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1. Loss of Endothelial TSPAN12 Promotes Fibrostenotic Eosinophilic Esophagitis via Endothelial Cell–Fibroblast Crosstalk

Author

Tetsuo Shoda, Ting Wen, Julie M. Caldwell, Netali Ben-Baruch Morgenstern, Garrett A. Osswald, Mark Rochman, Lydia E. Mack, Jennifer M. Felton, J. Pablo Abonia, Nicoleta C. Arva, Dan Atkins, Peter A. Bonis, Kelley E. Capocelli, Margaret H. Collins, Evan S. Dellon, Gary W. Falk, Nirmala Gonsalves, Sandeep K. Gupta, Ikuo Hirano, John Leung, Paul A. Menard-Katcher, Vincent A. Mukkada, Philip E. Putnam, Amanda K. Rudman Spergel, Jonathan M. Spergel, Joshua B. Wechsler, Guang-Yu Yang, Seema S. Aceves, Glenn T. Furuta, Marc E. Rothenberg, Seema Aceves, Samuel Almonte, Rachel Andrews, Ashley Arrington, Nicoleta Arva, Fred Atkins, Dominique Bailey, Alexis Berry, Bridget Besl, Scott Bolton, Peter Bonis, Wendy Book, Kimberly Bray, Teresa Brown, Cassandra Burger, Deirdre Burke, Jonathon Cahoon, Kelley Capocelli, Mirna Chehade, Margaret Collins, Carla Davis, Evan Dellon, Maureen DeMarshall, Lauren DiTommaso, Ranjan Dohil, Michael Eby, Gary Falk, David Fleischer, Heather Foote, Kelci Foss, Joel Friedlander, Patricia Fulkerson, Glenn Furuta, Debra Geno, Thomas Greuter, Sandeep Gupta, Frank Hamilton, Kirk Harris, Jennifer Harris, Girish Hiremath, Nicole Holland-Thomas, Lea Jacinto, Amir Kagalwalla, Timothy Kaseta, David Katzka, Kaitlin Keeley, Emad Khosh-Hemmat, Paneez Khoury, Eileen King, Kara Kliewer, Amy Klion, Jennifer Knowles, Kendra Kocher, Ellyn Kodroff, Jeffrey Krischer, Shay Kyle, Meredith Levy, Chris Liacouras, Denise Mack, Lisa Martin, Ellen Martin, Talaya McCright-Gill, Paul Menard-Katcher, Calies Menard-Katcher, Gabriela Mendoza, Melissa Mingler, Mike Minnicozzi, Amanda Muir, Vincent Mukkada, Cristin MurrayPetzold, Robert Newbury, Quan Nhu, Oghenekpaobor (Joel) Oyibo, Allisa Paliana, Zhaoxing Pan, Robbie Pesek, Kathryn Peterson, Heidi Poppendeck, Philip Putnam, Fabian Rivera, Marc Rothenberg, Amanda Rudman Spergel, Kathleen Sable, Alain Schoepfer, Melissa Scott, Rachel Sheridan, Selma Sinanovic, Jonathan Spergel, MaryJo Strobel, Kiki Sun, Amy Tasco, Crystal Tholen, Katherine Thompson, Tiffany Tomkinson, Daisy Tran, Alexandra Tylicki, Tiina Urv, Mei-Lun Wang, Joshua Wechsler, Barry Wershil, Lisa Wheatley, Leah Wilkey, Angelika Zalewski, and Amy Zicarelli

Subjects
Adult, Male, Pathology, medicine.medical_specialty, Thymic stromal lymphopoietin, Adolescent, Endothelium, Tetraspanins, medicine.drug_class, Proton-pump inhibitor, Young Adult, Esophagus, Fibrosis, Eosinophilic, medicine, Humans, Gene Silencing, RNA, Small Interfering, Child, Eosinophilic esophagitis, Interleukin-13, Hepatology, business.industry, Gastroenterology, Endothelial Cells, Eosinophilic Esophagitis, Fibroblasts, Middle Aged, Eosinophil, medicine.disease, medicine.anatomical_structure, Gene Expression Regulation, Gastrointestinal disease, Child, Preschool, Esophageal Stenosis, Female, business
Abstract

