Meeting SummariesA Summary of the Meetings of the Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) International Multidisciplinary Consensus
Section snippets
Meeting Summary: Overview
The Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) collaborators are a group of more than 70 gastroenterologists, pathologists, allergists, researchers, dietitians, psychologists, and methodologists who convened in a series of in-person and virtual meetings between 2018 and 2020 with the aim of developing a core outcome set (COS) for use in therapeutic studies of pharmacologic and dietary therapies for the treatment of eosinophilic esophagitis (EoE). Given
Forming the COREOS Collaboration: Introductory Sessions
The COREOS steering committee first convened in person on June 5, 2018 at Digestive Disease Week 2018 in Washington, DC. This was followed by a teleconference on July 13, 2018. These first kick-off meetings aimed to establish timelines, primary objectives, strategic partnerships, participant recruitment, and roles and responsibilities for the group. The committee agreed that the aim of the COREOS collaboration would be to identify core outcomes in EoE to improve the efficiency of drug
Defining the Core Outcome Domains
A total of 11 core outcome domains were identified; in a Delphi survey, 66 panelists voted the following 4 outcome domains as critical for inclusion: patient-reported symptoms, EoE-specific quality of life, histopathology, and endoscopy. Domains considered important but optional for inclusion included genetic profiling, biomarkers, esophageal distensibility, immunologic dissection, and patient perception of health. Secondary impact on family/caregivers and resource utilization were voted as
Establishing Consensus and Core Outcome Set Ratification
A total of 122 statements across the 4 core outcome domains were developed for the first round of the phase 3 Delphi surveys. Before the survey was distributed, an introductory videoconference was held March 19, 2020 to review the aims of the survey, instructions for survey completion, and the 9-point Likert scoring system (with outcomes scored in the 7–9 range being considered critical for inclusion in a COS, outcomes scored in the 4–6 range being considered important but not critical, and
Conclusions and Future Directions
In summary, the COREOS collaborators developed an internationally guided, multidisciplinary COS for use in pharmacologic and dietary therapeutic studies in pediatric and adult patients with EoE. The ratification meeting was concluded with a discussion around strategies to disseminate these recommendations. The aim was to encourage adoption of the COS to reduce heterogeneity in end-point assessment, minimize risk of reporting bias, and improve the quality of evidence synthesis by facilitating
Acknowledgments
The COREOS Collaborators: Christopher Ma (Division of Gastroenterology and Hepatology, Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, Alberta, Canada and Alimentiv Inc, London, Ontario, Canada); Alain M. Schoepfer (Division of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland); Evan S. Dellon (Center for Esophageal Diseases and Swallowing, Division of Gastroenterology and
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Conflicts of interest These authors disclose the following: C. Ma has received consulting fees from AVIR Pharma Inc and Alimentiv (formerly Robarts Clinical Trials Inc).A. M. Schoepfer received consulting fees and/or speaker fees and/or research grants from Adare Pharmaceuticals, Inc, AstraZeneca, AG, Switzerland, Aptalis Pharma, Inc, Celgene Corp., Dr Falk Pharma, GmbH, Germany, Glaxo Smith Kline, AG, Nestlé S. A., Switzerland, Novartis, AG, Switzerland, Receptos, Inc, and Regeneron Pharmaceuticals, Inc E. S. Dellon received research funding from: Adare/Ellodi, Allakos, AstraZeneca, GSK, Meritage, Miraca, Nutricia, Celgene/Receptos/BMS, Regeneron, Shire/Takeda; consulting fees from: Abbott, Adare/Ellodi, Aimmune, Allakos, Amgen, Arena, AstraZeneca, Avir, Biorasi, Calypso, Celgene/Receptos/BMS, Celldex, Eli Lilly, EsoCap, GSK, Gossamer Bio, Parexel, Regeneron, Alimentiv Inc, Salix, Sanofi, Shire/Takeda; and educational grants from: Allakos, Banner, Holoclara.A. J. Bredenoord received research funding from Nutricia, Norgine, SST and Bayer and received speaker and/or consulting fees from Laborie, Arena, EsoCap, Medtronic, Dr Falk Pharma, Calypso Biotech, Gossamer, Alimentiv, Reckett Benkiser, Regeneron and AstraZeneca.M. Chehade received research funding from Regeneron, Allakos, Shire, AstraZeneca, Danone; consulting fees from Regeneron, Allakos, Adare, Shire/Takeda, AstraZeneca, Sanofi, Bristol Myers Squibb; lecture honoraria from Nutricia, Medscape, Vindico.M. H. Collins is a consultant for Allakos, Arena, Astra Zeneca, Calypso, Esocap, GSK, Receptos/BMS, Regeneron, Shire, a Takeda company, and Alimentiv (formerly Robarts Clinical Trials, Inc); and reports research grants from Receptos/BMS, Regeneron, and