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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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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

UEG Presentation

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... for medical therapy in inflammatory bowel diseases

Chris Lamb 1

1 Newcastle Hospitals NHS Foundation Trust, Newcastle, United Kingdom

Event

UEG Week Berlin 2025

Topics

Colorectal IBD Surgery

Session

Predicting patient outcomes...

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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Summary: Decision time in IBD - Difficult cases

Britta Siegmund 1

1 Charité - Universitätsmedizin Berlin, Berlin, Germany

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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The UC patient in the emergency room and beyond: Case presentation and how to manage acute UC in the hospital

Peter Bossuyt 1, Thibault Taelman 2

1 Imelda General Hospital, Bonheiden, Belgium

2 Az Groeninge, Kortrijk, Belgium

Event

UEG Postgraduate Teaching Programme Berlin 2025

Session

When the alarm bells go off: Approach to acute severe colitis

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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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

Event

UEG Week Vienna 2024

Topics

IBD

Submission format

Abstract

Session

Ameliorating acute disease through novel treatment in IBD: Part 1

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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