Introduction

Accurate diagnosis and monitoring of inflammatory bowel diseases (IBD) are essential for effective management and reduction of complications. Intestinal ultrasound (IUS) is a non-invasive and cost-effective imaging modality for IBD assessment, yet its widespread adoption is limited by operator dependency and interobserver variability. Artificial intelligence (AI) offers the potential to overcome these limitations by improving diagnostic accuracy and standardizing interpretation.

Aims & Methods

This study aimed to develop an AI-assisted model for the automatic detection of active inflammation in IUS images, using bowel wall thickness (BWT) as a key marker. We further aimed to create an automatic tool for detecting bowel segments within ultrasound images and to extend its application from single images to cine loops. Grayscale ultrasound images and cine-loops of the terminal ileum were collected from Crohn’s disease patients undergoing IUS at a tertiary center. The dataset included both normal and abnormal BWT and was annotated by an experienced operator. Preprocessing involved anonymization and normalization. Automated segmentation algorithms were used to isolate bowel wall structures, and deep learning techniques, including convolutional neural networks (CNNs) and YOLO (You Only Look Once) object detection, were employed to analyze the images.

Results

The study included 2,735 grayscale ultrasound images and cine-loops of the terminal ileum from patients with Crohn's disease. The dataset was divided into three sets: a training set of 1980 images, a validation set of 220 images, and a test set of 515 images. Our model achieved robust performance metrics, including sensitivity, specificity, and accuracy of 99.1%, 94.6%, and 91.5%, respectively, for BWT detection, with an area under the receiver operating characteristic curve (AUC) of 0.85. Our model was validated on 10 independent cine-loops, comprising 7 abnormal and 3 normal cases. It accurately identified bowel wall thickening (BWT) in all seven abnormal cases, correctly classifying them as abnormal. Additionally, the model successfully confirmed the absence of BWT in all three normal cine-loops, categorizing them appropriately as normal.

Conclusion

This study represents a significant advancement in the application of artificial intelligence to intestinal ultrasound interpretation by integrating automated segmentation, automatic analysis capabilities, and cine-loop evaluation. Our model extends beyond traditional static image analysis, paving the way for real-time and dynamic assessments of bowel inflammation. This approach highlights the potential of our AI tools to reduce operator dependency, improve diagnostic accuracy, and enhance clinical workflows, making IUS more accessible and reliable for clinicians with varying levels of expertise.

Disclosure

Prof. Dan Carter has received speaker’s fees, research support, or consultancy fees from Takeda, Janssen, AbbVie, and Taro

Introduction

The global burden of Inflammatory bowel disease (IBD), encompassing ulcerative colitis (UC) and Crohn’s disease (CD), is increasing. Due to its chronic nature, IBD entails long-term healthcare resource use, contributing to substantial economic and environmental costs. Digestive endoscopy, while a cornerstone of disease monitoring, is associated with high energy consumption, greenhouse gas (GHG) emissions, and medical waste. Intestinal ultrasound (IUS) has emerged as a non-invasive, accurate, and potentially more sustainable alternative.

Aims & Methods

The present study aimed to compare the environmental impacts in terms of CO₂ emissions, energy consumption (kWh), and disposable waste of IUS and endoscopy for therapeutic monitoring in IBD. In this single-center, retrospective observational study conducted at IRCCS Humanitas Research Hospital (Rozzano, Milan), all consecutive IUS and lower gastrointestinal endoscopies performed for therapeutic monitoring in IBD patients between January 2022 and December 2025 were included. Procedures for oncologic surveillance in long-standing disease, isolated rectal involvement (<15 cm from the anal verge), or without confirmed IBD were excluded. Clinical and procedural data were collected. Environmental metrics such as CO₂ emissions, energy consumption (kWh), and disposable waste were estimated using validated conversion factors and compared using appropriate statistical tests (Independent-samples t-test or Mann–Whitney U test).

