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2. Variation in Endoscopic Activity Assessment and Endoscopy Score Validation in Adults With Eosinophilic Esophagitis

Author

Schoepfer, Alain M, Hirano, Ikuo, Coslovsky, Michael, Roumet, Marie C, Zwahlen, Marcel, Kuehni, Claudia E, Hafner, David, Alexander, Jeffrey A, Dellon, Evan S, Gonsalves, Nirmala, Leung, John, Bussmann, Christian, Collins, Margaret H, Newbury, Robert O, Smyrk, Thomas C, Woosley, John T, Yang, Guang-Yu, Romero, Yvonne, Katzka, David A, Furuta, Glenn T, Gupta, Sandeep K, Aceves, Seema S, Chehade, Mirna, Spergel, Jonathan M, Falk, Gary W, Meltzer, Brian A, Comer, Gail M, Straumann, Alex, Safroneeva, Ekaterina, Group, International EEsAI Study, Achem, Sami R, Arora, Amindra S, Alpan, Oral, Armstrong, David, Attwood, Stephen E, Butterfield, Joseph H, Crowell, Michael D, DeVault, Kenneth R, Drouin, Eric, Enav, Benjamin, Enders, Felicity T, Fleischer, David E, Foxx-Orenstein, Amy, Francis, Dawn L, Guyatt, Gordon H, Harris, Lucinda A, Kagalwalla, Amir F, Kita, Hirohito, Krishna, Murli, Lee, James J, Lewis, John C, Lim, Kaiser, Locke, G Richard, Murray, Joseph A, Nguyen, Cuong C, Orbelo, Diana M, Pasha, Shabana F, Ramirez, Francisco C, Sheikh, Javed, Umar, Sarah B, Weiler, Catherine R, Wo, John M, Wu, Tsung-Teh, and Yost, Kathleen J

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Digestive Diseases, Clinical Research, Clinical Trials and Supportive Activities, Prevention, Adolescent, Adult, Aged, Anti-Inflammatory Agents, Dose-Response Relationship, Drug, Eosinophilic Esophagitis, Esophagoscopy, Esophagus, Female, Fluticasone, Humans, Male, Middle Aged, Prognosis, Severity of Illness Index, Young Adult, Index, Variability in Endoscopic Assessment, Instrument, International EEsAI Study Group, Gastroenterology & Hepatology, Clinical sciences
Abstract

Background & aimsEosinophilic esophagitis (EoE) is assessed endoscopically (endoscopic activity), based on grades of edema, rings, exudates, furrows, and strictures (EREFS). We examined variations in endoscopic assessments of severity, developed and validated 3 EREFS-based scoring systems, and assessed responsiveness of these systems using data from a randomized placebo-controlled trial of patients with EoE.MethodsFor the development set, 5 gastroenterologists reviewed EREFS findings from 266 adults with EoE and provided endoscopist global assessment scores (EndoGA, scale of 0 to 10); variation (ΔEndoGA) was assessed using linear regression. We evaluated simple scores (features given arbitrary values from 0 to 3) and developed 2 scoring systems (adjusted score range, 0-100). We then fitted our linear regression model with mean EndoGA to data from 146 adults recruited in centers in Switzerland and the United States between April 2011 and December 2012. For the validation set, we collected data from 120 separate adults (recruited in centers in Switzerland and the United States between May 2013 and July 2014), assessing regression coefficient-based scores using Bland-Altman method. We assessed the responsiveness of our scoring systems using data from a randomized trial of patients with EoE given fluticasone (n=16) or placebo (n=8).ResultsThe distribution of EndoGA values differed among endoscopists (mean ΔEndoGA, 2.6±1.8; range 0-6.6). We developed 2 regression-based scoring systems to assess overall and proximal and distal esophageal findings; variation in endoscopic features accounted for more than 90% of the mean EndoGA variation. In the validation group, differences between mean EndoGA and regression-based scores were small (ranging from -4.70 to 2.03), indicating good agreement. In analyses of data from the randomized trial, the baseline to end of study change in patients given fluticasone was a reduction of 24.3 in simple score (reduction of 4.6 in patients given placebo, P=.052); a reduction of 23.5 in regression-based overall score (reduction of 6.56 in patients given placebo, P=.12), and a reduction of 23.8 (reduction of 8.44 in patients given placebo, P=.11).ConclusionAssessments of endoscopic activity in patients with EoE vary among endoscopists. In an analysis of data from a randomized controlled trial, we found that newly developed scoring systems are no better than simple scoring system in detecting changes in endoscopic activity. These results support the use of a simple scoring system in evaluation of endoscopic activity in patients with EoE. clinicaltrials.gov no: NCT00939263 and NCT01386112.

Published
2019

7. Symptoms Have Modest Accuracy in Detecting Endoscopic and Histologic Remission in Adults With Eosinophilic Esophagitis

Author

Safroneeva, Ekaterina, Straumann, Alex, Coslovsky, Michael, Zwahlen, Marcel, Kuehni, Claudia E, Panczak, Radoslaw, Haas, Nadine A, Alexander, Jeffrey A, Dellon, Evan S, Gonsalves, Nirmala, Hirano, Ikuo, Leung, John, Bussmann, Christian, Collins, Margaret H, Newbury, Robert O, De Petris, Giovanni, Smyrk, Thomas C, Woosley, John T, Yan, Pu, Yang, Guang-Yu, Romero, Yvonne, Katzka, David A, Furuta, Glenn T, Gupta, Sandeep K, Aceves, Seema S, Chehade, Mirna, Spergel, Jonathan M, Schoepfer, Alain M, Group, International Eosinophilic Esophagitis Activity Index Study, Achem, Sami R, Arora, Amindra S, Alpan, Oral, Armstrong, David, Attwood, Stephen E, Butterfield, Joseph H, Crowell, Michael D, DeVault, Kenneth R, Drouin, Eric, Enav, Benjamin, Enders, Felicity T, Fleischer, David E, Foxx-Orenstein, Amy, Francis, Dawn L, Guyatt, Gordon H, Harris, Lucinda A, Kagalwalla, Amir F, Kita, Hirohito, Krishna, Murli, Lee, James J, Lewis, John C, Lim, Kaiser, Locke, G Richard, Murray, Joseph A, Nguyen, Cuong C, Orbelo, Diana M, Pasha, Shabana F, Ramirez, Francisco C, Sheikh, Javed, Umar, Sarah B, Weiler, Catherine R, Wo, John M, Wu, Tsung-Teh, and Yost, Kathleen J

