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COST AND CONVENIENCE: MAJOR DRIVERS OF PATIENT PREFERENCE ON ROUTE OF BIOLOGIC ADMINISTRATION

John Campion 1, Kate Finn 1, Aine Keogh 1, Linda Duane 1, Sabrina Purcell 1, Eoin Slattery 1, Mary Hussey 1

Affiliations

1 University Hospital Galway, Galway, Ireland

Summary

AI Generated

A study of 144 inflammatory bowel disease patients offered subcutaneous infliximab identified work/life disruption and Drug Payment Scheme enrolment as significant predictors of choosing to transition from intravenous administration, while concerns about reduced monitoring and healthcare contact were primary reasons for declining.

Of 144 patients offered subcutaneous infliximab, 55.5% elected to transition and 44.5% declined; being enrolled in the Drug Payment Scheme (OR 4.99, p=0.03) and missing school/work for infusions (OR 3.78, p=0.04) were statistically significant predictors of choosing to transition.
The strongest motivations for transitioning were reduced travel time (94.5% agreement), better work/life balance (87.3%), and less time away from work/school (74.5%).
The strongest reasons for declining were concerns about missing regular blood checks (84.8% agreement), feeling safer in the infusion unit (80.4%), reduced ability to voice treatment concerns (80.4%), and missing regular healthcare professional contact (69.6%).
At 8 weeks after first subcutaneous dose (n=36), median infliximab trough increased from 7.4 mg/mL to 17.8 mg/mL, while CRP and IBD-Control scores remained stable.
This material is most relevant to gastroenterologists and IBD teams planning subcutaneous biologic programmes and seeking to understand patient decision-making factors.

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This summary was generated by an AI large language model based on the content transcript. It is for informational purposes only and should not be considered a substitute for clinical judgment. Always rely on your professional expertise and the full clinical context when making clinical decisions.

Abstract

Introduction

Subcutaneous (SC) Infliximab (IFX) is non-inferior to intravenous (IV) IFX, for maintenance of remission in inflammatory bowel disease (IBD) (1). There are limited data on factors affecting the decisions of patients who choose SC administration of biologics (2, 3). Our centre offered suitable patients SC IFX from November 2022.

Aims & Methods

(1) Determine disease-related, economic, social and personal factors that affect the decision of a patient with IBD to transition from IV to SC administration of IFX.
(2) Assess effects of SC administration on pharmacokinetics and disease control. Participants completed a questionnaire on their IBD history, personal and financial circumstances, and reasons for electing or declining to transition. Clinical and biochemical data were retrieved from the electronic patient record (EPR). A bivariable logistic regression model was used to determine factors associated with electing to transition.

Results

144 patients were offered the opportunity to transition during the study period. 80 (55.5%) agreed to transition, 64 (44.5%) declined. 101 patients (70.1%) agreed to participate in the study. 59.4% were male, 67.3% had Crohn’s disease. Age ranged was 18-82 (median 41) years. Infusion frequency was every 4 (9.8%), 6 (22.8%), 7 (2.0%), or 8 weeks (65.4%). 76% were employed/self-employed, 41.6% had a medical card and 44.6% had private health insurance. Median (IQR) travel time was 90 mins (40, 130). 48 patients (47.5%) reported that they missed school/work for their infusions. At baseline, median (IQR) laboratory results were CRP 1.2mg/L (0.6, 2.7), IFX trough 7.4mg/mL (4.9, 11.8), faecal calprotectin 39 mg/g (10, 98), IBD-Control 14 (13, 16). 8 weeks after first SC dose, median (IQR) results (n=36) were CRP 1.1mg/L (0.8, 2.0) IFX trough 17.8mg/mL (12.5, 21.4), IBD-Control 16 (14, 16). The strongest reasons to transition (% agree/ strongly agree on five-point Likert) were, “I want to transition because it will…”
(1) reduce my travel time (94.5%),
(2) fit my work/life balance better (87.3%) and
(3) reduce my time away from work/school (74.5%). The strongest reasons against transition were,
(1)I would miss having my bloods checked regularly (84.8%),
(2) I feel safer attending the infusion unit (80.4%),
(3) I would not be able to voice concerns about my treatment as easily (80.4%) and
(4) I would miss regular contact with a healthcare professional (69.6%). Table 1 shows results of binary logistic regression used to determine factors associated with the likelihood of electing to transition.

Variable	OR	p
Age (years)	1.01	0.06
Sex (male = 1)	0.82	0.70
IBD Type (CD = 1)	0.65	0.46
Medical Card	2.88	0.13
Health Insurance	0.33	0.05
Drug Payment Scheme	4.99	0.03
Travel Time	1.01	0.22
IBD Control	1.01	0.85
Missing School/Work for Infusion	3.78	0.04

Conclusion

SC IFX is safe, effective and well-tolerated by those who choose to transition. It is attractive to many patients, because attending for IV infusions can interrupt their employment, education and family life, but cost is a significant barrier for some patients. IBD teams must be adequately resourced to assure patients who transition that they will continue to have ready access to high-quality medical care and disease monitoring. Discrepancies in healthcare markets may provide a perverse incentive to continue receiving IV biologic, for those who would prefer SC.

References

1. Schreiber S, Ben-Horin S, Leszczyszyn J, Dudkowiak R, Lahat A, Gawdis-Wojnarska B, et al. Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease. Gastroenterology. 2021;160(7):2340-53.
2. Remy C, Caron B, Gouynou C, Haghnejad V, Jeanbert E, Netter P, et al. Inflammatory Bowel Disease Patients’ Acceptance for Switching from Intravenous Infliximab or Vedolizumab to Subcutaneous Formulation: The Nancy Experience. Journal of Clinical Medicine. 2022;11(24):7296.
3. Ventress E, Young D, Rahmany S, Harris C, Bettey M, Smith T, et al. Transitioning from Intravenous to Subcutaneous Vedolizumab in Patients with Inflammatory Bowel Disease [TRAVELESS]. Journal of Crohn's and Colitis. 2022;16(6):911-21.

