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Technical Review on the Management of Eosinophilic Esophagitis 1 1 Technical Review on the Management of Eosinophilic Esophagitis: A report from Formatted: Numbering: Continuous 2 the American Gastroenterological Association Institute and the Joint Task Force 3 on Allergy-Immunology Practice Parameters 4 5 Matthew A. Rank MD1 * 6 Ravi N. Sharaf MD, MS2 * 7 Glenn T. Furuta MD3 8 Seema A. Aceves, MD, PhD4 9 Matthew Greenhawt, MD, MSc, MBA5 10 Jonathan M. Spergel, MD, PhD6 11 Yngve T. Falck-Ytter, MD7 * 12 Evan S. Dellon MD MPH8 * 13 14 Collaborators: Bernstein JA9, Dinakar C10 , Golden DBK11, Khan DA12, Lieberman J13, 15 Oppenheimer J14, Shaker M15, Stukus DR16, Wallace DV17, Wang J18 16 17 *These authors have contributed equally to this report. 18 1Division of Allergy, Asthma, and Clinical Immunology, Mayo Clinic, Scottsdale, AZ; 19 2Division of Gastroenterology, Donald and Barbara Zucker School of Medicine at 20 Hofstra/Northwell, Manhasset, NY; 3 Digestive Health Institute, Children’s Hospital 21 Colorado, Gastrointestinal Eosinophilic Diseases Program and University of Colorado 22 School of Medicine, Aurora, CO;4Division of Allergy Immunology Center for Immunity, 23 Infection, and Inflammation, University of California, San Diego Rady Children's 24 Hospital, San Diego, CA; 5 Section of Allergy/Immunology, Children’s Hospital Colorado, 25 University of Colorado School of Medicine, Aurora, CO; 6 Division of Allergy- 26 Immunology, Children’s Hospital of Philadelphia, Perelman School of Medicine at 27 University of Pennsylvania, Philadelphia, PA; 7Division of Gastroenterology and 28 Hepatology, Cleveland VA Medical Center and University Hospitals, Case Western 29 Reserve University School of Medicine, Cleveland, OH; 8 Center for Esophageal 30 Diseases and Swallowing, Division of Gastroenterology and Hepatology, University of 31 North Carolina School of Medicine, Chapel Hill, NC 9 Department of Internal Medicine, 32 University of Cincinnati College of Medicine, Cincinnati, OH; 10 Division of Allergy and 33 Asthma, Stanford University School of Medicine, Palo Alto, CA; 11 Department of Medicine, 34 Johns Hopkins University, Baltimore, MD; 12 Division of Allergy & Immunology, Department 35 of Medicine, University of Texas Southwestern Medical Center, Dallas, TX; 13 Division of 36 Allergy and Immunology, The University of Tennessee Health Science Center, LeBonheur 37 Children’s Hospital, Memphis, TN; 14 Department of Internal Medicine, New Jersey Medical 38 School, Morristown, NJ; 15 Section of Allergy and Immunology, Dartmouth-Hitchcock Medical 39 Center and Dartmouth Geisel School of Medicine, Lebanon and Hanover, NH; 16Division of 40 Allergy and Immunology, Nationwide Children's Hospital and The Ohio State University 41 College of Medicine, Columbus, OH 17 Department of Medicine, Nova Southeastern University, 42 Davie, FL; 18 Division of Allergy and Immunology, Department of Pediatrics, The Elliot and 2 43 Roslyn Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, Kravis Children’s 44 Hospital, New York NY. 45 46 47 48 Addresses for Correspondence: 49 Chair, Clinical Guidelines Committee, 50 American Gastroenterological Association 51 National Office, 4930 Del Ray Avenue, 52 Bethesda, Maryland 20814. 53 E-mail: ***gastro.org 54 Telephone: (301) 941-2618. 55 56 Joint Task Force on Allergy-Immunology Practice Parameters 57 555 E Wells Street , Suite 1100 58 Milwaukee, WI 53212 59 Email: [email protected] 60 61 62 Manuscript Word Count: 63 References: 116 64 Tables and Figures: 65 eTables and eFigures (in the supplement): 4 and 2 66 67 Keywords: Technical Review; eosinophilic esophagitis; proton pump inhibitor; 68 swallowed corticosteroids; corticosteroids; dietary therapy; elimination diet; elemental 69 diet; targeted elimination diet; biologic therapy; esophageal dilation 70 71 Disclosures and Conflicts of Interest: Conflict of interest disclosure: All members 72 were required to complete disclosure statement. These statements are maintained at 73 the American Gastroenterological Association Institute (AGA) headquarters in 74 Bethesda, Maryland and the Joint Task Force for Allergy-Immunology Practice 75 Parameters in Milwaukee, WI and pertinent disclosure are published with the report. 