Abstract
The US Food and Drug Administration hosted a workshop on July 21, 2021, to discuss the disease characteristics, natural history, and end points to assess treatment benefit in patients with eosinophilic gastrointestinal disorders (EGIDs) beyond eosinophilic esophagitis (EoE). Notably, EGIDs beyond EoE, such as eosinophilic gastritis, eosinophilic enteritis, and eosinophilic colitis, herein referred to as non-EoE EGIDs, are understudied relative to EoE. This workshop provided a forum for open discussion among stakeholders—medical professionals (including their societies and research groups), Food and Drug Administration representatives, an industry representative, and a patient representative—to facilitate drug development. Experts in many disciplines related to EGIDs, including allergy, immunology, epidemiology, gastroenterology, and pathology, and both adult and pediatric clinicians contributed. Herein, we discuss some of the insights of the material presented at the meeting and present perspectives on moving the field forward toward drug approval.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 844-853 |
| Number of pages | 10 |
| Journal | Journal of Allergy and Clinical Immunology |
| Volume | 149 |
| Issue number | 3 |
| DOIs | |
| State | Published - Mar 2022 |
Keywords
- Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR)
- Food and Drug Administration (FDA)
- diagnosis
- eosinophilic colitis
- eosinophilic duodenitis
- eosinophilic enteritis
- eosinophilic gastritis
- eosinophilic gastroenteritis
- eosinophilic gastrointestinal disorder
- food allergy
- treatment
ASJC Scopus subject areas
- Immunology and Allergy
- Immunology
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In: Journal of Allergy and Clinical Immunology, Vol. 149, No. 3, 03.2022, p. 844-853.
Research output: Contribution to journal › Article › peer-review
TY - JOUR
T1 - Impressions and aspirations from the FDA GREAT VI Workshop on Eosinophilic Gastrointestinal Disorders Beyond Eosinophilic Esophagitis and Perspectives for Progress in the Field
AU - Rothenberg, Marc E.
AU - Hottinger, Shawna K.B.
AU - Gonsalves, Nirmala
AU - Furuta, Glenn T.
AU - Collins, Margaret H.
AU - Talley, Nicholas J.
AU - Peterson, Kathryn
AU - Menard-Katcher, Calies
AU - Smith, Macie
AU - Hirano, Ikuo
AU - Genta, Robert M.
AU - Chehade, Mirna
AU - Gupta, Sandeep K.
AU - Spergel, Jonathan M.
AU - Aceves, Seema S.
AU - Dellon, Evan S.
N1 - Funding Information: This study was supported by the Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) (grant no. U54 AI117804 ), which is part of the Rare Diseases Clinical Research Network (RDCRN), an initiative of the Office of Rare Diseases Research, National Center for Advancing Translational Sciences (NCATS), and is cofunded by the National Institute of Allergy and Infectious Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, NCATS, and the Intramural Research Program of the National Institutes of Health. CEGIR is also supported by patient advocacy groups including the American Partnership for Eosinophilic Disorders, Campaign Urging Research for Eosinophilic Disease, and Eosinophilic Family Coalition. As a member of the RDCRN, CEGIR is also supported by its Data Management and Coordinating Center (DMCC) (grant no. U2CTR002818). Funding support for the DMCC is provided by the NCATS and the National Institute of Neurological Disorders and Stroke. These contents are not intended to convey official US Food and Drug Administration (FDA) policy, and no official endorsement by the US FDA should be inferred. Funding Information: This study was supported by the Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) (grant no. U54 AI117804), which is part of the Rare Diseases Clinical Research Network (RDCRN), an initiative of the Office of Rare Diseases Research, National Center for Advancing Translational Sciences (NCATS), and is cofunded by the National Institute of Allergy and Infectious Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, NCATS, and the Intramural Research Program of the National Institutes of Health. CEGIR is also supported by patient advocacy groups including the American Partnership for Eosinophilic Disorders, Campaign Urging Research for Eosinophilic Disease, and Eosinophilic Family Coalition. As a member of the RDCRN, CEGIR is also supported by its Data Management and Coordinating Center (DMCC) (grant no. U2CTR002818). Funding support for the DMCC is provided by the NCATS and the National Institute of Neurological Disorders and Stroke. These contents are not intended to convey official US Food and Drug Administration (FDA) policy, and no official endorsement by the US FDA should be inferred. Disclosure of potential conflict of interest: M. E. Rothenberg