Introduction

Intestinal ultrasound (IUS) is increasingly used to objectively assess inflammatory bowel disease (IBD), yet a structured framework for evaluating operator proficiency is lacking. Structured objective assessment exists for general ultrasound(1), but not for IUS. The study aims to develop international consensus criteria for the objective structured assessment of IUS skills (OSAIUS) using a structured, multidisciplinary Delphi process.

Aims & Methods

IUS gastroenterology, radiology, internal medicine, and pediatric experts were identified worldwide. A modified Delphi process achieved expert consensus through multiple survey rounds. Four key OSAIUS domains were identified. In the first round, all experts rated the relevance of 20 predefined topics across these domains using a five-point Likert scale and were invited to propose additional topics. In the second round, participants re-rated 2 original topics and evaluated the newly suggested topics, each accompanied by standardized anchor text for the five Likert scores. A third round was conducted for final anchor text acceptance. Topic descriptions and anchor text wording were continuously revised to ensure clarity, accuracy, and terminology consistency throughout the process. We defined inclusion in the final assessment as ≥70% of experts rating a topic as 4 or 5 (relevant/essential).

Results

Of the 23 experts invited, 21 participated in the first round and 19 completed the second. Most respondents were gastroenterologists (n=15). In the first round, 18 topics were accepted. Two existing topics were marked for reassessment, along with four newly proposed topics for inclusion in subsequent rounds. In the second round, 3 topics were accepted: research segment documentation (mean score/rank 4.5/2.1), machine care/hygiene (4.4/3.6), post-resection anastomosis (4.4/2.8), totaling 21 final topics for the OSAIUS (Table 1). The topics discarded were examiner position (3.6/3.5), advanced machine settings (3.5/4.0), appendix (3.8/4.4), and transperianal ultrasound (2.8/6.1).

Conclusion

An international, multispecialty consensus defined the core technical competencies required to assess IUS proficiency. These findings establish the foundation for a globally accepted OSAIUS, which may support future certification at varying levels of expertise. The OSAIUS covers 4 domains, each with 5 topics, all individually rated from 1-5, giving a total score of 20-100. The proposed framework aims to reduce operator variability and offers a yet-to-be-validated tool for optimizing and objectively comparing educational interventions. Integrating expert-rated elements provides a robust basis for developing an internationally recognized IUS curriculum and standardized assessment protocol.

References

1) Tolgsaaard et al. International Multispecialty Consensus on How to Evaluate Ultrasound Competence: A Delphi Consensus Survey, PLoS One, 2013 Feb 28;8(2):e57687. doi: 10.1371/journal.pone.0057687

Disclosure

This study is supported by a grant from The Leona M. and Harry B. Helmsley Charitable Trust, as part of the IBUS eIUS Ed Project.
No author deaclears specifice conflicts of interest for this study

Introduction

Janus kinase inhibitors (JAKi) exhibit distinct performance characteristics versus monoclonal antibody (mABs) biological agents in the management of ulcerative colitis (UC). There is a lack of direct comparative effectiveness data of JAKi small molecules versus mABs in the real world.

Aims & Methods

In the absence of direct head-to-head comparisons, we determined the persistence of tofacitinib (TOF) versus vedolizumab and tumour necrosis factor inhibitor (TNFi) mABs in advanced therapy (AT)-naïve and AT-exposed real-world UC subjects from a population-based prospective registry.

The Persistence Australian National IBD Cohort (PANIC5) registry collected AT prescribing data for the entire Australian population up until Dec 2021. In Australia, all advanced therapies for IBD are prescribed without a hierarchical order in subjects with moderate-severe UC refractory to conventional therapies, irrespective of occupation and insurance status. Treatment is provided indefinitely in those that enter into clinical remission. Non-persistence was defined as failure to continue AT prescriptions for >6-months. Propensity score matching (PSM) statistically controlled for baseline selection biases. Kaplan-Meier survival curves were generated for AT persistence and compared using the log-rank test. Cox proportional hazards regression models were employed to calculate hazard ratios (HR) and 95% confidence intervals (CI). P<0.05 was deemed statistically significant (SPSS, USA).

Results

A total of 9,671 consecutive UC patients were recruited (53% male, 23,348 patient-years of follow up). The cohort comprised 14,772 treatment lines: 6,044 infliximab (IFX), 1,981 adalimumab (ADA), 5,467 vedolizumab (VED), 750 golimumab (GOL) and 530 tofacitinib (TOF). TOF exhibited superior persistence versus IFX (HR: 1.88, 95%CI: 1.34-2.63, P<0.001), ADA (HR: 2.10, 95%CI: 1.49-2.94, P<0.001) and GOL (HR: 2.20, 95%CI: 1.55-3.11, P<0.001) but not versus VED (HR: 1.28, 95%CI: 0.92-1.80, P=0.14). Following PSM, TOF was not significantly higher in persistence compared to mABs among AT-naïve subjects (all P>0.05). However, TOF showed superior persistence compared to all mABs among AT-exposed (all P<0.001). The persistence of TOF (P=0.77) did not significantly decline moving from AT-naive- to AT-exposed treatment status, unlike for TNFi (-8 months) and VED (-19 months, both P<0.001). PSM-multivariate Cox regression showed predictors of higher persistence to be use of TOF, AT-naïve status, use of immunomodulator. Rankings of persistence of ATs are presented for AT-naïve- and AT-exposed UC subjects (Table).