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

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Using vacuum therapy in the management of anastomotic leaks

Wytze Lameris

IMMUNE SIGNATURES OF RECURRENCE IN POSTOPERATIVE CROHN’S DISEASE REVEAL UNIQUE BLOOD TRANSCRIPTOMIC AND CELLULAR PROFILE COMPARED TO PATIENTS IN REMISSION

Robert Battat

MACHINE LEARNING-DRIVEN MULTIMODAL RAMAN SPECTROSCOPY AND METABOLOMICS SIGNATURES IDENTIFY NON-INVASIVE BIOMARKERS OF INTESTINAL BARRIER INTEGRITY AND CLINICAL OUTCOMES IN INFLAMMATORY BOWEL DISEASE

Subrata Ghosh

ONE BLUE MUFFIN, THOUSAND ENGAGED: CITIZEN SCIENCE VALIDATES A CLINICAL BIOMARKER OF GUT TRANSIT TIME

João Sabino

DEVELOPMENT AND EXTERNAL VALIDATION OF A PREDICTION SCORE FOR FUNCTIONAL DIGESTIVE SYMPTOMS AFTER ILEOCECAL RESECTION IN CROHN'S DISEASE: THE PARIS SCORE FROM THE PARIS IBDU RESEARCH GROUP

Philippe Seksik

INTEGRATING MUCOSAL TRANSCRIPTOMIC AND MICROBIAL SIGNATURES TO DEFINE COMPREHENSIVE DISEASE CONTROL IN ULCERATIVE COLITIS AT MOLECULAR RESOLUTION

Philip Rosenstiel

UEG Presentation

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Using vacuum therapy in the management of anastomotic leaks

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Using vacuum therapy in the management of anastomotic leaks

Wytze Lameris 1

Affiliations

1 Amsterdam UMC, Amsterdam, Netherlands

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Abstract

Event

UEG Week Barcelona 2026

Topics

Endoscopy Surgery

Session

Anastomotic headaches: What the gastroenterologist needs to know

Citation

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

Published

2026

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Using vacuum therapy in the management of anastomotic leaks

Wytze Lameris

IMMUNE SIGNATURES OF RECURRENCE IN POSTOPERATIVE CROHN’S DISEASE REVEAL UNIQUE BLOOD TRANSCRIPTOMIC AND CELLULAR PROFILE COMPARED TO PATIENTS IN REMISSION

Robert Battat

MACHINE LEARNING-DRIVEN MULTIMODAL RAMAN SPECTROSCOPY AND METABOLOMICS SIGNATURES IDENTIFY NON-INVASIVE BIOMARKERS OF INTESTINAL BARRIER INTEGRITY AND CLINICAL OUTCOMES IN INFLAMMATORY BOWEL DISEASE

Subrata Ghosh

ONE BLUE MUFFIN, THOUSAND ENGAGED: CITIZEN SCIENCE VALIDATES A CLINICAL BIOMARKER OF GUT TRANSIT TIME

João Sabino

DEVELOPMENT AND EXTERNAL VALIDATION OF A PREDICTION SCORE FOR FUNCTIONAL DIGESTIVE SYMPTOMS AFTER ILEOCECAL RESECTION IN CROHN'S DISEASE: THE PARIS SCORE FROM THE PARIS IBDU RESEARCH GROUP

Philippe Seksik

INTEGRATING MUCOSAL TRANSCRIPTOMIC AND MICROBIAL SIGNATURES TO DEFINE COMPREHENSIVE DISEASE CONTROL IN ULCERATIVE COLITIS AT MOLECULAR RESOLUTION

Philip Rosenstiel

UEG Presentation

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IMMUNE SIGNATURES OF RECURRENCE IN POSTOPERATIVE CROHN’S DISEASE REVEAL UNIQUE BLOOD TRANSCRIPTOMIC AND CELLULAR PROFILE COMPARED TO PATIENTS IN REMISSION

Atena Karimi 1, Alessandro David 1, Katarzyna Orlicka 1, Edmond Jean Bernard 1, Jeremy Liu Chen Kiow 1, Raymond Leduc 1, William Lanteigne-Lamoureux 1, Nathalie Nashen 1, Alice Dufresne 1, Andraanne Morin 1, Robert Battat 1

Affiliations

1 Centre de Recherche de Centre Hospitalier de l'Université de Montréal (CRCHUM), Montreal, Canada

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Abstract

Introduction

Despite advances in biologic therapies, up to 70% of Crohn's disease (CD) patients require ileocolic resection (IR) within 10 years of diagnosis, and over 60% develop postoperative recurrence (POR) within one year(1). Biologic efficacy in preventing POR varies substantially, underscoring the need to identify immunological mechanisms that drive recurrence versus sustained remission (2).

Aims & Methods

This study aimed to identify transcriptomic and immune cell signatures in peripheral blood mononuclear cells (PBMCs) associated with endoscopic recurrence following IR in CD.
Bulk RNA sequencing was performed on PBMCs from 34 CD patients (44% male) following IR: 17 in endoscopic remission (Rutgeerts i0–i1) and 17 with endoscopic recurrence (i2–i4). Differential gene expression (DGE) analysis was conducted using the limma-voom pipeline, adjusting for biological therapy, sex, as well as four surrogate variables (SVA)(3,4). Immune cell composition was estimated using EPIC deconvolution. Pathway enrichment analysis was performed using Gene Set Enrichment Analysis (GSEA) with gene sets from MSigDB Hallmark, Reactome, and C7 immunologic.

