UEG Week 2025: Top Abstract Awards

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UEG Week 2025: Top Abstract Awards

Event

UEG Week Berlin 2025

Topics

Immunology

Session

Opening Plenary

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Podcast Episode

New

UEG Podcast

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Nutrition in coeliac disease for a clinician with Cristian Costas

Pradeep Mundre

Topics

Small Intestine & Nutrition

Published

2026

UEG Presentation

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LINERIXIBAT SIGNIFICANTLY IMPROVES CHOLESTATIC PRURITUS IN PRIMARY BILIARY CHOLANGITIS: RESULTS OF THE PIVOTAL PHASE 3 GLISTEN TRIAL

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Introduction

Cholestatic pruritus is common, debilitating and undertreated in patients with primary biliary cholangitis (PBC). Here, we describe the results of GLISTEN (NCT04950127), a Phase 3 study investigating the efficacy and safety of the ileal bile acid transporter inhibitor linerixibat for pruritus in PBC.

Aims & Methods

In this double-blind, randomised, placebo-controlled study, patients with PBC and moderate-to-severe pruritus received oral linerixibat 40 mg or placebo twice daily. Pruritus severity and pruritus-related sleep interference were assessed using a 0–10 numerical rating scale. The primary endpoint was change from baseline in worst itch over 24 weeks. Secondary endpoints included: at Week 2, change in worst itch; over 24 weeks, change in sleep interference; at Week 24, proportion of responders (≥ 2-, ≥ 3-, ≥ 4-point reduction in worst itch) and analysis of responses to 2 patient global impression items (itch severity and change). Safety endpoints included adverse event (AE) reporting.

Results

238 patients were randomised; 95% were female, itch severity was mean (standard deviation [SD]) 7.34 (1.54), 52% had alkaline phosphatase < 1.67 times upper limit of normal, and 47% were receiving stable therapy for pruritus. Pruritus improvement over 24 weeks was significantly greater with linerixibat than placebo: least-squares (LS) mean change -2.86 versus -2.15, adjusted mean difference -0.72; p = 0.001. At Week 24, the observed mean (SD) difference from baseline in pruritus was -3.66 (2.50) with linerixibat and -2.82 (2.32) with placebo. The effect of linerixibat was rapid and superior to placebo at Week 2: LS mean change -1.78 versus -1.07, adjusted mean difference -0.71; p < 0.001. Linerixibat also significantly improved pruritus-related sleep interference over 24 weeks versus placebo: LS mean change ‑2.77 versus -2.24, adjusted mean difference -0.53; p = 0.024. At Week 24, more patients on linerixibat than placebo achieved a ≥ 2-point (68% vs 64%), ≥ 3-point (56% vs 43%) or ≥ 4-point (41% vs 29%) reduction in pruritus and a higher proportion of linerixibat than placebo-treated patients reported their pruritus was very much improved (55% vs 37%) or absent (21% vs 9%). AEs reported more frequently with linerixibat than placebo were predominantly gastrointestinal (GI), including diarrhoea (61% vs 18% of patients) and abdominal pain (18% vs 3% of patients); 4% of patients in the linerixibat group discontinued treatment due to diarrhoea.

Conclusion

In patients with PBC and moderate-to-severe pruritus, linerixibat rapidly and significantly improved pruritus and pruritus-related sleep interference versus placebo. While GI AEs were more common with linerixibat than placebo, they rarely led to treatment discontinuation.

Disclosure

Funded by GSK. Various authors declare conflicts of interest as consultants, employee, recipients of grants and stockholders. These will be reported in full during the presentation.

LINERIXIBAT SIGNIFICANTLY IMPROVES CHOLESTATIC PRURITUS IN PRIMARY BILIARY CHOLANGITIS: RESULTS OF THE PIVOTAL PHASE 3 GLISTEN TRIAL

Gideon M. Hirschfield 1, Christopher L. Bowlus 2, David Jones 3, Andreas E. Kremer 4, Marlyn J. Mayo 5, Atsushi Tanaka 6, Pietro Andreone 7, Jidong Jia 8, Qinglong Jin 9, Ricardo Macias-Rodriguez 10, Alexander R. Cobitz 11, Brooke M. Currie 11, Ciara Gorey 12, Ivana Lazic 12, Danielle J. Podmore 12, Andrea Ribiero 13, Jennifer B. Shannon 14, Brandon Swift 14, Megan M. McLaughlin 11, Cynthia Levy 15

1 Toronto General Hospital, Toronto, Canada

2 University of California Davis School of Medicine, Sacramento, United States

3 Newcastle University, Newcastle Upon Tyne, United Kingdom

4 University Hospital Zurich, Zurich, Switzerland

5 University of Texas Southwestern Medical School, Dallas, United States

6 Teikyo University School of Medicine, Tokyo, Japan

7 Azienda Ospedaliero-Universitaria di Modena and Università di Modena e Reggio Emilia, Modena, Italy

8 Capital Medical University, Beijing, China

9 The First Hospital of Jilin University, Changchun, China

10 Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico

11 GSK, Collegeville, United States

12 GSK, London, United Kingdom

13 GSK, Madrid, Spain

14 GSK, Durham, United States

15 University of Miami, Miami, United States

Event

UEG Week Berlin 2025

Topics

Hepatobiliary Immunology Mechanisms & Personalised Medicine

Submission format

Abstract

Session

Advances in management of immune-mediated biliary disease

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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Words of welcome

