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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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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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Nutritional management of small intestinal enteropathies

Francisca Joly 1

1 Beaujon Hospital, Assistance Publique-Hôpitaux de Paris, Clichy, France

Event

UEG Week Berlin 2025

Topics

Immunology Small Intestine & Nutrition

Session

Coeliac or non-coeliac enteropathy?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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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

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CORTICOSTEROID-SPARING EFFECT OF MIRIKIZUMAB FOR THE TREATMENT OF MODERATELY-TO-SEVERELY ACTIVE ULCERATIVE COLITIS: EXTENDED INDUCTION SUBGROUP ANALYSIS FROM PHASE 3 TRIAL

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Introduction

Mirikizumab, an anti-IL-23p19 antibody, has demonstrated efficacy and safety in moderately-to-severely active ulcerative colitis (UC) Phase 3 trials (LUCENT-1 and -2; NCT03518086, NCT03524092). A treatment goal for patients with UC is corticosteroid (CS)-free remission. We assessed the CS-sparing effect of mirikizumab among the extended induction patient population receiving CS at induction baseline.

Aims & Methods

In LUCENT-1, patients in the modified intention to treat mirikizumab group (n=868) received mirikizumab 300 mg intravenously (IV) at Week (W)0, W4, and W8. Patients receiving mirikizumab on CS at baseline (n=351) remained on their stable baseline dose (prednisone ≤20 mg/day or equivalent, budesonide MMX 9 mg/day, or beclomethasone 5 mg/day) during induction (W0 to W12). Patients not achieving clinical response (≥2-point and ≥30% decrease in Modified Mayo Score from baseline; and rectal bleeding=0 or 1, or ≥1-point decrease from baseline) at W12 (n=272) entered LUCENT-2 open label (OL) extended induction and received 300 mg mirikizumab IV at W12, W16, and W20. Extended induction responders at W24 (n=144) entered OL maintenance and received 200mg mirikizumab subcutaneously (SC) Q4W until W52. CS taper was initiated if clinical response was achieved at W24 or earlier based on investigator discretion if symptomatic improvement was evident. Patients who discontinued CS and remained off throughout the study were considered “discontinued.” Descriptive statistics for efficacy outcomes were summarized. Missing data were imputed as non-response.

Results

Of the 272 mirikizumab patients in the extended induction population, 118 received CS at induction baseline. The mean prednisone equivalent dose was 15mg. At W24, among the 62/118 (52.5%) who achieved clinical response and continued with maintenance, 8 (12.9%) discontinued CS, 2 (3.2%) achieved clinical remission off CS, and 8 (12.9%) achieved symptomatic remission off CS. At W52, 43/62 (69.4%) of the extended induction responders discontinued CS, 18 (29.0%) achieved clinical remission off CS, and 37 (59.7%) achieved symptomatic remission off CS. Among patients with non-missing data who completed W52 of mirikizumab treatment, 89.6% had discontinued CS (Table).
Table. Corticosteroid-Sparing Effect of Mirikizumab in Extended Induction Population Receiving Corticosteroids at Induction Baseline

		Mirikizumab Extended Induction Responders^a (N=62)
		Observed n/Nx (%)	NRI n (%)
Week 24	Clinical remission^b and off CS	2/62 (3.2)	2 (3.2)
	Symptomatic remission^c and off CS	8/62 (12.9)	8 (12.9)
	Discontinued CS^d	8/53 (15.1)	8 (12.9)
Week 52	Clinical remission^b and off CS	18/50 (36.0)	18 (29.0)
	Symptomatic remission^c and off CS	37/52 (71.2)	37 (59.7)
	CS-free remission^e	16/49 (32.7)	16 (25.8)
	Discontinued CS^d	43/48 (89.6)	43 (69.4)
Abbreviations: CS=corticosteroid; N =number of patients in analysis population; n=number of patients in the specified category; NRI=non-responder imputation; Nx=number of patients with non-missing values ^a Patients without response at week 12 treated with mirikizumab extended induction and responded at week 24. Clinical response defined as ≥2-point and ≥30% decrease in Modified Mayo Score from baseline; and rectal bleeding=0 or 1, or ≥1-point decrease from baseline ^b Defined as stool frequency subscore=0 or 1 with ≥1-point decrease from induction baseline, a rectal bleeding subscore=0, and an endoscopic subscore=0 or 1 (excluding friability) ^c Defined as stool frequency subscore=0 or 1 with ≥1-point decrease from induction baseline, a rectal bleeding subscore=0 ^d Patients discontinued CS and remained off through Week 52 ^eClinical remission at Week 52 + symptomatic remission at Week 40 + off CS for ≥12 weeks

