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SEROLOGIC RESPONSE TO VACCINATION IN CHILDREN EXPOSED TO VEDOLIZUMAB OR USTEKINUMAB IN UTERO DUE TO MATERNAL IBD

Katarina Mitrova 1,2, Kristýna Zdychyncova 1, Karin Cerna 1, Barbora Pipek 3,4, Jana Švíková 5, Milan Lukas 1, Dana Duricova 1,6

Affiliations

1 IBD Clinical and Research Centre, ISCARE a.s., Prague, Czechia

2 Charles University in Prague and University Hospital Motol, Prague, Czechia

3 Palacky University and University Hospital Olomouc, Olomouc, Czechia

4 Digestive Diseases Centre, Hospital AGEL Vítkovice, Ostrava, Czechia

5 Jihlava Hospital, Jihlava, Czechia

6 Charles University in Prague, Prague, Czechia

Summary

AI Generated

A study of 21 children exposed in utero to ustekinumab or vedolizumab for maternal IBD found that most achieved adequate serologic responses to both live and non-live vaccines, though mumps response was lower in the ustekinumab group.

Twenty-one children (11 ustekinumab-exposed, 10 vedolizumab-exposed) born to mothers with IBD were assessed for serologic vaccine responses at median age 26 months after completing at least one year of mandatory vaccination.
Adequate serologic responses to tetanus, diphtheria, rubella, and measles were achieved in at least 80 percent of children in both exposure groups.
Mumps vaccine response was lower in ustekinumab-exposed children at 62.5 percent compared to 100 percent in vedolizumab-exposed children.
Median gestational week of last drug administration was week 30 for ustekinumab and week 31 for vedolizumab, with median cord blood levels of 2.4 mg/l and 5.3 mg/l respectively.
The authors note the study's limited sample size and the need for a control group of unexposed children for comparison.

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Abstract

Introduction

The evidence on efficacy of vaccination given to children exposed to ustekinumab (UST) or vedolizumab (VDZ) in utero is missing.

Aims & Methods

The aim of our study was to assess serologic response to vaccination in children exposed prenatally to this medication due to inflammatory bowel disease (IBD) of their mothers. Children ≥ 1 year of age exposed to UST or VDZ in utero who had completed at least 1 year mandatory vaccination were included. Serological response to the following vaccination was assessed: non-live vaccines: tetanus, diphtheria; live-vaccines: mumps, rubella, measles. Data on perinatal period were collected using predefined questionnaire filled by mother and/or treating physician and supplied from patient medical files. Information on cord blood levels of biologics were retrieved from patients' medical files.

Results

Twenty-one children were included, 10 exposed to VDZ and 11 to UST. Median age at blood sampling was 26 months (range: 13-49). Except one child exposed to VDZ, all children were born at term with median birth weight of 3250 g (range: 650 - 4000) with 3 (14%) infants having low birth weight. Median gestational week of the last drug administration was week 31 and week 30 in case of VDZ and UST, respectively. Cord levels were measured in 7 VDZ and 10 UST- exposed infants with median (range) cord blood levels of 5.3 mg/l (1.1-21.3) and 2.4 mg/l (0.4-30), respectively. Results on serologic response to vaccination are outlined in Table 1. Tetanus, diphtheria, rubella and measles vaccines demonstrated adequate serologic response in ≥ 80% of children exposed either to VDZ or UST. Regarding mumps lower serologic response was found in children exposed to UST (62.5%), with all infants exposed to VDZ responding adequately.

Table 1. Adequate serologic response to vaccination

	UST	VDZ
Diphtheria	11/11 (100%)	8/10 (80%)
Tetanus	10/11 (91%)	9/10 (90%)
Mumps	5/8 (62.5%)	8/8 (100%)
Rubella	8/8 (100%)	8/8 (100%)
Measles	8/8 (100%)	7/8 (87.5%)

Conclusion

Despite the limited sample size, most of the infants exposed to VDZ or UST in utero were successfully immunised to non-live (tetanus, diphtheria) and live vaccines. Somewhat lower rate of adequate serologic response to mumps in UST group is in line with previous report of anti-TNFa exposed infants and their controls (1). There is a need for a control group of unexposed children to make comparison.

References

Duricova D. et al. Safety of Anti-TNF-Alpha Therapy During Pregnancy on Long-term Outcome of Exposed Children: A Controlled, Multicenter Observation. Inflamm Bowel Dis 2019; 14;25(4):789-796.

Disclosure

The study was supported by IBD-Comfort foundation.