Results

Cell-type deconvolution revealed a striking shift in circulating immune cell composition. NK cells were enriched (median 0.127 vs. 0.088; p=0.0175) while CD8 T cells were markedly depleted (median 0.001 vs. 0.050; p=0.008) in endoscopic recurrence patients. These findings were consistent across biological therapy subgroups. At the gene level, DGE analysis identified 661 nominally significant genes (p<0.05), with none surviving FDR correction. Among the most differentially expressed genes, CXCR2 was notably upregulated in patients with recurrence (logFC = +0.613; p = 0.0008), reflecting neutrophil recruitment and innate immune activation. In a targeted analysis of canonical Crohn's disease marker genes, ITGA4 (logFC = −0.159; p = 0.004) and STAT1 (logFC = −0.390; p = 0.019) were significantly downregulated in recurrence compared to remission, suggesting reduced gut-homing lymphocyte trafficking via the α4β7 integrin pathway and attenuation of JAK/STAT interferon signalling in recurrence. Pathway analysis revealed a broad and coordinated suppression programme in patients with recurrence. Immune pathways, including IFN-γ response (NES=−2.89), IFN-α response (NES=−2.83), TNF-α/NF-κB signalling (NES=−2.71), were suppressed, alongside metabolic programmes such as oxidative phosphorylation, fatty acid metabolism, and myogenesis. Reactome analysis confirmed suppression of TCR/BCR signalling and MHC class I/II antigen presentation, with activation of neutrophil degranulation. C7 signatures showed suppression of CD4 memory T cell and effector T cell programmes (all FDR<0.05). Mechanistically, CD8 T cell abundance correlated positively with both IFN-γ (ρ=0.399; p=0.019) and TNF-α/NF-κB transcriptional scores (ρ=0.345; p=0.046), identifying CD8 T cell depletion as a likely driver of the observed interferon suppression.

Conclusion

Post-operative CD recurrence is associated with a systemic immune signature in PBMCs. This signature is characterised by coordinated suppression of interferon signalling, lymphocyte activation, and cellular metabolic programmes including oxidative phosphorylation, fatty acid metabolism, and myogenesis. This is accompanied by NK cell enrichment and CD8 T cell depletion. These findings reveal a dissociation between systemic and mucosal immune responses and support the use of PBMC transcriptomic and cellular features as candidate biomarkers for post-operative monitoring in CD.

References

1. Sensi B, Siragusa L, Efrati C, Petagna L, Franceschilli M, Bellato V, et al. The Role of Inflammation in Crohn’s Disease Recurrence after Surgical Treatment. J Immunol Res. 2020 Dec 26;2020:8846982. doi:10.1155/2020/8846982 PubMed PMID: 33426097; PubMed Central PMCID: PMC7781709.
2. Cruz PD, Kamm MA, Hamilton AL, Ritchie KJ, Krejany EO, Gorelik A, et al. Crohn’s disease management after intestinal resection: a randomised trial. The Lancet. 2015 Apr 11;385(9976):1406–17. doi:10.1016/S0140-6736(14)61908-5 PubMed PMID: 25542620.
3. voom: precision weights unlock linear model analysis tools for RNA-seq read counts | Genome Biology | Springer Nature Link. Available from: https://link.springer.com/article/10.1186/gb-2014-15-2-r29
4. Leek JT, Johnson WE, Parker HS, Jaffe AE, Storey JD. The sva package for removing batch effects and other unwanted variation in high-throughput experiments. Bioinformatics. 2012 Mar 15;28(6):882–3. doi:10.1093/bioinformatics/bts034

Disclosure

Robert Battat: Speaker/consulting/moderator: Bristol Myers Squibb, Johnson and Johnson Innovative Medicine, AbbVie, Takeda, Ferring, Celltrion, Pfizer, Merck, Eli Lilly

Advisory boards: Celltrion, AbbVie, Pfizer, Janssen, Bristol Myers Squibb, Takeda, Merck, Eli Lilly
Educational grants and educational sponsorships: Abbvie, Johnson and Johnson Innovative Medicine, Pfizer, Eli Lilly, Amgen, Pendopharm, Merck, Celltrion, Organon

Travel support: Pfizer, Celltrion, Johnson and Johnson Innovative Medicine, Abbvie.

Event

UEG Week Barcelona 2026

Topics

Mechanisms & Personalised Medicine Immunology IBD

Submission format

Abstract

Session

Immunologic pathways of disease and drug response in IBD

Citation

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

Published

2026

More Like This:

Using vacuum therapy in the management of anastomotic leaks

Wytze Lameris

IMMUNE SIGNATURES OF RECURRENCE IN POSTOPERATIVE CROHN’S DISEASE REVEAL UNIQUE BLOOD TRANSCRIPTOMIC AND CELLULAR PROFILE COMPARED TO PATIENTS IN REMISSION

Robert Battat

MACHINE LEARNING-DRIVEN MULTIMODAL RAMAN SPECTROSCOPY AND METABOLOMICS SIGNATURES IDENTIFY NON-INVASIVE BIOMARKERS OF INTESTINAL BARRIER INTEGRITY AND CLINICAL OUTCOMES IN INFLAMMATORY BOWEL DISEASE