Eosinophilic esophagitis (EoE) can progress to fibrostenosis by unclear mechanisms. Herein, we investigated gene dysregulation in fibrostenotic EoE, its association with clinical parameters and specific pathways, and the functional consequences.Esophageal biopsies from subjects with EoE were collected across 11 Consortium of Eosinophilic Gastrointestinal Disease Researchers sites (n = 311) and 2 independent replication cohorts (n = 83). Inclusion criteria for fibrostenotic EoE were endoscopic rings, stricture, and/or a history of dilation. Endoscopic, histologic, and molecular features were assessed by the EoE Endoscopic Reference Score, EoE Histology Scoring System, EoE Diagnostic Panel, and RNA sequencing. Esophageal endothelial TSPAN12 expression and functional effects on barrier integrity and gene expression were analyzed in vitro.TSPAN12 was the gene most correlated with fibrostenosis (r = -0.40, P.001). TSPAN12 was lower in fibrostenotic EoE and correlated with EoE Endoscopic Reference Score, EoE Diagnostic Panel, and EoE Histology Scoring System (r = 0.34-0.47, P.001). Lower TSPAN12 associated with smaller esophageal diameter (r = 0.44, P = .03), increased lamina propria fibrosis (r = -0.41, P.001), and genes enriched in cell cycle-related pathways. Interleukin (IL)-13 reduced TSPAN12 expression in endothelial cells. Conversely, anti-IL-13 therapy increased TSPAN12 expression. TSPAN12 gene silencing increased endothelial cell permeability and dysregulated genes associated with extracellular matrix pathways. Endothelial cell-fibroblast crosstalk induced extracellular matrix changes relevant to esophageal remodeling.Patients with fibrostenotic EoE express decreased levels of endothelial TSPAN12. We propose that IL-13 decreases TSPAN12, likely contributing to the chronicity of EoE by promoting tissue remodeling through fibroblast-endothelial cell crosstalk.

Published
2022

2. Advancing patient care through the Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR)

Author

Seema Aceves, Margaret H. Collins, Marc E. Rothenberg, Glenn T. Furuta, Nirmala Gonsalves, J. Pablo Abonia, Samuel Almonte, Rachel Andrews, Ashley Arrington, Nicoleta Arva, Fred Atkins, Dominique Bailey, Alexis Berry, Bridget Besl, Scott Bolton, Peter Bonis, Wendy Book, Kimberly Bray, Teresa Brown, Cassandra Burger, Deirdre Burke, Jonathon Cahoon, Kelley Capocelli, Mirna Chehade, Margaret Collins, Carla Davis, Evan Dellon, Maureen DeMarshall, Lauren DiTommaso, Ranjan Dohil, Michael Eby, Gary Falk, David Fleischer, Heather Foote, Kelci Foss, Joel Friedlander, Patricia Fulkerson, Glenn Furuta, Debra Geno, Thomas Greuter, Sandeep Gupta, Frank Hamilton, Kirk Harris, Jennifer Harris, Ikuo Hirano, Girish Hiremath, Nicole Holland-Thomas, Lea Jacinto, Amir Kagalwalla, Timothy Kaseta, David Katzka, Kaitlin Keeley, Emad Khosh-Hemmat, Paneez Khoury, Eileen King, Kara Kliewer, Amy Klion, Jennifer Knowles, Kendra Kocher, Ellyn Kodroff, Jeffrey Krischer, Shay Kyle, John Leung, Meredith Levy, Chris Liacouras, Denise Mack, Lisa Martin, Ellen Martin, Talaya McCright-Gill, Paul Menard-Katcher, Calies Menard-Katcher, Gabriela Mendoza, Melissa Mingler, Mike Minnicozzi, Amanda Muir, Vincent Mukkada, Cristin MurrayPetzold, Robert Newbury, Quan Nhu, Oghenekpaobor (Joel) Oyibo, Allisa Paliana, Zhaoxing Pan, Robbie Pesek, Kathryn Peterson, Heidi Poppendeck, Philip Putnam, Fabian Rivera, Marc Rothenberg, Amanda Rudman-Spergel, Kathleen Sable, Alain Schoepfer, Melissa Scott, Rachel Sheridan, Selma Sinanovic, Jonathan Spergel, MaryJo Strobel, Kiki Sun, Amy Tasco, Crystal Tholen, Katherine Thompson, Tiffany Tomkinson, Daisy Tran, Alexandra Tylicki, Tiina Urv, Mei-Lun Wang, Joshua Wechsler, Barry Wershil, Lisa Wheatley, Leah Wilkey, Guang-Yu Yang, Angelika Zalewski, and Amy Zicarelli