is a consultant for Pulm One, Spoon Guru, ClostraBio, Serpin Pharm, Allakos, Celldex, Celgene, Astra Zeneca, Adare/Ellodi Pharma, GlaxoSmithKline, Regeneron/Sanofi, Revolo Biotherapeutics, and Guidepoint and has an equity interest in the first 6 listed and royalties from reslizumab (Teva Pharmaceuticals), PEESSv2 (Mapi Research Trust), and UpToDate; and has done expert witness testimony and is an inventor of patents owned by Cincinnati Children's Hospital Medical Center. S. K. Hottinger declares receiving salary support from Cincinnati Children's Hospital Medical Center and the Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR; National Institutes of Health grant no. U54AI117804). N. Gonsalves declares being a consultant of Allakos, Sanofi-Regeneron, Abbvie, AstraZeneca, Knopp, and Nutritia; being on the speakers’ bureau of Takeda; and receiving royalites from UpToDate. G. T. Furuta declares that he is a cofounder of EnteroTrack and receives research funding from Arena and Holoclara. M. H. Collins has received research funding from AstraZeneca, Meritage Pharma Inc, Receptos/Celgene, Regeneron Pharmaceuticals, and Shire, a Takeda company, and is a consultant for Allakos, Arena Pharmaceuticals, AstraZeneca, Calypso Biotech, EsoCap Biotech, GlaxoSmithKline, Receptos/Celgene/BMS, Regeneron Pharmaceuticals, Robarts Clinical Trials Inc/Alimentiv, Inc, and Shire, a Takeda company. N. J. Talley reports nonfinancial support from the HVN National Science Challenge NZ, personal fees from Aviro Health (digestive health) (2019), Anatara Life Sciences, Brisbane (2019), Allakos (gastric eosinophilic disease) (2021), Bayer (irritable bowel syndrome [IBS]) (2020), Danone (probiotic) (2018), Planet Innovation (gas capsule IBS) (2020), Takeda, Japan (gastroparesis) (2019), twoXAR (IBS drugs) (2019), Viscera Labs, USA (IBS-diarrhea) (2021), Dr Falk Pharma (eosinophilic esophagitis) (2020), Censa, Wellesley, Mass (diabetic gastroparesis) (2019), Cadila PharmIncaceuticals (continuing medical education) (2019), Progenity, Inc, San Diego, Calif (intestinal capsule) (2019), Sanofi-Aventis, Sydney (probiotic) (2019), Glutagen (celiac disease) (2020), ARENA Pharmaceuticals (abdominal pain) (2019), IsoThrive (esophageal microbiome) (2021), BluMaiden (2021), Rose Pharma (2021), Intrinsic Medicine (2021), and Comvita Mānuka Honey (2021) for projects outside of the submitted work; reports a patent Nepean Dyspepsia Index (1998), Biomarkers of IBS licensed, a patent Licensing Questionnaires Talley Bowel Disease Questionnaire licensed to Mayo/Talley, a patent Nestec European Patent licensed, a patent Singapore Provisional Patent “Microbiota Modulation of BDNF Tissue Repair Pathway” issued, and an Australian Provisional Patent Application 2021901692 “Diagnostic marker for functional gastrointestinal disorders”; serves on committees for OzSage, Australian Medical Council (Council Member), Australian Telehealth Integration Programme, MBS Review Taskforce, National Health and Medical Research Council Principal Committee (Research Committee; Australia), and Asia Pacific Association of Medical Journal Editors; serves on boards for GESA Board (member), Sax Institute, and Committees of the Presidents of Medical Colleges; engages with community groups by being on the advisory boards of International Foundation for Functional GI Disorders and ausEE (Australian eosinophilic esophagitis patient advocacy group); judges research grants for the Avant Foundation; serves as an editor for the Medical Journal of Australia (Editor-in-Chief), UpToDate (Section Editor), Precision and Future Medicine, and the Journal of Cell Press (Sungkyunkwan University School of Medicine, South Korea, Med); and receives funding from the National Health and Medical Research Council (Australia) via the Centre for Research Excellence in Digestive Health and a National Health and Medical Research Council investigator grant. K. Peterson declares having an advisory role and/or receiving research support from Alladapt, AstraZeneca, Allakos, Bristol Meyers Squibb, CHobani, Ellodi, Lucid, Medscape, Peerview Regeneron, and Takeda and having equity in Nexeos. I. Hirano declares receiving research funding from Adare/Ellodi, Allakos, Arena, AstraZeneca, Meritage, Celgene/Receptos/BMS, Regeneron/Sanofi, and Shire/Takeda and receiving consulting fees from Adare/Ellodi, Allakos, Amgen, Arena, AstraZeneca, Celgene/Receptos/BMS, Eli Lilly, EsoCap, Gossamer Bio, Parexel/Calyx, Phathom, Regeneron, Sanofi, and Shire/Takeda. R. M. Genta declares that he is a consultant for Allakos, Adare/Ellodi, and Red Hill (all pharmaceutical companies). M. Chehade declares receiving consultant fees from Regeneron, Allakos, Adare/Ellodi, Shire/Takeda, AstraZeneca, Sanofi, Bristol