Results

Endoscopic procedures performed during study period (n=2698) ↓ Exclusion criteria - Endoscopic procedures in trial setting (n=1157) -Endoscopic surveillance in UC (n= 216) -Pouchoscopies & ulcerative proctitis monitoring (n=162) - Operative/ emergency procedures (n=71) ↓ Endoscopic procedures included in the analysis (n=1092) Colonoscopies (n= 710)↵ ↳ Sigmoidoscopies (n=382)

intestinal ultrasounds performed during study period (n=1541) ↓ Exclusion criteria - Indications other than disease monitoring/ patient BMI> 30 Kg/m2 (n= 231) ↓ Intestinal ultrasounds included in the analysis (n=1310) ​

Flowchart 1. Visual representation of the process of selecting procedures to be included in the final analysis. UC: Ulcerative colitis; BMI: Body Mass Index.

During the study period, a total of 1092 endoscopic procedures, comprising 710 colonoscopies and 382 sigmoidoscopies, along with 1310 IUS were performed in 1028 IBD patients (58% UC, 42% CD). Estimated resource use for all endoscopic procedures totaled 1,256 kWh of electricity, 72,080 L of CO₂ emissions, and 585.6 kg of disposable waste, based on procedural averages (~1.5 kWh, 80 L of CO₂, 650 g waste per colonoscopy; ~50% of values for sigmoidoscopies). In contrast, IUS was associated with an estimated 524 kWh of electricity and 196.5 kg of disposable waste (average ~0.4 kWh, almost no CO₂ consumption, 150 g waste per exam). Compared to endoscopy, IUS reduced energy use by 82%, CO₂ emissions by 95%, and waste generation by 66% (P < 0.05 for all comparisons).

Conclusion

While gastrointestinal endoscopy remains indispensable in certain clinical scenarios, its environmental impact is considerable. In contrast, IUS emits almost no equivalent of CO₂, consumes significantly less energy per examination and produces negligible wastes. For therapeutic monitoring in IBD, IUS has demonstrated high diagnostic accuracy with a markedly lower ecological footprint. These findings promote IUS as a sustainable and environmentally friendly alternative for routine IBD monitoring in appropriate scenarios.

Disclosure

A Armuzzi has received consulting and/or advisory board fees from AbbVie, Allergan, Amgen, Arena, Biogen, Bristol-Myers Squibb, Celltrion, Eli-Lilly, Ferring, Galapagos, Gilead, Janssen, MSD, Mylan, Pfizer, Protagonist Therapeutics, Roche, Samsung Bioepis, Sandoz, Takeda, lecture and/or speaker bureau fees from AbbVie, Amgen, Arena, Biogen, Bristol-Myers Squibb, Celltrion, Eli-Lilly, Ferring, Galapagos, Gilead, Janssen, MSD, Mitsubishi Tanabe, Novartis, Pfizer, Roche, Sandoz, Takeda, Tigenix, and research grants from MSD, Pfizer, Takeda and Biogen. A Repici received consulting fee from Medtronic, Fuji and Olympus and has received research grant from Alfa Sigma, Norgine, Boston and Erbe. C Bezzio received speaker’s fees and consulting fees from for Takeda, MSD, Ferring, Abbvie, Galapagos and Janssen. A Dal Buono has received speaker’s fees from Pfizer, MSD, Eli-Lilly, Celltrion, Janssen, and consulting fees from Ferring. R Gabbiadini has received speaker’s fees from Pfizer, MSD, Ferring, Eli-Lilly, Celltrion, Janssen, consulting fees from Pfizer and Abbvie. G. Privitera has received speaker’s fees from Janssen and Alphasigma. B. Masoni and G. Franchellucci declare no conflict of interests.

Introduction

Capsule endoscopy (CE) is a minimally invasive and essential tool for assessing small bowel disorders, especially Crohn’s disease. Accurate detection of ulcers and erosions is vital for evaluating disease activity, guiding treatment, and monitoring therapeutic response. Although CE has revolutionized lesion detection, its manual interpretation remains time-consuming and subject to interobserver variability. Recent advances in artificial intelligence (AI), particularly convolutional neural networks (CNNs), offer promising solutions by enhancing diagnostic accuracy, reducing variability, and improving workflow efficiency. This study aimed to develop and validate a robust AI model capable of detecting and distinguishing small bowel ulcers and erosions across multiple CE platforms and clinical centers.