Conference

UEG Week Copenhagen 2023

Topics

IBD

Submission format

Abstract

Session

Crohn's disease or ulcerative colitis: To diagnose or not to diagnose? (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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Mitchell Jones

IL-22–INDUCED PANETH CELL METAPLASIA PROMOTES EPITHELIAL PROLIFERATION AND IS ASSOCIATED WITH NEOPLASTIC RISK IN ULCERATIVE COLITIS

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Nadezda Apostolova

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Kirsty Brady

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Subrata Ghosh

UEG Presentation

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GUT-TARGETED PDE4 INHIBITION WITH ONCE-DAILY PALI-2108 DEMONSTRATES EARLY CLINICAL AND BIOMARKER IMPROVEMENTS IN FIBROSTENOTIC CROHN’S DISEASE: RESULTS FROM A PHASE 1B STUDY

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GUT-TARGETED PDE4 INHIBITION WITH ONCE-DAILY PALI-2108 DEMONSTRATES EARLY CLINICAL AND BIOMARKER IMPROVEMENTS IN FIBROSTENOTIC CROHN’S DISEASE: RESULTS FROM A PHASE 1B STUDY

James Izanec 1, Joerg Heyer 1, Patrick Colin 1, Florian Rieder 2, Mitchell Jones 1

Affiliations

1 Palisade Bio, Denver, United States

2 Cleveland Clinic Foundation, Cleveland, United States

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Abstract

Introduction

Fibrostenotic Crohn’s disease (FSCD) arises from chronic inflammation, leading to fibrosis and luminal narrowing. Approximately 50% of patients with Crohn’s disease develop strictures, and up to 70% require surgical intervention. There are currently no approved medical therapies for FSCD. PALI-2108 is an oral phosphodiesterase-4 (PDE4) inhibitor prodrug designed for targeted release in the ileum and colon, with reduced systemic exposure and demonstrated activity in ulcerative colitis. Finally, to our knowledge, this is the first published report of the treatment of Crohn’s patients treated with a PDE4 inhibitor.

Aims & Methods

To evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of PALI-2108 in patients with FSCD. This was a single-center, open-label, adaptive, multiple-dose Phase 1b study in patients with FSCD (n=5) with ileal strictures confirmed by ileocolonoscopy and associated symptoms. Patients received once-daily (QD) titrated PALI-2108 (20 mg [n=2], 25 mg [n=2], 30 mg [n=1]) for 14 days (10-day titration followed by 4 days at target dose), administered with food. Endpoints included: (i) safety and tolerability (adverse events [AEs]); (ii) plasma and tissue PK (ileum, ascending and descending colon); (iii) PD in plasma and ileal biopsies (RNA sequencing); (iv) ileal histology; (v) endoscopic outcomes (SES-CD, remission, response); and (vi) tissue cyclic AMP (cAMP) and fecal calprotectin (FCP).

Results

Five patients were enrolled (mean disease duration of 15.4 years). At baseline, mean SES-CD was 8.0 and mean FCP was 267.9 µg/g. Four patients (80%) were receiving concomitant biologic therapy, and two (40%) had prior intestinal resection. By Day 14, mean SES-CD decreased to 4.2 (−47.5%; nominal P<0.05). Two patients (40%) achieved endoscopic remission (SES-CD ≤2), and two (40%) achieved endoscopic response (≥50% reduction from baseline). Consistent with PDE4 inhibition, ileal tissue cAMP increased in 4/5 patients (mean ~33% increase), and FCP decreased by ~59% during treatment, with rebound observed following treatment discontinuation. Steady-state plasma and ileal concentrations of the active metabolite (PALI-0008) exceeded the IC90. PALI-2108 was well tolerated. No serious AEs, discontinuations, or moderate/severe AEs were reported. All AEs were mild and resolved by study end. Importantly, no cases of PDE4-related AEs were observed including nausea, vomiting, or diarrhea were observed; one patient reported mild abdominal discomfort.

Clinical Profile FSCD (n=5)		Baseline	End of Study (EOS)	Mean difference from baseline (%)
Disease Duration, yrs (mean, SD)	15.4 (11.1)	-	-	-
Prior Intestinal Resection (n, %)	2 (40%)	-	-	-
Prior Biological Use (n, %)	4 (80%)	-	-	-
SES-CD (mean, SD)	-	8 (1.2)	4.2	-47.5*
FCP (mean, SD)	-	267.8 ug/g	110.20 ug/g	-58.8

*P<0.05 versus baseline; EOS, end of study; FSCD, fibrostenotic Crohn’s disease; FCP, fecal calprotectin; SD, standard deviation; SES, simple endoscopic score

Conclusion

In this small, open-label Phase 1b study, once-daily PALI-2108 demonstrated a favorable safety profile, target engagement, and early signals of biological and endoscopic activity in patients with FSCD. These findings support further evaluation in larger, controlled studies.

