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Introduction

Eosinophilic esophagitis (EoE) is a chronic, progressive, type 2 inflammatory disease. Dupilumab is a fully human monoclonal antibody that blocks interleukin (IL)-4 and IL-13, key drivers of type 2 inflammation. The EoE-Endoscopic Reference Score (EREFS) is validated for assessment of esophageal features of EoE and includes subscores for inflammation and remodeling. This study assessed the impact of dupilumab on EREFS in children aged 1 to <12 years with active EoE in the Phase 3 EoE KIDS trial.

Aims & Methods

In Part A, patients were randomized 2:2:1:1 to receive dupilumab higher-exposure (HE) or lower-exposure (LE), or placebo (2 groups) for 16 weeks. Patients who completed Part A could enter Part B, where those on dupilumab continued the same regimen and those on placebo switched to their preassigned dupilumab regimen (dupilumab HE or LE) for a further 36 weeks. EREFS total score was calculated as the sum of edema (score range 0−1), rings (0−3), exudates (0−2), furrows (0−2), and strictures (0−1) in the distal and proximal (0–9 each) regions. Absolute change from baseline in centralized EREFS total score (0−18), EREFS inflammation (0−10) and remodeling (0−8) subscores, and proportion of patients achieving endoscopic remission, defined by EREFS total score ≤4, was assessed at Week (W) 16 and W52. This evaluation focused on patients who received dupilumab HE or placebo.

Results

102 patients were enrolled (37 HE dupilumab, 31 LE dupilumab, and 34 placebo); baseline EREFS scores were similar across treatment groups with EREFS inflammation subscores higher than remodeling subscores (6.0 vs 0.9 in the total population). EREFS total score was significantly reduced at W16 with dupilumab HE vs placebo (least squares mean change from baseline [95% confidence interval (CI)] -3.5 [-4.3, -2.6] vs 0.3 [-0.6, 1.2]; least squares mean difference [95% CI] -3.8 [-4.9, -2.6], p<0.0001). Improvement observed in the dupilumab HE group was sustained through W52 (mean change from Part A baseline [standard deviation (SD)] -4.8 [3.1]) and patients switching from placebo to dupilumab HE in Part B saw improvement at W52 (-3.6 [3.3]). At W16, a significantly greater proportion of dupilumab HE- vs placebo-treated patients achieved an EREFS total score ≤4 (mean difference [95% CI] 75.1% [60.3–90.0], nominal p<0.0001). At W52, EREFS total score ≤4 was achieved by 87.9% of patients receiving dupilumab for the duration of the study, and 58.8% of patients switching from placebo to dupilumab HE. EREFS inflammation subscore was reduced at W16 with dupilumab HE vs placebo (mean change from baseline [SD] -3.5 [2.2] vs 0.1 [2.2], nominal p<0.0001). Improvement was sustained through W52 in the continuous dupilumab HE group (mean change from Part A baseline [SD] -4.2 [2.5]) and patients switching from placebo to dupilumab HE in Part B improved at W52 (-3.2 [2.4]). As expected, assessment of changes in remodeling (W16: -0.2 [1.1] vs -0.2 [1.2]) was limited by low prevalence of fibrostenotic features in young children.

Conclusion

Dupilumab HE led to significant improvement in EREFS total score at W16 vs placebo, which was sustained through W52. This change was mainly driven by improvement in EREFS inflammation subscore. A significantly greater proportion of patients treated with dupilumab HE achieved endoscopic remission at W16 compared with placebo, which was sustained through W52.

