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Optimising nutritional status prior to IBD intervention

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Optimising nutritional status prior to IBD intervention

Stephan Bischoff 1

1 Universität Hohenheim Inst. für Nutritional Medizin - Inst. für Nutritional Medizin, Universität Hoh, Stuttgart, Germany

Event

UEG Postgraduate Teaching Programme 2023

Topics

IBD Small Intestine & Nutrition Surgery

Session

Are we ready to prevent/treat IBD with nutrition?

Published

2023

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PEGOZAFERMIN DEMONSTRATED ROBUST HISTOLOGICAL IMPROVEMENT AND BENEFIT IN HEPATIC AND METABOLIC BIOMARKERS: RESULTS FROM A 48-WEEK MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2B TRIAL (ENLIVEN)

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Introduction

Metabolic dysfunction-associated steatohepatitis (MASH) is often associated with metabolic disorders such as obesity, metabolic syndrome, and/or diabetes. FGF21 analogs are promising therapies for MASH due to their direct anti-fibrotic effects as well as additional hepatic and extrahepatic benefits. Pegozafermin (PGZ), an FGF21 analog, was evaluated for safety and efficacy in a Phase 2b trial (ENLIVEN) with either weekly (QW) or every two-week (Q2W) dosing versus matching placebo in MASH patients with biopsy-proven F2/F3 fibrosis. Primary histology endpoints and non-invasive tests (NITs) were assessed at week 24, followed by additional NIT evaluation at the end of a 24-week blinded extension for a total of 48 weeks.

Aims & Methods

Patients were randomized to PGZ 15mg QW, 30mg QW, or 44mg Q2W or placebo for 24 weeks (histology-based primary endpoints). During the 24-week extension, most patients continued their assigned treatment with the exception of a subset of placebo patients who were re-randomized to receive PGZ 30mg QW. The full analysis set includes F2/F3 patients with NAFLD activity score (NAS) ≥4 at baseline (n=192).

Results

At 24-weeks, PGZ 30mg QW or 44mg Q2W led to statistically significant and clinical meaningful improvement in both primary histological endpoints (one stage of fibrosis improvement without worsening of MASH and MASH resolution without worsening of fibrosis) compared to placebo. Non-invasive testing at weeks 24 and 48 demonstrated that PGZ treatment was associated with robust and sustained reductions in liver fat content (MRI-PDFF), biomarkers of fibrosis (VCTE, ELF, PRO-C3) and liver injury (ALT, AST). PGZ also improved metabolic parameters such as lipids and HbA1c at both 24 and 48 weeks. PGZ was generally safe and well tolerated with the most common treatment emergent adverse events (TEAEs) being mild/moderate nausea and diarrhea. No deaths occurred; six early terminations for TEAEs including one drug-related serious AE occurred.

Conclusion

At 24 weeks, treatment with PGZ in MASH patients with F2/F3 fibrosis led to significant fibrosis regression and MASH resolution, which was corroborated by improvement across a variety of non-invasive tests including liver fat, inflammation, fibrosis, and metabolic markers. Benefits on NITs were sustained over the full 48-weeks of the study, with favorable safety and tolerability. PGZ is the first therapy to achieve fibrosis regression and MASH resolution with a Q2W dosing regimen. Phase 3 studies in noncirrhotic (ENLIGHTEN-Fibrosis) and cirrhotic (ENLIGHTEN-cirrhosis) patients are currently underway to confirm these results.

