Outcome measures in coeliac disease trials: the Tampere recommendations

Jonas F Ludvigsson, Carolina Ciacci, Peter Hr Green, Katri Kaukinen, Ilma R Korponay-Szabo, Kalle Kurppa, Joseph A Murray, Knut Erik Aslaksen Lundin, Markku J Maki, Alina Popp, Norelle R Reilly, Alfonso Rodriguez-Herrera, David S Sanders, Detlef Schuppan, Sarah Sleet, Juha Taavela, Kristin Voorhees, Marjorie M Walker, Daniel A Leffler, Jonas F Ludvigsson, Carolina Ciacci, Peter Hr Green, Katri Kaukinen, Ilma R Korponay-Szabo, Kalle Kurppa, Joseph A Murray, Knut Erik Aslaksen Lundin, Markku J Maki, Alina Popp, Norelle R Reilly, Alfonso Rodriguez-Herrera, David S Sanders, Detlef Schuppan, Sarah Sleet, Juha Taavela, Kristin Voorhees, Marjorie M Walker, Daniel A Leffler

Abstract

Objective: A gluten-free diet is the only treatment option of coeliac disease, but recently an increasing number of trials have begun to explore alternative treatment strategies. We aimed to review the literature on coeliac disease therapeutic trials and issue recommendations for outcome measures.

Design: Based on a literature review of 10 062 references, we (17 researchers and 2 patient representatives from 10 countries) reviewed the use and suitability of both clinical and non-clinical outcome measures. We then made expert-based recommendations for use of these outcomes in coeliac disease trials and identified areas where research is needed.

Results: We comment on the use of histology, serology, clinical outcome assessment (including patient-reported outcomes), quality of life and immunological tools including gluten immunogenic peptides for trials in coeliac disease.

Conclusion: Careful evaluation and reporting of outcome measures will increase transparency and comparability of coeliac disease therapeutic trials, and will benefit patients, healthcare and the pharmaceutical industry.

Keywords: celiac disease; clinical trials; gluten; gluten free diet.

Conflict of interest statement

Competing interests: PHRG: scientific advisory board of Alvine Pharmaceuticals, ImmunogenX and ImmusanT. JAM: serves on the advisory board of Celimmune, was a consultant to BioLineRx, GlaxoSmithKline (GSK), Genentech, UCB Biopharma and Glenmark Pharmaceuticals Ltd and is a consultant to ImunnosanT, Institute for Protein Design (PvP Biologics), Takeda Pharmaceutical Company, Ltd., Innovate Biopharmaceuticals, Inc., Intrexon, 2GPharma Inc., Boeringer-Ingelheim and ImmusanT. KEAL: ImmusanT, Regeneron and Alvine Pharmaceuticals. DSS: holds a patent and receives royalties for the TG2-antibody assay, has received an educational grant from Coeliac UK, Biocard, Simtomax and Dr Schär to undertake an investigator-led research study on CD and/or gluten sensitivity. NRR: clinical advisory board for ImmusanT. DAL: Medical Director for Takeda Pharmaceuticals AR-H: coauthor detecting gluten peptides in human fluids (Patent No. US 20170160288 A1), consultant for Vircell. IRK-S: patent on rapid coeliac antibody detection licensed by the University of Tampere to Labsystems Oy, Finland. MJM: serves on the Advisory Board of Celimmune, USA, ImmusanT, USA and Innovate Pharmaceuticals Inc, USA; is consultant to FinnMedi Oy, Finland and Jilab Oy, Finland via his own company Maki HealthTech Oy, Finland; is an inventor in the patent Methods and Means for Detecting Gluten-Induced Diseases, USA (Patent No. 7,361,480—USA, European Patent No. 1390753). The patent resulted in a commercial product from FinnMedi at the Tampere University Hospital and the University of Tampere, a coeliac disease point-of-care test, Biocard Celiac Test, licensed to Labsystems Diagnostics Oy (former AniBiotech Oy), Finland.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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