Aims & Methods

In a prospective, multicenter study conducted between January 2021 and April 2024, data were collected from centers in Portugal, Spain, and the United States. Two CE devices—PillCamSB3 and Olympus EC-10—were used to analyze 137 anonymized exams. The AI-assisted readings generated by a deep learning model were compared to standard-of-care (SoC) interpretations, with an expert consensus panel serving as the reference standard. Performance metrics included sensitivity, specificity, positive and negative predictive values (PPV, NPV), and area under the receiver operating characteristic curve (AUROC).

Results

Expert consensus identified ulcers and erosions in 56 patients (40.9%). Compared to the reference standard, SoC readings achieved 60.7% sensitivity, 98.8% specificity, 97.1% PPV, 78.4% NPV, and 83.2% accuracy. In contrast, the AI-assisted model achieved 94.6% sensitivity, 80.2% specificity, 76.8% PPV, 95.6% NPV, and 86.1% accuracy. The AI model was found to be both non-inferior (p < 0.001) and statistically superior (p < 0.001) to SoC. Notably, it identified 68 lesions, nearly double those detected by SoC (35), and demonstrated consistent performance across devices and centers. The mean AI-assisted reading time was 239 seconds (SD 138 seconds) per exam.

Conclusion

The AI-assisted model significantly outperformed conventional SoC in the detection of small bowel ulcers and erosions, achieving higher sensitivity and overall accuracy while substantially reducing reading time. This is the first multicenter validation of an interoperable AI solution for CE, capable of high diagnostic performance across different devices and clinical environments. These findings highlight the potential of AI to transform endoscopic evaluation and management in inflammatory bowel disease.

Introduction

MORF-057 is an oral α₄β₇ integrin inhibitor that prevents immune cell entry into the gut to alleviate inflammation.

Aims & Methods

EMERALD-2 is a phase 2b, randomized, double-blind, placebo-controlled study evaluating MORF-057 efficacy and safety in adults with moderately to severely active ulcerative colitis (UC). Participants with Modified Mayo Score (MMS) 5–9, inadequate/loss of response or intolerance to conventional or advanced therapy (AT), and who were integrin inhibitor-naïve received 1 of 3 MORF-057 doses or placebo (1:1:1:1). The primary efficacy endpoint was clinical remission at Week 12; secondary and exploratory efficacy endpoints were rates of clinical response and endoscopic improvement, respectively. Pharmacokinetic and pharmacodynamic endpoints and safety were evaluated. The study is registered with ClinicalTrials.gov (NCT05611671).

Results

The study enrolled 280 participants (mean [SD] age, 40.2 [14.6] years; 55.4% male; mean [SD] time since UC diagnosis, 6.7 [7.2] years). At baseline, mean (SD) MMS was 6.7 (1.0); 39.3% of participants were on a stable corticosteroid dose, 20.4% were on an immunomodulator, and 31.1% were AT-experienced.
Clinical remission rate with MORF-057 at Week 12 was dose dependent, ranging from 17.1% (100 mg QD) to 31.9% (200 mg BID) vs. 24.3% with placebo (Table 1), with the same trend in the AT-experienced subgroup (N=87; 100 mg QD, 4.3%; 100 mg BID, 13.6%; 200 mg BID, 21.1%; placebo, 13.0%). Compared with placebo, 200 mg BID MORF-057 had numerically higher clinical response and endoscopic and histo-endoscopic mucosal improvement (HEMI) rates, with the latter 2 endpoints showing an increasing trend with higher doses.

Table 1. Efficacy endpoints in EMERALD-2 at Week 12

Rate (proportion of patients, %)	MORF-057			Placebo (n=70)
	100 mg QD (n=70)	100 mg BID (n=71)	200 mg BID (n=69)
Clinical Remissiona	17.1	23.9	31.9	24.3
Clinical Responseb	57.1	53.5	62.3	54.3
Endoscopic Improvementc	31.4	32.4	43.5	31.4
Histo-Endoscopic Mucosal Improvementd	27.1	31.0	42.0	25.7

^aBased on MMS (stool frequency=0/1, RB=0, MES=0/1 [excluding friability]). Non-significant vs. placebo.
^b≥2-point reduction in MMS and ≥30% change from baseline, and ≥1-point reduction in RB score from baseline or RB=0/1.
^cMES≤1.
^dMES=0/1 (excluding friability) and neutrophil infiltration in <5% of crypts; no crypt destruction; and no erosions, ulcerations, or granulation tissue (Geboes scoring).
MES, Mayo Endoscopic Subscore; MMS, Modified Mayo Score; RB, rectal bleeding.