Subrata Ghosh

ONE BLUE MUFFIN, THOUSAND ENGAGED: CITIZEN SCIENCE VALIDATES A CLINICAL BIOMARKER OF GUT TRANSIT TIME

João Sabino

DEVELOPMENT AND EXTERNAL VALIDATION OF A PREDICTION SCORE FOR FUNCTIONAL DIGESTIVE SYMPTOMS AFTER ILEOCECAL RESECTION IN CROHN'S DISEASE: THE PARIS SCORE FROM THE PARIS IBDU RESEARCH GROUP

Philippe Seksik

INTEGRATING MUCOSAL TRANSCRIPTOMIC AND MICROBIAL SIGNATURES TO DEFINE COMPREHENSIVE DISEASE CONTROL IN ULCERATIVE COLITIS AT MOLECULAR RESOLUTION

Philip Rosenstiel

UEG Presentation

New

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MACHINE LEARNING-DRIVEN MULTIMODAL RAMAN SPECTROSCOPY AND METABOLOMICS SIGNATURES IDENTIFY NON-INVASIVE BIOMARKERS OF INTESTINAL BARRIER INTEGRITY AND CLINICAL OUTCOMES IN INFLAMMATORY BOWEL DISEASE

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MACHINE LEARNING-DRIVEN MULTIMODAL RAMAN SPECTROSCOPY AND METABOLOMICS SIGNATURES IDENTIFY NON-INVASIVE BIOMARKERS OF INTESTINAL BARRIER INTEGRITY AND CLINICAL OUTCOMES IN INFLAMMATORY BOWEL DISEASE

Marietta Iacucci 1, Irene Zammarchi 1, Amy Morris 2, Abdulrahman Alzarooni 2, Cecilia Lina Pugliano 1, Snehali Majumder 1, Sumedha Chanda 3, Katarzyna Komolibus 3, Maria Victoria Fernandez 3, Stefan Andersson-Engels 3,1, Animesh Acharjee 2, Georgios V. Gkoutos 2, Rekha Gautam 3, Subrata Ghosh 1

Affiliations

1 University College Cork, Cork, Ireland

2 University Hospitals Birmingham NHS, Birmingham, United Kingdom

3 Tyndall National Institute, Cork, Ireland

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Abstract

Introduction

Intestinal barrier healing is an emerging therapeutic target in inflammatory bowel disease (IBD) and is associated with improved clinical outcomes. Advanced endoscopic techniques (probe-based confocal laser endomicroscopy [pCLE] and endocytoscopy [ECS]) enable real-time in vivo assessment of structural and functional barrier. Yet, their limited availability and complex interpretation highlight the need for non-invasive biomarkers. Raman spectroscopy (RS) and untargeted metabolomics provide label-free molecular fingerprints that reflect metabolic signatures linked to barrier dysfunction. We therefore aimed to identify multimodal Raman metabolomic signatures associated with epithelial and vascular barrier impairment (BI) and major adverse outcomes (MAOs).

Aims & Methods

Seventy patients [42 Crohn’s disease (CD), 28 ulcerative colitis (UC)] were prospectively enrolled. Epithelial and vascular barrier integrity were assessed using pCLE or ECS. RS was performed on plasma and confirmed at tissue level on advanced endoscopy-guided biopsies, while untargeted plasma metabolomics provided complementary biochemical validation. Multiple machine learning (ML) models (Lasso, Elastic Net, Random Forest, Gradient Boosting) and pathway enrichment were applied to integrate multi-omics analysis of plasma/tissue RS and metabolomics to identify biomarkers predictive of BI and 12-month outcomes, evaluating both single-modality and multimodal approaches.

Results

BI was observed in 19/42 patients (45%) by ECS and 27/36 (75%) by pCLE, while MAOs occurred in 31/70 (44.3%) patients. ML models showed excellent performance in predicting BI and clinical outcomes (Table). Multimodal integration of RS plasma, tissue and metabolomic outperformed single modalities for the prediction of epithelial and vascular BI (accuracy 77% and 76%; AUC 0.84 and 0.80), as well as MAOs (accuracy 74% and AUC 0.84), underscoring the need for multiple non-invasive modalities to capture barrier dysfunction.
At pathway enrichment analysis, tryptophan metabolism (pFDR 0.03); citrate cycle (pFDR 0.03); glutamate metabolism (pFDR 0.03); valine, leucine and isoleucine degradation (pFDR 0.06) and ketone body metabolism (pFDR 0.07) were linked to vascular barrier dysfunction in CD, while arginine and proline metabolism (pFDR 0.008) were associated to epithelial barrier dysfunction in UC.

		Multimodal	RS Plasma	RS Tissue	Metabolites
Epithelial barrier impairment	AUC % (95% CI)	84 (76 - 90)	59 (49 - 76)	65 (54 - 74)	59 (48 - 65)
	F1 score % (95% CI)	82 (78 - 86)	73 (69 - 76)	66 (54 - 74)	73 (67 - 78)
	Accuracy % (95% CI)	77 (70 - 82)	63 (61 - 66)	60 (48 - 67)	59 (51 - 66)
Vascular barrier impairment	AUC % (95% CI)	80 (74 - 90)	55 (44 - 65)	77 (71 - 84)	70 (55 - 82)
	F1 score % (95% CI)	73 (64 - 80)	53 (45 - 66)	70 (67 - 76)	67 (55 - 75)
	Accuracy % (95% CI)	76 (66 - 83)	54 (48 - 64)	72 (67 - 80)	68 (59 - 75)
Clinical outcome	AUC % (95% CI)	84 (75 – 93)	62 (52 - 71)	67 (59 - 74)	78 (68 - 87)
	F1 score % (95% CI)	73 (65 – 80)	57 (46 - 67)	64 (56 - 72)	70 (58 - 82)
	Accuracy % (95% CI)	74 (67 – 81)	57 (47 - 66)	62 (55 – 68)	71 (61 - 81)

Table. Multimodal and unimodal ML performance in predicting epithelial barrier impairment, vascular barrier impairment and clinical outcome in IBD.