Disclosure

The authors have nothing to disclose

Event

UEG Week Barcelona 2026

Topics

Mechanisms & Personalised Medicine Immunology IBD

Submission format

Abstract

Session

Abstract session: Hot topics in IBD

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

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Mitchell Jones

IL-22–INDUCED PANETH CELL METAPLASIA PROMOTES EPITHELIAL PROLIFERATION AND IS ASSOCIATED WITH NEOPLASTIC RISK IN ULCERATIVE COLITIS

Ryuichi Okamoto

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Nadezda Apostolova

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Kirsty Brady

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Subrata Ghosh

UEG Presentation

New

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IL-22–INDUCED PANETH CELL METAPLASIA PROMOTES EPITHELIAL PROLIFERATION AND IS ASSOCIATED WITH NEOPLASTIC RISK IN ULCERATIVE COLITIS

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IL-22–INDUCED PANETH CELL METAPLASIA PROMOTES EPITHELIAL PROLIFERATION AND IS ASSOCIATED WITH NEOPLASTIC RISK IN ULCERATIVE COLITIS

Tomohiro Muto 1, Go Ito 1, Hiromune Katsuda 1, Kurara Yamamoto 1, Yui Hiraguri 1, Joana P. Bernardes 2, Finn Hinrichsen 2, Eri Oshina 1, Shuji Hibiya 1, Satoru Fujii 1, Yasuhiro Nemoto 1, Stefan Schreiber 2, Philip Rosenstiel 2, Ryuichi Okamoto 1

Affiliations

1 Institute of Science Tokyo, Tokyo, Japan

2 Christian-Albrechts-University and University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany

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Abstract

Introduction

Paneth cells (PCs) maintain intestinal homeostasis by secreting antimicrobial peptides, and their differentiation is regulated by interleukin-22 (IL-22). Paneth cell metaplasia (PCM), characterized by ectopic PCs in the left colon, is observed in ulcerative colitis (UC). Although the role of PCM in intestinal inflammation remains poorly understood, PCM may represent an important mucosal alteration in UC. IL-22 expression is elevated in the colonic mucosa of UC, but its role in PCM has not been elucidated. UC is increasingly managed to achieve mucosal healing, including both endoscopic and histological remission. Reliable histological markers are needed to detect residual inflammation and prevent long-term complications such as UC-associated neoplasia.

Aims & Methods

We aimed to characterize PCM in UC and clarify its induction mechanisms by IL-22, functional roles, and clinical relevance. Colonic biopsy specimens from patients with UC were analysed together with clinical data. Spatial transcriptomic analysis was performed to compare gene expression between small intestinal PCs and colonic metaplastic Paneth cells (MPCs), with validation by RNAscope and immunofluorescence. Functional studies were performed using human colonic organoids (hCOs) with long-term IL-22 stimulation and IL22RA1-deficient hCOs. Colony-forming assays and Western blotting were used to evaluate epithelial proliferation and signalling pathways. Diagnostic endoscopic submucosal dissection (ESD) specimens from patients with suspected UC-associated neoplasia were analysed to evaluate PCM frequency.

Results

Spatial transcriptomic analysis identified PCM clusters enriched for antimicrobial peptides including DEFA5, DEFA6, and REG3A, all of which are reported to be IL-22-inducible antimicrobial peptides. RNAscope demonstrated IL22RA1 expression in MPCs, and immunofluorescence showed that REG3A and DEFA5 were specifically localized to PCM regions. Long-term IL-22 stimulation in hCOs induced LYZ, a PC marker, and REG3A expression, whereas DEFA5 and DEFA6 showed only modest, non-significant increases, suggesting preferential REG3A induction in colonic PCM. Loss of IL22RA1 reduced IL-22-induced expression of LYZ and REG3A in hCOs, indicating dependence on IL-22 signalling. Given the prominent REG3A expression in PCM, we next investigated the functional effects of REG3A on intestinal epithelial cells. Recombinant REG3A significantly enhanced proliferation of hCOs and increased phosphorylation of epidermal growth factor receptor (EGFR), indicating activation of proliferative signalling pathways. To assess the clinical relevance of these findings, biopsy specimens from patients with UC were analysed. PCM-positive biopsies showed a significantly higher proportion of specimens with active histological inflammation and higher Mayo endoscopic subscores than PCM-negative biopsies. Among specimens with active histological inflammation, PCM was identified in 75% of cases classified as endoscopic remission. PCM was also significantly more frequent in UC-associated neoplasia than in non-neoplastic ESD specimens.