There was a dose-dependent increasing trend in α4β7 receptor occupancy. Treatment-emergent adverse events (TEAEs) in the MORF-057 groups were mostly of mild (42/76, 55.3%) or moderate (25/76, 32.9%) severity; TEAE frequency was similar to the placebo group (36.0% [pooled rate for 3 dose regimens] vs. 34.8%). Among all participants, there were 5 serious AEs not considered treatment-related (UC exacerbation [n=2], AST increase, pneumothorax, vertebral disc herniation). There were no cases of progressive multifocal leukoencephalopathy or meaningfully increased absolute lymphocyte count and no deaths.

Conclusion

Dose-dependent responses to MORF-057 were observed for clinical remission and hard-to-achieve endpoints such as HEMI at Week 12. The clinical remission rate with MORF-057 was numerically higher but did not achieve statistical significance vs. placebo, which showed higher-than-expected responses. MORF-057 had a favorable safety profile with no meaningful safety findings. The study is ongoing to evaluate maintenance safety and efficacy, with further clinical development of MORF-057 planned.

Disclosure

BES: Honoraria for consulting--AbbVie, Adiso Therapeutics, Agomab, Alimentiv, Amgen, AnaptysBio, Arena Pharmaceuticals, Artugen Therapeutics, Astra Zeneca, Biolojic Design, Biora Therapeutics, Boehringer Ingelheim, Boston Pharmaceuticals, Calibr, Celgene, Celltrion, ClostraBio, Equillium, Enthera, Enveda Biosciences, Evommune, Ferring, Fresenius Kabi, Fzata, Galapagos, Genentech (Roche), Gilead Sciences, GlaxoSmithKline, Gossamer Bio, Imhotex, Index Pharmaceuticals, Innovation Pharmaceuticals, Inotrem, Kaleido, Kallyope, Merck & Co., Microbiotica, Mitsubishi Tanabe, Mobius Care, Morphic Therapeutics, MRM Health, Nexus Therapeutics, Nimbus Discovery, Odyssey Therapeutics, OSE Immunotherapeutics, Palisade Bio, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, Rasayana Therapeutics, Recludix Therapeutics, Reistone Biopharma, Sanofi, Sorriso Therapeutics, Spyre Therapeutics, Surrozen, Target RWE, Teva, TLL Pharmaceutical, Tr1X, Union Therapeutics, Ventyx Biosciences. Consulting and speaking fees--Abivax. Consulting and speaking fees and other support--Eli Lilly and Company. Research grants, consulting and speaking fees, and other support--Bristol Myers Squibb, Eli Lilly and Company, Janssen, Pfizer, Takeda. Research grants and consulting fees--Janssen. Stock/stock options--Ventyx Biopharma.
BGF: Senior Scientific Director at Alimentiv Inc. Consulting--AbbVie, Abivax, Adiso, AgomAB Therapeutics, Akros, Alira Health, Ally Bridge Group, AnaptysBio, Apini Therapeutics, Argenx, Attovia Tx, Avoro Capital Advisors, Belmore Law, BioFactura, BioJamp, Biora Therapeutics, Blackbird Laboratories, Boehringer-Ingelheim, Boxer Capital, Celsius Therapeutics, Celgene/Bristol Myers Squibb, Celltrion, Clarivate, Connect BioPharma, Disc Medicine, Duality, EcoR1, Eli Lilly and Company, Ensho Therapeutics, Equillium, Evida, Enveda, Faes Farma, First Wave, Forbion, Galapagos, Galen Atlantica, Genentech/Roche, General Atlantic, Genesis