Conclusion

ML-enabled multi-omics integration of RS and untargeted metabolomic accurately identifies non-invasive biomarkers predictive of BI and MAOs in IBD. Multimodal integration outperforms single modality assessment, enabling barrier endotypes stratification and prediction of clinical trajectories, supporting next-generation precision management strategies in IBD.

Event

UEG Week Barcelona 2026

Topics

Mechanisms & Personalised Medicine Immunology IBD

Submission format

Abstract

Session

Immunologic pathways of disease and drug response in IBD

Citation

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

Published

2026

More Like This:

Using vacuum therapy in the management of anastomotic leaks

Wytze Lameris

IMMUNE SIGNATURES OF RECURRENCE IN POSTOPERATIVE CROHN’S DISEASE REVEAL UNIQUE BLOOD TRANSCRIPTOMIC AND CELLULAR PROFILE COMPARED TO PATIENTS IN REMISSION

Robert Battat

MACHINE LEARNING-DRIVEN MULTIMODAL RAMAN SPECTROSCOPY AND METABOLOMICS SIGNATURES IDENTIFY NON-INVASIVE BIOMARKERS OF INTESTINAL BARRIER INTEGRITY AND CLINICAL OUTCOMES IN INFLAMMATORY BOWEL DISEASE

Subrata Ghosh

ONE BLUE MUFFIN, THOUSAND ENGAGED: CITIZEN SCIENCE VALIDATES A CLINICAL BIOMARKER OF GUT TRANSIT TIME

João Sabino

DEVELOPMENT AND EXTERNAL VALIDATION OF A PREDICTION SCORE FOR FUNCTIONAL DIGESTIVE SYMPTOMS AFTER ILEOCECAL RESECTION IN CROHN'S DISEASE: THE PARIS SCORE FROM THE PARIS IBDU RESEARCH GROUP

Philippe Seksik

INTEGRATING MUCOSAL TRANSCRIPTOMIC AND MICROBIAL SIGNATURES TO DEFINE COMPREHENSIVE DISEASE CONTROL IN ULCERATIVE COLITIS AT MOLECULAR RESOLUTION

Philip Rosenstiel

UEG Presentation

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ONE BLUE MUFFIN, THOUSAND ENGAGED: CITIZEN SCIENCE VALIDATES A CLINICAL BIOMARKER OF GUT TRANSIT TIME

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ONE BLUE MUFFIN, THOUSAND ENGAGED: CITIZEN SCIENCE VALIDATES A CLINICAL BIOMARKER OF GUT TRANSIT TIME

Sare Verstockt 1, Julie Vanderstappen 2, Lien Van Landeghem 1, Maaike De Kreek 1, Wei Li 1, Sien Hoekx 2, Sara Deleu 1, Eva Vissers 1, Marc Ferrante 2, Bram Verstockt 2, Séverine Vermeire 1, Christophe Matthys 1, Kristin Verbeke 1, João Sabino 2

Affiliations

1 KU Leuven, Leuven, Belgium

2 University Hospitals Leuven, Leuven, Belgium

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Abstract

Introduction

Traditional public health surveillance lacks scalable, real-time health measures such as whole-gut transit time (WGTT). Using a citizen-driven approach, we investigated the feasibility of a Blue Muffin test as a population-level biomarker for WGTT, and assessed its associations with other health indicators.

Aims & Methods

This cross-sectional citizen-generated data study (#HealthPass) recruited 1,055 participants (aged 6–81 years, non-fasted) via an open invitation to a two-day public event in Leuven (Belgium), where participants followed a route through 14 standardized health assessment stations. At the gastrointestinal station, participants completed 6 questions on habitual diet and bowel movements (i.e. less than once, once, or more than once daily), and then consumed a blue muffin containing a non-absorbable dye (Royal Blue – E133). Participants were instructed to report the time at which blue-colored stool was first observed and to classify their stool form (Bristol Stool Scale). WGTT was defined as the time between ingestion and first appearance of blue stool. WGTT was examined in relation to anthropometric and physical performance measures, including waist circumference, body mass index (BMI), and handgrip strength (JAMAR hand dynamometer). Group differences were assessed using Kruskal-Wallis tests, univariate associations by Spearman correlations with adjusted (adj.) p values for multiple comparisons, and multivariable modeling using linear regression (R 4.4.2).

Results

In total, 831 participants completed the gastro-intestinal report (41.5% male, median age of 49 years, participation ratio 79%). Most participants were omnivorous (89.7%), consumed at least two pieces of fruit daily (43.7%), at least one portion of vegetables daily (95.2%), wheat bread (44.2%) or whole grain bread (40.3%), and drank 1–2 liters of water daily (64.7%). Bowel movement frequency was reported once daily in 56.6%, and more than once daily in 26.8%. Normal stool form (Bristol Stool Scale Type 3, 4, or 5) was reported in 76.6%. WGTT followed a bimodal distribution, with a median of 23.9 hours, and 81.3% falling within the data-driven normative range of 13.3–51.2 hours. WGTT progressively decreased along the Bristol stool scale (p= 2.6E-20), ranging from a median [IQR] of 45.4 [28.3–80.4] hours in Type 1 (hard) to 18.4 [15.8–24.5] hours in Type 7 (loose), and increased progressively with decreasing bowel movement frequency (p= 1.1E-08). No significant correlations were found between dietary habits and WGTT. Females showed significantly slower transit time than males (median [IQR]: 25.9 [19.5–45.4] vs. 21.9 [18.2–34.8] hours; p= 9.9E-06). Notably, WGTT significantly correlated with BMI (r= -0.11, adj. p= 5.8E-03), waist circumference (r= -0.09, adj. p= 1.8E-02), and hand grip strength (r= -0.15, adj. p= 5.2 E-05). In multivariable analysis, age (β= 0.005, p= 0.001), sex (β= −0.156, p= 0.009), and BMI (β =−0.004, p= 0.047) remained significantly associated with WGTT, while the association with handgrip strength was attenuated (β= −0.003, p= 0.212).