Shire, a Takeda Company.B. G. Feagan reports consulting fees from Allakos, Alimentiv Inc (formerly Robarts Clinical Trials, Inc), Sanofi, Bristol Myers Squibb. G. T. Furuta reports salary support from EnteroTrack. S. K. Gupta reports personal fees from Allakos, Abbott, Adare, Celgene, Gossamer Bio, QOL, Medscape, Viaskin, research grants from Shire, and royalties from UpToDate. I. Hirano reports research funding from: Adare, Allakos, GSK, Meritage, Celgene/Receptos, Regeneron, Shire/Takeda; consulting fees from: Adare, Allakos, Arena, AstraZeneca, Celgene/Receptos, Eli Lilly, EsoCap, GSK, Gossamer Bio, Regeneron, Shire/Takeda.V. Jairath reports consulting fees from Alimentiv Inc (formerly Robarts Clinical Trials, Inc). D. A. Katzka reports consulting fees from Takeda, Sanofi, and Shire. R. K. Pai reports consulting fees from Eli Lilly, Genentech, Allergan, and Alimentiv (formerly Robarts Clinical Trials, Inc). M. E. Rothenberg reports personal fees from Celgene, Astra Zeneca, Arena Pharmaceuticals, Adare Pharmaceuticals, GlaxoSmith Kline, Guidepoint, and Suvretta Capital Management, and has an equity interest in Pulm One, Spoon Guru, ClostraBio, Serpin Pharm and Allakos, and royalties from reslizumab (Teva Pharmaceuticals), PEESS, version 2 (Mapi Research Trust) and UpToDate. M.E.R an inventor of patents owned by Cincinnati Children’s Hospital. A. Straumann reports personal fees from Allakos, Astra-Zeneca, Calypso, EsoCap, Falk Pharma, Gossamer, Nutricia, Pfizer, Receptos-Celgene, Regeneron-Sanofi, Roche-Genentec, Shire, Tillotts.S. S. Aceves reports being a consultant for Regeneron, Astra-Zeneca, Astellos, and AImmune and a UCSD patent licensed to Shire-Takeda Pharma. J. A. Alexander reports personal fees or grants from Regeneron and Adare Pharmaceuticals and has equity interest in Meritage Pharmacia.L. Biedermann reports personal fees from Vifor, Falk Pharma, Esocap, Calypso. C. Blanchard is an employee of Société des produits Nestlé S.A.C. Ciriza de los Rios reports consulting fees for Norgine and Allergan. C. M. Davis reports research grants from DBV Technologies, Aimmune Therapeutics, Regeneron Pharmaceuticals, and owns stock in Moonlight Therapeutics. G. W. Falk reports grants and/or personal fees from Allakos, Shire/Takeda, ADARE/Ellodi, Regeneron, and Bristol Myers Squibb. R. M. Genta reports consulting fees from Allakos, Adare/Ellodi, and RedHill Pharma. N. Gonsalves receives consulting fees from Allakos, Astra-Zeneca, Nutricia, and Sanofi/Regeneron and royalties from UpToDate. T. Greuter reports consulting contracts with Falk Pharma GmbH and Sanofi-Aventis, and research grant from Novartis. K. S. Hsu Blatman received research funding from Shire/Takeda. H. M. Larsson reports consulting fees from EsoCap Biotech AG.F. J. Moawad reports personal fees from Takeda and Salix. V. A. Mukkada reports grants and/or personal fees from Shire Pharmaceutical. K. Peterson reports personal fees from Alladapt, Eli Lily, Medscape, Ellodi, Takeda, Allakos, AstraZeneca, Regeneron-Sanofi and research funding from Astra Zeneca, Ellodi, Regeneron-Sanofi, Allakos, Chobani, and owes stock from Nexeos. C. Schlag reports consulting fees and/or speaker fees and/or research grants from Adare Pharmaceuticals, Inc, AstraZeneca, Calypso, EsoCap, Dr Falk Pharma, GmbH, Regeneron Pharmaceuticals, Inc. P. Schreiner reports consulting fees from Pfizer, Takeda and Janssen-Cilag. J. M. Spergel reports grants and/or personal fees from DBV Technologies, End Allergy Together, Food Allergy Research Education, Aimmune Therapeutics, UpToDate, Regeneron, and Shire. T. H. Taft reports speaking fees from Abbvie, consulting fees from Healthline. T. Vanuytsel has served as a speaker for Abbott, Dr Falk Pharma, Fresenius Kabi, Kyowa Kirin and Menarini, Takeda and Will Pharma; has served as a consultant and advisory board member for Baxter, Dr Falk Pharma, Takeda, Tramedico, Truvion, VectivBio, and Zealand Pharma; and has received research funding from Danone and MyHealth. C. Venter has provided and reviewed educational material for Danone, Reckitt Benckiser, Abbott Nutrition, DBV technologies, and Nestle Nutrition Institute and received research grants from the National Peanut Board and Reckitt Benckiser. M. C. Vieira reports speaker's fees from Danone Nutricia, and Nestlé S.A.M. Vieth reports speakers fees from Dr Falk Pharma, Shire and Menarini. U. von Arnim reports consulting fees from ESOCAP, Abbvie, MSD, Takeda, Falk Pharma. J. B. Wechsler receives consulting fees from Allakos and Regeneron. N. Zevit reports speakers fees for Dr Falk Pharma and as an advisory board member for Adare Pharmaceuticals. E. Safroneeva received consulting fees from AVIR Pharma Inc, Aptalis Pharma, Inc, Celgene Corp., Novartis, AG, and Regeneron Pharmaceuticals Inc. The remaining authors disclose no conflicts.
Funding This work was supported by grants from the Swiss National Science Foundation (32003B_160115/1 to A. M. Schoepfer and 32473B_185008 to E. Safroneeva).