Disclosure

Jörn Schattenberg: Consultant: Akero, Alentis Therapeutics, Astra Zeneca, 89Bio, Boehringer Ingelheim, GSK, Ipsen, Inventiva Pharma, Madrigal, MSD, Northsea Therapeutics, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi, Siemens Healthineers; Speaker: Gilead Sciences, Advanz, Echosens, MedPublico GmbH; Grants: Boehringer Ingelheim, Siemens Healthcare GmbH; Stock Options: AGED diagnostics, Hepta Bio
Arun J Sanyal: Consulting: Genefit, Gilead, Malinckrodt, Pfizer, Salix, Boehringer Ingelheim, Novartis, Bristol Meyers Squibb, Merck, Hemoshear, Lilly, Novo Nordisk, Terns, Albireo, Jannsen, Poxel, 89bio, Siemens, AstraZeneca, NGM Bio, Amgen, Regeneron, Genentech, Alnylam, Roche, Madrigal, Inventiva, Covance, Prosciento, HistoIndex, PathAI; Grants: Gilead, Malinckrodt, Boehringer Ingelheim, Novartis, Bristol Meyers Squibb, Merck, Lilly, Novo Nordisk, Fractyl, Madrigal, Inventiva; Stock holder: Exhalenz, GenFit, Hemoshear, Durect, Indalo, NorthSea, Tiziana, Rivus
Naim Alkhouri: Research funding: 89Bio, AbbVie/Allergan, Akero, Better Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Corcept, DSM, Galectin, Genentech, Genfit, Gilead, Hepagene, Healio, Intercept, Inventiva, Ionis, Madrigal, Merck, NGM, Noom, NorthSea, Novo Nordisk, Perspectum, Pfizer, Poxel, Viking, and Zydus; Speaker bureau: AbbVie/Allergan, Alexion, Echosens, Eisai, Exelixis, Gilead, Intercept, Perspectum, Salix, and Theratechnologies; Consultant: 89Bio, AbbVie/Allergan, Echosens, Fibronostics, Gilead, Intercept, Madrigal, Novo Nordisk, Perspectum, Pfizer, and Zydus.
Rohit Loomba: Consultant: Aardvark Therapeutics, Altimmune, Anylam/Regeneron, Amgen, Arrowhead Pharmaceuticals, AstraZeneca, Boston Pharmaceuticals, Bristol-Meyers Squibb, CohBar, Eli Lilly, Galmed, Gilead, Glympse Bio, Hightide, Inipharma, Intercept, Inventiva, Ionis, Janssen Inc., Madrigal, Metacrine, Inc., NGM Biopharmaceuticals, Novartis, Novo Nordisk, Merck, Pfizer, Sagimet, Theratechnologies, 89bio, Terns Pharmaceuticals and Viking Therapeutics; Grants: Arrowhead Pharmacetuicals, AstraZeneca, Boegringer-Ingelheim, Bristol-Meyers Squibb, Eli Lilly, Galectin Therapeutics, Galmeed Pharmaceuticals, Gilead, Hanmi, Intercept, Inventiva, Ionis, Janssen, Madrigal Pharmaceuticals, Merck, NGM Biopharmaceuticals, Novo Nordisk, Pfizer, Sonic Incytes and Terns Pharmaceuticals; Stockholder: Co-founder LipoNexus, Inc
Mildred D Gottwald, Shibao Feng, Germaine D Agollah, Cynthia L Hartsfield, Hank Mansbach, Maya Margalit: 89bio employee and stock holder

PEGOZAFERMIN DEMONSTRATED ROBUST HISTOLOGICAL IMPROVEMENT AND BENEFIT IN HEPATIC AND METABOLIC BIOMARKERS: RESULTS FROM A 48-WEEK MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2B TRIAL (ENLIVEN)

Jörn Schattenberg 1, Arun J Sanyal 2, Naim Alkhouri 3, Mildred D. Gottwald 4, Shibao Feng 4, Germaine D. Agollah 4, Cynthia L Hartsfield 4, Hank Mansbach 4, Maya Margalit 5, Rohit Loomba 6

1 Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes, Homburg, Germany

2 Virginia Commonwealth University School of Medicine, Richmond, United States

3 Arizona Liver Health, Phoenix, United States

4 89bio, San Francisco, United States

5 89bio, Rehovot, Israel

6 University of California San Diego MASLD Research Center, San Diego, United States

Event

UEG Week Berlin 2025

Topics

Hepatobiliary

Submission format

Abstract

Session

Lifestyle management and therapy in MASLD

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Introduction: What’s new in EIM

Hannah Gordon 1, Stephan Vavricka 2

1 Royal London Hospital, London, United Kingdom

2 University Hospital Zurich, Zürich, Switzerland

Event

UEG Postgraduate Teaching Programme Vienna 2024

Topics

Education & Training IBD Mechanisms & Personalised Medicine Primary Care

Session

What’s new in extra-intestinal manifestations of IBD?

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Summary: What’s new in EIM

Stephan Vavricka 1

1 University Hospital Zurich, Zürich, Switzerland

Event

UEG Postgraduate Teaching Programme Vienna 2024

Topics

Education & Training IBD Mechanisms & Personalised Medicine Primary Care

Session

What’s new in extra-intestinal manifestations of IBD?