Conclusion

PCM is induced by IL-22 signalling and is characterized by REG3A expression that promotes epithelial proliferation through EGFR activation. Clinically, PCM is enriched in UC-associated neoplasia, suggesting a potential role in UC-related tumorigenesis. PCM is associated with ongoing histological inflammation, including inflammatory activity not detectable by endoscopy. PCM may serve as a practical histological biomarker for residual mucosal inflammation and neoplastic risk in UC.

Disclosure

The authors declare no conflicts of interest.

Event

UEG Week Barcelona 2026

Topics

Gut Microbiota Mechanisms & Personalised Medicine Immunology IBD

Submission format

Abstract

Session

New insights into IBD mechanisms

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

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Mitchell Jones

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Ryuichi Okamoto

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Valery Naranjo

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Nadezda Apostolova

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Kirsty Brady

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Subrata Ghosh

UEG Presentation

New

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AI-DRIVEN PROBE CONFOCAL LASER ENDOMICROSCOPY ENABLES AUTOMATED ASSESSMENT OF INTESTINAL BARRIER IMPAIRMENT IN IBD

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AI-DRIVEN PROBE CONFOCAL LASER ENDOMICROSCOPY ENABLES AUTOMATED ASSESSMENT OF INTESTINAL BARRIER IMPAIRMENT IN IBD

Marietta Iacucci 1,2, Irene Zammarchi 1, Ilan Carretero 3, Pablo Meseguer 3, Cecilia Lina Pugliano 1, Giovanni Santacroce 1, Rocio Del Amor 3,4, Ujwala Chaudhari 5, Bisi Bode Kolawole 5, Rory Crotty 6, Brian Hayes 6, Subrata Ghosh 1, Enrico Grisan 5, Valery Naranjo 3,4

Affiliations

1 University College Cork, Cork, Ireland

2 University of Calgary, Calgary, Canada

3 Universitat Politècnica de València, Valencia, Spain

4 Artikode Intelligence S.L., Valencia, Spain

5 London South Bank University, London, United Kingdom

6 Cork University Hospital, Cork, Ireland

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Abstract

Introduction

Barrier healing is emerging as a key therapeutic target in Inflammatory bowel disease (IBD), and is increasingly associated with improved long-term outcomes than endoscopic and histological remission alone. However, objective and reproducible assessment of barrier integrity remains challenging. Probe-based confocal laser endomicroscopy (pCLE) enables real-time structural and functional assessment of epithelial and vascular barrier features, including villi and crypt architecture, goblet cells, fluorescein leakage and vessel architecture. However, its interpretation remains complex and highly operator-dependent, limiting reproducibility and widespread application. ¹. We aimed to develop and validate an artificial intelligence (AI)-driven pCLE system for automated standardised assessment of epithelial and vascular barrier impairment (BI) in IBD.

Aims & Methods

A total of 297 high-quality pCLE videos from IBD patients undergoing colonoscopy in two tertiary centers (University College Cork, Ireland and University of Calgary, Canada) were considered. Experienced endoscopists assessed the presence of overall barrier and feature-specific impairment according to a previously developed pCLE-scoring system ², providing a reference standard for AI. 196 videos from the Calgary cohort were used to train and validate the framework (using cross-validation) and 101 videos from the Cork cohort were considered for external validation.
An AI algorithm was developed to predict pCLE-based overall- and feature-level BI using a weakly supervised learning paradigm that exclusively employs video-level scoring. First, frame-level representations were extracted with a DINOv2 foundation model³. Later, a multiple instance learning (MIL) model aggregates frame-features into a global representation to produce the predicted score of the video⁴. The model’s diagnostic performance to predict overall, epithelial, vascular and feature-level impairment was evaluated.

Results

Overall, 297 videos from 141 IBD patients were considered. BI was detected in 187/297 (63.0%) videos, including 68/101 (67.3%) in Cork and 119/196 (60.7%) in the Calgary cohort.
Table 1 details the diagnostic performance of the model. The AI algorithm achieved remarkable performance in both the development and validation cohorts, with 71.4% (95% 63.3-79.5) and 89.7% (95% CI 82.3-97.1) sensitivity, 71.4% (95% CI 61.3-81.5) and 39.4% (95% CI 22.7-56.1) specificity, 71.4% (95% CI 65.1-77.8) and 73.3% (95% CI 64.6-81.9) accuracy, and 0.77 and 0.72 AUC for detecting overall BI at the video level. Performance remained consistent for most epithelial and vascular components, although slightly lower for villi/crypts architecture and goblet cells, likely reflecting the more challenging assessment of these features with pCLE.

