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Introduction

Biologic therapies are associated with an increased risk for adverse events such as infections and malignancies. This is of particular importance in elderly patients with inflammatory bowel disease (IBD).

Aims & Methods

The aim of this study was to compare the efficacy and safety of different biologic therapies between IBD patients aged over 60 years and younger patients.All adult patients with IBD treated with biologic agents from 2010 to 2022 in the sole tertiary referral center for inflammatory bowel disease in central Greece were screened for eligibility and their electronic medical records were retrospectively reviewed. Data collected included the socio-demographic and clinical characteristics of the study population, endoscopy reports as well as information regarding treatment compliance and drug sustainability. Adverse events (AEs) and serious AEs were also recorded. Patients with incomplete information were excluded from the analysis.

Results

267 IBD patients were screened for eligibility and 187 were included. The majority (65%) of the patients had Crohn's disease. Of all patients, 47.8% received infliximab, 18% adalimumab, 18% vedolizumab, and 16% ustekinumab. The median duration of biologic treatments was 10 years. Parallel steroid therapy was required in 70% at baseline, 35% at 3 months, 18 % at 6 months, and 5% at 12 months from treatment onset. The efficacy of biologic therapies did not differ significantly between patients aged > 60 years and younger patients. Kaplan-Meyer analysis did not show statistical differences or trends in drug sustainability (P > 0.05), time to an adverse event (P >0.05), and infection rates (P >0.05) among the different classes of biologic agents compared. The most common AEs leading to drug discontinuation were loss of response and local injection site reactions. After adjusting for differences in baseline characteristics between the two age groups, no significant differences in drug sustainability and the need for treatment optimization were found between elderly and younger patients (p >0.05).

Conclusion

Available biologic therapies were characterized by comparable efficacy, sustainability, and safety among elder and younger patients, hardening the preferential selection among the available biologic agents for the elderly. More real-world evidence is required to make treatment recommendations.

References

1. de Silva S, Devlin S, Panaccione R. Optimizing the safety of biologic therapy for IBD. Nat Rev Gastroenterol Hepatol. 2010 Feb;7(2):93-101. doi: 10.1038/nrgastro.2009.221. PMID: 20134491.
2. Lasa JS, Olivera PA, Danese S, Peyrin-Biroulet L. Efficacy and safety of biologics and small molecule drugs for patients with moderate-to-severe ulcerative colitis: a systematic review and network meta-analysis. Lancet Gastroenterol Hepatol. 2022 Feb;7(2):161-170. doi: 10.1016/S2468-1253(21)00377-0. Epub 2021 Nov 29. PMID: 34856198.

COMPARATIVE EFFICACY AND SAFETY OF BIOLOGIC THERAPIES IN ELDERLY AND YOUNGER PATIENTS WITH INFLAMMATORY BOWEL DISEASE

Konstantinos Argyriou 1, Anastasios Manolakis 1, Stylianos Kyriakidis 1, Christina Kateri 1, Tryfon Bektsis 1, Eirini Tsakiridou 2, AIKATERINI PAPPA 1, Andreas N. Kapsoritakis 1

1 University of Thessaly Medical School and University Hospital of Larissa, Larissa, Greece

2 Medical School, University of Thessaly, Larissa, Greece

Conference

UEG Week Copenhagen 2023

Topics

IBD

Submission format

Abstract

Session

PP 05 IBD (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

UEG Presentation

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THE MEDITERRANEAN DIET FOR IRRITABLE BOWEL SYNDROME

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Introduction

Patients with irritable bowel syndrome (IBS) frequently seek dietary advice. However, few evidence-based options exist. Societal guidelines recommend traditional dietary advice (TDA) as first-line therapy, with the cumbersome and resource-intensive low FODMAP diet reserved as second-line therapy.
Recent pilot data suggests that the Mediterranean diet (MD), renowned for its general health benefits, improves the symptoms of IBS. Whether it can be considered another first-line dietary option is not known.

Aims & Methods

This randomized non-inferiority clinical trial assigned 139 individuals with IBS, from across the United Kingdom, to follow the MD (n=68) or TDA (n=71) for six weeks. The primary endpoint was the proportion of participants achieving clinical response, defined as a ≥50-point reduction in the IBS Symptom Severity Scale (IBS-SSS). Secondary outcomes included changes in IBS-SSS, psychological health, somatic symptom reporting, quality of life, diet satisfaction, and the Mediterranean Diet Adherence Screener (MEDAS).

