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MetALD: A new entity in liver disease

Angelo Armandi 1

1 University of Turin, Torino, Italy

Event

UEG Week Vienna 2024

Topics

Hepatobiliary Paediatrics

Session

From frequent to rare: Update on the liver disease landscape

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Exploiting the immune response in GI cancer: Next chapter

Tamara Matysiak-Budnik 1

1 CHU de Nantes IMAD, Nantes, France

Event

UEG Week Berlin 2025

Topics

Digestive Oncology Hepatobiliary Immunology Mechanisms & Personalised Medicine Small Intestine & Nutrition

Session

The art of making clinical research precise: What will be new in therapy in 2030?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Gut-brain chaos: Here’s how primary care can restore order

Christos D Lionis 1

1 University of Crete, Heraklion, Greece

Event

UEG Week Berlin 2025

Topics

Neurogastroenterology & Motility Paediatrics Standards & Guidelines Stomach & H. Pylori

Session

From guidelines to clinical practice: The gut-brain connection - PPIs and guideline application in clinical practice

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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COMPARISON OF ATEZOLIZUMAB PLUS BEVACIZUMAB AND DURVALUMAB PLUS TREMELIMUMAB TREATMENTS FOR ADVANCED STAGE HEPATOCELLULAR CARCINOMA IN LIVER CIRRHOSIS PATIENTS WITH CHILD-PUGH CLASS B

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Introduction

An important issue for unresectable advanced stage hepatocellular carcinoma (uHCC) patients with Child-Pugh class B liver cirrhosis (CP-B), is lack of safe treatment options that show therapeutic efficacy, thus it is considered to be an unmet need. Atezolizumab plus bevacizumab (At/Bv) and durvalumab plus tremelimumab (Dur/Tre) have each been used as first-line systemic immunotherapy for uHCC.

Aims & Methods

The present study aimed to elucidate clinical outcomes of uHCC patients with CP-B treated with those combination treatments. The records of 169 uHCC patients with CP-B in Japan, treated with At/Bv or Dur/Tre as first-line systemic therapy from 2020 to 2024 at participating institutions were examined (median age: 73 years, males: 143, Child-Pugh score 7:8:9 = 121:43:5, BCLC stage B:C = 65:104, At/Bv:Dur/Tre = 131:38). Each regimen was analyzed for therapeutic efficacy and safety, and the results compared, in a retrospective manner.

Results

Using RECIST, ver. 1.1, the objective response rate (ORR) was shown to be 25.9% in the At/Bv group, and 18.4% in the Dur/Tre group (p=0.08). Disease control rate (DCR) was significantly higher in the At/Bv group (64.9% vs. 39.5%, p=0.01). There were no significant differences between the groups for progression-free survival (PFS) [At/Bv vs. Dur/Tre=5.3 vs. 3.5 months (95% CI: 3.9–6.5 and 2.3–7.2, respectively), p=0.90], overall survival (OS) [10.5 vs. 12.5 months (95% CI: 9.1–13.3 and 7.9–NA, respectively), p=0.58], or post-progression survival (PPS) [4.9 vs. 7.5 months (95% CI: 3.7–7.5 and 2.2–NA, respectively), p=0.60]. The rate of incidence of immune-related adverse events (irAEs) of any grade was 11.5% in the At/Bv group and 23.7% in the Dur/Tre group (p=0.07), while irAEs of grade 3 or higher were noted in 3.1% and 15.8%, respectively (p=0.02) significantly greater in the Dur/Tre group).

Conclusion

The incidence rate of irAEs in each group was similar to that observed in clinical trials previously performed for these regimens. uHCC patients with CP-B, who received Dur/Tre had a greater rate of incidence of high-grade irAEs, while the At/Bv group had a better DCR, though there were no significant differences for PFS, OS, or PPS between the groups. Neither treatment was found to sufficiently improve the prognosis of uHCC patients with CP-B. Development of safe and effective treatment options for patients affected by uHCC, that can be administered even to those with CP-B remains necessary.

Disclosure

Atsushi Hiraoka: lecture fee Chugai, AstraZeneca, and Lilly.

