Updates are available Correction dated 2021-10-13
Click to view Correction: https://doi.org/10.1007/s40257-021-00638-z
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Authors
Simpson, Eric L.
Silverberg, Jonathan I.
Nosbaum, Audrey
Winthrop, Kevin L.
Guttman-Yassky, Emma
Hoffmeister, Karin M.
Egeberg, Alexander
Valdez, Hernan
Zhang, Min
Farooqui, Saleem A.
Romero, William
Thorpe, Andrew J.
Rojo, Ricardo
Johnson, Susan http://orcid.org/0000-0001-5016-5768
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Clinical Trials BETA
Clinical trials referenced in this document:
nct02780167 at ClinicalTrials.govnct03349060 at ClinicalTrials.govDocuments that mention this clinical trial
Durability of Response to Abrocitinib in Patients with Moderate-to-Severe Atopic Dermatitis After Treatment Discontinuation in a Phase 2b Trial
https://doi.org/10.1007/s13555-022-00764-4
Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis
https://doi.org/10.1007/s40262-021-01104-z
Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program
https://doi.org/10.1007/s40257-021-00618-3
nct03575871 at ClinicalTrials.govDocuments that mention this clinical trial
Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis
https://doi.org/10.1007/s40262-021-01104-z
Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program
https://doi.org/10.1007/s40257-021-00618-3
nct03720470 at ClinicalTrials.govDocuments that mention this clinical trial
Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis
https://doi.org/10.1007/s40262-021-01104-z
Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program
https://doi.org/10.1007/s40257-021-00618-3
nct03627767 at ClinicalTrials.govDocuments that mention this clinical trial
Early Itch Response with Abrocitinib Is Associated with Later Efficacy Outcomes in Patients with Moderate-to-Severe Atopic Dermatitis: Subgroup Analysis of the Randomized Phase III JADE COMPARE Trial
https://doi.org/10.1007/s40257-022-00738-4
Rapidity of Improvement in Signs/Symptoms of Moderate-to-Severe Atopic Dermatitis by Body Region with Abrocitinib in the Phase 3 JADE COMPARE Study
https://doi.org/10.1007/s13555-022-00694-1
Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program
https://doi.org/10.1007/s40257-021-00618-3
nct03422822 at ClinicalTrials.govDocuments that mention this clinical trial
Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program
https://doi.org/10.1007/s40257-021-00618-3
Documents that mention this clinical trial
Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program
https://doi.org/10.1007/s40257-021-00618-3
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Funding
Funding for this research was provided by:
Pfizer Inc.
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Article History
Accepted: 16 June 2021
First Online: 18 August 2021
Change Date: 2 May 2022
Change Type: Update
Change Details: A peer-reviewed video abstract was retrospectively added to this publication.
Change Date: 13 October 2021
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1007/s40257-021-00638-z
Declarations
:
: This study was sponsored by Pfizer, Inc.
: <i>E. L. Simpson</i> reports grants from Pfizer Inc., Eli Lilly, Kyowa Kirin, LEO Pharma, Merck, and Regeneron and personal fees from Pfizer Inc., Bausch Health (Valeant), Dermira, Eli Lilly, Galderma, LEO Pharma, Menlo Therapeutics, Novartis, Regeneron, and Sanofi Genzyme. <i>J. I. Silverberg</i> is an investigator for AbbVie, Celgene, Eli Lilly, GSK, Kiniksa, LEO Pharma, Menlo Therapeutics, Realm Therapeutics, Regeneron, Roche, and Sanofi; a consultant for Pfizer Inc., AbbVie, Anacor, AnaptysBio, Arena Pharmaceuticals, Asana Biosciences, Dermira, Dermavant, Eli Lilly, Galderma, GSK, Glenmark, Incyte, Kiniksa, LEO Pharma, MedImmune, Menlo Therapeutics, Novartis, Realm Therapeutics, Regeneron, and Sanofi; a speaker for Regeneron and Sanofi; and is on advisory boards for Pfizer Inc., Dermira, LEO Pharma, and Menlo Therapeutics. <i>A.</i> <i>Nosbaum</i> is an investigator for AbbVie, Eli Lilly, Incyte, LEO Pharma, Novartis, and Sanofi; a consultant for Pfizer Inc., AbbVie, Eli Lilly, Galderma, LEO Pharma, Novartis, and Sanofi; a speaker for AbbVie, Regeneron, and Sanofi; and is on advisory boards for Pfizer Inc., AbbVie, LEO Pharma, and Sanofi. <i>K. L. Winthrop</i> reports research grants from Bristol Myers Squibb and consultant honorarium from Pfizer, Eli Lilly, Bristol Myers Squibb, UCB, AbbVie, Gilead, Roche, Novartis, Regeneron, and Sanofi. <i>E. Guttman-Yassky</i> is an advisory board member for Celgene, Dermira, Galderma, Glenmark, Medimmune, Novartis, Pfizer, Regeneron, Sanofi, Stiefel/GlaxoSmithKline, Vitae, and Asana Biosciences (honorarium); consultant for AbbVie, Anacor, Celgene, Dermira, Galderma, Glenmark, LEO Pharma, Medimmune, Novartis, Pfizer, Regeneron, Sanofi, Stiefel/GlaxoSmithKline, Vitae, Mitsubishi Tanabe, Eli Lilly, Asana Biosciences, Kiowa Kirin, and Almirall (honorarium); and investigator for Celgene, LEO Pharma, Medimmune, Regeneron, and Eli Lilly (grants to institution). <i>K. M. Hoffmeister</i> has received honoraria as consultant from Pfizer. <i>A. Egeberg</i> has received research funding from Pfizer, Eli Lilly, Novartis, AbbVie, Janssen Pharmaceuticals, the Danish National Psoriasis Foundation, the Simon Spies Foundation, and the Kgl Hofbundtmager Aage Bang Foundation, and honoraria as consultant and/or speaker from AbbVie, Almirall, LEO Pharma, Galápagos NV, Samsung Bioepis Co., Ltd., Pfizer, Eli Lilly and Company, Novartis, Galderma, Dermavant, UCB, Mylan, Bristol Myers Squibb, and Janssen Pharmaceuticals. <i>H. Valdez</i>, <i>M. Zhang</i>, <i>S. A. Farooqui</i>, <i>W. Romero</i>, <i>A. J. Thorpe</i>, <i>R.</i> <i>Rojo</i>, and <i>S. Johnson</i> are employees of and shareholders in Pfizer.
: Ethics approval was obtained for individual studies included in this integrated safety analysis.
: Informed consent was obtained from all participants of the individual studies included in this integrated safety analysis.
: Upon request, and subject to certain criteria, conditions, and exceptions (see ExternalRef removed for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines and medical devices (1) for indications that have been approved in the US and/or EU or (2) in programs that have been terminated (i.e., development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.
: EGY, AE, HV, MZ, WR, AJT, RR, and SJ contributed to the conceptualization and design of the analysis. ELS, AN, KLW, KMH, AE, MZ, WR, AJT, and SJ performed or supported the data analysis. All authors contributed to the data interpretation, critically reviewed the manuscript and approved the submitted version.