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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REDO ENDOSCOPIC SLEEVE GASTROPLASTY (RE-ESG): THE GROWING EXPERIENCE OF A TERTIARY CENTER

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Introduction

Obesity is a chronic relapsing multifactorial disease. As such, a “one and done” strategy may not lead to satisfying results in the long term for both surgical and endoscopic procedures. Endoscopic Sleeve Gastroplasty (ESG) is an effective, safe and repeatable bariatric procedure. As loss of satiety with weight regain or insufficient weight loss may occur after a primary ESG, re-ESG may play a role in such patients to improve weight loss. In this case series, we evaluate the short and medium-term outcomes of the re-ESG.

Aims & Methods

A retrospective analysis was performed on a prospective database including patients who underwent ESG between March 2017 and September 2022; patients who received a re-ESG because of progressive loss of satiety, insufficient weight loss and weight regain ≥ 50% after primary ESG were included in the analysis. %EWL, %TBWL, and the Bariatric Analysis and Reporting Outcome System (BAROS) questionnaire were assessed during follow-up. Weight loss parameters were calculated both after re-ESG and overall.

Results

Of 406 patients that underwent ESG, twenty-seven required a re-ESG (6.7%). The mean time between the primary ESG and the re-ESG was 20 months (range 7-42). Re-ESG was technically feasible in all patients and no periprocedural adverse events occurred. The adherence to follow-up was 22/27 (81.5%) at 1 month, 17/26 (65.4%) at 3 months, 15/23 (60.9%) at 6 months and 13/19 (68.4%) at 12 months.
The mean BMI was 38.4 ± 6.5 kg/m² and 35.5 ± 6.0 kg/m² at primary ESG and re-ESG, respectively. The overall mean %TBWL was 18.2% ± 8.1 and 18.7% ± 6.2 at 6 and 12 months, respectively. The mean %TBWL after re-ESG was 10.3% ± 6 at 1 month, 13.2% ± 6.4 at 3 months, 13.6% ± 7.7 at 6 months, 14.1% ± 7.5 at 12 months. BAROS questionnaire mean score was 4.2 ± 2.0 and 4.1 ± 1.8 at 6 and 12 months, respectively. More details are summarized in Table 1. All patients reported a proper sense of satiety and substantial improvement in quality of life after the re-ESG.

Table 1. Weight loss and quality of life outcomes after re-ESG
	1 month	3 months	6 months	12 months
Overall %TBWL	15.2% ± 8.0	19.0% ± 8	18.2% ± 8.1	18.7% ± 6.2
Re-ESG %TBWL	10.3% ± 6	13.2% ± 6.4	13.6% ± 7.7	14.1% ± 7.5
Overall %EWL	47.1% ± 21.3	57.1% ± 21.9	53.8% ± 21.9	55.5% ± 18.5
Re-ESG %EWL	38.0% ± 17.2	47.4% ± 21.7	46.2% ± 22.1	47.8% ± 24.9
BAROS score	3.6 ± 1.5	4.2 ± 1.6	4.2 ± 2.0	4.1 ± 1.8
Values are mean ± standard deviation.

Conclusion

According to our experience, re-ESG has satisfying short and medium-term outcomes in terms of satiety, weight loss and quality of life. As such, repeating ESG should not be seen as a failure, but a further step in the endoscopic approach to obesity.

Disclosure

Ivo Boskoski is a consultant for Apollo Endosurgery, Cook Medical, BostonScientific, and Nitinotes.

REDO ENDOSCOPIC SLEEVE GASTROPLASTY (RE-ESG): THE GROWING EXPERIENCE OF A TERTIARY CENTER

Maria Valeria Matteo 1, Giorgio Carlino 1, Vincenzo Bove 1, Valerio Pontecorvi 1, Martina De Siena 1, Laila Vinti 1, Giulia Giannetti 1, Giulia Palumbo 1, Giulia Polidori 1, Nausicaa Antonini 1, Chiara Massari 1, Cristiano Spada 1, Guido Costamagna 1, Ivo Boskoski 1

1 Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy

Event

UEG Week Copenhagen 2023

Topics

Endoscopy Gut Microbiota Hepatobiliary IBD Small Intestine & Nutrition Pancreas

Submission format

Abstract

Session

The various impacts of diet: From IBD to liver

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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Biomarkers of IBD

Joachim Høg Mortensen 1

1 Nordic Bioscience A/S, Herlev, Denmark

Event

UEG Week Vienna 2024

Topics

Colorectal IBD Paediatrics Pancreas Primary Care

Session

Mistakes in...: Lower GI

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

UEG Presentation

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RANDOMIZED CONTROLLED TRIAL COMPARING ENDOSCOPIC BALLOON DILATION VERSUS ENDOSCOPIC STRICTUROTOMY FOR SHORT STRICTURES (&LT; 3 CM) RELATED TO CROHN’S DISEASE (THE BEST-CD TRIAL) (NCT05521867)

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Introduction

Although endoscopic balloon dilation (EBD) remains the standard intervention for Crohn’s disease (CD)-associated strictures, its efficacy is limited by high recurrence and surgery rates. Retrospective analyses suggest endoscopic stricturotomy (ES) may offer superior outcomes, particularly in anastomotic strictures. However, no randomized trials have directly compared EBD and ES for short CD-related strictures.

