Feagan, Brian G.
Sandborn, William J.
Sands, Bruce E.
Liu, Yan
Vetter, Marion
Mathias, Susan D.
Huang, Kuan-Hsiang Gary
Johanns, Jewel
Germinaro, Matthew
Han, Chenglong http://orcid.org/0000-0001-7175-7834
Article History
Received: 13 February 2023
Accepted: 9 October 2023
First Online: 14 November 2023
Declarations
:
: The study protocol for the qualitative research and informed consent forms were reviewed and approved by an independent scientific review committee prior to the start of the study. Similarly, the study protocols for the GALAXI and VEGA studies were approved by the Institutional Review Board or Independent Ethics Committee at each participating investigative center. All patients provided written informed consent prior to participating in the qualitative interview and prior to enrollment in the GALAXI and VEGA trials.
: All authors have reviewed the final manuscript and provided their consent for publication.
: BGF received grant/research support from AbbVie Inc, Amgen Inc, AstraZeneca/MedImmune Ltd, Atlantic Pharmaceuticals Ltd, Boehringer Ingelheim, Celgene Corporation, Celltech, Genentech Inc/Hoffmann-La Roche Ltd, Gilead Sciences Inc, GlaxoSmithKline (GSK), Janssen Research & Development LLC, Pfizer Inc, Receptos Inc/Celgene International, Sanofi, Santarus Inc, Takeda Development Center Americas Inc, Tillotts Pharma AG, and UCB; was a consultant for Abbott/AbbVie, AdMIRx Inc, Akebia Therapeutics, Allergan, Amgen, Applied Molecular Transport Inc, Aptevo Therapeutics, Asta Pharma, AstraZeneca, Atlantic Pharma, Avir Pharma, Biogen Idec, BioMx Israel, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol-Myers Squibb, Calypso Biotech, Celgene, Elan/Biogen, EnGene, Ferring Pharma, Genentech/Roche, Galapagos, Galen/Atlantica, GiCare Pharma, Gilead, Gossamer Pharma, GSK, Inception IBD Inc, Intact Therapeutics, Johnson & Johnson/Janssen, Kyowa Kakko Kirin Co Ltd, Lexicon, Lilly, Lycera BioTech, Merck, Mesoblast Pharma, Millennium, Nestle, Nextbiotix, Novonordisk, ParImmune, Parvus Therapeutics Inc, Pfizer Inc, Prometheus Therapeutics and Diagnostics, Progenity, Protagonist, Qu Biologics, Rebiotix, Receptos, Salix Pharma, Shire, Sienna Biologics, Sigmoid Pharma, Sterna Biologicals, Synergy Pharma Inc, Takeda, Teva Pharma, TiGenix, Tillotts, UCB Pharma, Vertex Pharma, Vivelix Pharma, VHsquared Ltd, and Zyngenia; was a member of the speakers bureau for Abbott/AbbVie, Johnson & Johnson/Janssen, Lilly, Takeda, Tillotts, and UCB Pharma; was a member of the scientific advisory board for Abbott/AbbVie, Allergan, Amgen, AstraZeneca, Atlantic Pharma, Avaxia Biologics Inc, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Centocor Inc, Elan/Biogen, Galapagos, Genentech/Roche, Johnson & Johnson/Janssen, Merck, Nestle, Novartis, Novonordisk, Pfizer Inc, Prometheus Laboratories, Protagonist, Salix Pharma, Sterna Biologicals, Takeda, Teva, TiGenix, Tillotts Pharma AG, and UCB Pharma; and is a Senior Scientific Officer - Robarts Clinical Trials Inc.WJS reports research grants from Abbvie, Abivax, Arena Pharmaceuticals, Boehringer Ingelheim, Bristol-Meyers Squibb, Genentech/Roche, Gilead Sciences, Inc., GSK, Janssen, Lilly, Pfizer, Prometheus Laboratories, Seres Therapeutics, Shire Pharmaceuticals, Takeda, Theravance Biopharma; consulting fees from Abbvie, Abivax, Alfasigma, Alimentiv (previously Robarts Clinical Trials, owned by Alimentiv Health Trust), Allakos, Amgen, Arena Pharmaceuticals, AstraZeneca, Atlantic Pharmaceuticals, Beigene, Boehringer Ingelheim, Bristol-Meyers Squibb, Celltrion, Clostrabio, Forbion, Galapagos, Genentech/Roche, GSK, Gossamer Bio, Index Pharmaceuticals, Iota Biosciences, Janssen, Lilly, Morphic Therapeutics, Novartis, Oppilan Pharma (now Ventyx Biosciences), Pfizer, Pharm Olam, Polpharm, Progenity, Prometheus