COMPARISON OF ATEZOLIZUMAB PLUS BEVACIZUMAB AND DURVALUMAB PLUS TREMELIMUMAB TREATMENTS FOR ADVANCED STAGE HEPATOCELLULAR CARCINOMA IN LIVER CIRRHOSIS PATIENTS WITH CHILD-PUGH CLASS B

Yuka Kimura 1, Hideko Ohama 1, Atsushi Hiraoka 1, Fujimasa Tada 1, Takeshi Hatanaka 2, Toshifumi Tada 3, Satoru Kakizaki 4, Yoichi Hiasa 5, Takashi Kumada 6

1 Ehime Prefectural Central Hospital, Matsuyama, Japan

2 Gunma Saiseikai Maebashi Hospital, Maebashi, Japan

3 Kobe University, Kobe, Japan

4 NHO Takasaki General Medical Center, Takasaki, Japan

5 Ehime University Graduate School of Medicine, Toon, Japan

6 Gifu Kyoritsu University, Gifu, Japan

Event

UEG Week Berlin 2025

Topics

Hepatobiliary Immunology Mechanisms & Personalised Medicine

Submission format

Abstract

Session

Bench to bedside and beyond frontiers in HCC

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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EFFICACY AND SAFETY OF APRAGLUTIDE ONCE-WEEKLY IN PATIENTS WITH SHORT BOWEL SYNDROME AND INTESTINAL FAILURE (SBS-IF): RESULTS FROM THE STARS STUDY – A GLOBAL PHASE 3 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL

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Introduction

In SBS-IF, patients (pts) depend on parenteral support (PS) to meet nutritional and/or fluid requirements. Apraglutide (APRA) is a long-acting novel GLP-2 analogue dosed once-weekly that stimulates intestinal adaptation, with the potential to reduce PS requirements. This phase 3 trial assessed the efficacy and safety of APRA vs placebo (PBO) in adult pts with SBS-IF.

Aims & Methods

In this phase 3 double-blind, PBO-controlled trial (NCT04627025) conducted in 73 centres and 18 countries, 164 pts were randomized 2:1 to once-weekly subcutaneous APRA (5 mg if pt ≥50 kg, 2.5 mg if pt <50 kg) or PBO, stratified by intestinal anatomy (stoma or colon-in-continuity [CIC]). The primary endpoint was relative change from baseline (BL) in weekly PS volume at Week (Wk) 24. Key secondary endpoints at Wk 24 were reduction of additional ≥1 day/Wk off PS from BL, and in the stoma subgroup, relative change from BL in weekly PS volume. Two other key secondary endpoints at Wk 48 in the CIC subgroup were reduction of ≥1 day/Wk off PS, and percentage of pts reaching total enteral autonomy. Wk 24 clinical responders were defined as proportion of pts with ≥20% PS reduction at Wks 20 and 24. Adverse events (AEs) were collected.

Results

A total of 163 dosed pts (80 stoma; 83 CIC),155 (95%) completed the study. BL demographics and mean BL weekly PS volume (APRA 13.1 L; PBO 12.9 L) were similar in both arms. At Wk 24, APRA-treated pts had a significantly larger reduction from BL in weekly PS volume vs PBO (APRA -25.5%; PBO -12.5%; p=0.001); both stoma and CIC subgroups demonstrated comparable treatment effects. In pts with stoma, the relative reduction from BL to Wk 24 in weekly PS volume in APRA pts vs PBO was statistically significant (-25.6% vs -7.8%; p<0.001) (Table 1). In pts with CIC, there was a numerical benefit in APRA that did not reach statistical significance (APRA -25.2%; PBO -17.6%; nominal p=0.179). In the overall population, statistically significant PS reductions from BL were seen from Wk 8 onward. A significantly higher proportion of APRA pts achieved a reduction of ≥1 day/Wk off PS at Wk 24 (APRA 43.0%; PBO 27.5%; p=0.040). At Wk 48 in the CIC subgroup, 51.8% of APRA vs 44.4% of PBO-treated pts achieved ≥1 day/wk off PS (p=0.348), and enteral autonomy was reached in 7 of 56 (12.5%) APRA vs 2 of 27 (7.4%). APRA was well tolerated. Of 110 APRA-treated pts, only 4 (3.6%) discontinued APRA due to an AE, vs 1 of 53 (1.9%) PBO-treated pts.

