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Introduction

Recent studies have indicated an increased prevalence of steatosis and liver fibrosis(LF), obesity and cardiovascular diseases among inflammatory Bowel disease(IBD) patients. We aimed to characterize these conditions and risk factors associated.

Aims & Methods

Cross-sectional study on patients with IBD. Pregnancy or known cause of chronic liver disease were excluded. All patients underwent transient elastography, clinical and laboratorial assessment. International Physical Activity Questionnaire(IPAQ) classified activity as low, moderate, or high. Presence of steatosis and fibrosis was defined as Controlled Attenuated Parameter(CAP) measurement of >248dB/m and Liver Stiffness Measurement(LSM) >8kPa, respectively. Fibrosis-4 score (FIB4) was also calculated. For cardiovascular risk (CVR), SCORE2 was calculated according to European Society of Cardiology (if >40 years).

Results

79 consecutive patients were enrolled [53 Crohn’s disease (CD), 24 Ulcerative colitis (UC)]. Baseline characteristics and CVR factors are presented in table 1. Median SCORE2 was 4 (IQR3-10) and 5 (IQR2-10), (p=0.83), conferring low cardiovascular risk; 36% of CD and 70% of UC patients had liver steatosis (p=0.04) and 11% of CD and 25% of UC had LF (p=0.13). Median LSM and CAP was 4.7, IQR (4-6) kPa vs 4.6, IQR (3.6-8.6) kPa (p=0.86) and 234, IQR (171-284) vs 217, IQR (179-294) dB/m (p=0.86), for CD and UC respectively. We found a moderate correlation between FIB4 and LSM in CD (r=0.66, p<0.001), but not in UC (r=0.37, p=0.37). Comparison between patients with and without fibrosis in IBD showed significant differences in terms of age (47, IQR [45-66] vs 36, IQR [29-54]), p=0.01); body mass index (BMI) (31.01, [26.54-37.83] vs 24.61, [20.61-28.05], p=0.03), and history of thromboembolic diseases (23%vs 3%,p=0.007). In a multivariate regression, adjusting for clinically relevant variables, only higher BMI showed higher risk of fibrosis (OR 1.25, CI [1.05-1.48],p=0.01).

	CD	UC	p
Male,%	53%	46%	0.57
Age, median,IQR	55, (31-54)	45,(29-56)	0.42
Low IPAQ,%	87%	71%	0.13
Dyslipidemia,%	11%	8%	0.13
Diabetes,%	4%	4%	0.93
Smoker/Previous smoker,%	44%	65%	0.93
BMI, median,IQR	25.5,(21- 29)	26.53,(21-29)	0.93

Conclusion

In our population, IBD patients had a low cardiovascular risk, and 11% of CD and 25% of UC had liver fibrosis. A potential factor linking both conditions is a higher BMI, was independent risk factor for the development of fibrosis.

CHARACTERIZATION OF CARDIOVASCULAR RISK, LIVER STEATOSIS AND FIBROSIS IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE

André Bargas Bárbara 1, Catarina Moreira-Barbosa 1, Ana Guedes 1, Ana Catarina Bravo 1, Bárbara Abreu 1, Joana Revés 2, Catarina Gouveia 1, Catarina Frias-Gomes 1, Lídia Maria Roque Ramos 1, Manuela Canhoto 1, Maria Luisa Gloria 1, Carolina Palmela 1, Joana Torres 1

1 Hospital de Loures, Lisboa, Portugal

2 Hospital Beatriz Angelo, Lisboa, Portugal

Conference

UEG Week Vienna 2024

Topics

IBD

Submission format

Abstract

Session

IBD (Posters)

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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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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Biologic drugs

Luc Biedermann 1

1 USZ Zürich, Zürich, Switzerland

Event

UEG Week Berlin 2025

Topics

Mechanisms & Personalised Medicine Small Intestine & Nutrition Oesophagus Paediatrics

Session

Therapy update: EoE

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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A COHORT STUDY OF INFLAMMATORY BOWEL DISEASE CARE IN PREGNANCY IN A LARGE TERTIARY CENTRE

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Introduction

Treatment of IBD during pregnancy poses a clinical challenge. Myths and misconceptions abound. Numerous studies have shown active IBD is associated with adverse maternal and fetal outcomes. A growing field of new medication also creates challenges. We conducted a retrospective cohort study to report pregnancy outcomes and clinical practice in a large tertiary centre in the UK in 2023.