Conclusion

This large-scale study establishes the Blue Muffin test as a valid clinical biomarker for WGTT at population level, and underscores the interrelated associations between age, sex, body composition, and physical function with gut transit. Future studies integrating detailed dietary intake assessments will be essential to fully elucidate the role of nutrition among these determinants, ultimately informing individualized nutritional strategies across diverse health conditions.

Disclosure

Marc Ferrante: Research grants from: AbbVie, EG Pharma, Celltrion, Janssen, Pfizer, Takeda and Viatris; Consultancy fees from: AbbVie, AgomAb Therapeutics, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Janssen-Cilag, Merck Sharp and Dohme, MRM Health, Numab Therapeutics AG, Pfizer, Takeda, Thermo Fisher and ZipBio; Speakers’ fees from: AbbVie, Biogen, Boehringer Ingelheim, Dr Falk Pharma, Ferring, Janssen-Cilag, Merck Sharp and Dohme, Pfizer, Takeda, Truvion Healthcare and Viatris.
Bram Verstockt: Research support from AbbVie, Biora Therapeutics, Celltrion, Landos, Pfizer, Sanofi, Sossei Heptares/Nxera and Takeda.\n-\tSpeaker’s fees from Abbvie, Agomab, Alfasigma, Biogen, Bristol Myers Squibb, Celltrion, Eli Lily, Falk, Ferring, Galapagos, Materia Prima, Johnson and Johnson, Pfizer, Sandoz, Takeda, Tillots Pharma, Truvion and Viatris.Consultancy fees from Abbvie, Alfasigma, Alimentiv, Anaptys Bio, Applied Strategic, Astrazeneca, Atheneum, BenevolentAI, Biora Therapeutics, Boxer Capital, Bristol Myers Squibb, Domain Therapeutics, Eli Lily, Galapagos, Guidepont, Landos, Merck, Mirador Therapeutics, Mylan, Nxera, Inotrem, Ipsos, Johnson and Johnson, Pfizer, Sandoz, Sanofi, Santa Ana Bio, Sapphire Therapeutics, Sosei Heptares, Takeda, Tillots Pharma and Viatris.
João Sabino: Speaker’s fees: Lilly, Pfizer, Abbvie, Ferring, Falk, Takeda, Janssen, Fresenius, and Galapagos.Consultancy fees: Takeda, Pfizer, Janssen, Ferring, Fresenius, Abbvie, Galapagos, Celltrion, Pharmacosmos, and Pharmanovia.Research support: Galapagos, Viatris, and Eurogenerics.JS is supported by a Senior Clinical researcher grant from the Research foundation – Flanders.

Event

UEG Week Barcelona 2026

Topics

Surgery Small Intestine & Nutrition Endoscopy

Submission format

Abstract

Session

Nutrition, metabolism and the therapeutics of obesity

Citation

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

Published

2026

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DEVELOPMENT AND EXTERNAL VALIDATION OF A PREDICTION SCORE FOR FUNCTIONAL DIGESTIVE SYMPTOMS AFTER ILEOCECAL RESECTION IN CROHN'S DISEASE: THE PARIS SCORE FROM THE PARIS IBDU RESEARCH GROUP

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Philip Rosenstiel

UEG Presentation

New

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DEVELOPMENT AND EXTERNAL VALIDATION OF A PREDICTION SCORE FOR FUNCTIONAL DIGESTIVE SYMPTOMS AFTER ILEOCECAL RESECTION IN CROHN'S DISEASE: THE PARIS SCORE FROM THE PARIS IBDU RESEARCH GROUP

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DEVELOPMENT AND EXTERNAL VALIDATION OF A PREDICTION SCORE FOR FUNCTIONAL DIGESTIVE SYMPTOMS AFTER ILEOCECAL RESECTION IN CROHN'S DISEASE: THE PARIS SCORE FROM THE PARIS IBDU RESEARCH GROUP

Nathan Grellier 1, Julien Kirchgesner 1, Heithem Soliman 2, Alexandre Nuzzo 3, Yves Panis 4, Franck Carbonnel 5, Antoine Brouquet 6, Aurelien Amiot 5, Matthieu Uzzan 7, Francesco Brunetti 7, Matthieu Allez 8, Leon Maggiori 9, Anne Laure Pelletier 10, Ahmad Tarhini 10, Bénédicte PIGNEUR 11, Harry Sokol 1, Laurent Beaugerie 1, Jeremie Lefevre 1, Philippe Seksik 1

Affiliations

1 Saint-Antoine Hospital, Paris, Paris, France

2 Hôpital Louis Mourier - AP-HP, Colombes, France

3 Beaujon Hospital, Paris, France

4 Institut des MICI, Neuilly-sur-Seine, France

5 CHU Bicetre - Dept. de Hepato-Gastroenterologie, CHU Bicetre; Le Kremlin Bicetre/FR - Dept. de Hepat, Le Kremlin Bicetre, France

6 Hôpital Kremlin Bicêtre, AP-HP, Kremlin Bicêtre, France

7 Hôpital Henri Mondor, AP-HP, Créteil, France

8 Hopital Saint-Louis APHP, Université Denis Diderot Paris 7, Paris, France

9 Hôpital Saint-Louis, Paris, France

10 Hôpital Bichat Claude Bernard, AP-HP, Paris, France

11 Hôpital Necker Enfants - Malades, Paris, France

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Abstract

Introduction

Ileocecal resection (ICR) is increasingly considered first-line therapy for localized ileal Crohn's disease (CD), yet postoperative functional digestive symptoms remain poorly characterized. We aimed to develop and externally validate a prediction score for functional digestive symptoms after primary ICR for CD and to assess its performance.