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Digestive Diseases, Cancer, Clinical Research, 4.2 Evaluation of markers and technologies, Detection, screening and diagnosis, Adolescent, Adult, Aged, Aged, 80 and over, Area Under Curve, Biopsy, Eosinophilic Esophagitis, Eosinophils, Esophagoscopy, Female, Humans, Leukocyte Count, Male, Middle Aged, Predictive Value of Tests, Prospective Studies, ROC Curve, Remission Induction, Reproducibility of Results, Severity of Illness Index, Surveys and Questionnaires, Switzerland, Treatment Outcome, United States, Young Adult, EEsAI, Remission, Endoscopic Grading, Disease Monitoring, International Eosinophilic Esophagitis Activity Index Study Group, Neurosciences, Paediatrics and Reproductive Medicine, Gastroenterology & Hepatology, Clinical sciences, Nutrition and dietetics
Abstract

Background & aimsIt is not clear whether symptoms alone can be used to estimate the biologic activity of eosinophilic esophagitis (EoE). We aimed to evaluate whether symptoms can be used to identify patients with endoscopic and histologic features of remission.MethodsBetween April 2011 and June 2014, we performed a prospective, observational study and recruited 269 consecutive adults with EoE (67% male; median age, 39 years old) in Switzerland and the United States. Patients first completed the validated symptom-based EoE activity index patient-reported outcome instrument and then underwent esophagogastroduodenoscopy with esophageal biopsy collection. Endoscopic and histologic findings were evaluated with a validated grading system and standardized instrument, respectively. Clinical remission was defined as symptom score

Published
2016

8. Variation in Endoscopic Activity Assessment and Endoscopy Score Validation in Adults With Eosinophilic Esophagitis

Author

Achem, Sami R., Arora, Amindra S., Alpan, Oral, Armstrong, David, Attwood, Stephen E., Butterfield, Joseph H., Crowell, Michael D., DeVault, Kenneth R., Drouin, Eric, Enav, Benjamin, Enders, Felicity T., Fleischer, David E., Foxx-Orenstein, Amy, Francis, Dawn L., Guyatt, Gordon H., Harris, Lucinda A., Kagalwalla, Amir F., Kita, Hirohito, Krishna, Murli, Lee, James J., Lewis, John C., Lim, Kaiser, Locke, G. Richard, III, Murray, Joseph A., Nguyen, Cuong C., Orbelo, Diana M., Pasha, Shabana F., Ramirez, Francisco C., Sheikh, Javed, Umar, Sarah B., Weiler, Catherine R., Wo, John M., Wu, Tsung-Teh, Yost, Kathleen J., Schoepfer, Alain M., Hirano, Ikuo, Coslovsky, Michael, Roumet, Marie C., Zwahlen, Marcel, Kuehni, Claudia E., Hafner, David, Alexander, Jeffrey A., Dellon, Evan S., Gonsalves, Nirmala, Leung, John, Bussmann, Christian, Collins, Margaret H., Newbury, Robert O., Smyrk, Thomas C., Woosley, John T., Yang, Guang-Yu, Romero, Yvonne, Katzka, David A., Furuta, Glenn T., Gupta, Sandeep K., Aceves, Seema S., Chehade, Mirna, Spergel, Jonathan M., Falk, Gary W., Meltzer, Brian A., Comer, Gail M., Straumann, Alex, and Safroneeva, Ekaterina

Published
2019
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15. Mepolizumab for treatment of adolescents and adults with eosinophilic oesophagitis: a multicentre, randomised, double-blind, placebo-controlled clinical trial.

Author

Dellon, Evan S., Peterson, Kathryn A., Mitlyng, Benjamin L., Iuga, Alina, Bookhout, Christine E., Cortright, Lindsay M., Walker, Kacie B., Gee, Timothy S., McGee, Sarah J., Cameron, Brenderia A., Galanko, Joseph A., Woosley, John T., Eluri, Swathi, Moist, Susan E., and Hirano, Ikuo

Subjects
EOSINOPHILIC esophagitis, CLINICAL trials, ADULTS, INFLAMMATORY bowel diseases, TEENAGERS, CHURG-Strauss syndrome
Published
2023
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19. Obesity is associated with decreased risk of microscopic colitis in women

Author

Sandler, Robert S, Keku, Temitope O, Woosley, John T, Sandler, Dale P, Galanko, Joseph A, and Peery, Anne F

Subjects
Male, Gastroenterology, General Medicine, Case Control Study, Colitis, Body Mass Index, Colitis, Microscopic, Diarrhea/epidemiology, Risk Factors, Case-Control Studies, Humans, Microscopic/epidemiology, Female, Obesity, Aged
Abstract

