Understanding celiac disease monitoring patterns and outcomes after diagnosis: A multinational, retrospective chart review study
Knut EA Lundin, K.G. Jebsen Coeliac Disease Research Centre, University of Oslo, Oslo 0450, Norway
Knut EA Lundin, Ellen S Pettersen, Department of Gastroenterology, Oslo University Hospital Rikshospitalet, Oslo 0372, Norway
Ciaran P Kelly, Caitlin Barrett, Shakira Yoosuf, Celiac Center Beth Israel Deaconess Medical Center, Celiac Research Program Harvard Medical School, Boston, MA 02115, United States
David S Sanders, Royal Hallamshire Hospital, University of Sheffield, Sheffield S10 2TN, United Kingdom
Kristina Chen, Daniel A Leffler, Takeda Pharmaceuticals International Co., Cambridge, MA 02139, United States
Sheena Kayaniyil, Rajvi J Wani, Real World Evidence Strategy and Analytics, ICON plc., Toronto, ON L7N 3G2, Canada
Sisi Wang, Robert Sambrook, Real World Evidence Strategy and Analytics, ICON plc., Vancouver, BC V6B 1P1, Canada
Author contributions: Lundin KE, Kelly CP, and Sanders DS provided data acquisition and interpretation and contributed equally to the study; Chen K provided data interpretation; Kayaniyil S, Wang S, Sambrook R and Leffler DA were responsible for design of the study, and provided data acquisition, analysis, and interpretation; Wani RJ provided data analysis and interpretation; Barrett C, Yoosuf S and Pettersen ES provided data acquisition and interpretation; all authors contributed to the development of the manuscript.
Institutional review board statement: Ethics approval was obtained before data collection commenced at each site (Beth Israel Deaconess Medical Center 09/11/2018; Health Research Authority 19/11/2018; and Regional Committees for Medical and Health Research Ethics 05/06/2018).
Informed consent statement: A waiver of consent was approved for the United States site; the other sites had collected patient consent for research with their patient database.
Conflict-of-interest statement: KEA Lundin has served as a speaker/consultant/advisory board member for Amyra Biotech AG, Bioniz Therapeutics, Chugai Pharmaceutical, Dr. Falk Pharma GMBH, Immusant Therapeutics, and Interexon Actobiotics. CP Kelly has served as a consultant/advisory board member for Aptalis, Cour Pharma, Glutenostics, ImmunogenX, Innovate, Janssen, Kanyos, Takeda Pharmaceuticals, Merck, and Theravance; CP Kelly has received a grant from Aptalis; S Kayaniyil, S Wang, RJ Wani, and R Sambrook are salaried employees of ICON, which received research funds from Takeda Pharmaceuticals for conducting the study and preparation of the manuscript for publication. K Chen was a salaried employee of Takeda Pharmaceuticals at the time of study. DA Leffler is a salaried employee of Takeda Pharmaceuticals; CP Kelly owns shares in Cour Pharma and Glutenostics; DS Sanders, C Barrett, S Yoosuf, and ES Pettersen have no conflicts of interest to declare.
Data sharing statement: Data are available upon request from the corresponding author.
STROBE statement: The authors have read the STROBE Statement – checklist of items, and the manuscript was prepared and revised according to the STROBE Statement – checklist of items.
: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Daniel A Leffler, MD, Doctor, Takeda Pharmaceuticals International Co., 40 Landsdowne Street, Cambridge, MA 02139, United States. firstname.lastname@example.org
Received: November 12, 2020
Peer-review started: November 12, 2020
First decision: January 23, 2021
Revised: March 9, 2021
Accepted: April 28, 2021
Article in press: April 28, 2021
Published online: May 28, 2021