Subjects
Clinical Trials as Topic, Medical education, Biomedical Research, Eosinophilic gastritis, business.industry, Immunology, Eosinophilic Esophagitis, Patient advocacy, Enteritis, United States, Article, Patient care, Clinical trial, Natural history, National Institutes of Health (U.S.), Multidisciplinary approach, Gastritis, Eosinophilia, Eosinophilic, Immunology and Allergy, Medicine, Patient-reported outcome, business
Abstract

Recent advances in rare disease research are accelerated by the work of consortia that have been supported by the National Institutes of Health. Development of such consortia rely on multidisciplinary relationships and engagement with patient advocacy groups, as well as the National Institutes of Health and industry and academic partners. In this rostrum we present the development of such a process that focuses on eosinophilic gastrointestinal diseases. Principal investigators, patient advocacy groups, research assistants, and trainees work together to perform natural history studies that promote clinical trial readiness tools, conduct clinical trials, train a new generation of investigators, and perform innovative pilot studies.

Published
2020

3. Long-Term Treatment of Eosinophilic Esophagitis With Budesonide Oral Suspension

Author

Evan S. Dellon, Margaret H. Collins, David A. Katzka, Vincent A. Mukkada, Gary W. Falk, Robin Morey, Bridgett Goodwin, Jessica D. Eisner, Lan Lan, Nirav K. Desai, James Williams, Ikuo Hirano, Curtis Baum, Pradeep Bekal, David Chaletsky, Mirna Chehade, Larry Clark, Evan Dellon, Reed Dimmitt, David Dulitz, Gary Falk, Ronald Fogel, Keith Friedenberg, Scott Gabbard, Andrew Gentry, Benjamin Gold, Michael Goldstein, Sandeep Gupta, Karen Hsu-Blatman, Vikram Jayanty, David Katzka, Vidhya Kunnathur, John Lee, John Leung, Jonathan Markowitz, Calies Menard-Katcher, Benjamin Mitlyng, Sam E. Moussa, Vincent Mukkada, Molly O’Gorman, Juan Olazagasti, Timothy Ritter, Wael Sayej, Shauna Schroeder, Yamen Smadi, Daniel Soteres, Theodore Stathos, Michael F. Vaezi, Tom Whitlock, John Wo, Ziad Younes, and Salam Zakko

Subjects
Budesonide, medicine.medical_specialty, Long term treatment, Anti-Inflammatory Agents, Administration, Oral, Placebo, Gastroenterology, Double-Blind Method, Suspensions, Maintenance therapy, Internal medicine, Eosinophilia, medicine, Clinical endpoint, Humans, Therapy duration, Eosinophilic esophagitis, Hepatology, business.industry, Eosinophilic Esophagitis, medicine.disease, Dysphagia, Enteritis, humanities, Treatment Outcome, Gastritis, medicine.symptom, Deglutition Disorders, business, medicine.drug
Abstract

BACKGROUND & AIMS We evaluated treatment withdrawal, long-term outcomes, and safety of budesonide oral suspension (BOS) 2.0 mg twice daily in patients with eosinophilic esophagitis who completed a 12-week induction study. METHODS Induction full responders (≤6 eosinophils per high-power field [eos/hpf] and ≥30% reduction in the Dysphagia Symptom Questionnaire score) to BOS 2.0 mg twice daily (ORBIT1/SHP621-301/NCT02605837) were randomized to continue BOS (BOS-BOS) or withdraw to placebo (BOS-PBO) for 36 weeks (ORBIT2/SHP621-302/NCT02736409). Induction partial responders and nonresponders, and patients who received induction placebo, received BOS for 36 weeks. The primary end point was the proportion of BOS-BOS and BOS-PBO patients who relapsed (≥15 eos/hpf and ≥4 days of dysphagia [Dysphagia Symptom Questionnaire] over 2 weeks) by week 36. The key secondary end point was the proportion of induction partial responders and nonresponders who fully responded after 52 weeks of total BOS therapy. Other secondary end points included the proportion of induction full responders with histologic responses (≤1, ≤6

Published
2022

4. AGA Institute and the Joint Task Force on Allergy-Immunology Practice Parameters Clinical Guidelines for the Management of Eosinophilic Esophagitis

Author

Ikuo Hirano, Edmond S. Chan, Matthew A. Rank, Rajiv N. Sharaf, Neil H. Stollman, David R. Stukus, Kenneth Wang, Matthew Greenhawt, Yngve T. Falck-Ytter, Karen A. Chachu, Lukejohn Day, Benjamin Lebwohl, Thiruvengadam Muniraj, Amit Patel, Anne F. Peery, Raj Shah, Harminder Singh, Siddharth Singh, Stuart J. Spechler, Shahnaz Sultan, Grace L. Su, Aaron P. Thrift, Jennifer M. Weiss, Adam V. Weizman, Jonathan A. Bernstein, Chitra Dinakar, David B.K. Golden, David A. Khan, Jay Lieberman, John Oppenheimer, Marcus Shaker, Dana V. Wallace, Julie Wang, Glenn Furuta, Evan Dellon, Jonathan Spergel, Seema Aceves, Yngve Falck-Ytter, and Rajiv Sharaf