Disclosure

Hirano I: Adare Pharmaceuticals/Ellodi Pharmaceuticals, Allakos, Aslan Pharmaceuticals, AstraZeneca, Calyx/Parexel, Celldex Therapeutics, Inc., Eli Lilly, EsoCap Biotech, Gossamer Bio, Meritage Pharma Inc., Nexstone Immunology, Pfizer/Arena Pharmaceuticals, Phathom Pharmaceuticals, Receptos/Celgene/Bristol Myers Squibb, Sanofi/Regeneron Pharmaceuticals Inc., Shire/Takeda – consultant; Adare Pharmaceuticals/Ellodi Pharmaceuticals, Allakos, AstraZeneca, Meritage Pharma, Inc., Pfizer/Arena Pharmaceuticals, Receptos/Celgene/Bristol Myers Squibb, Regeneron Pharmaceuticals Inc., Shire/Takeda – research funding; Sanofi/Regeneron Pharmaceuticals Inc. – speaker fees. Schroeder S: EvoEndo, Regeneron Pharmaceuticals Inc., Sanofi – consultant; Allakos, AstraZeneca, Celgene, Regeneron Pharmaceuticals Inc. – research funding. Chehade M: Adare Pharma Solutions/Ellodi, Allakos, AstraZeneca, BMS, Nexstone Immunology, Phathom, Recludix Pharma, Regeneron Pharmaceuticals Inc., Sanofi, Shire/Takeda ‒ consultant; Adare Pharma Solutions/Ellodi, Allakos, AstraZeneca, Celgene/BMS, Danone, Regeneron Pharmaceuticals Inc., Shire/Takeda ‒ research funding. Menard-Katcher C: No disclosures to report. Virk Hundal N: AstraZeneca, Celgene/BMS, Regeneron Pharmaceuticals Inc. – research funding. Liu R, Maloney J, and Radin A: Regeneron Pharmaceuticals Inc. – employees and shareholders. Abdulai R and Glotfelty L: Sanofi – employees, may hold stock and/or stock options in the company.

DUPILUMAB IMPROVES ESOPHAGEAL INFLAMMATORY FEATURES AS MEASURED BY ENDOSCOPIC REFERENCE SCORE IN CHILDREN WITH EOSINOPHILIC ESOPHAGITIS: 52-WEEK RESULTS FROM THE PHASE 3 EOE KIDS TRIAL

Ikuo Hirano 1, Shauna Schroeder 2, Mirna Chehade 3, Calies Menard-Katcher 4, Navneet Virk Hundal 5, Ruiqi Liu 6, Raolat M. Abdulai 7, Jennifer Maloney 6, Margee Louisias 7, Allen Radin 6

1 Northwestern University, Chicago, United States

2 Division of Gastroenterology, Hepatology, and Nutrition, Phoenix Children's, Phoenix, United States

3 Mount Sinai Center for Eosinophilic Disorders, Icahn School of Medicine at Mount Sinai, New York, United States

4 GI Digestive Health Institute, Children's Hospital Colorado, Aurora, United States

5 Food Allergy Center, Massachusetts General Hospital, Boston, United States

6 Regeneron Pharmaceuticals Inc., Tarrytown, United States

7 Sanofi, Bridgewater, United States

Conference

UEG Week Vienna 2024

Topics

Oesophagus

Submission format

Abstract

Session

Eosinophilic oesophagitis: Mechanisms (Posters)

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Best practises for caring for LGBTQ+ people in GI with Alexander Goldowsky (rewind)

Published

2025

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Journal Podcast

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UEG Journal Best Paper Award

Mohsan Subhani, Maria Manuela Estevinho, Malte Buchholz

Published

2025

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Definition and surveillance of "trivial" pancreatic cysts

Iris J. M. Levink 1

1 Erasmus University Medical Center, Rotterdam, Netherlands

Event

UEG Week Berlin 2025

Topics

Digestive Oncology Gut Microbiota Pancreas

Session

Cystic neoplasms of the pancreas

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Introduction

Short bowel syndrome (SBS) is a severe complication of extensive small intestinal resection, most commonly occurring in Crohn’s disease (CD), a chronic inflammatory disorder defined by transmural immune infiltration. Cytokines and chemokines are central mediators in the immune cascade driving intestinal inflammation and tissue damage^1,2. Despite advances in care, no biomarkers currently predict SBS onset or progression to intestinal failure (IF). Profiling systemic cytokine and chemokine signatures may thus offer novel insight into disease trajectory and risk stratification.