BACKGROUND Microscopic colitis is a leading cause of diarrhea in the older adults. There is limited information about risk factors. We hypothesized that obesity would be associated with microscopic colitis. AIM To examine the association between obesity and microscopic colitis in men and women undergoing colonoscopy. METHODS We conducted a case-control study at the University of North Carolina Hospitals. We identified and enrolled men and women referred for elective, outpatient colonoscopy for chronic diarrhea. We excluded patients with a past diagnosis of Crohn’s disease or ulcerative colitis. A research pathologist reviewed biopsies on every patient and classified them as microscopic colitis cases or non-microscopic colitis controls. Patients provided information on body weight, height and exposure to medications via structured interviews or Internet based forms. The analysis included 110 patients with microscopic colitis (cases) and 252 non-microscopic colitis controls. Multivariable analyses were performed using logistic regression to estimate odds ratios and 95% confidence intervals. RESULTS Cases were older and more likely than controls to be white race. Study subjects were well educated, but cases were better educated than controls. Cases with microscopic colitis had lower body mass index than controls and reported more weight loss after the onset of diarrhea. Compared to patients who were normal or under-weight, obese (BMI > 30 kg/m2) patients were substantially less likely to have microscopic colitis after adjusting for age and education, adjusted OR (aOR) 0.35, 95% confidence interval (CI) 0.18-0.66). When stratified by sex, the association was limited to obese women, aOR 0.21, 95%CI: 0.10-0.45. Patients with microscopic colitis were more likely to report weight loss after the onset of diarrhea. After stratifying by weight loss, there remained a strong inverse association between obesity and microscopic colitis, aOR 0.33, 95%CI: 0.10 – 1.11 among the patients who did not lose weight. Ever use of birth control pills was associated with lower risk of microscopic colitis after adjusting for age, education and BMI, aOR 0.38, 95%CI: 0.17-0.84. CONCLUSION Compared to controls also seen for diarrhea, microscopic colitis cases were less likely to be obese. Mechanisms are unknown but could involve hormonal effects of obesity or the gut microbiome.

Published
2022

20. Type 2 innate lymphoid cells treat and prevent acute gastrointestinal graft-versus-host disease

Author

Bruce, Danny W., Stefanski, Heather E., Vincen, Benjamin G., Reisdorf, Trisha A. DanShannon, Bommiasamy, Hemamalini, Serody, David A., Wilson, Justin E., McKinnon, Karen P., Shlomchik, Warren D., Armistead, Paul M., Ting, Jenny P.Y., Woosley, John T., Blazar, Bruce R., Zaiss, Dietmar M.W., McKenzie, Andrew N.J., Coghill, James M., and Serody, Jonathan S.

Subjects
Lymphocytes -- Research, Graft vs. host disease -- Care and treatment -- Prevention -- Research, Health care industry
Abstract

Acute graft-versus-host disease (aGVHD) is the most common complication for patients undergoing allogeneic stem cell transplantation. Despite extremely aggressive therapy targeting donor T cells, patients with grade III or greater aGVHD of the lower GI tract, who do not respond to therapy with corticosteroids, have a dismal prognosis. Thus, efforts to improve understanding of the function of local immune and non-immune cells in regulating the inflammatory process in the GI tract during aGVHD are needed. Here, we demonstrate, using murine models of allogeneic BMT, that type 2 innate lymphoid cells (ILC2s) in the lower GI tract are sensitive to conditioning therapy and show very limited ability to repopulate from donor bone marrow. Infusion of donor ILC2s was effective in reducing the lethality of aGVHD and in treating lower GI tract disease. ILC2 infusion was associated with reduced donor proinflammatory Th1 and Th17 cells, accumulation of donor myeloid-derived suppressor cells (MDSCs) mediated by ILC2 production of IL-13, improved GI tract barrier function, and a preserved graft-versus-leukemia (GVL) response. Collectively, these findings suggest that infusion of donor ILC2s to restore gastrointestinal tract homeostasis may improve treatment of severe lower GI tract aGVHD., Introduction Allogeneic stem cell transplant (allo-SCT) has the potential to provide curative therapy for patients with high-risk acute leukemia, lymphoid malignancies, and other malignant diseases (1-3). Despite improvements in HLA [...]

Published
2017
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26. Clinical, histological and molecular profiling of different stages of alcohol-related liver disease.

Author

UCL - (SLuc) Service de gastro-entérologie, UCL - SSS/IREC/GAEN - Pôle d'Hépato-gastro-entérologie, Ventura-Cots, Meritxell, Argemi, Josepmaria, Jones, Patricia D, Lackner, Carolin, El Hag, Mohamed, Abraldes, Juan G, Alvarado, Edilmar, Clemente, Ana, Ravi, Samitha, Alves, Antonio, Alboraie, Mohamed, Altamirano, Jose, Barace, Sergio, Bosques, Francisco, Brown, Robert, Caballeria, Juan, Cabezas, Joaquin, Carvalhana, Sofia, Cortez-Pinto, Helena, Costa, Adilia, Degré, Delphine, Fernandez-Carillo, Carlos, Ganne-Carrie, Nathalie, Garcia-Tsao, Guadalupe, Genesca, Joan, Koskinas, John, Lanthier, Nicolas, Louvet, Alexandre, Lozano, Juan José, Lucey, Michael R, Masson, Steven, Mathurin, Philippe, Mendez-Sanchez, Nahum, Miquel, Rosa, Moreno, Christophe, Mounajjed, Taofic, Odena, Gemma, Kim, Won, Sancho-Bru, Pau, Warren Sands, R, Szafranska, Justyna, Verset, Laurine, Schnabl, Bern, Sempoux, Christine, Shah, Vijay, Shawcross, Debbie Lindsay, Stauber, Rudolf E, Straub, Beate K, Verna, Elizabeth, Tiniakos, Dina, Trépo, Eric, Vargas, Victor, Villanueva, Càndid, Woosley, John T, Ziol, Marianne, Mueller, Sebastian, Starkel, Peter, Bataller, Ramon, UCL - (SLuc) Service de gastro-entérologie, UCL - SSS/IREC/GAEN - Pôle d'Hépato-gastro-entérologie, Ventura-Cots, Meritxell, Argemi, Josepmaria, Jones, Patricia D, Lackner, Carolin, El Hag, Mohamed, Abraldes, Juan G, Alvarado, Edilmar, Clemente, Ana, Ravi, Samitha, Alves, Antonio, Alboraie, Mohamed, Altamirano, Jose, Barace, Sergio, Bosques, Francisco, Brown, Robert, Caballeria, Juan, Cabezas, Joaquin, Carvalhana, Sofia, Cortez-Pinto, Helena, Costa, Adilia, Degré, Delphine, Fernandez-Carillo, Carlos, Ganne-Carrie, Nathalie, Garcia-Tsao, Guadalupe, Genesca, Joan, Koskinas, John, Lanthier, Nicolas, Louvet, Alexandre, Lozano, Juan José, Lucey, Michael R, Masson, Steven, Mathurin, Philippe, Mendez-Sanchez, Nahum, Miquel, Rosa, Moreno, Christophe, Mounajjed, Taofic, Odena, Gemma, Kim, Won, Sancho-Bru, Pau, Warren Sands, R, Szafranska, Justyna, Verset, Laurine, Schnabl, Bern, Sempoux, Christine, Shah, Vijay, Shawcross, Debbie Lindsay, Stauber, Rudolf E, Straub, Beate K, Verna, Elizabeth, Tiniakos, Dina, Trépo, Eric, Vargas, Victor, Villanueva, Càndid, Woosley, John T, Ziol, Marianne, Mueller, Sebastian, Starkel, Peter, and Bataller, Ramon

