A Summary of the Meetings of the Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) International Multidisciplinary Consensus

COREOS Collaborators

doi:https://doi.org/10.1053/j.gastro.2021.04.081

A Summary of the Meetings of the Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) International Multidisciplinary Consensus

COREOS Collaborators

Research output: Contribution to journal › Article › Academic

Original language	English
Pages (from-to)	778-784
Number of pages	7
Journal	Gastroenterology
Volume	161
Issue number	3
DOIs	https://doi.org/10.1053/j.gastro.2021.04.081
Publication status	Published - 1 Sept 2021

Keywords

Clinical Trials
End Points
Endoscopy
Eosinophilic Esophagitis
Histology
Histopathology
Outcomes
Patient-Reported Outcomes
Quality of Life
Symptoms

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https://doi.org/10.1053/j.gastro.2021.04.081

Cite this

@article{5df500d00f1d4fa6816e2c3cfe6dd66a,

title = "A Summary of the Meetings of the Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) International Multidisciplinary Consensus",

keywords = "Clinical Trials, End Points, Endoscopy, Eosinophilic Esophagitis, Histology, Histopathology, Outcomes, Patient-Reported Outcomes, Quality of Life, Symptoms",

author = "{COREOS Collaborators} and Christopher Ma and Schoepfer, {Alain M.} and Ekaterina Safroneeva and Dellon, {Evan S.} and Bredenoord, {Albert J.} and Mirna Chehade and Collins, {Margaret H.} and Feagan, {Brian G.} and Furuta, {Glenn T.} and Gupta, {Sandeep K.} and Ikuo Hirano and Vipul Jairath and Katzka, {David A.} and Pai, {Rish K.} and Rothenberg, {Marc E.} and Alex Straumann and Aceves, {Seema S.} and Alexander, {Jeffrey A.} and Arva, {Nicoleta C.} and Dan Atkins and Luc Biedermann and Carine Blanchard and Antonella Cianferoni and {Ciriza de los Rios}, Constanza and Frederic Clayton and Davis, {Carla M.} and {de Bortoli}, Nicola and Dias, {Jorge A.} and Falk, {Gary W.} and Genta, {Robert M.} and Gisoo Ghaffari and Nirmala Gonsalves and Thomas Greuter and Russell Hopp and {Hsu Blatman}, {Karen S.} and Jensen, {Elizabeth T.} and Doug Johnston and Kagalwalla, {Amir F.} and Larsson, {Helen M.} and John Leung and Hubert Louis and Masterson, {Joanne C.} and Calies Menard-Katcher and Menard-Katcher, {Paul A.} and Moawad, {Fouad J.} and Muir, {Amanda B.} and Mukkada, {Vincent A.} and Roberto Penagini and Pesek, {Robert D.} and Ingrid Terreehorst",

note = "Funding Information: 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, Nestl{\'e} 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{\textquoteright}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 Soci{\'e}t{\'e} des produits Nestl{\'e} 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 Nestl{\'e} 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 Information: 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). Funding Information: The Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) authors would like to acknowledge the following contributors: European Consortium for Eosinophilic Diseases of the GI Tract (EUREOS) and Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) for endorsing the COREOS exercise; the members of CEGIR, EUREOS, and Eosinophil-Associated Gastrointestinal Disorders Committee of American Academy of Allergy, Asthma, and Immunology for participating in domains round but not in other rounds, including Heather Dawson, Marion Groetch, Cord Langner, Sameer Mathur, Stephan Miehlke, Melanie Mukhija, Isabel P{\'e}rez-Mart{\'i}nez, Caroline Saad, Divya Seth, and Hans-Uwe Simon; Leonardo Guizzetti, PhD, employee of Alimentiv Inc, for help with statistical methodology; John MacDonald for assistance with technical editing of the manuscript; and patients participating in the study for informing the content of this exercise. Research reported in this publication was supported by the Swiss National Science Foundation (under award number 32003B_160115/1 to A. M. Schoepfer and 32473B_185008 to E. Safroneeva). All authors have approved the final version of this manuscript. Christopher Ma and Alain M. Schoepfer contributed equally to this work.",

year = "2021",

month = sep,

day = "1",

doi = "https://doi.org/10.1053/j.gastro.2021.04.081",

language = "English",

volume = "161",

pages = "778--784",

journal = "Gastroenterology",

issn = "0016-5085",

publisher = "W.B. Saunders Ltd",

number = "3",

}

TY - JOUR

T1 - A Summary of the Meetings of the Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) International Multidisciplinary Consensus

AU - COREOS Collaborators

AU - Ma, Christopher

AU - Schoepfer, Alain M.

