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Introduction

Ozanimod (OZA), a sphingosine 1-phosphate (S1P) receptor modulator that selectively targets S1P₁ and S1P₅, is approved in the European Union, United States, and other countries for the treatment of moderately to severely active ulcerative colitis (UC). Mucosal healing (MH), a key treatment goal for patients (pts) with UC, is associated with improved long-term pt outcomes.

Aims & Methods

The goal of this analysis was to determine the rate of early MH after treatment with OZA at Week (W) 10 using stringent MH criteria (mucosal endoscopy subscore [MES] = 0 plus histologic remission [Geboes score <2.0]) and to assess the relationship between achievement of stringent MH at W10 and clinical outcomes at W52. Outcomes were compared to pts achieving MH using a standard definition (MES ≤1 plus histologic remission). This analysis included pts from True North (NCT02435992) who achieved clinical response on once-daily oral OZA 0.92 mg at W10 and continued OZA during the 42-wk maintenance period. In this post hoc analysis, we examined MH, clinical remission, and corticosteroid (CS)–free remission at W52 in pts with stringent MH vs without stringent MH at W10 and with stringent MH vs with standard MH.

Results

Of the 230 pts who achieved clinical response on OZA at W10 and continued OZA during the maintenance period, 44 (19.1%) achieved MH using a standard definition and 13 (5.7%) achieved stringent MH at W10. Demographic and clinical characteristics were generally balanced between OZA-treated pts with stringent MH (n=13) and without stringent MH (n=217) at W10. Notably, there were fewer male pts with stringent MH vs without stringent MH, all pts with stringent MH had moderate disease (based on endoscopy), and more pts with stringent MH vs without stringent MH had left-sided UC disease. CS use at screening and prior tumor necrosis factor inhibitor (TNFi) use were lower in those with stringent MH vs without stringent MH. Similar differences in disease severity, extent of disease, and CS and TNFi use were seen in pts with stringent MH vs standard MH. At W52, more pts treated with OZA with stringent MH at W10 vs without stringent MH at W10 had clinical remission (53.8% vs 35.9%), CS-free remission (53.8% vs 30.4%), MH (61.5% vs 27.6%), endoscopic improvement (61.5% vs 44.7), and histologic remission (61.5% vs 31.8%). Except for endoscopic improvement, a slightly higher percentage of pts with stringent MH vs standard MH at W10 achieved clinical outcomes at W52 (Table).

Clinical outcomes at W52
W52 outcome, n (%)	With stringent MH (MES=0 and Geboes score <2.0) at W10 (n=13)	With standard MH (MES ≤1 and Geboes score <2.0) at W10 (n=44)	Without stringent MH (MES>0 and/or Geboes score ≥2.0) at W10 (n=217)
Clinical remission,^a	7 (53.8)	21 (47.7)	78 (35.9)
CS-free clinical remission^b	7 (53.8)	20 (45.5)	66 (30.4)
MH^c	8 (61.5)	23 (52.3)	60 (27.6)
Endoscopic improvement^d	8 (61.5)	28 (63.6)	97 (44.7)
Histologic remission^e	8 (61.5)	25 (56.8)	69 (31.8)
^aRBS=0, SFS ≤1 (plus a ≥1-point reduction from baseline), and MES ≤1. ^bRemission with no CS use for ≥12 wk. ^cMES ≤1 and Geboes score <2.0. ^dMES ≤1. ^eGeboes score <2.0. RBS, rectal bleeding subscore; SFS, stool frequency subscore.

Conclusion

While difficult to achieve, a small proportion of pts treated with OZA experienced stringent MH by W10. Compared with pts who achieved standard MH at W10, those with stringent MH at W10 demonstrated numerically better clinical outcomes at W52 on OZA treatment. Achieving stringent MH at W10 correlated with better clinical, endoscopic, and mucosal outcomes at W52.