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, medicine.drug_class, Administration, Topical, Immunology, Advisory Committees, MEDLINE, Proton-pump inhibitor, Article, law.invention, Randomized controlled trial, law, Adrenal Cortex Hormones, Internal medicine, Allergy and Immunology, medicine, Immunology and Allergy, Humans, Eosinophilic esophagitis, Expert Testimony, Societies, Medical, Hepatology, medicine.diagnostic_test, Task force, Extramural, Esophagogastroduodenoscopy, Allergy immunology, business.industry, Disease progression, Gastroenterology, Proton Pump Inhibitors, Eosinophilic Esophagitis, medicine.disease, Confidence interval, United States, Phenotype, Relative risk, Practice Guidelines as Topic, Disease Progression, business
Published
2020

5. Budesonide Oral Suspension Improves Symptomatic, Endoscopic, and Histologic Parameters Compared With Placebo in Patients With Eosinophilic Esophagitis

Author

Evan S. Dellon, David A. Katzka, Margaret H. Collins, Mohamed Hamdani, Sandeep K. Gupta, Ikuo Hirano, Amir Kagalwalla, Jeffrey Lewis, Jonathan Markowitz, Samuel Nurko, John Wo, Evan Dellon, Thirumazhisai S. Gunasekaran, Sandeep Gupta, Brad Pasternak, Mark Ellis, Kathryn Peterson, Gary Falk, John Leung, Laurel Prestridge, Michael Hart, Neal Leleiko, Michael Vaezi, Rebecca Cherry, David Katzka, Keith Friedenberg, Yehudith Assouline-Dayan, and Vincent Mukkada

Subjects
Budesonide, Adult, Male, medicine.medical_specialty, Adolescent, medicine.medical_treatment, Anti-Inflammatory Agents, Administration, Oral, Cell Count, Placebo, Gastroenterology, Severity of Illness Index, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Double-Blind Method, Suspensions, Internal medicine, Severity of illness, medicine, Eosinophilia, Humans, Eosinophilic esophagitis, Child, Hepatology, business.industry, Eosinophilic Esophagitis, medicine.disease, Dysphagia, Surgery, Eosinophils, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Patient-reported outcome, Female, Esophagoscopy, medicine.symptom, business, Topical steroid, medicine.drug
Abstract

BACKGROUND & AIMS: Pharmacologic treatment of eosinophilic esophagitis (EoE) is limited to off-label use of corticosteroids not optimized for esophageal delivery. We performed a randomized, controlled phase 2 trial to assess the ability of budesonide oral suspension (BOS), a novel muco-adherent topical steroid formulation, to reduce symptoms and esophageal eosinophilia in adolescents and adults with EoE. METHODS: In this multicenter, randomized, double-blind, placebo-controlled, parallel-group trial, 93 EoE patients between the ages of 11 and 40 years with dysphagia and active esophageal eosinophilia were randomized to receive either BOS 2 mg or placebo twice daily for 12 weeks. Co-primary outcomes were change in Dysphagia Symptom Questionnaire (DSQ) score from baseline, and proportion of patients with a histologic response (≤6 eosinophils/high-power field) after treatment. Endoscopic severity scores and safety parameters were assessed. RESULTS: At baseline, mean DSQ scores were 29.3 and 29.0, and mean peak eosinophil counts were 156 and 130 per hpf in the BOS and placebo groups, respectively. After treatment, DSQ scores were 15.0 and 21.5, and mean peak eosinophil counts were 39 and 113 per high-power field, respectively (P < .05 for all). For BOS vs placebo, change in DSQ score was -14.3 vs -7.5 (P = .0096), histologic response rates were 39% vs 3% (P < .0001), and change in endoscopic severity score was -3.8 vs 0.4 (P < .0001). Adverse events were similar between groups. CONCLUSIONS: Treatment with BOS was well tolerated in adolescent and young adult patients with EoE and resulted in improvement in symptomatic, endoscopic, and histologic parameters using validated outcome instruments. ClinicalTrials.gov ID NCT01642212.

Published
2017
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