Conclusion

This is the first real-world study comparing treatment effectiveness using a national universal insurance persistence dataset. It found that tofacitinib had significantly greater persistence than biological agents in patients with ulcerative colitis who had previously received advanced therapy. Unlike monoclonal antibodies, tofacitinib did not show a decline in persistence after exposure to advanced therapy. Given these findings, JAK inhibitors like tofacitinib should be strongly considered for patients switching advanced therapies in ulcerative colitis.

Disclosure

RL advisory board: AbbVie, Aspen, BMS, Celgene, Celltrion, Chiesi, Ferring, Glutagen, Hospira, Janssen, Lilly, MSD, Novartis, Pfizer, Prometheus Biosciences, Takeda; research grants: Joanna Tiddy USYD, McCusker Charitable Foundation, Celltrion, Shire, Janssen, Takeda, Gastroenterological Society of Australia, NHMRC, Gutsy Group, Pfizer, MRFF

Introduction

Epithelial injury is a hallmark of chronic mucosal damage in Crohn’s disease (CD), which can lead to fibrostenotic strictures. Type VII collagen, a critical component of the epithelial basement membrane, forms U-shaped anchoring fibrils that link the basement membrane to the interstitial matrix by binding fibrillar collagen. Genetic mutations in the COL7A1 gene, which encodes type VII collagen, are known to impair fibril formation and reduce tissue tensile strength, resulting in epithelial dysfunction, as seen in disorders such as dystrophic epidermolysis bullosa. This highlights the essential structural role of type VII collagen in maintaining matrix stability. In CD, the importance of this protein is underscored by the presence of autoantibodies targeting type VII collagen in up to 50% of patients with CD. Loss of tissue integrity, because of loss of the interaction between the basement and interstitial matrix, leads to tissue dysfunction and fibrosis.

Aims & Methods

We investigated C7M, a biomarker of type VII collagen degradation, to assess its specificity for intestinal mucosal damage. We analyzed serum samples from CD patients enrolled in a prospective cohort study. The cohort included 62 CD patients undergoing surgical resection for fibrostenotic strictures and 49 patients with luminal disease receiving treatment adjustments without surgery. Serum was collected at baseline, post-operative day 1 (POD1), and one-month post-resection. C7M levels were quantified using a competitive ELISA.

Results

At baseline, C7M levels were significantly elevated in fibrostenotic CD patients (median: 9.79ng/mL) compared to those with luminal CD patients (median: 6.03ng/mL) (p<0.01, AUC: 0.69). In the resected group, C7M levels rose sharply on POD1 (p<0.0001, AUC: 0.81), suggesting acute release in response to surgical injury. By one-month post-surgery, C7M levels had returned to baseline, closely resembling those observed in luminal CD patients (p<0.0001, AUC: 0.80). C7M also demonstrated mild-moderate correlations to biochemical markers of inflammation, including CRP (rho=0.62, p<0.0001), hemoglobin (rho=-0.28, p=0.0024), thrombocytes (rho=0.24, p=0.0105), albumin (rho=-0.52, p<0.0001), and fecal calprotectin (rho=0.25, p=0.019).

Conclusion

C7M was elevated in fibrostenotic CD patients relative to luminal CD, indicating its potential as a biomarker of more severe or complex mucosal pathology. The pronounced but transient increase following surgery, with normalization within one month, further supports C7M as a dynamic marker of intestinal epithelial damage. These findings suggest C7M may serve as a novel, disease-specific biomarker for assessing mucosal integrity and inflammatory burden in CD.

Disclosure

Full time employee at Nordic Bioscience

Introduction

In corticosteroid-resistant acute severe ulcerative colitis (ASUC), second-line treatment involves infliximab or cyclosporine (CYCLO). With increasing antiTNFα exposed patients, CYCLO is often chosen to prevent emergency colectomy but is limited to the induction phase due to tolerability, serving as a bridge until effective maintenance therapy. In this setting, limited data on vedolizumab (VDZ) and ustekinumab (UST) as maintenance make the choice of an optimal bridge strategy challenging. This study aimed to compare the efficacy of VDZ and UST after CYCLO induction in corticosteroid-resistant ASUC.