Aims & Methods

A cohort study was conducted using prospectively collected data from eight academic IBD centers. The discovery cohort comprised first ICR with no residual macroscopic disease at Saint-Antoine Hospital (SAT, 2017–2024) with systematic symptom and morphological assessment at 6–12 months; the external validation cohort included patients from 7 other Paris Inflammatory Bowel Disease University (Paris-IBDU) centers. The primary outcome was digestive discomfort, defined as ≥4 liquid stools/day, or fecal urgency, or moderate-to-severe abdominal pain. The PARIS score (Postoperative Assessment of Resection-related Intestinal Symptoms) was developed to predict digestive discomfort using multivariable logistic regression with bootstrap internal validation. Variables were entered in the model if p<0.1 in univariate analysis and retained if p<0.05 in multivariable analysis. Discrimination (AUC), negative predictive value (NPV), and sensitivity were assessed, and a stratified analysis by disease activity status (remission vs. recurrence, defined as Rutgeerts score ≥i2b or MRI signs of recurrence) was performed to assess score performance independently of disease activity.

Results

A total of 322 patients were included (discovery cohort SAT n=131, validation cohort n=191). Median disease duration was 78.6 months (IQR 16.9–145.0) in SAT and 53.0 months (IQR 10.4–114.5) in the validation cohort. Fistulizing disease predominated (59.5% and 54.5%), followed by stricturing disease (34.4% and 41.9%). Median resection length was 27.0 cm (IQR 20.0–40.0) in SAT and 30.0 cm (IQR 20.0–41.0) in the validation cohort. Digestive discomfort occurred in 23.7% (SAT) and 31.4% (validation cohort) of patients. The primary outcome was more frequent in patients with morphological recurrence than in remission (37.9% vs 22.2%, p=0.004). In the discovery cohort, only limited resection (≤40 cm) and early surgery (≤24 months) were independently associated with reduced discomfort (aOR=0.14 [0.05–0.38] and aOR=0.25 [0.07–0.76]) in the multivariate analysis. These clinical variables at surgery constitute the PARIS score (1 point each for late surgery >24 months and resection >40 cm, range 0–2), achieving good discrimination in the discovery cohort (AUC=0.751 [0.671–0.832]). This result was confirmed in the validation cohort (AUC=0.677 [0.603–0.752]). Discomfort increased stepwise: score 0 (2.8% discovery, 12.2% validation), score 1 (25.6%, 32.7%), score 2 (58.8%, 54.3%). A score of 0 showed high NPV (97.2% discovery, 87.8% validation cohort; sensitivity 92.3%). Both variables remained predictive in morphological remission (C-statistic=0.751).

Conclusion

The PARIS score, based on early surgery (≤24 months) and limited resection (≤40 cm), provides a simple and externally validated tool for stratifying functional digestive risk after a first ICR for CD. A score of 0 effectively rules out discomfort independently of morphological recurrence, while a score of 2 identifies a high-risk group requiring targeted management. This study reinforces the growing evidence that early and limited ICR is associated with better functional outcomes in patients with localized ileal CD.

Event

UEG Week Barcelona 2026

Topics

Histopathology Surgery Radiology & Imaging Mechanisms & Personalised Medicine Immunology IBD

Submission format

Late-Breaking Abstract

Session

Late-Breaking in IBD: From translational discoveries to treatment

Citation

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

Published

2026

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ONE BLUE MUFFIN, THOUSAND ENGAGED: CITIZEN SCIENCE VALIDATES A CLINICAL BIOMARKER OF GUT TRANSIT TIME

João Sabino

DEVELOPMENT AND EXTERNAL VALIDATION OF A PREDICTION SCORE FOR FUNCTIONAL DIGESTIVE SYMPTOMS AFTER ILEOCECAL RESECTION IN CROHN'S DISEASE: THE PARIS SCORE FROM THE PARIS IBDU RESEARCH GROUP

Philippe Seksik

INTEGRATING MUCOSAL TRANSCRIPTOMIC AND MICROBIAL SIGNATURES TO DEFINE COMPREHENSIVE DISEASE CONTROL IN ULCERATIVE COLITIS AT MOLECULAR RESOLUTION

Philip Rosenstiel

UEG Presentation

New

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INTEGRATING MUCOSAL TRANSCRIPTOMIC AND MICROBIAL SIGNATURES TO DEFINE COMPREHENSIVE DISEASE CONTROL IN ULCERATIVE COLITIS AT MOLECULAR RESOLUTION

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INTEGRATING MUCOSAL TRANSCRIPTOMIC AND MICROBIAL SIGNATURES TO DEFINE COMPREHENSIVE DISEASE CONTROL IN ULCERATIVE COLITIS AT MOLECULAR RESOLUTION

Finn Hinrichsen 1,2, Joana P. Bernardes 1, Víctor A. López-Agudelo 1, Neha Mishra 1, Lina Wehkamp 1,2, Florian Tran 1,2, Konrad Aden 1,2, Stefan Schreiber 1,2, Philip Rosenstiel 1,2