Conclusion

APRA is the first once-weekly GLP-2 analogue to demonstrate efficacy in a phase 3 trial in SBS-IF. At Wk 24, APRA demonstrated significantly greater relative reductions in weekly PS volume from BL and a higher proportion of pts achieved an additional ≥1 day off PS, with comparable treatment effects in pts with stoma or CIC. APRA showed a favourable safety profile consistent with prior APRA studies in SBS-IF.

n for the first key secondary is observed value and the percentage, difference in percentages and its p-value is based on results of multiple imputations. *nominal p-value. APRA, apraglutide; BL, baseline; CI, confidence interval; LSM, least square mean; PBO, placebo; PS, parenteral support; SBS-IF, short bowel syndrome and intestinal failure.
Endpoint	Population	Apraglutide (n=110)	Placebo (n=53)	APRA vs PBO Difference [LSM or % (95% CI)]	p-value
Primary Endpoint		LSM or n (%)
Relative % change from BL in actual PS weekly volume at Wk 24, Least Square Mean (LSM)	Overall	-25.5	-12.5	-13.0 (-20.9, -5.0)	0.001
Key Secondary Endpoints
Percentage of subjects achieving a reduction of ≥1 day/wk off PS from BL at Wk 24, n (%) *	Overall	46 (43.0)	14 (27.5)	15.6 (0.7, 30.5)	0.040
Relative % change from BL in actual PS weekly volume at Wk 24, mean	Stoma (n=80)	-25.6	-7.8	-17.8 (-28.4, -7.3)	<0.001
Percentage of subjects achieving a reduction of ≥1 day/wk off PS from BL at Wk 48, n (%)	CIC (n=83)	29/56 (51.8)	12/27 (44.4)	7.3 (-16.4, 29.8)	0.348
Subjects reaching enteral autonomy at Wk 48, n (%)	CIC (n=83)	7/56 (12.5)	2/27 (7.4)	5.1 (-12.9, 18.5)	0.387
Other Secondary Endpoint Clinical responders at Week 24 (≥20% PS reduction at both Wks 20 and 24), n (%)	Overall	47 (42.7)	11 (20.8)	22.0 (7.7, 36.2)	0.003**

Disclosure

FJ: Research funding from Takeda Pharma, VectivBio, Zealand, Baxter, Mobile3esolutions, Carembouche Consultant or advisor for Takeda, VectivBio, Ironwood; NorthSea Therapeutics, Hamni, Zealand, Mobile3esolutions, Carembouche. Lecturer for Baxter, BBraun, Fresenius Kabi, Janssen, Theradial; TV: Research Grants for Danone, MyHealth, Takeda, VectivBio. Consultancy for Baxter, BMS, Dr. Falk Pharma, Hanmi Pharm, North Sea Therapeutics, Takeda, Truvion, VectivBio, Zealand Pharma. Lecturer for Abbott, Baxter, Biocodex, Dr. Falk Pharma, Fresenius Kabi, Ipsen, Menarini, MyHealth, Remedus, Takeda, Truvion, VectivBio. DK: Consultant or advisor forTakeda Pharma, VectivBio, OWYN; SL: Investigator-initiated/unrestricted research grants from Fresenius Kabi, Baxter and Takeda. Honoraria and/or educational support from Takeda, Zealand, VectivBio, Fresenius Kabi, B Braun, Baxter, Northsea. KT: Board Member/Advisory Panel/Speaker for Abbott Nutrition Health Institute, Nutricia North America,Takeda Pharmaceuticals, VectivBio – now part of Ironwood Pharmaceuticals, Inc; PJ: Honoraria, educational and/or grants from Albumedix A/S, ArTara Therapeutics, Bainan Biotech, Baxter, Coloplast A/S, Ferring Pharmaceuticals, Fresenius Kabi, GlyPharma Therapeutic, Hanmi Pharmaceuticals, Ironwood, Naia Pharmaceuticals, NPS Pharmaceuticals, Protara Therapeutics, Shire, Takeda, The Novo Nordisk Foundation, Therachon, VectivBio AG, Zealand Pharma A/S; NNY, CL, RS, IS, SH: Ironwood employees; FB: Ironwood consultant; KI: Grant support from Takeda Pharma, VectivBio, NorthSea Therapeutics. Consultant or advisor for Takeda Pharma, VectivBio, Northsea Therapeutics, Hanmi Pharmaceuticals. Speaker or member of speakers bureau for Takeda Pharma.