Abstract

Alcohol-related liver disease (ALD) ranges from never-decompensated ALD (ndALD) to the life-threatening decompensated phenotype, known as alcohol-related hepatitis (AH). A multidimensional study of the clinical, histological and molecular features of these subtypes is lacking. Two large cohorts of patients were recruited in an international, observational multicentre study: a retrospective cohort of patients with ndALD (n=110) and a prospective cohort of patients with AH (n=225). Clinical, analytical, immunohistochemistry and hepatic RNA microarray analysis of both disease phenotypes were performed. Age and mean alcohol intake were similar in both groups. AH patients had greater aspartate amino transferase/alanine amino transferase ratio and lower gamma-glutamyl transferase levels than in ndALD patients. Patients with AH demonstrated profound liver failure and increased mortality. One-year mortality was 10% in ndALD and 50% in AH. Histologically, steatosis grade, ballooning and pericellular fibrosis were similar in both groups, while advanced fibrosis, Mallory-Denk bodies, bilirubinostasis, severe neutrophil infiltration and ductular reaction were more frequent among AH patients. Transcriptome analysis revealed a profound gene dysregulation within both phenotypes when compare to controls. While ndALD was characterised by deregulated expression of genes involved in matrisome and immune response, the development of AH resulted in a marked deregulation of genes involved in hepatocyte reprogramming and bile acid metabolism. Despite comparable alcohol intake, AH patients presented with worse liver function compared with ndALD patients. Bilirubinostasis, severe fibrosis and ductular reaction were prominent features of AH. AH patients exhibited a more profound deregulation of gene expression compared with ndALD patients.

Published
2022

27. Development of a core outcome set for therapeutic studies in eosinophilic esophagitis (COREOS)

Author

Ma, Christopher, Schoepfer, Alain M., Dellon, Evan S., Bredenoord, Albert J., Chehade, Mirna, Collins, Margaret H., Feagan, Brian G., Furuta, Glenn T., Gupta, Sandeep K., Hirano, Ikuo, Jairath, Vipul, Katzka, David A., Pai, Rish K., Rothenberg, Marc E., Straumann, Alex, Aceves, Seema S., Alexander, Jeffrey A., Arva, Nicoleta C., Atkins, Dan, Biedermann, Luc, Blanchard, Carine, Cianferoni, Antonella, Ciriza de los Rios, Constanza, Clayton, Frederic, Davis, Carla M., de Bortoli, Nicola, Dias, Jorge A., Falk, Gary W., Genta, Robert M., Ghaffari, Gisoo, Gonsalves, Nirmala, Greuter, Thomas, Hopp, Russell, Hsu Blatman, Karen S., Jensen, Elizabeth T., Johnston, Doug, Kagalwalla, Amir F., Larsson, Helen M., Leung, John, Louis, Hubert, Masterson, Joanne C., Menard-Katcher, Calies, Menard-Katcher, Paul A., Moawad, Fouad J., Muir, Amanda B., Mukkada, Vincent A., Penagini, Roberto, Pesek, Robert D., Peterson, Kathryn, Putnam, Philip E., Ravelli, Alberto, Savarino, Edoardo V., Schlag, Christoph, Schreiner, Philipp, Simon, Dagmar, Smyrk, Thomas C., Spergel, Jonathan M., Taft, Tiffany H., Terreehorst, Ingrid, Vanuytsel, Tim, Venter, Carina, Vieira, Mario C., Vieth, Michael, Vlieg-Boerstra, Berber, von Arnim, Ulrike, Walker, Marjorie M., Wechsler, Joshua B., Woodland, Philip, Woosley, John T., Yang, Guang-Yu, Zevit, Noam, Safroneeva, Ekaterina, Ma, Christopher, Schoepfer, Alain M., Dellon, Evan S., Bredenoord, Albert J., Chehade, Mirna, Collins, Margaret H., Feagan, Brian G., Furuta, Glenn T., Gupta, Sandeep K., Hirano, Ikuo, Jairath, Vipul, Katzka, David A., Pai, Rish K., Rothenberg, Marc E., Straumann, Alex, Aceves, Seema S., Alexander, Jeffrey A., Arva, Nicoleta C., Atkins, Dan, Biedermann, Luc, Blanchard, Carine, Cianferoni, Antonella, Ciriza de los Rios, Constanza, Clayton, Frederic, Davis, Carla M., de Bortoli, Nicola, Dias, Jorge A., Falk, Gary W., Genta, Robert M., Ghaffari, Gisoo, Gonsalves, Nirmala, Greuter, Thomas, Hopp, Russell, Hsu Blatman, Karen S., Jensen, Elizabeth T., Johnston, Doug, Kagalwalla, Amir F., Larsson, Helen M., Leung, John, Louis, Hubert, Masterson, Joanne C., Menard-Katcher, Calies, Menard-Katcher, Paul A., Moawad, Fouad J., Muir, Amanda B., Mukkada, Vincent A., Penagini, Roberto, Pesek, Robert D., Peterson, Kathryn, Putnam, Philip E., Ravelli, Alberto, Savarino, Edoardo V., Schlag, Christoph, Schreiner, Philipp, Simon, Dagmar, Smyrk, Thomas C., Spergel, Jonathan M., Taft, Tiffany H., Terreehorst, Ingrid, Vanuytsel, Tim, Venter, Carina, Vieira, Mario C., Vieth, Michael, Vlieg-Boerstra, Berber, von Arnim, Ulrike, Walker, Marjorie M., Wechsler, Joshua B., Woodland, Philip, Woosley, John T., Yang, Guang-Yu, Zevit, Noam, and Safroneeva, Ekaterina