Myers Squibb, and Phathom and research funding from Regeneron, Allakos, Shire/Takeda, AstraZeneca, Adare/Ellodi, and Danone. S. K. Gupta declares being a consultant of Abbott, Adare, Allakos, Celgene, Gossamer Bio, QOL Medical, UpToDate, Medscape, and Viaskin and receiving research support from Shire, Allakos, Adare, and the National Institutes of Health grant to CEGIR. J. M. Spergel declares receiving grants or contracts from Novartis, Abbott, Regeneron, Sanofi, and the National Institutes of Health; royalties or licenses from UpToDate; consulting fees from Regeneron, Sanofi, Novartis, Takeda, Allakos, and Alladapt; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Medscape and Rockpointe; and being on the Safety Monitoring Board or Advisory Board of the National Institute of Allergy and Infectious Disease and of Syneos. S. S. Aceves declares being a consultant for AstraZeneca and Regeneron, a speaker for MedScape and Sanofi-Genzyme (Regeneron), and a coinventor of oral viscous budesonide (patented by the University of California, San Diego, and licensed by Takeda). E. S. Dceves declares receiving research funding from Adare/Ellodi, Allakos, Arena, AstraZeneca, GlaxoSmithKline, Meritage, Miraca, Nutricia, Celgene/Receptos/BMS, Regeneron, and Shire/Takeda; being a consultant of Abbott, Abbvie, Adare/Ellodi, Aimmune, Allakos, Amgen, Arena, AstraZeneca, Avir, Biorasi, Calypso, Celgene/Receptos/BMS, Celldex, Eli Lilly, EsoCap, GlaxoSmithKline, Gossamer Bio, InveniAI, Landos, LucidDx, Morphic, Nutricia, Parexel/Calyx, Phathom, Regeneron, Revolo, Robarts/Alimentiv, Salix, Sanofi, and Shire/Takeda; and receiving educational grants from Allakos, Banner, and Holoclara. The rest of the authors declare that they have no relevant conflicts of interest. Publisher Copyright: © 2021 American Academy of Allergy, Asthma & Immunology
PY - 2022/3
Y1 - 2022/3
N2 - The US Food and Drug Administration hosted a workshop on July 21, 2021, to discuss the disease characteristics, natural history, and end points to assess treatment benefit in patients with eosinophilic gastrointestinal disorders (EGIDs) beyond eosinophilic esophagitis (EoE). Notably, EGIDs beyond EoE, such as eosinophilic gastritis, eosinophilic enteritis, and eosinophilic colitis, herein referred to as non-EoE EGIDs, are understudied relative to EoE. This workshop provided a forum for open discussion among stakeholders—medical professionals (including their societies and research groups), Food and Drug Administration representatives, an industry representative, and a patient representative—to facilitate drug development. Experts in many disciplines related to EGIDs, including allergy, immunology, epidemiology, gastroenterology, and pathology, and both adult and pediatric clinicians contributed. Herein, we discuss some of the insights of the material presented at the meeting and present perspectives on moving the field forward toward drug approval.
AB - The US Food and Drug Administration hosted a workshop on July 21, 2021, to discuss the disease characteristics, natural history, and end points to assess treatment benefit in patients with eosinophilic gastrointestinal disorders (EGIDs) beyond eosinophilic esophagitis (EoE). Notably, EGIDs beyond EoE, such as eosinophilic gastritis, eosinophilic enteritis, and eosinophilic colitis, herein referred to as non-EoE EGIDs, are understudied relative to EoE. This workshop provided a forum for open discussion among stakeholders—medical professionals (including their societies and research groups), Food and Drug Administration representatives, an industry representative, and a patient representative—to facilitate drug development. Experts in many disciplines related to EGIDs, including allergy, immunology, epidemiology, gastroenterology, and pathology, and both adult and pediatric clinicians contributed. Herein, we discuss some of the insights of the material presented at the meeting and present perspectives on moving the field forward toward drug approval.
KW - Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR)
KW - Food and Drug Administration (FDA)
KW - diagnosis
KW - eosinophilic colitis
KW - eosinophilic duodenitis
KW - eosinophilic enteritis
KW - eosinophilic gastritis
KW - eosinophilic gastroenteritis
KW - eosinophilic gastrointestinal disorder
KW - food allergy
KW - treatment
UR - http://www.scopus.com/inward/record.url?scp=85122613896&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85122613896&partnerID=8YFLogxK
U2 - 10.1016/j.jaci.2021.12.768
DO - 10.1016/j.jaci.2021.12.768
M3 - Article
C2 - 34953790
AN - SCOPUS:85122613896
SN - 0091-6749
VL - 149
SP - 844
EP - 853
JO - Journal of Allergy and Clinical Immunology
JF - Journal of Allergy and Clinical Immunology
IS - 3
ER -