76 77 Dr. Rank is supported by the Robert E. and Patricia D. Kern Center for the Science of 78 Healthcare Delivery at Mayo Clinic and the Levin Family Foundation. Dr. Sharaf is 79 supported by the National Cancer Institute NCI 1K07CA216326-01A1 and NCI R01 80 1R01CA211723-01A1. Dr. Furuta is supported by the LaCache Chair from Children’s 81 Hospital Colorado 1K24DK100303 (FurutaGT) and Consortium for Gastrointestinal 82 Eosinophilic Researchers (CEGIR). CEGIR (U54 AI117804) is part of the Rare 83 Diseases Clinical Research Network (RDCRN), an initiative of the Office of Rare 84 Diseases Research (ORDR), NCATS, and is funded through collaboration between 85 NIAID, NIDDK, and NCATS and APFED, CURED and EFC. Dr. Aceves is supported by 86 R01, K24 AI, NIAID, and Consortium for Gastrointestinal Eosinophilic Researchers 87 (CEGIR). CEGIR (U54 AI117804) is part of the Rare Diseases Clinical Research 88 Network (RDCRN), an initiative of the Office of Rare Diseases Research (ORDR), 3 89 NCATS, and is funded through collaboration between NIAID, NIDDK, and NCATS and 90 APFED, CURED and EFC. Dr. Greenhawt is supported by grant #5K08HS024599-02 91 from the Agency for Healthcare Quality and Research. Dr. Spergel is supported by the 92 Consortium for Gastrointestinal Eosinophilic Researchers (CEGIR). CEGIR (U54 93 AI117804) is part of the Rare Diseases Clinical Research Network (RDCRN), an 94 initiative of the Office of Rare Diseases Research (ORDR), NCATS, and is funded 95 through collaboration between NIAID, NIDDK, and NCATS and APFED, CURED and 96 EFC and Stuart Starr Chair of Pediatrics. Dr. Dellon is supported by National Institutes 97 of Health grant R01DK101856. 98 99 Acknowledgements: We sincerely thank Kellee Kaulbeck, HBA, MISt for assistance 100 with the medical information search and Stephanie Stanford of the American 101 Gastroenterology Association and Natalie Aumann of the Joint Task Force for Allergy- 102 Immunology PractiCe Parameters for administrative support. We sincerely thank the 103 following investigators for sharing unpublished data from their studies: Jeff Alexander 104 and Fred Clayton. 105 106 Abbreviations used in this paper: APT, atopy patch test; CI, confidence interval; 107 CRD, component-resolved diagnostic; EGD, esophagogastroduodenoscopy; EoE, 108 eosinophilic esophagitis; GERD, gastroesophageal reflux disease; GRADE, Grading of 109 Recommendations Assessment, Development, and Evaluation; HPF, high-powered 110 field; ITT, intention-to-treat; LR, likelihood ratio; OR, odds ratio; PICO, population, 111 intervention, comparator, and outcome; PPI, proton pump inhibitor; RCT, randomized 112 control trial; RR, risk ratio; sIgE, specific IgE testing in serum; SPT, skin prick testing 113 114 ABSTRACT 115 116 Eosinophilic esophagitis (EoE) is a chronic inflammatory condition of the esophagus. 117 Many new studies have been reported recently that describe EoE management. An 118 expert panel was convened by the American Gastroenterological Association Institute 119 and the Joint Task Force on Allergy-Immunology Practice Parameters to provide a 120 technical report to be used as the basis for an updated clinical guideline. This technical 121 review was developed using the Grading of Recommendations Assessment, 122 Development, and Evaluation (GRADE) framework. Eighteen focused EoE 123 management questions were considered, with 15 answered using the GRADE 124 framework and 3 with a narrative summary. There is moderate certainty in the evidence 125 that topical glucocorticosteroids effectively reduce esophageal eosinophil counts to 126 <15/hpf over a short-term treatment period of 4-12 weeks, but very low certainty about 127 the effects of using topical glucocorticosteroids as maintenance therapy. Multiple 128 dietary strategies may be effective in reducing esophageal eosinophil counts to <15/hpf 129 over a short-term treatment period, with moderate certainty for elemental diets, low 130 certainty for empiric 2,4 and 6 food elimination diets, and very low certainty that allergy- 131 based testing dietary eliminations have a higher failure rate compared to empiric diet 132 elimination. There is very low certainty for the effect of PPIs in patients with esophageal 133 eosinophilia. Although esophageal dilation appears to be relatively safe there is no 134 evidence that it reduces esophageal eosinophil counts. There is very low certainty in 4 135 the effects of multiple other medical treatments for EoE: anti-IL-5 therapy, anti-IL-13 136 therapy, anti-IgE therapy, montelukast, cromolyn, and anti-TNF therapy. 137 138 INTRODUCTION 139 140 Eosinophilic esophagitis (EoE) is a chroniC rare inflammatory condition of the 141 esophagus that is estimated to affect 1 in every 2000 people.(1) The incidence of EoE 142 is increasing. EoE can occur in children and adults and is more common in Whites, 143 males, and is associated with other atopic diseases. EoE negatively impacts the quality 144 of life for patients and their families. Medical resource utilization costs in EoE may be 145 significant for some. (2, 3) 146 147 EoE can be characterized by the associated symptoms, visual esophageal endoscopic 148 findings, and histopathology. In adolescents and adults, symptoms often include 149 dysphagia and food impaction, but can be less specific in children, and can include 150 failure to thrive,
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