Aims & Methods

This single-center retrospective cohort included all patients hospitalized for ASUC, responding to CYCLO induction, and starting VDZ or UST maintenance. ASUC was defined by modified Truelove and Witts criteria, with response to CYCLO defined by a Lichtiger score reduction to <10 points for 2 consecutive days, with a minimum 3-point decrease by day 7. The primary outcome was colectomy-free survival; secondary outcomes were treatment persistence and safety.

Results

From 2014-2024, 62 ASUC patients received CYCLO. Eighteen were excluded (non-response, tofacitinib [n=7], infliximab [n=3], and/or emergency colectomy [n=14]), leaving 44 CYCLO-responsive ASUC patients (median age 39, IQR 30-58, 60% female), with 35 on VDZ (79%) and 9 on UST (21%). ASUC was related to ulcerative colitis in 84% (73% pancolitis) and undetermined or Crohn's colitis in 16%. Disease duration was 7 years (IQR 2-15), with 91% prior biologic exposure, primarily antiTNF. Presentation included Lichtiger score 10 (IQR 10-12), CRP 46 mg/L (22-79), albumin 29 g/L (27-30), fecal calprotectin 778 µg/g (450-1650), UCEIS 7 (5-8), and Mayo endoscopic score 3 (3-3). Colectomy-free survival at 2 years was 79% with VDZ and 47% with UST (p=0.03). Treatment persistence at 2 years was 43% with VDZ, and 47% with UST (p=0.47). After adjusting for maintenance therapy, disease type, and severity, colectomy risk factors included hypoalbuminemia (HR=1.2; 95%CI:1.02-1.4, p=0.018) and prior tofacitinib exposure (HR=9.1; 95%CI:1.5-55.6, p=0.017). Over a median 37-month follow-up (95%CI:35-40), 34% of patients experienced adverse events, with 19% severe (mainly CYCLO-related), including 2 deep vein thromboses in the VDZ group and 1 infection in the UST group. No deaths occurred.

Conclusion

Our study suggests that VDZ may provide higher colectomy-free survival at 2 years than UST in CYCLO-responsive ASUC, with comparable treatment persistence. Hypoalbuminemia and prior tofacitinib exposure were identified as independent risk factors for colectomy, emphasizing the role of patient profiling in treatment selection. Further prospective studies are needed to refine bridge strategies in ASUC.

Introduction

Artificial intelligence tools for endoscopic assessment of Ulcerative Colitis remain limited due to suboptimal agreement with expert readers and reliance on small, inconsistently labeled datasets. We developed a novel computer vision model (DovaVision) trained on a large-scale, expert-annotated video dataset to assess UC activity using detailed frame-level features.

Aims & Methods

DovaVision was pre-trained using DINOv2 self-supervised learning on 845 colonoscopies and millions of GI images, then significantly refined using annotations collected via a proprietary platform. 15 IBD central readers (CRs) scored video frames for five UC features (vascular pattern, bleeding, ulcers/erosions, friability, erythema) across multiple severity levels. Annotators underwent standardized onboarding to ensure high inter-rater reliability. The model comprises two vision transformer architectures: a Quality Control (QC) module to exclude low-quality/non-diagnostic frames, and a Scoring module that outputs feature-specific severity grades. Model outputs include burned-in heatmaps (for mapping of disease activity to specific timepoints) and structured JavaScript Object Notation (JSON) files.

Results

A total of 83.8 million frames from 200 colonoscopy videos were labeled by 3 expert CRs across 7 categories per video, yielding 16.9 million merged labels by majority vote. Inter-rater agreement on modified Mayo Endoscopic Score (MES) showed strong reliability (ICC = 0.86; QWK = 0.88). On a 31-video validation set from 3 separate data sources, DovaVision showed equivalency with the gold standard of CR consensus (2+1 majority vote), achieving a QWK of 0.904 and ICC of 0.907. In comparison, the pool of 3x CRs assigned/video on this same set showed ICC of 0.905. On friability assessment—a challenging feature-- DovaVision showed 90% agreement and 0.811 ICC when compared to gold standard (3x CR majority vote), while the agreement for 3 CRs per video was only 0.447 ICC on the same set. The average model inference time was short at 3.5 minutes per video. The model also outputs continuous “frame-by-frame” level information on the sub-score characteristics. The model is an entire data processing pipeline deployed on a cloud architecture with an API for secure authentication, bulk data upload, and secure results storage/retrieval.

Conclusion

DovaVision is a validated AI-based model for automated grading of UC severity on endoscopy. Its high concordance with expert readers, detailed feature-level (sub-score characteristics) analysis, and rapid inference support real-world integration into clinical and research workflows. Although further validation with additional datasets is required.

Disclosure

Dr. Michael Byrne is the Chairman, Founder and CMO at Dova Health Intelligence