Aims & Methods

This study investigates circulating inflammatory mediators in patients with established IF/SBS and CD patients at high risk of progression. A total of 150 patients with CD were enrolled and stratified into five groups based on intestinal function and surgical history: A1, SBS with IF requiring parenteral nutrition (PN) or intravenous fluids; A3, SBS without IF and inactive disease; B, high risk of IF with multiple or extensive resections; C1, low risk for IF with no history of resection; and C2, low risk for IF with prior resection. Serum cytokine and chemokine profiles were quantified at baseline (T0) and after six months (T6) using the human 27-PLEX multiplex immunoassay.

Results

Serum cytokines and chemokines profiling at baseline (T0) and after six months (T6) revealed distinct inflammatory patterns across the study groups. Patients with SBS and IF (group A1) showed persistently elevated levels of IP-10, IL-12, MIP-1α, and G-CSF, reflecting sustained immune activation. Whereas, patients at high risk of IF (group B) displayed increased Eotaxin, bFGF, IL-15, and IL-6, indicative of subclinical inflammation and possible tissue remodelling.
A general reduction in cytokine levels was observed at T6, though anti-inflammatory mediators remained minimally modulated, suggesting ongoing low-grade inflammation. Comparisons between groups highlighted divergent cytokine signatures correlating with disease severity and nutritional support requirements.

Conclusion

These findings suggest that specific circulating cytokines may serve as potential biomarkers for early identification of patients at risk of IF. The differential expression patterns observed across groups support their relevance in stratifying disease severity in CD and SBS. Further large-scale studies are needed to validate these preliminary results and to fully establish their prognostic significance.
Funded by: 2.1 “Rafforzamento e potenziamento della ricerca biomedica del SSN”, finanziato dall’Unione europea – NextGenerationEU, CUP C53C22001140007. 2022 PNRR Project “Changing the future of intestinal failure in intestinal chronic inflammation: towards innovative predictive factors and therapeutic targets” code: PNRR-MAD-2022-12376791.

References

1. Friedrich M, Pohin M, Powrie F. Cytokine Networks in the Pathophysiology of Inflammatory Bowel Disease. Immunity. 2019;50(4):992-1006. doi:10.1016/j.immuni.2019.03.017
2. Singh UP, Singh NP, Murphy EA, et al. Chemokine and cytokine levels in inflammatory bowel disease patients. Cytokine. 2016;77:44-49. doi:10.1016/j.cyto.2015.10.008

PREDICTING INTESTINAL FAILURE IN SHORT BOWEL SYNDROME: THE EMERGING ROLE OF CIRCULATING CYTOKINES AND CHEMOKINES

Cesare Pane 1, Miriam Di Mattia 1, Valentina Petito 2, Elisa Foscarini 3, Francesca Profeta 3, Guia Becherucci 3, Letizia Masi 2, Sara Troisi 4, Valeria Emoli 2, Barbara Rondinone 3, Alessia Lamolinara 1, Manuela Iezzi 1, Laura Turchini 3, Antonio Gasbarrini 5, Alfredo Papa 6, Franco Scaldaferri 5, Loris Riccardo Lopetuso 7

1 Center for Advanced Studies and Technology CAST "G. d’Annunzio" University of Chieti-Pescara, Chieti, Italy

2 CEMAD Translational Research Laboratories - Digestive Disease Center CeMAD - Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy

3 IBD Unit - Digestive Disease Center CeMAD - Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy

4 Center for Advanced Studies and Technology CAST "G. d’Annunzio" University of Chieti-Pescara, Chieti, Italy|||CEMAD Translational Research Laboratories - Digestive Disease Center CeMAD - Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy

5 IBD Unit - Digestive Disease Center CeMAD - Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy|||CEMAD Translational Research Laboratories - Digestive Disease Center CeMAD - Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome,

6 Catholic University of the Sacred Heart, Rome, Italy|||IBD Unit - Digestive Disease Center CeMAD - Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy

7 Link Campus University, Rome, Italy|||IBD Unit - Digestive Disease Center CeMAD - Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

IBD (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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From the hot springs of Yellowstone to Crohn's disease

Zaeem Cader 1

1 University of Cambridge, Cambridge, United Kingdom

Event

UEG Week Vienna 2024

Topics

Digestive Oncology IBD Mechanisms & Personalised Medicine Primary Care

Session

Focus on personalised approaches in IBD

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Introduction

The IBD-Disk is a widely used, self-administered visual analogue tool for measuring disability in patients with inflammatory bowel disease (IBD). However, it does not capture key aspects of daily life, particularly diet and nutrition, which are critical for IBD patients and may significantly influence disability.

Aims & Methods

This cross-sectional study explored the prevalence of moderate to severe disability in young adults with IBD and evaluated the use of a modified IBD-Disk (mIBD-Disk) to screen for eating disorders and food avoidance. Patients previously diagnosed with IBD during childhood and adolescence (<18 years old), and currently followed at two adult IBD academic centers, were consecutively enrolled. All participants were assessed for disability and screened for eating disorders (ED) and avoidant restrictive food intake disorder (ARFID). Restrictive eating behaviours were evaluated using the Nine Item ARFID Screen (NIAS), which assesses three domains: picky eating, low appetite, and food-related fear with a score >23 suggesting probable ARFID. The Eating Attitudes Test (EAT-26) was used to screen for ED, with a score ≥20 indicating a positive result. Disability was measured using the IBD-Disk with a score >40 indicating moderate to severe disability) and the modified IBD-Disk (mIBD-Disk)¹, which consisted of the original 10 items plus an additional question on dietary habits, for a total of 11 items

Results

A total of 144 patients (50.7% with Crohn’s disease) were included, with a median age of 24 years (range: 21–28), and 54.2% were female. One-third (34.7%) had clinically active disease, and the median BMI was 21.8 (range: 20.1–24.2). Moderate to severe disability, as assessed by the IBD-Disk, was observed in 38.9% (56/144) of the cohort, and the median mIBD-Disk score was 33 (IQR: 16–61). ARFID risk was identified in 24 participants (16.7%), with food-related fear being the most frequent domain (13.2%). The median EAT-26 score was 5 (range: 3–12), with ED present in 17 patients (11.8%). In both univariate and multivariate analyses, moderate to severe disability (OR: 4.03; 95% CI: 1.23–13.17; p = 0.02) and a score greater than 4 on question 11 of the mIBD-Disk related to dietary habits (OR: 3.49; 95% CI: 1.06–11.47; p = 0.04) were independently associated with ARFID risk. ROC curve analysis showed that the mIBD-Disk Q11 had an 82% diagnostic accuracy (95% CI: 0.73-0.91) for predicting ARFID.

Conclusion

Patients diagnosed with IBD in childhood and adolescence have an increased prevalence of moderate to severe disability. Integrating the mIBD-Disk into clinical practice could provide an effective tool to identify patients at risk for eating behaviours and food avoidance, supporting timely referrals for nutritional and psychological interventions

References

Nardone OM, et al. Dig Liver Dis. 2025 Mar;57(3):753-761. doi: 10.1016/j.dld.2024.11.004. . PMID: 39617658.

REAL-WORLD USE OF THE MODIFIED IBD DISK TOOL FOR EVALUATION OF EATING DISORDERS IN YOUNG ADULTS WITH INFLAMMATORY BOWEL DISEASE

Olga Maria Nardone 1, Ferdinando D'Amico 2, Giulio Calabrese 1, Tommaso Lorenzo Parigi 2, Alessia La Mantia 1, Sarah Bencardino 2, Flavia Palumbo 1, Alessia Dalila Guarino 1, Antonio Rispo 1, Anna Testa 1, Silvio Danese 2, Fabiana Castiglione 1

1 University of Naples Federico II, Naples, Italy

2 IRCCS San Raffaele Hospital and Vita-Salute, Milan, Italy

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

IBD (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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