EFFICACY AND SAFETY OF APRAGLUTIDE ONCE-WEEKLY IN PATIENTS WITH SHORT BOWEL SYNDROME AND INTESTINAL FAILURE (SBS-IF): RESULTS FROM THE STARS STUDY – A GLOBAL PHASE 3 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL

Francisca Joly 1, Tim Vanuytsel 2, Donald Kirby 3, Simon Lal 4, Kelly Tappenden 5, Palle Bekker Jeppesen 6, Nader N. Youssef 7, Carrie Li 7, Reda Sheik 7, Isabelle Statovci 7, Susanna Huh 8, Federico Bolognani 7, Kishore Iyer 9

1 Beaujon Hospital Service de Gastroenterologie, Clichy, France

2 KU Leuven, Leuven, Belgium

3 Cleveland Clinic, Cleveland, United States

4 University of Manchester, Manchester, United Kingdom

5 The University of Utah, Salt Lake City, United States

6 Rigshospitalet, Copenhagen, Denmark

7 Ironwood Pharmaceuticals, Basel, Switzerland

8 Ironwood Pharmaceuticals, Boston, United States

9 Mount Sinai Medical Center, New York, United States

Event

UEG Week Vienna 2024

Topics

Mechanisms & Personalised Medicine Neurogastroenterology & Motility Radiology & Imaging Small Intestine & Nutrition

Submission format

Abstract

Session

Short bowel syndrome

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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What the gastroenterologist can offer

Giovanni Sarnelli 1

1 University of Naples 'Federico II', Pozzuoli NA, Italy

Event

UEG Week Berlin 2025

Topics

Neurogastroenterology & Motility Primary Care

Session

Therapy update: Dyspepsia

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Poster

Standard Poster

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Introduction

Sarcopenia is increasingly recognized as a major prognostic factor in patients with hepatocellular carcinoma (HCC). Its evaluation may improve patient risk stratification and therapeutic decision-making

Aims & Methods

To assess the prevalence of sarcopenia among patients with hepatocellular carcinoma (HCC), identify associated factors, and evaluate the MELD-sarcopenia score as a potential predictor of mortality.
We conducted a retrospective monocentric study over a 10-year period, including patients aged over 18 years with a confirmed diagnosis of HCC based on radiological, biological, and/or histological criteria. Only patients with an available abdominal CT scan including the L3 vertebral level were included. Exclusion criteria were liver transplantation, other primary liver tumors, non-HCC malignancies, incomplete records, or poor-quality imaging. Sarcopenia was diagnosed by calculating the Total Psoas Area Index (TPAI) on CT, using thresholds of 5.45 cm²/m² for men and 3.85 cm²/m² for women. MELD and MELD-sarcopenia scores were calculated. Survival time from HCC diagnosis was recorded.

Results

Among 30 screened patients, 5 were excluded due to missing imaging. In the final cohort of 25 patients, the prevalence of sarcopenia was 52%. Compared to non-sarcopenic patients, sarcopenic patients were older (67.6 vs 56 years) and more often male. The most frequent etiology in sarcopenic patients was hepatitis C (46.2%), while hepatitis B was predominant in non-sarcopenic patients (58.3%). Cirrhosis was mostly compensated in both groups. HCC was typically unifocal, infiltrative, and multilobar in both groups. The mean time from HCC diagnosis to death was shorter in sarcopenic patients (13.4 vs 33.9 months). Male sex and older age were significantly associated with sarcopenia (p < 0.05), whereas tumor characteristics, Child-Pugh class, and biological tests were not. Kaplan-Meier analysis showed a tendency toward worse survival in patients with higher MELD-sarcopenia scores, although the difference was not statistically significant (p > 0.05).

Table : Comparison of clinical and survival characteristics between sarcopenic and non-sarcopenic patients with hepatocellular carcinoma

Parameters	Sarcopenic Group	Non-Sarcopenic Group
Mean age	67.6 years	55.0 years
OMS status	OMS 0-1: 8 (61.5%) OMS 2: 3 (38.5%)	OMS 0-1: 11 (91.7%) OMS 2: 1 (8.3%)
Child-Pugh class	Compensated: 66.7% Decompensated: 33.3%	Compensated: 54.5% Decompensated: 45.5%
MELD score	Median: 11 IQR: 3.25	Median: 14 IQR: 5.5
ALBI grade	Grade 1: 23.1% Grade 2: 53.8% Grade 3: 15.4%	Grade 1: 16.7% Grade 2: 33.3% Grade 3: 41.7%
MELD-sarcopenia score	Median: 21.35 IQR: 3.25
Mortality	Deceased: 76.9% Alive: 23.1%	Deceased: 83.3% Alive: 16.7%
Median survival time after HCC diagnosis	13.4 months	33.9 months

Conclusion

Sarcopenia is highly prevalent among patients with HCC and is independently associated with male sex and older age. The MELD-sarcopenia score appears to be a promising tool for mortality risk stratification and may aid clinical decision-making.