AbbVie and the authors thank the patients who participated in the study and all of the study investigators for their contributions.
Funding
Sponsorship for this study and the journal’s Rapid Service fee and Open Access charge was funded by AbbVie Inc., North Chicago, IL.
Medical Writing Assistance
Medical writing assistance was provided by Alan Saltzman, PhD, CMPP, of Fishawack Facilitate Ltd, part of Fishawack Health, and was funded by AbbVie Inc., North Chicago, IL.
Authorship
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, and have given their approval for this version to be published. AbbVie sponsored the study; contributed to the design; participated in collection, analysis, and interpretation of data; and in writing, reviewing and approval of the final version.
Disclosures
L. Peyrin-Biroulet reports personal fees from Galapagos, AbbVie, Janssen, Genentech, Ferring, Tillots, Pharmacosmos, Celltrion, Takeda, Boehringer Ingelheim, Pfizer, Index Pharmaceuticals, Sandoz, Celgene, Biogen, Samsung Bioepis, Alma, Sterna, Nestle, Inotrem, Enterome, Allergan, MSD, Roche, Arena, Gilead, Hikma, Amgen, BMS, Vifor, Norgine, Mylan, Lilly, Fresenius Kabi, Oppilan Pharma, Sublimity Therapeutics, Applied Molecular Transport, OSE Immunotherapeutics, Enthera, and Theravance; has received grants from AbbVie, MSD, and Takeda; and has stock options from CTMA. E. Louis has received research grants from Takeda, Pfizer, and Janssen; has received educational grants from AbbVie, MSD, Takeda, and Janssen; reports speaker fees from AbbVie, Ferring, MSD, Falk, Takeda, Hospira, Janssen, and Pfizer; participated in advisory boards for AbbVie, Ferring, MSD, Takeda, Celgene, Hospira, Janssen, and Pfizer; and is a consultant for AbbVie. E. V. Loftus has received consulting fees from AbbVie, Takeda, Janssen, UCB, Amgen, Pfizer, Eli Lilly, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Gilead, Genentech, and Celltrion Healthcare and research support from AbbVie, Takeda, Janssen, UCB, Amgen, Pfizer, Genentech, Receptos, Gilead, Celgene, Bristol Myers Squibb, Theravance, and Robarts Clinical Trials. A. Lacerda, Q. Zhou, and Y. Sanchez Gonzalez are AbbVie employees and may own AbbVie stock/stock options. S. Ghosh is a steering committee member for Pfizer, Janssen, AbbVie, BMS, Celgene, and Boehringer-Ingelheim and has received speaker honoraria from AbbVie, Janssen, Takeda, Shield, Ferring, and Falk Pharma.
Compliance with Ethics Guidelines
This study was conducted in compliance with Good Clinical Practice guidelines, applicable local regulations, and the Declaration of Helsinki. This study protocol was approved by the relevant ethics committees or institutional review boards (see electronic supplementary material). All patients provided informed consent before study participation.
Data Availability
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 and clinical study reports), as long as 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 after review and approval of a research proposal and statistical analysis plan and execution of a data sharing agreement. Data requests can be submitted at any time, and the data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visit https://www.abbvie.com/our-science/clinical-trials/clinical-trialsdata-and-information-sharing/data-and-information-sharing-with-qualifiedresearchers.html.