Mahadevan, Uma http://orcid.org/0000-0002-3067-8061
Levy, Gweneth
Gensler, Lianne
Ali, Mira
Lacerda, Ana P.
Wegrzyn, Lani
Palac, Hannah
Bhutani-Jacques, Tina
Long, Millie
Clowse, Megan E. B.
Kimball, Alexa B.
Chambers, Christina
Scialli, Anthony R.
Funding for this research was provided by:
AbbVie
Article History
Accepted: 30 May 2024
First Online: 15 July 2024
Declarations
:
: This work/study was funded by AbbVie Inc. AbbVie participated in the study design, research, data collection, analysis and interpretation of data, writing, reviewing, and approving the publication. All authors had access to the data results, and participated in the development, review, and approval of this paper. No honoraria or payments were made for authorship.
: Uma Mahadevan has received consultant fees from AbbVie, Bristol Myers Squibb, Boeringher Ingelheim, Celltrion, Enveda, Gilead, Janssen, Lilly, Pfizer, Protagonist, Roivant, and Takeda; has served on the data and safety monitoring board for Merck and Prometheus Bioscienes; has served on the scientific advisory board for Rani Therapeutics; and has received research funding from the Helmsley Charitable Trust. Anthony R. Scialli has received consulting fees from AbbVie. Millie Long has received consultant fees from AbbVie, Janssen, Pfizer, Lilly, Takeda, BMS, Prometheus, Intercept, and Target RWE and has received research support from Takeda, Lilly, and Pfizer. Alexa B. Kimball has received consulting fees from AbbVie, Alumis, Bayer, Boehringer Ingelheim, Eli Lilly, Evoimmune, Janssen, Novartis, Moonlake, Pfizer, Priovant, Sanofi, Sonoma Bio, Target RWE, UCB, Union Therapeutics, Ventyx, Janssen, Meiji, LEO, and Concert Pharmaceuticals and serves on the board of directors for Almirall and University of California, San Diego-led pregnancy registries. Her institution has received grants from AbbVie, Bristol Myers Squibb, Eli Lilly, Incyte, Janssen, Novartis, Pfizer, Sanofi, Sonoma Bio, and UCB. Tina Bhutani-Jacques is currently a principal investigator for studies being sponsored by Amgen, Castle, CorEvitas, Pfizer, and Regeneron. She has received additional research funding from Novartis and has served as an advisor for AbbVie, Arcutis, Boehringer-Ingelheim, Bristol Myers Squibb, Dermavant, Janssen, Leo, Lilly, Pfizer, Novartis, Sanofi, Sun, and UCB. Gweneth Levy, Mira Ali, Ana P. Lacerda, Lani Wegrzyn, and Hannah Palac are employees of AbbVie and may own stock or stock options. Megan E.B. Clowse has received consulting fees from UCB and GSK, research grant funding from GSK, educational grant funding from UCB and GSK, and serves on review boards for University of California, San Diego-led pregnancy registries. Christina Chambers receives research funding from the following industry sponsors and a foundation: Amgen, AstraZeneca, GlaxoSmithKline, Janssen Pharmaceuticals, Pfizer, Regeneron, Hoffman La-Roche-Genentech, Genzyme Sanofi-Aventis, Takeda Pharmaceutical Company Limited, Sanofi, UCB Pharma USA, Leo Pharma, Sun Pharma Global FZE, Gilead, Novartis, and the Gerber Foundation. Lianne Gensler has received grants from Novartis and UCB Pharma paid to her institution and consulting fees from AbbVie, Fresenius Kabi, Gilead, Janssen, Eli Lilly, MoonLake, Novartis, Pfizer, and UCB Pharma.
: Each individual trial included in this report was conducted in accordance with the ethical principles that have their origin in the current Declaration of Helsinki and was consistent with International Conference on Harmonization Good Clinical Practice, Good Epidemiology Practices, and applicable regulatory requirements. Each individual trial included in this report was approved by an independent ethics committee/institutional review board at each study site (ESM). Initial submission of unsolicited postmarketing reports by physicians or patients is voluntary. For the collection of further information after the initial report, a reporter’s consent was obtained through a query in the global safety database. Authors had access to de-identified anonymized data to prepare this report.
: All patients provided written informed consent before enrolling in each clinical trial.
: Not applicable.
: This study was sponsored by AbbVie. AbbVie and the authors are committed to responsible data sharing regarding clinical trial participation. This includes access to anonymized, individual, and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), 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. Studies are available for sharing when all the following criteria are met: 12 months after the global end of the trial date, after the studied product and indication have been approved by regulatory authorities in the following countries/regions: USA and European Union, USA or European Union (when regulatory submissions in both regions are not planned), other country (when US or European Union regulatory submissions are not planned), the study is not part of an ongoing or planned regulatory submission in the regions listed above, and after the primary manuscript describing the results has been accepted for publication. AbbVie may choose to proactively share studies beyond the criteria noted above. For more information on the process, or to submit a request, visit the following link: .
: Not applicable.
: All authors contributed to the interpretation of data and drafting and revising of the publication. GL and HP substantially contributed to the acquisition of data and data analysis. GL and MA substantially contributed to the study conception and design. Substantial contributions to conception and design: GL, MA. Acquisition of data: GL, HP. Data analysis: GL, HP. Interpretation of data: UM, LG, GL, MA, APL, LW, HP, TB-J, ML, MEBC, ABK, CC, ARS. Involved in drafting/revising critically for intellectual content: UM, LG, GL, MA, APL, LW, HP, TB-J, ML, MEBC, ABK, CC, ARS. All authors read and approved the final version.