Conclusion

Nearly 70% of extended induction responders discontinued CS by W52. CS-sparing effect of mirikizumab in patients with moderately-to-severely active UC is clinically meaningful and aligns with the treatment goal of CS discontinuation.

Disclosure

DL declares counseling, boards, transports or fees from Abbvie, Biogaran, Biogen, Ferring, HAC-pharma, Janssen, MSD, Novartis, Pfizer, Prometheus, Roche, Takeda, Theradiag, Tillots.
CS reports advisory board and consultant fees for Abbvie, BMS, Lilly, Janssen, Pfizer, Prometheus, Takeda and Trellus Health; speaker for CME activities for Abbvie, Janssen, Pfizer and Takeda; received grant support from Abbvie, Janssen, Pfizer and Takeda; intellectual property for a “System and Method of Communicating Predicted Medical Outcomes”; co-founder of MiTest Health, LLC (software company) that has technology (PROSPECT/CDPATH) that has been licensed to Takeda.
PD reports consulting fees from Johnson and Johnson, Gilead, Lilly, BMS, Novartis, Pfizer, and Takeda; financial support for research from Takeda and Pfizer; stock options for DigbiHealth; and licensing royalties from PreciDiag.
KM has received speaker fees and research grants from AbbVie, EA Pharma, Mochida, Mitsubishi-Tanabe, ZERIA, Nippon Kayaku, and JIMRO; speaker fees from Takeda, Janssen, Pfizer, Kyorin, Kissei, Gilead, Eli Lilly, and Celltrion Healthcare.
JPG has served as speaker, consultant, and advisory member for or has received research funding from MSD, Abbvie, Pfizer, Kern Pharma, Biogen, Mylan, Takeda, Janssen, Roche, Sandoz, Celgene/Bristol Myers, Gilead/Galapagos, Lilly, Ferring, Faes Farma, Shire Pharmaceuticals, Dr Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Norgine and Vifor Pharma.
KHS, IR,SB are employees and minor shareholders of Eli Lilly and Company
JP is an employee of Syneos Health and contractor for Eli Lilly and Company
VJ has received consulting/advisory board fees from AbbVie, Alimentiv Inc. (formerly Robarts Clinical Trials), Arena Pharmaceuticals, Asieris, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Fresenius Kabi, Galapagos, GlaxoSmithKline, Genentech, Gilead, Janssen, Merck, Mylan, Pandion, Pendopharm, Pfizer, Reistone Biopharma, Roche, Sandoz, Takeda and TopiVert, and speaker’s fees from AbbVie, Ferring, Galapagos, Janssen, Pfizer, Shire and Takeda.

CORTICOSTEROID-SPARING EFFECT OF MIRIKIZUMAB FOR THE TREATMENT OF MODERATELY-TO-SEVERELY ACTIVE ULCERATIVE COLITIS: EXTENDED INDUCTION SUBGROUP ANALYSIS FROM PHASE 3 TRIAL

David Laharie 1, Corey A Siegel 2, Parambir Singh Dulai 3, Matsuoka Katsuyoshi 4, Javier P. Gisbert 5, Karen Samaan 6, Isabel Redondo 6, Simin K. Baygani 6, Jerome Paulissen 7, Vipul Jairath 8

1 CHU de Bordeaux Hopital Haut-Leveque Dept. de Gastroenterologie, Bordeaux, France

2 Dartmouth-Hitchcock Medical Center, Lebanon, United States

3 Northwestern Medicine Digestive Health Center, Chicago, United States

4 Tokyo Medical and Dental University, Tokyo, Japan

5 Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa [IIS-Princesa], Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas [CIBEREHD], Madrid, Spain

6 Eli Lilly and Company, Indianapolis, United States

7 Syneos Health, Morrisville, United States

8 University of Western Ontario, London, Canada