Abstract

Background: End points used to determine treatment efficacy in eosinophilic esophagitis (EoE) have evolved over time. With multiple novel therapies in development for EoE, harmonization of outcomes measures will facilitate evidence synthesis and appraisal when comparing different treatments. Objective: We sought to develop a core outcome set (COS) for controlled and observational studies of pharmacologic and diet interventions in adult and pediatric patients with EoE. Methods: Candidate outcomes were generated from systematic literature reviews and patient engagement interviews and surveys. Consensus was established using an iterative Delphi process, with items voted on using a 9-point Likert scale and with feedback from other participants to allow score refinement.

Published
2022

28. Clinical, histological and molecular profiling of different stages of alcohol-related liver disease.

Author

Ventura-Cots, Meritxell, Argemi, Josepmaria, Jones, Patricia D, Lackner, Carolin, El Hag, Mohamed, Abraldes, Juan G, Alvarado, Edilmar, Clemente, Ana, Ravi, Samhita, Alves, Antonio, Alboraie, Mohamed, Altamirano, Jose, Barace, Sergio, Bosques, Francisco, Brown, Robert, Caballeria, Juan, Cabezas, Joaquin, Carvalhana, Sofia, Cortez-Pinto, Helena, Costa, Adilia, Degré, Delphine, Fernandez-Carrillo, Carlos, Ganne-Carrie, Nathalie, Garcia-Tsao, Guadalupe, Genesca, Joan, Koskinas, John, Lanthier, Nicolas, Louvet, Alexandre, Lozano, Juan José, Lucey, Michael R, Masson, Steven, Mathurin, Philippe, Mendez-Sanchez, Nahum, Miquel, Rosa, Moreno, Christophe, Mounajjed, Taofic, Odena, Gemma, Kim, Won, Sancho-Bru, Pau, Warren Sands, R, Szafranska, Justyna, Verset, Laurine, Schnabl, Bernd, Sempoux, Christine, Shah, Vijay H, Shawcross, Debbie Lindsay, Stauber, Rudolf, Straub, Beate K, Verna, Elizabeth, Tiniakos, Dina, Trepo, Eric, Vargas, Victor, Villanueva, Cándido, Woosley, John T, Ziol, Marianne, Mueller, Sebastian, Stärkel, Peter, Bataller, Ramon, Ventura-Cots, Meritxell, Argemi, Josepmaria, Jones, Patricia D, Lackner, Carolin, El Hag, Mohamed, Abraldes, Juan G, Alvarado, Edilmar, Clemente, Ana, Ravi, Samhita, Alves, Antonio, Alboraie, Mohamed, Altamirano, Jose, Barace, Sergio, Bosques, Francisco, Brown, Robert, Caballeria, Juan, Cabezas, Joaquin, Carvalhana, Sofia, Cortez-Pinto, Helena, Costa, Adilia, Degré, Delphine, Fernandez-Carrillo, Carlos, Ganne-Carrie, Nathalie, Garcia-Tsao, Guadalupe, Genesca, Joan, Koskinas, John, Lanthier, Nicolas, Louvet, Alexandre, Lozano, Juan José, Lucey, Michael R, Masson, Steven, Mathurin, Philippe, Mendez-Sanchez, Nahum, Miquel, Rosa, Moreno, Christophe, Mounajjed, Taofic, Odena, Gemma, Kim, Won, Sancho-Bru, Pau, Warren Sands, R, Szafranska, Justyna, Verset, Laurine, Schnabl, Bernd, Sempoux, Christine, Shah, Vijay H, Shawcross, Debbie Lindsay, Stauber, Rudolf, Straub, Beate K, Verna, Elizabeth, Tiniakos, Dina, Trepo, Eric, Vargas, Victor, Villanueva, Cándido, Woosley, John T, Ziol, Marianne, Mueller, Sebastian, Stärkel, Peter, and Bataller, Ramon

Abstract

Alcohol-related liver disease (ALD) ranges from never-decompensated ALD (ndALD) to the life-threatening decompensated phenotype, known as alcohol-related hepatitis (AH). A multidimensional study of the clinical, histological and molecular features of these subtypes is lacking., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2022