AU - Safroneeva, Ekaterina

AU - Dellon, Evan S.

AU - Bredenoord, Albert J.

AU - Chehade, Mirna

AU - Collins, Margaret H.

AU - Feagan, Brian G.

AU - Furuta, Glenn T.

AU - Gupta, Sandeep K.

AU - Hirano, Ikuo

AU - Jairath, Vipul

AU - Katzka, David A.

AU - Pai, Rish K.

AU - Rothenberg, Marc E.

AU - Straumann, Alex

AU - Aceves, Seema S.

AU - Alexander, Jeffrey A.

AU - Arva, Nicoleta C.

AU - Atkins, Dan

AU - Biedermann, Luc

AU - Blanchard, Carine

AU - Cianferoni, Antonella

AU - Ciriza de los Rios, Constanza

AU - Clayton, Frederic

AU - Davis, Carla M.

AU - de Bortoli, Nicola

AU - Dias, Jorge A.

AU - Falk, Gary W.

AU - Genta, Robert M.

AU - Ghaffari, Gisoo

AU - Gonsalves, Nirmala

AU - Greuter, Thomas

AU - Hopp, Russell

AU - Hsu Blatman, Karen S.

AU - Jensen, Elizabeth T.

AU - Johnston, Doug

AU - Kagalwalla, Amir F.

AU - Larsson, Helen M.

AU - Leung, John

AU - Louis, Hubert

AU - Masterson, Joanne C.

AU - Menard-Katcher, Calies

AU - Menard-Katcher, Paul A.

AU - Moawad, Fouad J.

AU - Muir, Amanda B.

AU - Mukkada, Vincent A.

AU - Penagini, Roberto

AU - Pesek, Robert D.

AU - Terreehorst, Ingrid

N1 - Funding Information: 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 Information: 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). Funding Information: The Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) authors would like to acknowledge the following contributors: European Consortium for Eosinophilic Diseases of the GI Tract (EUREOS) and Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) for endorsing the COREOS exercise; the members of CEGIR, EUREOS, and Eosinophil-Associated Gastrointestinal Disorders Committee of American Academy of Allergy, Asthma, and Immunology for participating in domains round but not in other rounds, including Heather Dawson, Marion Groetch, Cord Langner, Sameer Mathur, Stephan Miehlke, Melanie Mukhija, Isabel Pérez-Martínez, Caroline Saad, Divya Seth, and Hans-Uwe Simon; Leonardo Guizzetti, PhD, employee of Alimentiv Inc, for help with statistical methodology; John MacDonald for assistance with technical editing of the manuscript; and patients participating in the study for informing the content of this exercise. Research reported in this publication was supported by the Swiss National Science Foundation (under award number 32003B_160115/1 to A. M. Schoepfer and 32473B_185008 to E. Safroneeva). All authors have approved the final version of this manuscript. Christopher Ma and Alain M. Schoepfer contributed equally to this work.

PY - 2021/9/1

Y1 - 2021/9/1

KW - Clinical Trials

KW - End Points

KW - Endoscopy

KW - Eosinophilic Esophagitis

KW - Histology

KW - Histopathology

KW - Outcomes

KW - Patient-Reported Outcomes

KW - Quality of Life

KW - Symptoms

UR - http://www.scopus.com/inward/record.url?scp=85112838285&partnerID=8YFLogxK

U2 - https://doi.org/10.1053/j.gastro.2021.04.081

DO - https://doi.org/10.1053/j.gastro.2021.04.081

M3 - Article

C2 - 34051239

SN - 0016-5085

VL - 161

SP - 778

EP - 784

JO - Gastroenterology

JF - Gastroenterology

IS - 3

ER -

A Summary of the Meetings of the Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) International Multidisciplinary Consensus

Keywords

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