of Life for Patients with Atopic Dermatitis: Analyses from BREEZE-AD1, 2, and 7
https://doi.org/10.1007/s13555-021-00577-x
Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials
https://doi.org/10.1007/s40257-021-00602-x
Documents that mention this clinical trial
Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials
https://doi.org/10.1007/s13555-022-00828-5
Baricitinib Rapidly Improves Skin Pain Resulting in Improved Quality of Life for Patients with Atopic Dermatitis: Analyses from BREEZE-AD1, 2, and 7
https://doi.org/10.1007/s13555-021-00577-x
Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials
https://doi.org/10.1007/s40257-021-00602-x
Documents that mention this clinical trial
Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials
https://doi.org/10.1007/s13555-022-00828-5
Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials
https://doi.org/10.1007/s40257-021-00602-x
Documents that mention this clinical trial
Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials
https://doi.org/10.1007/s40257-021-00602-x
Clinical Tailoring of Baricitinib 2 mg in Atopic Dermatitis: Baseline Body Surface Area and Rapid Onset of Action Identifies Response at Week 16
https://doi.org/10.1007/s13555-021-00640-7
Documents that mention this clinical trial
Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials
https://doi.org/10.1007/s13555-022-00828-5
Baricitinib Rapidly Improves Skin Pain Resulting in Improved Quality of Life for Patients with Atopic Dermatitis: Analyses from BREEZE-AD1, 2, and 7
https://doi.org/10.1007/s13555-021-00577-x
Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials
https://doi.org/10.1007/s40257-021-00602-x
Documents that mention this clinical trial
Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials
https://doi.org/10.1007/s13555-022-00828-5
Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials
https://doi.org/10.1007/s40257-021-00602-x
Documents that mention this clinical trial
Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials
https://doi.org/10.1007/s40257-021-00602-x
Funding for this research was provided by:
Eli Lilly and Company
Article History
Accepted: 26 March 2021
First Online: 7 April 2021
Declarations
:
: This study was sponsored by Eli Lilly and Company, under license from Incyte Corporation.
: Brett King served as a consultant for Eli Lilly and Company. Catherine Maari served as an advisory board member, investigator, and/or speaker for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Galderma, GSK Stiefel, Janssen, Novartis, and Pfizer. Edward Lain served as an advisory board member, investigator, speaker and/or consultant for AbbVie, Allergan, Almirall, Amgen, Arcutis, Athenex, Brickell Biotech, Bristol-Myers Squibb, Dermavant, Dermira, Eli Lilly and Company, Galderma, Johnson & Johnson, Kiniksa, L’Oreal, Leo Pharma, Novartis, Ortho Dermatologics, Pfizer, Pierre-Fabre, Pulse Biosciences, Regeneron/Sanofi Genzyme, Sebacia, UCB Pharma, and Vyne Therapeutics. 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. Maher Issa, Katrin Holzwarth, Dennis Brinker, and Tracy Cardillo are employees and shareholders of Eli Lilly and Company. Fabio P. Nunes is a former employee of Eli Lilly and Company and is a current employee and shareholder of Janssen. 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.
: Trials were conducted in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice guidelines and approved by the ethics committee or institutional review board of each center.
: All patients provided written informed consent.
: Not applicable.
: 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 European Union 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 ExternalRef removed.
: Not applicable.
: 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, were involved in drafting the article or revising it critically for important intellectual content, and have given their approval for this version to be published. Study conception and design: MI, DB, TC, FPN. Acquisition of data: EL, JIS, MI, DB. Analysis and interpretation of data: BK, CM, EL, JIS, MI, KH, DB, FPN, ELS.