Early and Sustained Improvements in Symptoms and Quality of Life with Upadacitinib in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: 52-Week Results from Two Phase III Randomized Clinical Trials (Measure Up 1 and Measure Up 2)

Funding

AbbVie Inc. provided financial support to conduct this study/analysis, prepare the manuscript, and sponsor the open access fee.

Conflict of interest

Jonathan I. Silverberg receives consulting fees from AbbVie, Anacor Pharmaceuticals, GlaxoSmithKline, Eli Lilly, Regeneron Pharmaceuticals, Pfizer, Procter & Gamble, and MedImmune. He serves as an investigator in trials sponsored by Celgene, GlaxoSmithKline, Eli Lilly, Regeneron Pharmaceuticals, and Roche. Melinda J. Gooderham has been an investigator, speaker and/or advisor for AbbVie, Amgen, Akros, Arcutis, AnaptysBio, Apogee, Aristea, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Janssen, Kyowa Kirin, LEO Pharma, MedImmune, Meiji, Merck, Moonlake, Nimbus, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, Tarsus, Takeda, UCB, Union, and Ventyx. Amy S. Paller has been an investigator for AbbVie, Applied Pharma Research, Dermavant, Eli Lilly, Incyte, Janssen, Krystal, Regeneron, and UCB; has been a consultant for Aegerion Pharma, Azitra, BioCryst, Boehringer Ingelheim, Bristol Myers Squibb, Castle Creek, Eli Lilly, Janssen, Krystal, LEO Pharma, Novartis, Regeneron, Sanofi Genzyme, Seanergy, TWI Biotechnology, and UCB; and has served on the data safety monitoring board for AbbVie, Abeona, Catawba, Galderma, and InMed. Mette Deleuran receives consulting, lecturer, and/or investigator fees from AbbVie, Almirall, Arena Pharmaceuticals, ASLAN Pharmaceuticals, Eli Lilly, Incyte, Kymab, La Roche Posay, LEO Pharma, Numab, Pfizer, Pierre Fabre Laboratories, Regeneron Pharmaceuticals, and Sanofi. Christopher G. Bunick has served as an investigator for Almirall, Palvella, and Timber; a consultant for AbbVie, Almirall, Amgen, Apogee, Arcutis, Bristol Myers Squibb, Eli Lilly, LEO Pharma, Novan, Novartis, Ortho-Dermatologics, Pfizer, Sanofi-Regeneron, and UCB; and a speaker for and received honoraria from Allergan, Almirall, LEO Pharma, and UCB. Linda F. Stein Gold has served as an investigator/consultant or speaker for AbbVie, Arcutis, Dermavant, Incyte, LEO Pharma, Lilly, Novartis, Ortho Dermatologics, Pfizer, Sun Pharma, and UCB. DirkJan Hijnen has served as an investigator, consultant, and/or speaker for AbbVie, Almirall, AstraZeneca, Galderma, Janssen, LEO Pharma, Lilly, Novartis, Pfizer, and Sanofi. Brian M. Calimlim, Wan-Ju Lee, Henrique D. Teixeira, Xiaofei Hu, Shiyu Zhang, Yang Yang, Ayman Grada, and Andrew M. Platt are full-time employees of AbbVie, and may hold AbbVie stock or stock options. Diamant Thaçi is an advisor, speaker, or consultant for AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Galderma, Janssen, Kyowa Kirin, L'Oréal, LEO Pharma, Lilly, Novartis, Pfizer, Regeneron, Sanofi/Genzyme, and UCB.

Ethics approval

The institutional review board and/or independent ethics committee at each study site approved the study protocols, informed consent forms, and recruitment materials before patient enrollment. The studies were conducted in accordance with the International Conference for Harmonisation guidelines, applicable regional regulations, and the Declaration of Helsinki.

Consent to participate

All patients provided written informed consent to participate in this study before screening.

Consent for publication

Not applicable.

Availability of data and material

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, clinical study reports, or analysis plans), provided the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. These clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following a review and approval of a research proposal, statistical analysis plan, and execution of a data sharing agreement. Data requests can be submitted at any time after approval in the USA and Europe and after acceptance of this manuscript for publication. The data will be accessible for 12 months, with possible extensions considered. For more information on the process or to submit a request, visit the following link: https://vivli.org/ourmember/abbvie/, then select “Home.”

Code availability

Not applicable.

Author contributions

All authors participated in data interpretation, critically reviewed this manuscript, and provided final approval for publication. JIS, BMC, W-JL, HDT, and XH participated in the study concept/design. ASP, MD, LFSG, HDT, XH, and DT participated in the data acquisition. XH and YY participated in the statistical analysis.

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