Disclosure

The study was funded by Bristol Myers Squibb, Princeton, NJ, USA.
WR: speaker for 4SC, Abbott Laboratories, AbbVie, Aesca, Aptalis, Astellas, Centocor, Celltrion, Danone Austria, Elan, Falk Pharma GmbH, Ferring, Immundiagnostik, Medice, Mitsubishi Tanabe Pharma Corporation, MSD, Otsuka, PDL, Pharmacosmos, PLS Education, Schering-Plough, Shire, Takeda, Therakos, Vifor, and Yakult; consulted for Abbott Laboratories, AbbVie, Aesca, Algernon, Amgen, AM Pharma, AMT, AOP Orphan, Arena, Astellas, AstraZeneca, Avaxia, Roland Berger GmbH, Bioclinica, Biogen IDEC, Boehringer Ingelheim, Bristol Myers Squibb, Calyx, Celgene, Cellerix, Celltrion, Centocor, ChemoCentryx, Covance, Danone Austria, DSM, Elan, Eli Lilly, Ernst & Young, Falk Pharma GmbH, Ferring, Galapagos, Gatehouse Bio, Genentech, Gilead, Grünenthal, ICON, Index Pharma, Inova, Intrinsic Imaging, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Landos, Lipid Therapeutics, LivaNova, Mallinckrodt, MedAhead, MedImmune, Millennium, Mitsubishi Tanabe Pharma, MSD, Nash Pharmaceuticals, Nestle, Nippon Kayaku, Novartis, Ocera, OMass, Otsuka, Parexel, PDL, Peri Consulting, Pharmacosmos, Philip Morris Institute, Pfizer, Procter & Gamble, Prometheus, Protagonist, Provention, Quell Therapeutics, Robarts Clinical Trial, Sandoz, Schering-Plough, Second Genome, Seres, Setpoint Medical, Sigmoid, Sublimity, Takeda, Teva, Therakos, Theravance, TiGenix, UCB, Vifor, Zealand, and Zyngenia; served as an advisory board member for 4SC, Abbott Laboratories, AbbVie, Aesca, Amgen, AM Pharma, Astellas, AstraZeneca, Avaxia, Biogen IDEC, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Cellerix, Celltrion, Centocor, ChemoCentryx, Danone Austria, DSM, Elan, Ferring, Galapagos, Genentech, Grünenthal, Inova, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millennium, Mitsubishi Tanabe Pharma, MSD, Nestle, Novartis, Ocera, Otsuka, PDL, Pharmacosmos, Pfizer, Procter & Gamble, Prometheus, Sandoz, Schering-Plough, Second Genome, Setpoint Medical, Takeda, Therakos, TiGenix, UCB, Zealand, and Zyngenia; received research funding from Abbott Laboratories, AbbVie, Aesca, Centocor, Falk Pharma GmbH, Immundiagnostik, Janssen, MSD, Sandoz, and Takeda.
AH: Consultant, advisory board member, or speaker for AbbVie, Atlantic, Bristol-Myers Squibb, Celltrion, Falk, Ferring, Janssen, MSD, Napp Pharmaceuticals, Pfizer, Pharmacosmos, Shire, and Takeda. Global Steering Committee for Genentech.
CS: served as a speaker for AbbVie, Bristol Myers Squibb, Janssen, Pfizer, Takeda, and UCB.
RKC: consulted for AbbVie, Bristol Myers Squibb, Janssen, LabCorp, Pfizer, Samsung Bioepis, and Takeda.
HAA, AJ, HW, and MTO: employees and/or shareholders of Bristol Myers Squibb.
RL: consulted for Bristol Myers Squibb and Pfizer.
JA: received consulting fees from AbbVie, BioFire Diagnostics, Janssen, and Pfizer; received research grants from BioFire Diagnostics.