Results

Baseline characteristics (mean age 40.4 [range 19-65] years, 80% female) and IBS-SSS (mean 309, SD 90) were similar between groups. On modified intention-to-treat analysis, the primary endpoint was met by 62% (95% CI 50%-73%) taking a MD versus 42% (95% CI 31%-55%) taking TDA. The difference in clinical response between the groups was in favor of the MD (20%, 95% CI 4%-36%), demonstrating it to be non-inferior based on the a priori defined requirement for the CI to exclude -5%. Rather, the MD was superior to TDA (odds ratio 2.3 [95% CI: 1.16-4.64], p = 0.017). There was a greater reduction in the mean IBS-SSS following a MD than TDA (-101.2 vs. -64.5, ∆-36.7 [95% C.I. -70.5 to -2.8], p=0.034). No significant differences were observed between the groups with regards to changes in mood, somatic symptoms, quality of life or diet satisfaction. The MEDAS significantly increased following a MD compared with TDA (p< 0.001).

Conclusion

The MD is non-inferior (rather, it demonstrated superiority) to TDA in managing the symptoms of IBS, and can be considered as another first-line dietary option.
Clinical trials registration: NCT05985018

Disclosure

Nil

THE MEDITERRANEAN DIET FOR IRRITABLE BOWEL SYNDROME

Joy Bamidele 1, Grace Brownlow 1, Rosie Flack 1, Rachel Buckle 2, Christian Shaw 2, Mo Shiha 1, Imran Aziz 1

1 University of Sheffield, Sheffield, United Kingdom

2 Sheffield Teaching Hospitals, Sheffield, United Kingdom

Event

UEG Week Berlin 2025

Topics

Gut Microbiota Neurogastroenterology & Motility Small Intestine & Nutrition Colorectal

Submission format

Abstract

Session

Lower GI motility II

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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EFFICACY AND SAFETY OF MIRIKIZUMAB THERAPY IN PEDIATRIC PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS: RESULTS FROM THE PHASE 2 SHINE-1 STUDY

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Introduction

Mirikizumab is a humanized immunoglobulin G4 monoclonal antibody against the p19 subunit of interleukin-23, a key inflammatory mediator in ulcerative colitis (UC). Here we report efficacy and safety in pediatric patients with moderate to severe UC from the Phase 2 SHINE-1 study (NCT04004611) following 52 weeks of mirikizumab treatment.

Aims & Methods

Patients aged 2 to <18 years with active UC who had an inadequate response, loss of response, or intolerance to corticosteroids, immunosuppressants, or biologic therapies, or had corticosteroid-dependent colitis, were included in the study. Patients weighing >40 kg received an induction dose of 300 mg via intravenous infusion; patients weighing ≤40 kg received 5 or 10 mg/kg via intravenous infusion at weeks 0, 4, and 8. At week 12, patients were assessed for clinical response using the Modified Mayo Score. Responders entered the maintenance period and received subcutaneous doses of mirikizumab at 200 mg (>40 kg), 100 mg (>20 kg to ≤40 kg), or 50 mg (≤20 kg) once every 4 weeks, with the last patient visit at week 52.

Results

All patients (N=26) completed induction through week 12, and 73.1% (N=19) completed through week 52. At week 12, 69.2% (18/26) were Modified Mayo Score responders; at week 52, 55.6% (10/18) of responders were in clinical and endoscopic remission. Clinical response, remission, and endoscopic remission rates were consistent with LUCENT Phase 3 UC adult studies.
The safety profile of mirikizumab was consistent with the safety profile in LUCENT adults. Three serious adverse events (11.5%) were reported: non-infective appendicitis, UC flare, and pseudarthrosis. The UC flare resulted in study discontinuation.

Conclusion

Mirikizumab demonstrated an acceptable safety profile, and similar clinical response, clinical remission, and endoscopic remission compared to LUCENT adults. These results are the foundation of the pivotal Phase 3 pediatric SHINE-2 study.

Disclosure

J. L. Kaplan has nothing to disclose; D. Turner received consulting fees from: AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Ferring Pharmaceuticals, Janssen, Pfizer, Prometheus Biosciences, Takeda, Galapagos, and Sorriso Pharmaceuticals; and research funding from: AbbVie, Ferring Pharmaceuticals, Janssen, Pfizer, and Takeda; A. Bousvaros has received research support from: AbbVie, Arena Pharmaceuticals, Bristol Myers Squibb, BUHLMANN Diagnostics, Eli Lilly and Company, Janssen, Procise Diagnostics, and Takeda; was a consultant for: Best Doctors, Eli Lilly and Company, Fresenius Kabi, and Takeda; and has received honoraria and royalties from: Boston University and UptoDate; M. Dubinsky has received honoraria as a consultant for: AbbVie, Arena Pharmaceuticals, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly and Company, F. Hoffmann-La Roche, Genentech, Gilead Sciences, Janssen, Pfizer, Prometheus Therapeutics and Diagnostics, Takeda, and UCB Pharma; has been contracted for research by: AbbVie, Janssen, Pfizer, and Prometheus Biosciences; has stock interest in: Trellus Health; and has received licensing fees from: Takeda; W. J. Komocsar, A. Larkin, J. Johns, X. Zhang, W. Crandall, V. Arora, and K. Todd are employees and shareholders of: Eli Lilly and Company; J. S. Hyams is on an advisory board for: AbbVie, Eli Lilly and Company, Janssen, and Pfizer; and has been a consultant to: Boehringer Ingelheim, Bristol Myers Squibb, and Takeda.