33. Development of a core outcome set for therapeutic studies in eosinophilic esophagitis (COREOS)

Author

Ma, Christopher, primary, Schoepfer, Alain M., additional, Dellon, Evan S., additional, Bredenoord, Albert J., additional, Chehade, Mirna, additional, Collins, Margaret H., additional, Feagan, Brian G., additional, Furuta, Glenn T., additional, Gupta, Sandeep K., additional, Hirano, Ikuo, additional, Jairath, Vipul, additional, Katzka, David A., additional, Pai, Rish K., additional, Rothenberg, Marc E., additional, Straumann, Alex, additional, Aceves, Seema S., additional, Alexander, Jeffrey A., additional, Arva, Nicoleta C., additional, Atkins, Dan, additional, Biedermann, Luc, additional, Blanchard, Carine, additional, Cianferoni, Antonella, additional, Ciriza de los Rios, Constanza, additional, Clayton, Frederic, additional, Davis, Carla M., additional, de Bortoli, Nicola, additional, Dias, Jorge A., additional, Falk, Gary W., additional, Genta, Robert M., additional, Ghaffari, Gisoo, additional, Gonsalves, Nirmala, additional, Greuter, Thomas, additional, Hopp, Russell, additional, Hsu Blatman, Karen S., additional, Jensen, Elizabeth T., additional, Johnston, Doug, additional, Kagalwalla, Amir F., additional, Larsson, Helen M., additional, Leung, John, additional, Louis, Hubert, additional, Masterson, Joanne C., additional, Menard-Katcher, Calies, additional, Menard-Katcher, Paul A., additional, Moawad, Fouad J., additional, Muir, Amanda B., additional, Mukkada, Vincent A., additional, Penagini, Roberto, additional, Pesek, Robert D., additional, Peterson, Kathryn, additional, Putnam, Philip E., additional, Ravelli, Alberto, additional, Savarino, Edoardo V., additional, Schlag, Christoph, additional, Schreiner, Philipp, additional, Simon, Dagmar, additional, Smyrk, Thomas C., additional, Spergel, Jonathan M., additional, Taft, Tiffany H., additional, Terreehorst, Ingrid, additional, Vanuytsel, Tim, additional, Venter, Carina, additional, Vieira, Mario C., additional, Vieth, Michael, additional, Vlieg-Boerstra, Berber, additional, von Arnim, Ulrike, additional, Walker, Marjorie M., additional, Wechsler, Joshua B., additional, Woodland, Philip, additional, Woosley, John T., additional, Yang, Guang-Yu, additional, Zevit, Noam, additional, and Safroneeva, Ekaterina, additional

Published
2022
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35. Detection of Dysplasia in Barrett's Esophagus With In Vivo Depth-Resolved Nuclear Morphology Measurements

Author

Terry, Neil G., Zhu, Yizheng, Rinehart, Matthew T., Brown, William J., Gebhart, Steven C., Bright, Stephanie, Carretta, Elizabeth, Ziefle, Courtney G., Panjehpour, Masoud, Galanko, Joseph, Madanick, Ryan D., Dellon, Evan S., Trembath, Dimitri, Bennett, Ana, Goldblum, John R., Overholt, Bergein F., Woosley, John T., Shaheen, Nicholas J., and Wax, Adam

Published
2011
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36. Clinical, histological and molecular profiling of different stages of alcohol-related liver disease

Author

Ventura-Cots, Meritxell, primary, Argemi, Josepmaria, additional, Jones, Patricia D, additional, Lackner, Carolin, additional, El Hag, Mohamed, additional, Abraldes, Juan G, additional, Alvarado, Edilmar, additional, Clemente, Ana, additional, Ravi, Samhita, additional, Alves, Antonio, additional, Alboraie, Mohamed, additional, Altamirano, Jose, additional, Barace, Sergio, additional, Bosques, Francisco, additional, Brown, Robert, additional, Caballeria, Juan, additional, Cabezas, Joaquin, additional, Carvalhana, Sofia, additional, Cortez-Pinto, Helena, additional, Costa, Adilia, additional, Degré, Delphine, additional, Fernandez-Carrillo, Carlos, additional, Ganne-Carrie, Nathalie, additional, Garcia-Tsao, Guadalupe, additional, Genesca, Joan, additional, Koskinas, John, additional, Lanthier, Nicolas, additional, Louvet, Alexandre, additional, Lozano, Juan José, additional, Lucey, Michael R, additional, Masson, Steven, additional, Mathurin, Philippe, additional, Mendez-Sanchez, Nahum, additional, Miquel, Rosa, additional, Moreno, Christophe, additional, Mounajjed, Taofic, additional, Odena, Gemma, additional, Kim, Won, additional, Sancho-Bru, Pau, additional, Warren Sands, R, additional, Szafranska, Justyna, additional, Verset, Laurine, additional, Schnabl, Bern, additional, Sempoux, Christine, additional, Shah, Vijay, additional, Shawcross, Debbie Lindsay, additional, Stauber, Rudolf E, additional, Straub, Beate K, additional, Verna, Elizabeth, additional, Tiniakos, Dina, additional, Trépo, Eric, additional, Vargas, Victor, additional, Villanueva, Càndid, additional, Woosley, John T, additional, Ziol, Marianne, additional, Mueller, Sebastian, additional, Stärkel, Peter, additional, and Bataller, Ramon, additional

Published
2022
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43. Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS): An International Multidisciplinary Consensus