	Overall BI	Epithelial BI	Vascular BI	Villi/ crypts architecture	Goblet cells	Vessel architecture	Fluorescein leakage
Development cohort (N=196)
AUC % (95% CI)	0.77	0.74	0.77	0.80	0.78	0.78	0.77
F1 score % (95% CI)	75.2 (68.8-81.6)	74.2 (67.5-80.9)	75.3 (68.7-81.9)	68.6 (59.0-78.0)	76.5 (70.0-83.0)	63.5 (54.1-72.7)	76.5 (70.2-82.8)
Accuracy % (95% CI)	71.4 (65.1-77.8)	70.9 (64.4-77.3)	70.9 (64.4-77.3)	78.1 (72.3-83.9)	74.0 (67.9-80.1)	68.9 (62.4-75.4)	72.5 (66.2-78.6)
Validation cohort (N=101)
AUC % (95% CI)	0.72	0.71	0.75	0.58	0.73	0.79	0.74
F1 score % (95% CI)	81.9 (72.4-89.6)	69.6 (60.0-79.2)	79.2 (70.9-87.3)	47.9 (35.2-60.6)	53.1 (42.1-64.1)	75.9 (66.2-85.6)	77.7 (69.8-85.6)
Accuracy % (95% CI)	73.3 (64.6-81.9)	59.4 (49.8-68.9)	70.3 (61.4-79.2)	50.5 (40.8-60.2)	47.5 (42.1-64.1)	72.3 (63.6-81.0)	69.3 (60.4-78.2)

Table. Diagnostic performance of the AI algorithm to predict barrier impairment on pCLE videos.

Conclusion

Our AI-driven pCLE enables automated, standardised in vivo assessment of epithelial and vascular barrier features, offering an objective, reproducible tool to monitor barrier healing as a novel therapeutic endpoint in IBD.

References

1. Iacucci M, Jeffery L, Acharjee A, et al. Computer-Aided Imaging Analysis of Probe-Based Confocal Laser Endomicroscopy With Molecular Labeling and Gene Expression Identifies Markers of Response to Biological Therapy in IBD Patients: The Endo-Omics Study. Inflamm Bowel Dis. 2023;29(9):1409-1420. doi:10.1093/ibd/izac233
2. Iacucci M, Majumder S, Zammarchi I, et al. Automated real-time imaging of intestinal barrier integrity and molecular profiling for early outcome prediction in inflammatory bowel disease - Endo-Histo-Barrier-Omics study. J Crohns Colitis.
3. Oquab M, Darcet T, Moutakanni T, et al. DINOv2: Learning Robust Visual Features without Supervision. Published online February 2, 2024.
4. Carretero I, Meseguer P, et al. Time-aware semantic prototypes for weakly-supervised endomicroscopy video classification. Published online April, 2026.

Event

UEG Week Barcelona 2026

Topics

Colorectal IBD

Submission format

Abstract

Session

IBD diagnostics: In search of optimal implementation

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

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GUT-TARGETED PDE4 INHIBITION WITH ONCE-DAILY PALI-2108 DEMONSTRATES EARLY CLINICAL AND BIOMARKER IMPROVEMENTS IN FIBROSTENOTIC CROHN’S DISEASE: RESULTS FROM A PHASE 1B STUDY

Mitchell Jones

IL-22–INDUCED PANETH CELL METAPLASIA PROMOTES EPITHELIAL PROLIFERATION AND IS ASSOCIATED WITH NEOPLASTIC RISK IN ULCERATIVE COLITIS

Ryuichi Okamoto

AI-DRIVEN PROBE CONFOCAL LASER ENDOMICROSCOPY ENABLES AUTOMATED ASSESSMENT OF INTESTINAL BARRIER IMPAIRMENT IN IBD

Valery Naranjo

A NOVEL ROLE OF CYCLOPHILIN C (PEPTIDYLPROLYL ISOMERASE C) IN INFLAMMATORY BOWEL DISEASE: INTESTINAL FIBROSIS AND BEYOND

Nadezda Apostolova

EMPOWERING COLORECTAL CANCER PATIENT JOURNEY: ENHANCING PATIENT INFORMATION THROUGH PATIENT ENGAGEMENT

Kirsty Brady

TOWARD PRECISION THERAPY IN ULCERATIVE COLITIS: GENOTYPE-BASED SINGLE-NUCLEOTIDE POLYMORPHISM (SNPS) SIGNATURES PREDICT DEEP RESPONSE TO USTEKINUMAB - A POST-HOC ANALYSIS OF THE UNIFI TRIAL

