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How not to poison our patients: Avoiding and managing extraintestinal drug reactions in IBD

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How not to poison our patients: Avoiding and managing extraintestinal drug reactions in IBD

Thomas Greuter 1

1 Hospital Zürich, 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

UEG Presentation

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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

UEG Presentation

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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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Psychology

Laurie Keefer 1

1 Icahn School of Medicine, New York, United States of America

Event

UEG Week Vienna 2024

Topics

Neurogastroenterology & Motility Primary Care

Session

The patient with a challenging functional disorder

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

UEG Presentation

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Stricturing Crohn's disease: Surgery and medical therapy

Christianne Johanna Buskens 1, Krisztina Barbara Gecse 2

1 Academic Medical Center, Amsterdam, Netherlands

2 Amsterdam University Medical Center, Amsterdam, Netherlands

Event

UEG Postgraduate Teaching Programme Vienna 2024

Topics

Education & Training IBD Immunology Mechanisms & Personalised Medicine Surgery

Session

Decision time in IBD: Difficult cases

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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DEEP LEARNING FOR AUTOMATIC DIAGNOSIS AND MORPHOLOGIC CHARACTERIZATION OF MALIGNANT BILIARY STRICTURES USING DIGITAL CHOLANGIOSCOPY: A MULTICENTRIC STUDY

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Introduction

Diagnosis and characterization of biliary strictures are challenging. The introduction of digital single-operator cholangioscopy (D-SOC) significantly improved the diagnostic yield of indeterminate biliary strictures. Pilot studies using artificial intelligence (AI) algorithms applied to D-SOC have shown promising results. We aimed to develop an AI system based on convolutional neural networks (CNN) for the automatic detection and characterization of malignant biliary strictures in D-SOC images.

Aims & Methods

Our group developed, trained, and validated a CNN based on D-SOC images from two centers in Portugal and Spain. Each frame was labeled as normal/benign findings or as a malignant lesion if histopathological evidence of biliary malignancy was available. Also, we evaluated the network's performance for detecting morphologic features, including tumor vessels, papillary projections, and nodules. The image dataset was split for the constitution of training and validation datasets. The performance of the CNN was measured by calculating the area under the curve (AUC), sensitivity, specificity, and positive and negative predictive values (PPV and NPV, respectively).

Results

A total of 84994 images from 130 D-SOC exams were included (44743 of malignant strictures and 40521 of benign findings). The model had an overall accuracy of 98.3%, a sensitivity of 98.3%, a specificity of 98.3%, and an AUROC of 1.00.
Our group evaluated the performance of the CNN for the detection of morphological characteristics associated with malignancy, particularly tumor vessels and papillary projection. The CNN detected tumor vessels with a sensitivity of 95.7%, a specificity of 88.6%, and an overall accuracy of 93.0%. Papillary projections were identified by the CNN with a sensitivity of 74.1%, a specificity of 94.5%, and an overall accuracy of 91.2%.
The CNN completed the reading of the 4250 batches of images (each batch comprising 128 images) in 23 minutes and 16 seconds, which can be translated to an approximate reading rate of 390 frames per second.

Conclusion

The developed deep learning algorithm accurately detected and differentiated malignant strictures from benign biliary conditions. Furthermore, the AI model provided accurate morphological characterization of the biliary strictures.
The potential of deep learning algorithms to impact the care of patients with suspected biliary malignancy is vast. This study assessed the performance of a CNN for detecting and differentiating malignant and benign biliary disorders using a large pool of D-SOC images. The excellent performance of this model lays the foundations for future exploration of AI technologies in this subset of patients, aiming to improve the clinical outcome of patients with suspected biliary malignancy.

References

1 Larghi A, Tringali A, Lecca PG, Giordano M, Costamagna G. Management of hilar biliary strictures. Am J Gastroenterol. 2008;103(2):458-73.
2 Tummala P, Munigala S, Eloubeidi MA, Agarwal B. Patients with obstructive jaundice and biliary stricture ± mass lesion on imaging: prevalence of malignancy and potential role of EUS-FNA. J Clin Gastroenterol. 2013;47(6):532-7.
3 Paranandi B, Oppong KW. Biliary strictures: endoscopic assessment and management. Frontline Gastroenterol. 2017;8(2):133-7.
4 Singhi AD, Slivka A. Evaluation of indeterminate biliary strictures: Is there life on MARS? Gastrointestinal Endoscopy. 2020;92(2):320-2.
5 Burnett AS, Calvert TJ, Chokshi RJ. Sensitivity of endoscopic retrograde cholangiopancreatography standard cytology: 10-y review of the literature. J Surg Res. 2013;184(1):304-11.
6 Navaneethan U, Njei B, Lourdusamy V, Konjeti R, Vargo JJ, Parsi MA. Comparative effectiveness of biliary brush cytology and intraductal biopsy for detection of malignant biliary strictures: a systematic review and meta-analysis. Gastrointest Endosc. 2015;81(1):168-76.
7 Pereira P, Vilas-Boas F, Peixoto A, Andrade P, Lopes J, Macedo G. How SpyGlass™ May Impact Endoscopic Retrograde Cholangiopancreatography Practice and Patient Management. GE Port J Gastroenterol. 2018;25(3):132-7.