Julia Mayerle 1

1 Klinikum der LMU München-Grosshadern, München, Germany

Event

UEG Week Berlin 2025

Topics

Immunology

Session

Opening Plenary

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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Navigating the IL-23 universe: breaking frontiers in Crohn’s disease (Johnson and Johnson) (Complete Session)

Alessandro Armuzzi 1, Laurent Peyrin-Biroulet 2, David T. Rubin 3, Yamile Zabana 4, Sebastian Zeissig 5

1 IRCCS Humanitas Research Hospital, Rozzano, Italy

2 Inserm NGERE and University of Lorraine, Vandœuvre-lès-Nancy, France

3 The University of Chicago Medicine, Chicago, United States of America

4 Hospital Universitari Mútua Terrassa, Terrassa, Spain

5 Inselspital - Bern University Hospital, Bern, Switzerland

Event

UEG Week Berlin 2025

Session

Navigating the IL-23 universe: breaking frontiers in Crohn’s disease (Johnson and Johnson)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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PLASMA PROTEOMIC PROFILES FOR PREDICTING HEPATIC COMPLICATIONS UP TO 16 YEARS BEFORE ONSET

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Introduction

Chronic liver disease is a major global health concerns, contributing to over 1.4 million annual deaths worldwide¹. Its primary fatal outcomes, hepatic complications^2,3, arise from liver cirrhosis, hepatocellular carcinoma and hepatic decompensation. The early, reversible stages of chronic liver disease are frequently asymptomatic and overlooked, leading to delayed diagnoses and irreversible complications that treatment options are limited.^4,5. Therefore, reliable tools to identify whether a person will develop hepatic complications in the future have become a public health priority, enabling early diagnosis and timely intervention in high-risk populations.

Aims & Methods

This study aimed to employ machine learning to develop proteomics-based models for the early identification of hepatic complications. In this study, 37,178 adults without hepatic complications at baseline were analyzed from a prospective cohort from United Kingdom, with plasma levels of 2,736 proteins measured using Olink technology. Cox regression was used to identify significant proteins associated with incident hepatic complications. Models based on importance-top-ranking proteins were constructed using LightGBM learners of Automated Machine Learning (AutoML) and internal validated through 5-fold cross validation in the derivation set (n = 37,178). Independent validation was then conducted in a geographically distinct UKB cohort (n = 15,767).

Results

Over a median follow-up of 13.8 years, 338 participants developed hepatic complications. Cox regression identified 593 proteins significantly associated with incident hepatic complications. Among them, GDF15, PROC, GGT1, ANXA10, IL18, MFAP4, COL4A1, CDCP1 and IL6 were ranked highest in protein importance ordering. The protein model showed a considerable predictive accuracy for hepatic complications under different time scenarios in the UKB validation set: all-year (area under the curve [AUC] = 0.89), within 5 years (AUC = 0.88), within 10 years (AUC = 0.91), over 10 years (AUC = 0.81), and achieved superior predictive performance compared to models with demographic predictors, laboratory indicators, polygenic risk score (PRS) and traditional risk score models (Protein 0.89 vs. Demographics 0.83, Laboratory 0.85, PRS 0.49; Fibrosis-4 index [FIB-4] 0.76, Aspartate aminotransferase to platelet ratio index [APRI] 0.78; all P < 0.05). Combined with clinical data and PRS, the predictor performance is further enhanced: all-year (AUC = 0.91), within 5 years (AUC = 0.91), within 10 years (AUC = 0.90), over 10 years (AUC = 0.83). Individuals in the high-risk group stratified by the protein model were 16.27 times more likely to develop hepatic complications.

Conclusion

Our study constructed a novel protein model for hepatic complications risk stratification and could be used to predict individuals who will develop hepatic complications up to 16 years in advance in the general population.

References

1. Tham EKJ, Tan DJH, Danpanichkul P, et al. The Global Burden of Cirrhosis and Other Chronic Liver Diseases in 2021. Liver Int 2025;45:e70001.
2. Åberg F, Asteljoki J, Männistö V, et al. Combined use of the CLivD score and FIB-4 for prediction of liver-related outcomes in the population. Hepatol Baltim Md 2024;80:163–172.
3. Innes H, Morling JR, Buch S, et al. Performance of routine risk scores for predicting cirrhosis-related morbidity in the community. J Hepatol 2022;77:365–376.
4. Karlsen TH, Sheron N, Zelber-Sagi S, et al. The EASL–Lancet Liver Commission: protecting the next generation of Europeans against liver disease complications and premature mortality. The Lancet 2022;399:61–116.
5. Serra-Burriel M, Juanola A, Serra-Burriel F, et al. Development, validation, and prognostic evaluation of a risk score for long-term liver-related outcomes in the general population: a multicohort study. Lancet Lond Engl 2023;402:988–996.

PLASMA PROTEOMIC PROFILES FOR PREDICTING HEPATIC COMPLICATIONS UP TO 16 YEARS BEFORE ONSET

Shuo Chen 1, Jing Feng 1, Yajie Zhang 1, Tong Lin 1, Wuzheng Xia 2, Weihong Sha 1, Hao Chen 1

1 Department of Gastroenterology, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China

2 Department of Organ transplantation, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China