Affiliations

1 University Hospital Schleswig-Holstein UKSH, Kiel, Kiel, Germany

2 University Hospital Schleswig-Holstein UKSH, Campus Kiel, Kiel, Germany

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Abstract

Introduction

In the last decennary treatment goals in ulcerative colitis (UC) have progressed beyond simple symptom relief toward achieving deeper, multidimensional forms of remission. This evolution has led to a critical re-evaluation of traditional single endpoints in accurately reflecting disease activity and therapeutic response. A recent Delphi consensus introduced the concept of comprehensive disease control (CDC) in UC, by integrating clinical, endoscopic, and patient-reported outcomes to characterize a state of true disease quiescence. We proposed that this stringent combination of endpoints might correspond to a distinct molecular signature indicating minimal residual inflammation. To test this, we analyzed mRNA and mucosa-associated microbiota signatures in a cohort of UC patients across different remission states.

Aims & Methods

A total of 211 colonic biopsies were obtained from 173 UC patients at Kiel University Hospital between 2010 and 2020. Bulk mRNA sequencing and mucosal 16S rRNA profiling were conducted. Patients were classified according to established remission domains: Biomarker Remission: CRP < 5mg/dL and leukocytes 2.5-9/nL; Clinical Remission: Partial Mayo Score 0-1; Histological Remission: Nancy Index 0-1; Endoscopic Remission: Endoscopic Mayo Score 0. Individuals meeting all 4 criteria were designated as achieving CDC. To identify molecular features predictive of CDC, we applied an iterative random forest model using an 80% training and 20% testing split.

Results

Microbial and transcriptomic profiles mirrored inflammation gradients. Analyses revealed overlapping but distinct signatures across remission domains, exemplified by enrichment of Dorea formicigenerans in endoscopic, histological, and clinical -but not biomarker- remission. None of the 31 CDC patients CDC required IBD-related hospitalization or surgery over 2 years, highlighting CDC as a clinically meaningful state of profound disease inactivity. Linear mixed modeling showed differential abundance of IBD-associated taxa Lachnoclostridium and Lachnospiraceae FC020 in CDC. Transcriptomic profiling revealed a molecular gradient between CDC and non-CDC patients, with enrichment of fatty acid metabolism and suppression of immune programs. A random forest classifier identified 19 transcriptomic markers predictive of CDC (AUC 0.856), including known IBD-associated genes (CXCL1, KRT7, SLC6A14, ESRRA, FGFR3, ITPKA) and novel markers (ATP5PBP8, CHPT1, CPVL-AS2, CTDSPL, GRIK2, MAZ, MCM9, MED7, RIMKLA, RND1, TIGD5, TMEM115, ZDHHC23).

Conclusion

CDC reflects a biologically profound state of disease quiescence in UC, extending to both the molecular and microbial landscape of the intestinal mucosa. The observed molecular gradient suggests a continuum of mucosal healing and highlights the potential for objective biomarkers capable of quantifying minimal residual disease activity. Importantly, such molecular signatures might help identify patients with low disease activity who are in a molecularly inactive state of disease, even if they do not fulfill all Comprehensive Disease Control criteria. External validation of this molecular signature will determine its prognostic value for long-term clinical outcomes.

Disclosure

Hinrichsen, Finn: Received travel support from Pfizer.
P. Bernardes, Joana: I have no conflict of interest to declare
Lopez Agudelo, Victor Alonso: No conflicts
Mishra, Neha: none
Welz, Lina: Received support from Celltrion for independent reporting from scientific congresses.
Tran, Florian: Grant: Sanofi/Regeneron Personal Fees: Speaker’s fees: Abbvie, Bristol-Myers-Squibb, Celltrion Healthcare, Dr Falk Pharma, Eli Lilly, Ferring Pharmaceuticals, J & J, Sanofi, Takeda Consulting honoraria: AbbVie, J & J, Takeda Non-financial Support: Sanofi for statistical analysis
Aden, Konrad: Personal Fees: Lecture fee: Takeda, Janssen, Lilly, Abbvie
Consulting fee: Takeda, Jannsen, Lilly, Guidepoint
Schreiber, Stefan Wolfgang: Personal Fees: AbbVie, Alfasigma, Amgen, Arena, Biogen, Boehringer Ingelheim, Bristol Meyers Squibb, Celgene, Celltrion, Falk, Ferring, Fresenius Kabi, Galapagos, Gilead, IMAB, Janssen, Lilly, MSD, Mylan, Novartis, Pfizer, Protagonist, Provention Bio, Roche, Sandoz/Hexal, Shire, Takeda, Theravance
Rosenstiel, Philip: stock ownership Gerion

Event

UEG Week Barcelona 2026

Topics

Mechanisms & Personalised Medicine Immunology IBD

Submission format

Abstract

Session

Immunologic pathways of disease and drug response in IBD

Citation

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

Published

2026

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Using vacuum therapy in the management of anastomotic leaks

Wytze Lameris

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Robert Battat

MACHINE LEARNING-DRIVEN MULTIMODAL RAMAN SPECTROSCOPY AND METABOLOMICS SIGNATURES IDENTIFY NON-INVASIVE BIOMARKERS OF INTESTINAL BARRIER INTEGRITY AND CLINICAL OUTCOMES IN INFLAMMATORY BOWEL DISEASE

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Philippe Seksik

INTEGRATING MUCOSAL TRANSCRIPTOMIC AND MICROBIAL SIGNATURES TO DEFINE COMPREHENSIVE DISEASE CONTROL IN ULCERATIVE COLITIS AT MOLECULAR RESOLUTION

Philip Rosenstiel