EFFICACY AND SAFETY OF MIRIKIZUMAB THERAPY IN PEDIATRIC PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS: RESULTS FROM THE PHASE 2 SHINE-1 STUDY

Jess L. Kaplan 1, Athos Bousvaros 2, Dan Turner 3, Marla C. Dubinsky 4, Wendy Komocsar 5, Amy Larkin 5, Jordan Johns 5, Xin Zhang 5, Wallace Crandall 5, Vipin Arora 5, Kris Todd 5, Jeffrey Hyams 6

1 Massachusetts General for Children, Boston, United States

2 Boston Children’s Hospital, Boston, United States

3 Shaare Zedek Medical Center, Jerusalem, Israel

4 Mount Sinai Hospital, Mount Sinai, New York City, United States

5 Eli Lilly and Company, Indianapolis, United States

6 Connecticut Children’s Medical Center, Hartford, United States

Event

UEG Week Vienna 2024

Topics

IBD Mechanisms & Personalised Medicine

Submission format

Abstract

Session

IBD: New horizons in medical treatment - Part 2

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Introduction

The IBD-Disk is a widely used, self-administered visual analogue tool for measuring disability in patients with inflammatory bowel disease (IBD). However, it does not capture key aspects of daily life, particularly diet and nutrition, which are critical for IBD patients and may significantly influence disability.

Aims & Methods

This cross-sectional study explored the prevalence of moderate to severe disability in young adults with IBD and evaluated the use of a modified IBD-Disk (mIBD-Disk) to screen for eating disorders and food avoidance. Patients previously diagnosed with IBD during childhood and adolescence (<18 years old), and currently followed at two adult IBD academic centers, were consecutively enrolled. All participants were assessed for disability and screened for eating disorders (ED) and avoidant restrictive food intake disorder (ARFID). Restrictive eating behaviours were evaluated using the Nine Item ARFID Screen (NIAS), which assesses three domains: picky eating, low appetite, and food-related fear with a score >23 suggesting probable ARFID. The Eating Attitudes Test (EAT-26) was used to screen for ED, with a score ≥20 indicating a positive result. Disability was measured using the IBD-Disk with a score >40 indicating moderate to severe disability) and the modified IBD-Disk (mIBD-Disk)¹, which consisted of the original 10 items plus an additional question on dietary habits, for a total of 11 items

Results

A total of 144 patients (50.7% with Crohn’s disease) were included, with a median age of 24 years (range: 21–28), and 54.2% were female. One-third (34.7%) had clinically active disease, and the median BMI was 21.8 (range: 20.1–24.2). Moderate to severe disability, as assessed by the IBD-Disk, was observed in 38.9% (56/144) of the cohort, and the median mIBD-Disk score was 33 (IQR: 16–61). ARFID risk was identified in 24 participants (16.7%), with food-related fear being the most frequent domain (13.2%). The median EAT-26 score was 5 (range: 3–12), with ED present in 17 patients (11.8%). In both univariate and multivariate analyses, moderate to severe disability (OR: 4.03; 95% CI: 1.23–13.17; p = 0.02) and a score greater than 4 on question 11 of the mIBD-Disk related to dietary habits (OR: 3.49; 95% CI: 1.06–11.47; p = 0.04) were independently associated with ARFID risk. ROC curve analysis showed that the mIBD-Disk Q11 had an 82% diagnostic accuracy (95% CI: 0.73-0.91) for predicting ARFID.

Conclusion

Patients diagnosed with IBD in childhood and adolescence have an increased prevalence of moderate to severe disability. Integrating the mIBD-Disk into clinical practice could provide an effective tool to identify patients at risk for eating behaviours and food avoidance, supporting timely referrals for nutritional and psychological interventions

References

Nardone OM, et al. Dig Liver Dis. 2025 Mar;57(3):753-761. doi: 10.1016/j.dld.2024.11.004. . PMID: 39617658.