Aims & Methods

Tertiary care for pregnant patients with IBD is provided through a specialist joint gastroenterology-obstetrics service. Data was retrospectively extracted from the electronic health records of 50 women looked after between January 1st and July 1st 2023. We describe the patient population including IBD characteristics, treatments and disease activity during pregnancy and report obstetric outcomes.

Results

50 unique pregnant women were included; 30 (60.0%) had Crohn’s disease (CD) and 20 (60.0%) had Ulcerative Colitis (CD) with a median age of 34. Within the CD cohort, 4 (13.3%) had prior or active perianal disease. Vaginal delivery is relatively contraindicated in this cohort and all patients underwent C-section.  
Overall, 22/50 (44.0%) patients were taking biologics, 6/50 (12.0%) on thiopurines, 14/50 (28.0%) on mesalazine only and 14/50 (28%) were on no IBD medication at the time of conception. Of those taking biologics, 3/22 (13.6%) discontinued in the third trimester while 19/22 (86.4%) continued biologics throughout pregnancy. This reflects a recent change in practice; only patients in remission with low risk of flare stopped biologic medication during pregnancy. ¹
50% experienced an IBD flare during pregnancy. A flare was defined as a faecal calprotectin >250μg/g or exacerbation of symptoms requiring change in medical management.   
A significant proportion (20/50, 40.0%) developed anaemia during pregnancy (Hb <116g/L). 6 (12%) developed anaemia according to pregnancy parameters (Hb <106g/L. 21 (42.0%) received iron supplementation. 11 (52.4%) received it exclusively orally, 3 (14.3%) exclusively intravenously and 5 (23.8%) received both. Oral iron was tolerated poorly.  
 Regarding obstetric outcomes; 48 (96.0%) had live singleton births, with 1 (2.00%) miscarriage and 1 (2.00%) elective termination following an abnormal anomaly scan; found at post-mortem to have Turner’s syndrome. 35/48 (72.9%) women delivered in our hospital while 13/48 (18.1%) delivered in a local hospital.   
1/48 (3.9%) baby was born prematurely (<37 weeks). Median birthweight was 3235g (2410g – 4280g). 2/48 (4.2%) were born with low birth weight (<2.5Kg), and 4/48 (8.3%) had fetal macrosomia (>4.0Kg). Median birthweight was lower in mothers who experienced flare (3210g) compared to those with no flare (3310g).
Incidence of gestational diabetes mellitus (GDM) (25.7%) was higher compared with the national average of 5%. Antenatal steroid use is associated with hyperglycaemia and GDM. Steroids were required to control disease flares in 6/48 (12.5%) women; 3 had prednisolone, 2 had budesonide and 1 buccal hydrocortisone. Only 1/6 (16.7%) exposed to steroids developed GDM.

Conclusion

IBD flares were common in pregnancy, which may reflect the complexity of patients referred to the tertiary service. Most patients continued biologic medication during pregnancy including the third trimester. Obstetric and neonatal outcomes were similar to the general population. Anaemia was similar to and GDM was more common than the local population. Awareness and proactive management of these issues including continuing IBD medication is important to reduce the risk of associated complications.

References

1. Torres J, Chaparro M, Mette Julsgaard, Katsanos K, Zuzana Zelinkova, Agrawal M, et al. European Crohn’s and Colitis Guidelines on Sexuality, Fertility, Pregnancy, and Lactation. Journal of Crohn’s and Colitis [Internet]. 2022 Aug 25;17(1):1–27. Available from: https://academic.oup.com/ecco-jcc/article/17/1/1/6675338

A COHORT STUDY OF INFLAMMATORY BOWEL DISEASE CARE IN PREGNANCY IN A LARGE TERTIARY CENTRE

Harry Mackenzie 1, Sara Mccartney 1, Diane Nzelu 1, David Williams 1, Paul Harrow 1

1 University College London Hospitals NHS Foundation Trust, London, United Kingdom

Event

UEG Week Vienna 2024

Topics

IBD Mechanisms & Personalised Medicine Radiology & Imaging

Submission format

Abstract

Session

IBD: Diagnosis and monitoring

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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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

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

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Introduction

Inflammatory bowel disease (IBD) is a chronic multi-factorial disease characterized by inflammation of the gastrointestinal tract. Currently, the mechanisms underlying the disease are far from being elucidated. Thus, the study of proteins involved in its pathogenesis would allow further insights into the molecular mechanisms underlying IBD.