EFFECTS OF EARLY MUCOSAL HEALING AT WEEK 10 USING STRINGENT CRITERIA IN PATIENTS WITH ULCERATIVE COLITIS TREATED WITH OZANIMOD ON CLINICAL OUTCOMES AT WEEK 52

Walter Reinisch 1, Ailsa L Hart 2, Charles Sninsky 3, Raymond Cross 4, HARRIS AHMAD 5, Anjali Jain 5, Hsiuanlin Wu 5, Mark Osterman 5, Randy Longman 6, Jordan Axelrad 7

1 Medical University of Vienna, Vienna, Austria

2 St. Mark’s Hospital & Imperial College, London, United Kingdom

3 Digestive Disease Associates, Gainesville, United States

4 University of Maryland School of Medicine, Baltimore, United States

5 Bristol Myers Squibb, Princeton, United States

6 Weill Cornell Medicine, New York, United States

7 NYU Grossman School of Medicine, New York, United States

Conference

UEG Week Copenhagen 2023

Topics

IBD

Submission format

Abstract

Session

Targeting immune cell trafficking in IBD (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

UEG Podcast Episode

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Well-rounded care in functional disorders with Tim Vanuytsel

Tim Vanuytsel, Egle Dieninyte - Misiune

Topics

Primary Care

Published

2025

UEG Podcast Episode

Journal Podcast

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UEG Journal Best Paper Award 2022 - Combining biologics and small molecules in IBD

Katarzyna Pawlak 1, Laurent Goessens 2

1 Department Gastroenterology, Endoscopy Unit, Hospital of the Ministry of Interior and Administration, Szczecin, Poland

2 Centre Hospitalier de Mouscron, Belgium

Topics

IBD

Published

2022

UEG Podcast Episode

UEG Podcast

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Physician Wellbeing

Martina Müller-Schilling, Egle Dieninyte - Misiune

Published

2024

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Introduction

Contrast-enhanced harmonic endoscopic ultrasound (CEH-EUS) can demonstrate microvascularization of the tumors. However, most images acquired from CEH-EUS are interpreted subjectively without quantification by time-intensity curves (TICs) analysis. The role of quantitative CEH-EUS through time-intensity curve (TIC) has not been explored in differential diagnosis of gallbladder(GB) polypoid lesions.

Aims & Methods

Aim: In this study, we used a handcrafted software to quantify TIC curve of CEH-EUS images to differentiate malignant gallbladder polypoid lesions from benign ones.
Method: We analyzed the videos of CEH-EUS for GB polypoid lesions from the patients in National Taiwan University Hospital. The convex-type echoendoscope (GF-UCT260; Olympus, Tokyo, Japan) equipped with ultrasound (US) systems (EU-ME2) was used for the procedures. The second generation of US contrast agent with Sonazoid (GE Healthcare, Oslo, Norway), which contains perfluorobutane microbubbles with a median diameter of 2–3 μm, was administered bolus and intravenously with a dosage of 0.015 ml encapsulated gas per kilogram body weight. The videos were recorded in AVI formats with 30 frames/second.
The algorithm for getting TICs includes the following steps:
(1) Circling the region of interest(ROI) in the B-mode
(2) Performing speckle tracking of the ROI in the B-mode
(3) Simultaneously obtaining the intensity of ROI (the mean pixel values in the ROI) in the corresponding contrast-enhanced harmonic image
(4) Outputting TICs after subtracting the baseline intensity (for eliminating the different baseline intensities caused by other settings).
(5) Outputting histogram of pixel values and excel file containing all pixel values from the frame with the highest mean pixel value automatically.
(6) Calculating the standard variance of (5) to represent the heterogeneity inside the ROI.
The speckling tracking composes of searching and matching processes. We used full search for the searching process and normalization cross-correlation for the matching process. By using the hardware of CPU with Intel i7-8750H and GPU with Nvidia GTX 1050 Ti, the computation time was 0.7 ms/frame. Based on this algorithm, we designed a graphical user interface of this model.