Author

Ma, Christopher, primary, Schoepfer, Alain M., additional, Safroneeva, Ekaterina, additional, Ma, Christopher, additional, Dellon, Evan S., additional, Bredenoord, Albert J., additional, Chehade, Mirna, additional, Collins, Margaret H., additional, Feagan, Brian G., additional, Furuta, Glenn T., additional, Gupta, Sandeep K., additional, Hirano, Ikuo, additional, Jairath, Vipul, additional, Katzka, David A., additional, Pai, Rish K., additional, Rothenberg, Marc E., additional, Straumann, Alex, additional, Aceves, Seema S., additional, Alexander, Jeffrey A., additional, Arva, Nicoleta C., additional, Atkins, Dan, additional, Biedermann, Luc, additional, Blanchard, Carine, additional, Cianferoni, Antonella, additional, Ciriza de los Rios, Constanza, additional, Clayton, Frederic, additional, Davis, Carla M., additional, de Bortoli, Nicola, additional, Dias, Jorge A., additional, Falk, Gary W., additional, Genta, Robert M., additional, Ghaffari, Gisoo, additional, Gonsalves, Nirmala, additional, Greuter, Thomas, additional, Hopp, Russell, additional, Hsu Blatman, Karen S., additional, Jensen, Elizabeth T., additional, Johnston, Doug, additional, Kagalwalla, Amir F., additional, Larsson, Helen M., additional, Leung, John, additional, Louis, Hubert, additional, Masterson, Joanne C., additional, Menard-Katcher, Calies, additional, Menard-Katcher, Paul A., additional, Moawad, Fouad J., additional, Muir, Amanda B., additional, Mukkada, Vincent A., additional, Penagini, Roberto, additional, Pesek, Robert D., additional, Peterson, Kathryn, additional, Putnam, Philip E., additional, Ravelli, Alberto, additional, Savarino, Edoardo V., additional, Schlag, Christoph, additional, Schreiner, Philipp, additional, Simon, Dagmar, additional, Smyrk, Thomas C., additional, Spergel, Jonathan M., additional, Taft, Tiffany H., additional, Terreehorst, Ingrid, additional, Vanuytsel, Tim, additional, Venter, Carina, additional, Vieira, Mario C., additional, Vieth, Michael, additional, Vlieg-Boerstra, Berber, additional, von Arnim, Ulrike, additional, Walker, Marjorie M., additional, Wechsler, Joshua B., additional, Woodland, Philip, additional, Woosley, John T., additional, Yang, Guang-Yu, additional, and Zevit, Noam, additional

Published
2021
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44. A Summary of the Meetings of the Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) International Multidisciplinary Consensus

Author

Ma, Christopher, primary, Schoepfer, Alain M., additional, Safroneeva, Ekaterina, additional, Ma, Christopher, additional, Dellon, Evan S., additional, Bredenoord, Albert J., additional, Chehade, Mirna, additional, Collins, Margaret H., additional, Feagan, Brian G., additional, Furuta, Glenn T., additional, Gupta, Sandeep K., additional, Hirano, Ikuo, additional, Jairath, Vipul, additional, Katzka, David A., additional, Pai, Rish K., additional, Rothenberg, Marc E., additional, Straumann, Alex, additional, Aceves, Seema S., additional, Alexander, Jeffrey A., additional, Arva, Nicoleta C., additional, Atkins, Dan, additional, Biedermann, Luc, additional, Blanchard, Carine, additional, Cianferoni, Antonella, additional, Ciriza de los Rios, Constanza, additional, Clayton, Frederic, additional, Davis, Carla M., additional, de Bortoli, Nicola, additional, Dias, Jorge A., additional, Falk, Gary W., additional, Genta, Robert M., additional, Ghaffari, Gisoo, additional, Gonsalves, Nirmala, additional, Greuter, Thomas, additional, Hopp, Russell, additional, Hsu Blatman, Karen S., additional, Jensen, Elizabeth T., additional, Johnston, Doug, additional, Kagalwalla, Amir F., additional, Larsson, Helen M., additional, Leung, John, additional, Louis, Hubert, additional, Masterson, Joanne C., additional, Menard-Katcher, Calies, additional, Menard-Katcher, Paul A., additional, Moawad, Fouad J., additional, Muir, Amanda B., additional, Mukkada, Vincent A., additional, Penagini, Roberto, additional, Pesek, Robert D., additional, Peterson, Kathryn, additional, Putnam, Philip E., additional, Ravelli, Alberto, additional, Savarino, Edoardo V., additional, Schlag, Christoph, additional, Schreiner, Philipp, additional, Simon, Dagmar, additional, Smyrk, Thomas C., additional, Spergel, Jonathan M., additional, Taft, Tiffany H., additional, Terreehorst, Ingrid, additional, Vanuytsel, Tim, additional, Venter, Carina, additional, Vieira, Mario C., additional, Vieth, Michael, additional, Vlieg-Boerstra, Berber, additional, von Arnim, Ulrike, additional, Walker, Marjorie M., additional, Wechsler, Joshua B., additional, Woodland, Philip, additional, Woosley, John T., additional, Yang, Guang-Yu, additional, and Zevit, Noam, additional

Published
2021
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47. A Summary of the Meetings of the Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) International Multidisciplinary Consensus