Subrata Ghosh

UEG Poster

New

Standard Poster

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A NOVEL ROLE OF CYCLOPHILIN C (PEPTIDYLPROLYL ISOMERASE C) IN INFLAMMATORY BOWEL DISEASE: INTESTINAL FIBROSIS AND BEYOND

Cristina Benavides Tutillo 1,2, Andrea Cejudo-Garcés 1, Ana Blas-García 2,1,3, María Dolores Barrachina 1,2,3, Marta Maia Bosca-Watt 4,5, Jesus Cosin-Roger 1,2,3, Nadezda Apostolova 1,2,3

Affiliations

1 Universitat de València, Valencia, Spain

2 FISABIO (Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana), Valencia, Spain

3 CIBERehd (Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestiva

4 CIBERehd (Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas), Valencia, Spain

5 Servicio Enfermedades Digestivas, Hospital Clínico Universitario de Valencia, Valencia, Spain

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Abstract

Introduction

Cyclophilins are ubiquitous proteins with different biological functions that participate in pathological processes such as inflammation and tumorigenesis. Several members of this family have been implicated in Inflammatory Bowel Disease (IBD), which includes Crohn´s disease (CD) and Ulcerative Colitis (UC), but specific information regarding cyclophilin C (Peptidylprolyl isomerase C, PPIC) remains limited. Located in the endoplasmic reticulum, it plays a key role in redox homeostasis and has also been suggested to affect collagen maturation in the skin and in the liver.

Aims & Methods

The general aim of this study was to determine the implication of PPIC in IBD. PPIC expression was evaluated in vivo, in vitro and in human plasma samples. Acute and chronic colitis were induced in female wild-type C57BL/6 mice (9–12 weeks old, 20–25 g) with 2% DSS in drinking water for 7 days followed by 3 days with water or 2 cycles of seven days with 2% DSS followed
by 10 days with normal water, respectively. Human Small Intestine Fibroblasts (HSIFs) were stimulated with TGF-β1 (10 ng/mL) for 24h. PPIC gene and protein expression were determined by qRT-PCR and Western blot, respectively. Plasma PPIC concentrations were determined by ELISA in a cohort of CD patients (n=34), UC patients (n=36) and non-IBD patients (n=10), from the Hospital Clínico Universitario de Valencia (Spain).

Results

PPIC mRNA and protein levels were significantly increased in both acute and chronic colitis models. Conversely, TGF-β1- treated HSIFs showed a significant upregulation of profibrotic genes, including COL1A1 , with no changes in PPIC mRNA levels. Additionally, both CD and UC patients exhibited a significant increase of plasmatic PPIC levels compared to non-IBD patients, with no
significant differences between disease types. Of note, PPIC levels positively correlated with disease severity in complicated CD patients (B2-B3), showing higher values than in B1-CD patients. No correlation was observed between PPIC levels and anthropometric parameters such as age or sex. Finally, given the reported association between PPIC and liver fibrosis (LF), we analyzed FIB-4 (a score based on blood tests used to estimate the presence of LF) to ensure that the changes in PPIC in this cohort were not due to the presence of LF. FIB-4 score in both patients and controls had normal values with no significant differences between groups.

Conclusion

PPIC expression increased in acute and chronic models of colitis and in plasma of IBD patients compared to healthy individuals, where the increase correlated with the severity of the disease. These findings underscore the role of PPIC in IBD pathogenesis and highlight its potential as a plasma biomarker. Furthermore, they are consistent with previous evidence implicating PPIC in fibrotic processes across tissues.

Conference

UEG Week Barcelona 2026

Topics

IBD

Submission format

Abstract

Session

Fibrosis in IBD (Posters)

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

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Subrata Ghosh

UEG Presentation

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EMPOWERING COLORECTAL CANCER PATIENT JOURNEY: ENHANCING PATIENT INFORMATION THROUGH PATIENT ENGAGEMENT

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EMPOWERING COLORECTAL CANCER PATIENT JOURNEY: ENHANCING PATIENT INFORMATION THROUGH PATIENT ENGAGEMENT

Hazel Cagayon 1, Kirsty Brady 1

Affiliations

1 Northumbria NHS Trust, Northumberland, United Kingdom

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Abstract

Introduction

Quality patient information is the cornerstone of personalised cancer care, empowering treatment decisions and improving patient outcomes. As a team of colorectal nurse specialists in a large hospital trust in the Northeast of England we undertook a quality improvement project to enhance information provision for patients diagnosed with bowel cancer. This initiative was prompted by recognition of both the critical importance of accurate information for cancer patients and the need to adapt service delivery during the COVID-19 pandemic