Biosciences, Protagonist Therapeutics, PTM Therapeutics, Seres Therapeutics, Shoreline Biosciences, Sublimity Therapeutics, Surrozen, Takeda, Theravance Biopharma, Vedanta Biosciences, Ventyx Biosciences, Vimalan Biosciences, Vivreon Gastrosciences, Xencor, Zealand Pharmaceuticals; stock or stock options from Allakos, BeiGene, Gossamer Bio, Oppilan Pharma (now Ventyx Biosciences), Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Shoreline Biosciences, Ventyx Biosciences, Vimalan Biosciences, Vivreon Gastrosciences; and employee at Shoreline Biosciences and Ventyx Biosciences. Spouse: Iveric Bio - consultant, stock options; Progenity - stock; Oppilan Pharma (now Ventyx Biosciences) - stock; Prometheus Biosciences - employee, stock, stock options; Prometheus Laboratories - stock, stock options, consultant; Ventyx Biosciences - stock, stock options; Vimalan Biosciences - stock, stock options.BES reports grants, personal fees, and other from Abivax during the conduct of the study; personal fees from Abbvie; personal fees from Alimentiv (previously Robarts Clinical Trials; owned by Alimentiv Health Trust); personal fees from Amgen; personal fees and other from Arena Pharmaceuticals; personal fees from AstraZeneca; personal fees from Bausch Health (Salix Pharmaceuticals); personal fees from Boehringer Ingelheim; personal fees from Boston Pharmaceuticals; personal fees and other from Bristol-Myers Squibb; personal fees and other from Celgene; personal fees from Celltrion; personal fees from Clostrabio; personal fees from Equillium; personal fees from Galapagos; personal fees from Genentech/Roche; personal fees from Gilead Sciences; personal fees from GSK; personal fees from Gossamer Bio; personal fees from Immunic; personal fees from Index Pharmaceuticals; personal fees from Inotrem; grants, personal fees, and other from Janssen; grants, personal fees, and other from Lilly; personal fees from Morphic Therapeutics; personal fees from Novartis; personal fees from Oppilan Pharma (acquired by Ventyx Biosciences); personal fees from Otuska; grants, personal fees, and other from Pfizer; personal fees from Progenity; personal fees from Prometheus Biosciences; personal fees from Prometheus Laboratories; personal fees from Protagonists Therapeutics; personal fees from Seres Therapeutics; personal fees from Shire Pharmaceuticals; personal fees from Surrozen; grants, personal fees, and other from Takeda; grants and personal fees from Theravance Biopharma; personal fees from Teva; personal fees from UCB; personal fees from Vedanta Biosciences; personal fees and other from Ventyx Biosciences; personal fees from Vivelix Pharmaceuticals; personal fees from Ironwood Pharmaceuticals; personal fees from OSE Immunotherapeutics; personal fees from Redhill Biopharma; personal fees from Target RWE; personal fees from Bacainn Therapeutics; personal fees from Capella Bioscience; personal fees from Palatin Technologies; personal fees from Rheos Medicines; personal fees from USWM Enterprises; personal fees from Viela Bio; personal fees from Artugen Therapeutics; personal fees from Calibr; personal fees from Entera; personal fees from Evommune; personal fees from Innovation Pharmaceuticals; personal fees from Kaleido; personal fees from Merck; personal fees from MRM Health; personal fees from Q32 Bio; personal fees from Sun Pharma; personal fees from TLL Pharmaceutical; and other from Vivante Health outside the submitted work.SDM is an employee at Health Outcomes Solutions, which received research funding from Janssen Pharmaceuticals for conducting the qualitative research portion of this study.YL (at the time study was conducted), MV, K-HGH, JJ, MG, and CH are employees of Janssen Research & Development, LLC and own stock/stock options.