Aims & Methods

This single-center, randomized controlled trial (August 2022–March 2025) enrolled adult CD patients (18–65 years) with symptomatic, predominantly fibrotic or mixed, short strictures (<3 cm), including both de novo and anastomotic types, accessible via standard endoscopy. Patients with multiple (>2) strictures, strictures beyond endoscopic reach, or prior stricturotomy were excluded. Participants were randomized to undergo either EBD or ES. The primary outcome was clinical recurrence at 1 year. Secondary outcomes included re-intervention, surgery, emergency visits, hospitalization, technical success, and adverse events.

Results

Out of 70 randomized patients, 69 were analyzed (EBD: 35; ES: 34). Baseline characteristics were comparable between groups. Technical success was similar (EBD: 91.4%, ES: 94.1%). On time to event analysis, clinical recurrence was significantly lower in the ES group (OR=0.343, 95% CI: 0.134–0.881; p=0.026). Re-intervention rates favored ES (EBD: 25.7%, ES: 8.8%; OR=0.337, 95% CI: 0.131–0.870; p=0.025). Surgery rates were numerically lower with ES (EBD: 11.4%, ES: 5.9%) but not statistically significant (p=0.581). Hospitalization was significantly more frequent in the EBD arm (OR=0.276, 95% CI: 0.091–0.840; p=0.023). ED visits also trended lower with ES, though not statistically significant (p=0.062) (see table). Adverse events occurred in 25.7% of EBD patients (bleeding n=3 [1 hemoclip], pain with admission n=3, micro-perforation n=1, post-procedure pain n=2) and 14.7% of ES patients (bleeding n=3 [1 self-limited, 1 coagrasper, 1 hemoclip], none required transfusion, suspected perforation n=1, mild pain n=1).

Outcome	EBD (n=35)	ES (n=34)	p-value	Odds Ratio (95% CI)
Technical Success (%)	91.4% (32/35)	94.1% (32/34)	0.70	-
Clinical Recurrence (%)	48.6%	23.5%	0.026	0.343 (0.134–0.881)
Re-intervention Rate (%)	25.7%	8.8%	0.025	0.337 (0.131–0.870)
Surgery (%)	11.4%	5.9%	0.581	0.707 (0.207–2.422)
Stricture-related ED Visits (%)	20.0%	11.8%	0.062	0.404 (0.156–1.047)
Stricture-related Hospitalizations (%)	25.7%	8.8%	0.023	0.276 (0.091–0.840)
Any Adverse Event (%)	25.7% (9/35)	14.7% (5/34)	0.45	-

Conclusion

In this interim analysis, ES was associated with significantly lower clinical recurrence, re-intervention, and hospitalization compared to EBD for short CD-related strictures, with similar safety outcomes. These findings support ES as a potentially superior first-line endoscopic strategy over EBD in selected patients with Crohn’s disease strictures. (NCT05521867)

References

Lan N, Shen B. Endoscopic Stricturotomy Versus Balloon Dilation in the Treatment of Anastomotic Strictures in Crohn's Disease. Inflamm Bowel Dis. 2018 Mar 19;24(4):897-907. doi: 10.1093/ibd/izx085. PMID: 29546384.

RANDOMIZED CONTROLLED TRIAL COMPARING ENDOSCOPIC BALLOON DILATION VERSUS ENDOSCOPIC STRICTUROTOMY FOR SHORT STRICTURES (&LT; 3 CM) RELATED TO CROHN’S DISEASE (THE BEST-CD TRIAL) (NCT05521867)

Partha Pal 1, Kanapuram Pooja 1, Rajesh Gupta 1, Manu Tandan 1, D. Nageshwar Reddy 1

1 Asian Institute of Gastroenterology, Hyderabad, India

Event

UEG Week Berlin 2025

Topics

Endoscopy Radiology & Imaging IBD

Submission format

Abstract

Session

Advances in the investigation of the small bowel

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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