Results & Findings

The quality improvement project began with a comprehensive survey designed to evaluate patients' perceptions of current information provision and gather suggestions for enhancement. Twenty patients, deliberately selected to represent diverse demographic profiles, participated in the survey. A striking finding was that 80% of respondents sought additional information about their condition from internet sources, particularly from trusted websites like NHS Choices, Macmillan, and Cancer Research UK. The same percentage expressed interest in more visual content such as photos of staff, and most indicated a preference for accessing digital information alongside traditional printed materials.
Following the survey, two focus group workshops were conducted in collaboration with the NHS organisation dedicated to personalised care approaches. The focus groups examined patient experiences across the entire care pathway, from initial referral through treatment and follow-up, guided by principles of realistic medicine and shared decision-making.
We presented several innovative proposals for information delivery: an interactive diagram of the colorectal cancer journey accessible via the Trust's website; patient contact cards containing team details, phone numbers, website links, and QR codes; a webpage featuring QR codes linking to specific information resources; a video depicting the patient journey from referral through investigations; and plans to refresh the existing service webpage. These proposals aligned with the survey finding that most patients used online resources for information.

Summary & Discussion

This quality improvement initiative has provided us with valuable insights and confidence to advance information provision strategy in ways that genuinely reflect patient needs and experiences. The findings support a multimedia approach combining digital and traditional resources, with particular emphasis on accessible online information that patients can engage with at their own pace. As a team we created a patient information pathway that mirrors the actual patient journey and authentically reflects diverse patient experiences.

Conclusion

The project demonstrates the value of collaborative approaches to service improvement that meaningfully involve patients as partners. By putting patients at the heart of t project, the colorectal nursing team was positioned to develop information resources that truly meet patient needs during a challenging time in their lives. This patient-centred approach to information provision exemplifies the team's commitment to not only meet but exceed patient expectations in their privileged role as cancer care providers.

Disclosure

NONE

Event

UEG Week Berlin 2025

Topics

Nurses

Submission format

Abstract

Session

Abstracts II: Patient care and endoscopic techniques

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Subrata Ghosh

UEG Presentation

New

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TOWARD PRECISION THERAPY IN ULCERATIVE COLITIS: GENOTYPE-BASED SINGLE-NUCLEOTIDE POLYMORPHISM (SNPS) SIGNATURES PREDICT DEEP RESPONSE TO USTEKINUMAB - A POST-HOC ANALYSIS OF THE UNIFI TRIAL

This content is part of Gutflix. Log in with your myUEG account, or create one free, to watch it.

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TOWARD PRECISION THERAPY IN ULCERATIVE COLITIS: GENOTYPE-BASED SINGLE-NUCLEOTIDE POLYMORPHISM (SNPS) SIGNATURES PREDICT DEEP RESPONSE TO USTEKINUMAB - A POST-HOC ANALYSIS OF THE UNIFI TRIAL

Marietta Iacucci 1, Santanu Das 1, Irene Zammarchi 1, Cecilia Lina Pugliano 1, Subrata Ghosh 1

Affiliations

1 University College Cork, Cork, Ireland

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Abstract

Introduction

Despite advances in treat-to-target strategies, a substantial proportion of ulcerative colitis (UC) patients fail to achieve endoscopic and histological remission [1]. This gap reflects the complex biological heterogeneity underlying UC pathogenesis and the limitations of current one-size-fits-all treatment algorithms. The absence of validated biomarkers predicting response to biologic therapy remains a major barrier to precision treatment selection. Pharmacogenetic studies captured by SNPs may help explain inter-individual heterogeneity in therapeutic response [2,3]. We aimed to identify SNPs signatures predictive of response to Ustekinumab in patients with moderate-to-severe UC enrolled in the Phase 3 UNIFI clinical trial [4].

Aims & Methods

Genome-wide data from 654 participants with moderate-to-severe UC were processed and analysed using PLINK v1.9 [5]. The binary genotype files generated were subjected to standard quality control (QC) parameters, including sample call rate filtering followed by variant call, minor allele frequency (MAF), and Hardy-Weinberg equilibrium (HWE) filtering. Genome-wide association analyses (GWAS) evaluated SNPs associated with Clinical remission (Mayo ≤2), endoscopic improvement and remission (Mayo endoscopic score [MES] 1 and 0, respectively), histological improvement and remission (Geboes score <3.1 and <2B.0, respectively), and mucosal healing (endoscopic and histological remission) at maintenance week 44. A multimodal logistic regression model, adjusted for relevant covariates, was applied. The threshold for identifying Single Nucleotide Polymorphism (SNP) was considered at 1 X 10^-5(suggestive threshold) for further downstream interpretations.