Aims & Methods

The serum and intestinal mucosa (ileum and left colon) proteomic profiles of patients with Crohn´s disease (CD) and ulcerative colitis (UC) and healthy controls (HC) were analyzed through label-free relative quantitative proteomic profiling using nLC MS/MS. Data mining and pattern recognition techniques were performed to identify hidden relationships that are not detectable using classical linear classifiers, and thus identify potential markers able to discriminate between the different study groups. Six candidate biomarkers were selected for further validation using enzyme-linked immunosorbent assay (ELISA) and immunohistochemistry (IHC) in serum and intestinal tissue samples, respectively.

Results

Comparison of serum proteins between UC patients and HC revealed statistically lower levels of protein 1 and 2 and higher levels of protein 3. The comparison of potential biomarkers between CD and HC group showed lower levels of protein 1 and higher levels of protein 3. In addition, protein 4 was differentially upregulated in CD patients compared to UC. Regarding the intestinal biopsies, protein 5 showed higher intensity in the IHC staining of ileum from CD patients compared to HC, whereas protein 6 was significantly decreased in left colon and ileum from CD and UC patients compared to HC. These proteins are involved in thyroxine transport, regulation of chemotactic chemokine activity, inflammatory processes, triglyceride homeostasis, oxidative stress and regulation of NF-kappa-B activation in the cytosol.

Conclusion

In this study, we have identified a panel of six potential biomarkers that could help to elucidate mechanisms involved in IBD pathogenesis. Their roles in the pathophysiology need to be clarified in further experiments.

NOVEL BIOMARKERS ASSOCIATED WITH INFLAMMATORY BOWEL DISEASE

Montse Baldan Martin 1, Ibon Iloro 2, Mikel Azkargorta 2, Macarena Orejudo del Río 1, Cristina Ramírez 1, Irene Soleto 1, Jore Mercado 1, Fabio Suarez-Trujillo 1, Cristina Sánchez Sánchez 1, Carlos H. Gordillo 3, Ruth María de Francisco García 4, Montserrat Rivero 5, Ana Gutiérrez-Casbas 6, Iago Rodríguez-Lago 7, Luis Fernández-Salazar 8, Daniel Sebastian Ceballos Santos 9, JOSE MANUEL BENITEZ CANTERO 10, Mariam Aguas 11, Iria Bastón-Rey 12, Fernando Bermejo 13, María José Casanova 1, Rufo Lorente Poyatos 14, Yolanda Ber Nieto 15, Vanesa Royo Escosa 16, Maria Esteve Comas 17, Felix Elortza 2, Javier Gisbert 1, María Chaparro 1

1 Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM) and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain

2 Proteomics Platform, CIC bioGUNE, BRTA (Basque Research & Technology Alliance), CIBERehd, Derio, Spain

3 Hospital Universitario de La Princesa, Madrid, Spain

4 Hospital Universitario Central de Asturias and Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain

5 Hospital Universitario Marqués de Valdecilla and IDIVAL, Santander, Spain

6 Hospital General Universitario Alicante, CIBERehd and Instituto de Investigación Sanitaria y Biomédica de Alicante, Alicante, Spain

7 Hospital Galdakao-Usansolo, Vizcaya, Spain

8 Hospital Clínico Universitario de Valladolid, Valladolid, Spain

9 Hospital Universitario de Gran Canaria Dr. Negrín, Las Palmas de Gran Canaria, Spain

10 Hospital Universitario Reina Sofía and IMIBIC, Córdoba, Spain

11 Hospital Universitari i Politecnic La Fe and Health Research Institute (IISLaFe), Valencia, Spain

12 Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain

13 Hospital Universitario de Fuenlabrada, Madrid, Spain

14 Hospital General Universitario de Ciudad Real, Ciudad Real, Spain

15 Hospital San Jorge, Huesca, Spain

16 Hospital Universitari Son Espases, Palma de Mallorca, Spain

17 Hospital Universitari Mutua Terrassa and CIBERehd, Barcelona, Spain

Conference

UEG Week Vienna 2024

Topics

IBD

Submission format

Abstract

Session

IBD (Posters)

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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