REAL-WORLD USE OF THE MODIFIED IBD DISK TOOL FOR EVALUATION OF EATING DISORDERS IN YOUNG ADULTS WITH INFLAMMATORY BOWEL DISEASE

Olga Maria Nardone 1, Ferdinando D'Amico 2, Giulio Calabrese 1, Tommaso Lorenzo Parigi 2, Alessia La Mantia 1, Sarah Bencardino 2, Flavia Palumbo 1, Alessia Dalila Guarino 1, Antonio Rispo 1, Anna Testa 1, Silvio Danese 2, Fabiana Castiglione 1

1 University of Naples Federico II, Naples, Italy

2 IRCCS San Raffaele Hospital and Vita-Salute, Milan, Italy

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

IBD (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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How to boost wound healing in- and outside

Ailsa L Hart 1

1 St Mark’s Hospital and Academic Institute, Harrow, United Kingdom

Event

UEG Week Berlin 2025

Topics

IBD Primary Care Surgery

Session

Disease primer: From inflammation to restoration - wound healing in IBD

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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KRAS-M6A EPITRANSCRIPTOME AXIS PROMOTES CD4+ T-CELL-MEDIATED IMMUNOSUPPRESSION IN COLORECTAL CANCER

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Introduction

Most colorectal cancer (CRC) patients are nonresponsive to immune checkpoint blockade (ICB) therapy. KRAS is a key oncogenic factor in CRC, and it has been reported that mutant KRAS blunts ICB therapy efficacy. Thus, there is a need to unravel immunotherapeutic targets for KRAS-mutant CRC. In this study, we demonstrated that mutant KRAS-driven m⁶A epitranscriptome underlies immunosuppression in CRC through the regulation of CD4⁺ T cells in the tumor immune microenvironment.

Aims & Methods

M⁶A modification in KRAS-mutant CRC cells, transgenic Apc^Min/+Kras^G12D/+ mice, and human CRC patients were determined by dot blot and LC-MS. Mutant KRAS-driven m⁶A epitranscriptome was characterized by integrative m⁶A sequencing, RNA sequencing, RNA co-immunoprecipitation sequencing and ribosome-sequencing. The immune landscape in Apc^Min/+ and Apc^Min/+Kras^G12D/+ mice was profiling by mass cytometry-time of flight analysis and flow cytometry. Effect of KRAS-m6A axis on antitumor immunity was investigated by knockout of target genes and in vivo validation.

Results

Analysis of isogenic CRC cell lines harbouring wildtype and mutant KRAS showed that mutant KRAS dramatically global m⁶A RNA modification, and overall m⁶A level was also increased in transgenic Apc^Min/+Kras^G12D/+ mice. Consistent with this, mutant KRAS strongly elevated protein expression of METTL3, a m⁶A writer, as well as YTHDF1, a m⁶A reader, in CRC cells and mouse models, an effect mediated by suppressing their protein degradation via autophagic pathway. To decipher the consequence of KRAS-induced m⁶A, integrated m⁶A-seq, RNA-immunoprecipitation-seq and RNA-seq were performed, identifying BCL9L as a unique gene with concomitant upregulation of METTL3-driven m⁶A and mRNA expression in KRAS-mutant CRC, and is targeted by YTHDF1 for translation. The co-operative interplay between METTL3 and YTHDF1 led to increased expression of BCL9L in KRAS-mutant CRC cells and in Apc^Min/+Kras^G12D/+ mice. Functional investigation demonstrated that BCL9L did not exert a proliferative effect; instead, it was closely correlated with cytokine-cytokine receptor pathway. Indeed, BCL9L silencing downregulated secretion of immunosuppressive cytokines TGFβ1-3, LIF, and TIMP1, implying that m⁶A-BCL9L axis might be involved in immunosuppression in KRAS-mutant CRC. We hence performed multi-parameter immune cell phenotyping by mass cytometry in Apc^Min/+ and Apc^Min/+Kras^G12D/+ mice, mutant KRAS markedly depleted CD4⁺ T cells whilst promoting the accumulation of CD4⁺ T_reg cells. On the other hand, the knockout of BCL9L reversed the effect of mutant KRAS in vivo by reactivation of CD4⁺ T cells and their TNF-α and IFN-γ expression, together with the suppression of CD4⁺ T_reg cells, inferring the role of BCL9L in mutant KRAS-mediated immunosuppression. Finally, we demonstrated that BCL9L mRNA and protein expression as novel prognostic factors that predict poor survival in KRAS-mutant CRC, but not KRAS-wildtype CRC patients.

Conclusion

We identified a mutant KRAS-m⁶A axis in CRC leading to increased expression of BCL9L, which in turn drives an immunosuppressive tumor microenvironment by regulating CD4⁺ T cells and CD4⁺ T_reg cells. BCL9L is a potential therapeutic target and prognostic marker for KRAS-mutant CRC.