Therapeutics, Gilead, Gossamer Pharma, GSK, Imhotex, ImmiDomics, Immunic Therapeutics, Intercept, Janssen, Japan Tobacco Inc., Klick Health, LifeMine Therapeutics, Mage Biologics, Merck, Mestag, Mirador Therapeutics, Mobius Care, Monte Rosa Tx, Morphic Therapeutics, Nexys Therapeutics, Nighthawk Therapeutics, Nimbus Therapeutics, Novartis, OncoC4, OrbiMed, Orphagen, Palisade Bio, Pendopharm, Pfizer, Protagonist,32 Bio, REDX, Roche, Roivant/Televant, Sanofi, Sobi, Sorriso, Spyre Therapeutics, SRT Therapeutics, Sun Pharma, Surrozen Inc., Synedgen, Takeda, Teva, Triastek, Trex Bio, TR1X Inc. TVM Lifesciences, Ventyx Biosciences, Versant Ventures, Vida Ventures, Zagbio. Speaker's Bureau--AbbVie, Janssen, Takeda. Scientific Advisory Board (DSMB)--AbbVie, AnaptysBio, Boehringer-Ingelheim, Celgene/Bristol Myers Squibb, Eli Lilly and Company, Genentech/Roche, Janssen, Merck, MiroBio, Origo BioPharma, Pfizer, REDX Pharma, Sanofi, Takeda, Teva, Ecor1Capital, Morphic, GSK. Stock shareholder--Connect BioPharma, EnGene. Provided expert testimony--Belmore Law.
SS: Received fees--AbbVie, Amgen, Arena, Biogen, Bristol Meyers Squibb, Celgene, Celltrion, Falk, Ferring, Fresenius Kabi, Galapagos, Gilead, IMAB, Janssen, Eli Lilly and Company, MSD, Mylan, Novartis, Pfizer, Protagonist, Provention Bio, Roche, Sandoz/Hexal, Shire, Takeda, Ventyx.
LP-B: Consulting--AbbVie, Abivax, Adacyte, Alimentiv, Amgen, Applied Molecular Transport, Arena, Banook, Biogen, Bristol Myers Squibb, Celltrion, Connect Biopharm, Cytoki Pharma, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Gossamer Bio, GSK, IAC Image Analysis, Index Pharmaceuticals, Inotrem, Janssen, Lilly, Medac, Mopac, Morphic, MSD, Nordic Pharma, Novartis, Oncodesign Precision Medicine, ONO Pharma, OSE Immunotherapeuthics, Pandion Therapeuthics, Par' Immune, Pfizer, Prometheus, Protagonist, Roche, Samsung, Sandoz, Sanofi, Satisfay, Takeda, Telavant, Theravance, Thermo Fischer, Tigenix, Tillots, Viatris, Vectivbio, Ventyx, Ysopia. Grants--Celltrion, Fresenius Kabi, Medac, MSD, Takeda. Lectures--AbbVie, Alfasigma, Amgen, Arena, Biogen, Celltrion, Ferring, Galapagos, Genentech, Gilead, Janssen, Kern Pharma, Eli Lilly and Company, Medac, MSD, Nordic Pharma, Pfizer, Sandoz, Takeda, Tillots, Viatris. Travel support--AbbVie, Alfasigma, Amgen, Celltrion, Connect Biopharm, Ferring, Galapagos, Genentech, Gilead, Gossamer Bio, Janssen, Eli Lilly and Company, Medac, Morphic, MSD, Pfizer, Sandoz, Takeda, Thermo Fischer, Tillots.
SD: Consultancy fees--AbbVie, Alimentiv, Allergan, Amgen, Applied Molecular Transport, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Dr Falk Pharma, Eli Lilly and Company, Enthera, Ferring Pharmaceuticals Inc., Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, Morphic, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, Teladoc Health, TiGenix, UCB Inc., Vial, Vifor. Lecture fees--AbbVie, Amgen, Ferring Pharmaceuticals Inc., Gilead, Janssen, Mylan, Pfizer, Takeda.
BA, MC, YW, SKL, MM, AW, XZ, NME: Employees and stockholders of Eli Lilly and Company.