Results

A total of 30 eligible videos were enrolled for analysis. Fourteen lesions were pathologically proven of malignancies (including 11 adenocarcinomas, two neuroendocrine tumors, one B-cell lymphoma) and the other 16 lesions were benign cases. Among 16 benign lesions, 6 were chronic cholecystitis, 4 were adenomyoma, 2 were intracholecystic papillary neoplasm, one was xanthogranulomatous cholecystitis, one was cholesterol polyps, one was hyperplastic polyp and one was Mycobacterium tuberculosis. The lesion size ranged from 8.1 to 90mm in malignant group and from 4.4 to 29mm in benign group. The mean peak intensity was 46.36 dB (SD=31.77) in malignant group and 55.94 dB (SD=44.59) in benign group respectively (p=.509). The mean time to peak was 30.14 s (SD=10.00) in malignant group and 20.50 s (SD=6.70) in benign group respectively (p=.004).

Conclusion

This preliminary report of using TIC of CEH-EUS images for differential diagnosis of GB polypoid lesions showed significant difference in time to peak between malignant group and benign group. Further large scale of studies are needed for comfirming the application of this novel technique.

Disclosure

Conflict of Interest

APPLICATION OF QUANTITATIVE CONTRAST-ENHANCED HARMONIC EUS ON DIFFERENTIAL DIAGNOSIS OF GALLBLADDER POLYPOID LESIONS

MING-LUEN HAN 1, Kuan Chih Chen 2, Pai-Chi Li 3, Hsiu-Po Wang 1

1 National Taiwan University Hospital, Taipei, Taiwan, Province of China

2 Graduate Institute of Biomedical Electronics and Bioinformatics, National Taiwan University, Taipei, Taiwan, Province of China|||Far Eastern Memorial Hospital, New Taipei, Taiwan, Province of China

3 Graduate Institute of Biomedical Electronics and Bioinformatics, National Taiwan University, Taipei, Taiwan, Province of China

Conference

UEG Week Copenhagen 2023

Topics

Hepatobiliary

Submission format

Abstract

Session

PP 07 Liver & biliary (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

UEG Webinar

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UEG Webinar: AI Talk for Busy GI Doctors with Beatriz Gros Alcalde and Alexander Hann

Alexander Hann, Beatriz Gros Alcalde, Lucas Wauters

Topics

Endoscopy Education & Training

Published

2026

UEG Standards and Guidelines

New

Clinical Practice Guideline

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ABSTRACT

Introduction

Since the publication of the first European Society for the Study of Coeliac Disease (ESsCD) guidelines in 2019, substantial advances have been made in understanding the management and complex disease courses of coeliac disease (CeD) in adults. These 2025 updated guidelines aim to integrate new evidence, refine management strategies, and promote a personalised and multidisciplinary approach to care.

Methods

The ESsCD convened a multidisciplinary panel of experts to revise the 2019 guidelines using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) framework. Evidence was appraised and graded according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. Statements and recommendations were draughted within working groups and finalised through a structured Delphi consensus process.

Results

The updated guidelines are presented in two parts. Part 1, which has already been published, addresses the diagnostic approach to CeD in adults, whereas Part 2 focuses on disease management, structured follow-up, and the evaluation and treatment of persistent symptoms despite a gluten-free diet or refractory disease. New or expanded sections include guidance on the safe inclusion of oats, use of low-FODMAP diets in patients with persistent symptoms, management of exocrine pancreatic insufficiency, recognition of functional asplenia and related vaccination recommendations, and stratified bone-health screening. The guidelines also discuss nutritional and psychosocial support, digital models of care, and structured transition from paediatric to adult services. Updated therapeutic strategies for refractory CeD are provided, including immunosuppressive and novel pharmacologic options.

Conclusions

These updated guidelines offer a comprehensive, evidence-based framework for the management and follow-up of adults with CeD. By integrating recent scientific advances with pragmatic, patient-centred recommendations, they seek to optimise clinical outcomes, quality of life, and long-term health in individuals with CeD.

European Society for the Study of Coeliac Disease (ESsCD) 2025 Updated Guidelines on the Diagnosis and Management of Coeliac Disease in Adults. Part 2: Management, Follow-Up, and Complex Disease Courses

Abdulbaqi Al-Toma

Guideline

Clinical Practice Guideline

Topics

Immunology Small Intestine & Nutrition

Citation

United European Gastroenterology Journal, 2026

Published

2026

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