Author

Ma, Christopher, Schoepfer, Alain M., Safroneeva, Ekaterina, Dellon, Evan S., Bredenoord, Albert J., Chehade, Mirna, Collins, Margaret H., Feagan, Brian G., Furuta, Glenn T., Gupta, Sandeep K., Hirano, Ikuo, Jairath, Vipul, Katzka, David A., Pai, Rish K., Rothenberg, Marc E., Straumann, Alex, Aceves, Seema S., Alexander, Jeffrey A., Arva, Nicoleta C., Atkins, Dan, Biedermann, Luc, Blanchard, Carine, Cianferoni, Antonella, Ciriza de los Rios, Constanza, Clayton, Frederic, Davis, Carla M., de Bortoli, Nicola, Dias, Jorge A., Falk, Gary W., Genta, Robert M., Ghaffari, Gisoo, Gonsalves, Nirmala, Greuter, Thomas, Hopp, Russell, Hsu Blatman, Karen S., Jensen, Elizabeth T., Johnston, Doug, Kagalwalla, Amir F., Larsson, Helen M., Leung, John, Louis, Hubert, Masterson, Joanne C., Menard-Katcher, Calies, Menard-Katcher, Paul A., Moawad, Fouad J., Muir, Amanda B., Mukkada, Vincent A., Penagini, Roberto, Pesek, Robert D., Peterson, Kathryn, Putnam, Philip E., Ravelli, Alberto, Savarino, Edoardo V., Schlag, Christoph, Schreiner, Philipp, Simon, Dagmar, Smyrk, Thomas C., Spergel, Jonathan M., Taft, Tiffany H., Terreehorst, Ingrid, Vanuytsel, Tim, Venter, Carina, Vieira, Mario C., Vieth, Michael, Vlieg-Boerstra, Berber, von Arnim, Ulrike, Walker, Marjorie M., Wechsler, Joshua B., Woodland, Philip, Woosley, John T., Yang, Guang-Yu, Zevit, Noam, Ma, Christopher, Schoepfer, Alain M., Safroneeva, Ekaterina, Dellon, Evan S., Bredenoord, Albert J., Chehade, Mirna, Collins, Margaret H., Feagan, Brian G., Furuta, Glenn T., Gupta, Sandeep K., Hirano, Ikuo, Jairath, Vipul, Katzka, David A., Pai, Rish K., Rothenberg, Marc E., Straumann, Alex, Aceves, Seema S., Alexander, Jeffrey A., Arva, Nicoleta C., Atkins, Dan, Biedermann, Luc, Blanchard, Carine, Cianferoni, Antonella, Ciriza de los Rios, Constanza, Clayton, Frederic, Davis, Carla M., de Bortoli, Nicola, Dias, Jorge A., Falk, Gary W., Genta, Robert M., Ghaffari, Gisoo, Gonsalves, Nirmala, Greuter, Thomas, Hopp, Russell, Hsu Blatman, Karen S., Jensen, Elizabeth T., Johnston, Doug, Kagalwalla, Amir F., Larsson, Helen M., Leung, John, Louis, Hubert, Masterson, Joanne C., Menard-Katcher, Calies, Menard-Katcher, Paul A., Moawad, Fouad J., Muir, Amanda B., Mukkada, Vincent A., Penagini, Roberto, Pesek, Robert D., Peterson, Kathryn, Putnam, Philip E., Ravelli, Alberto, Savarino, Edoardo V., Schlag, Christoph, Schreiner, Philipp, Simon, Dagmar, Smyrk, Thomas C., Spergel, Jonathan M., Taft, Tiffany H., Terreehorst, Ingrid, Vanuytsel, Tim, Venter, Carina, Vieira, Mario C., Vieth, Michael, Vlieg-Boerstra, Berber, von Arnim, Ulrike, Walker, Marjorie M., Wechsler, Joshua B., Woodland, Philip, Woosley, John T., Yang, Guang-Yu, and Zevit, Noam

Abstract

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 heterogeneity in reported outcomes and uncertainties regarding the most appropriate end points for use in both randomized controlled trials (RCTs) and observational studies involving EoE patients, the EoE experts launched the COREOS exercise in 2018 to standardize outcome definitions using methods established by the Core Outcome Measures in Effectiveness Trials (COMET) initiative.1,2 The COS was developed using a multiphase approach, which is summarized in Figure 1. In the first phase, systematic reviews of the literature and patient engagement surveys were conducted to identify candidate outcomes that have been previously measured and are important to patients with EoE. Next, this information was used to build a framework of different outcome domains, and working groups for each domain were assembled to review the literature for relevant end points.3–6 The relative importance of these domains was categorized in a Delphi survey as core, important, and research agenda domains, and discussed in a moderated in-person meeting on May 17, 2019 at Digestive Disease Week (San Diego, CA). In phase 3, a comprehensive list of outcome measures within each of the core domains was evaluated by the COREOS collaborators in a 2-round Delphi survey and, finally, outcomes were ratified in a virtual meeting on December 8, 2020. In this meeting summary, we highlight the major points of discussion that occurred during the development of the EoE COS.

Published
2021

49. Determination of a treatment response threshold for the Eosinophilic Esophagitis Endoscopic Reference Score.

Author

Cotton, Cary C., Woosley, John T., Moist, Susan E., McGee, Sarah J., Iuga, Alina, Shaheen, Nicholas J., and Dellon, Evan S.

Subjects
*EOSINOPHILIC esophagitis, *EOSINOPHILS, *ESOPHAGOSCOPY, *RESEARCH, *RESEARCH methodology, *DEGLUTITION disorders, *EVALUATION research, *COMPARATIVE studies, *RANDOMIZED controlled trials, *DISEASE complications
Abstract

Background: Endoscopic features of eosinophilic esophagitis (EoE) are measured using the validated EoE Endoscopic Reference Score (EREFS); however, a threshold for treatment response has not been defined. We aimed to determine a cut-point for endoscopic response as measured by EREFS.Methods: We performed a secondary analysis of a randomized clinical trial comparing budesonide slurry with swallowed fluticasone multidose inhaler for initial treatment of EoE. In the parent trial, EREFS was determined before and after treatment (score range 0-9), as were histologic findings and dysphagia symptoms. We performed tabular, flexible trend, and dependent mixture analyses of measures of treatment response to select the best clinical EREFS threshold.Results: In the 111 included patients (mean age 39 years; 67 % male; 96 % white), an EREFS threshold of ≤ 2 was 80 % sensitive (95 % confidence interval [CI] 69 % to 88 %) and 83 % specific (95 %CI 67 % to 94 %) for histologic response (peak of < 15 eosinophils per high-power field). Flexible trend analysis and dependent mixture modeling similarly suggested that a threshold of ≤ 2 best captured the correlation of EREFS with histologic and symptomatic measures. Dependent mixture modeling found near-total membership in the response class at EREFS of 0 or 1 and > 75 % at EREFS of 2 or 3.Conclusions: An EREFS of ≤ 2 was the best clinical threshold for endoscopic response to topical steroid treatment, and was consistent with clinical and histologic response. Therefore, future studies can report a binary outcome of endoscopic response when EREFS is 2 or less. [ABSTRACT FROM AUTHOR]

Published
2022
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