Results

QC filtered data generated a total of 1,528,830 variants retained for downstream analyses with an overall genotype rate of 0.9993. Table 1 summarise the identified SNPs with corresponding therapeutic outcomes. GWAS analysis with treatment response phenotypes demonstrated associations with 41 SNPs (9 protective, 32 risk‑increasing) for clinical remission, 25 SNPs for endoscopic improvement (23 protective, 2 risk‑increasing), and 5 protective SNPs for histological improvement. Additionally, SNPs signatures were associated with endoscopic remission (10 SNPs; 8 protective, 2 risk‑increasing), histological remission (4 risk‑increasing SNPs), and mucosal healing (14 SNPs; 8 protective, 6 risk‑increasing). Notably, several loci mapped to immune regulatory genes, including RGS1 and IL7R [6], suggesting a mechanistic link between host immunogenetic variation and response to IL-12/23 pathway inhibition.

Table 1: Summary of therapeutic outcomes with corresponding identified SNPs

Therapeutic outcomes	N of patients	N of associated SNPs	Genes involved in SNPs	Biological Significance
Clinical remission (Mayo ≤2)	344 (52.92%)	41 (9 protective, 32 risk-increasing)	RGS1, HLA‑DQA1 region, MAPT locus, IL7R, FHIT	Immune system regulation (T cell activation, lymphocyte trafficking), DNA damage response and epithelial integrity, microtubule stability
Endoscopic improvement (MES 1)	216 (33.23%)	25 (23 protective and 2 risk increasing)	RGS1 and genes of unknown functions	Immune system regulation (lymphocyte trafficking)
Histological improvement (Geboes < 3.1)	237 (36.46%)	5 (all protective)	RGS1	Immune system regulation (lymphocyte trafficking)
Endoscopic remission (MES 0)	123 (18.92 %)	10 (8 protective 2 risk-increasing)	MAPT locus, RGS1, C12orf65, SLC4A10	Immune system regulation (T cell activation, lymphocyte trafficking, microtubule stability, regulatory function)
Histological remission (Geboes < 2B.0)	194 (29.84%)	4 (all risk increasing)	RGS1, FHIT, Il7R	Immune system regulation (T cell activation, lymphocyte trafficking), microtubule stability, DNA damage response and epithelial integrity
Mucosal healing (endoscopic and histological remission)	102 (15.69 %)	14 (8 protective 6 risk-increasing)	MAPT locus, RGS1, C12orf65, SLC4A10, FHIT, Il7R	Immune system regulation (T cell activation, lymphocyte trafficking), microtubule stability, DNA damage response and epithelial integrity, regulatory function

Conclusion

Genome-wide SNPs signatures identify patients more likely to achieve a deep response to Ustekinumab, supporting the feasibility of genetically guided biologic selection in UC. These findings represent a step towards precision therapy in IBD. Further integration with multi-Omics data is ongoing to refine this predictive framework.

References

[1] Turner D, Ricciuto A, Lewis A, et al. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021;160(5):1570-1583. doi:10.1053/j.gastro.2020.12.031
[2] Plaza J, Mínguez A, Bastida G, et al. Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review. Int J Mol Sci. 2024;25(7):3717. 2024. doi:10.3390/ijms25073717
[3] van der Werf J, Fleming NI. Are single nucleotide polymorphisms underutilized for guiding treatment of inflammatory bowel disease?. Immunol Cell Biol. 2025;103(6):551-562. doi:10.1111/imcb.70029
[4] Sands BE, Sandborn WJ, Panaccione R, et al. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2019;381(13):1201-1214. doi:10.1056/NEJMoa1900750
[5] Chang C. C., Chow C. C., Tellier L. C., et al. Second-generation PLINK: rising to the challenge of larger and richer datasets. Gigascience. 2015; 4(1), s13742-015.
[6] Fercoq F. & Carlin L. M. “Mind the GAP”: RGS1 hinders antitumor lymphocytes. Nature Immunology. 2021; 22(7), 802-804.

Event

UEG Week Barcelona 2026

Topics

Gut Microbiota Mechanisms & Personalised Medicine IBD

Submission format

Abstract

Session

One patient, multiple futures: Predicting outcomes in IBD

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

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