Introduction

Colonoscopy as gold standard for colorectal cancer screening remains subject to subjective interpretation. Computer-aided detection (CADe) improves colorectal polyp detection and needs to be clinically tested as an objective measure.

Aims & Methods

This trial aimed to validate a novel CADe system for colorectal polyp detection versus trained endoscopists in an innovative endoscopist blinded set-up with real-time unblinding by a second observer. This study design allows to assess the performances of both CADe and endoscopists.
The CAD-ARTIPOD trial is an investigator-initiated prospective multicenter trial conducted in 9 European centers. The CADe system is unique in design combining a convolutional neural network with a recurrent neural network for detection of colorectal polyps trained in all imaging modalities. Sample size analysis for superiority in polyp detection required 2048 polyps assuming a difference in sensitivity of 2% with endoscopic diagnosis as gold standard. All participating endoscopists (adenoma detection rate (ADR) 20-50%) were blinded to the CADe output. A trained second observer assessed and classified in real time the CADe output in
(1) true positive, either detected or not detected by the endoscopist,
(2) False negative or
(3) clinically relevant or irrelevant false positive detection.
The endoscopist was the gold standard for the primary endpoint (endoscopic lesion detection) and if a CADe detected polyp was not picked-up by the endoscopist, the endoscopist was unblinded for confirmation of the finding. All polyps detected and confirmed endoscopically were resected. Histological assessment was performed by two independent histopathologists.

Results

A total number of 2141 polyps were collected in 946 patients of which 1958 (91.5%) polyps were resected and 1608 (82.1%) were histologically confirmed, with 475 hyperplastic polyps , 989 adenomas, and 119 sessile serrated lesions, 15 inflammatory pseudopolyps and 10 carcinomas.
For the primary endpoint superiority was not reached between CADe and endoscopists with a sensitivity of 0.946 and 0.961, respectively (non-inferiority margin of 5%, p = 0.0216). The CADe system detected 3.9% extra polyps, missed by the endoscopist. False positive rate was 1.8/min clean withdrawal time and 36.3% of those were deemed clinically relevant.
With histology as gold standard, CADe outperformed the endoscopists with a sensitivity of 0.9602 versus 0.9496 (p=0.03) and showed an extra detection rate of 5.0%. Remarkably, baseline polyp detection rate (PDR) increased from 0.47 to 0.70 during the trial (D0.48, OR 2.76 (95% CI: 2.26 – 3.37)). Similarly, ADR increased from 0.38 at baseline to 0.45 (D0.21, OR 1.52 (95% CI: 1.26 ; 1.85)).

Conclusion

This multiplatform CADe system, used in an innovative and competitive study design, demonstrated non-inferiority in comparison to endoscopists’ polyp detection. However, with histology as gold standard, CADe outperformed endoscopists. Our study also shows that “watching over a shoulder” in itself leads to higher PDR and ADR.

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

Treatment goals in inflammatory bowel disease (IBD) have evolved beyond symptom control to include mucosal healing, prevention of disease-related complications, improvement of health-related quality of life, and reduction of long-term disability, as outlined by the STRIDE II initiative¹. Despite significant progress in the development of advanced therapies (ADTs), up to 50% of IBD patients fail to respond to currently available treatments, underscoring the urgent need for new therapies, which are investigated in randomized clinical trials (RCTs). However, stringent eligibility criteria in RCTs limit the inclusion of real-world IBD patients, potentially compromising the generalizability of trial findings to daily clinical practice.

Aims & Methods

The aim of this study was to evaluate the proportion of real-life IBD patients who would be eligible for ongoing RCTs and to assess the representativeness of this population. Moreover, we aimed to identify the most frequently unmet eligibility criteria leading to patient exclusion and to characterize the clinical profiles that differentiate eligible from ineligible patients.
This prospective, observational, multicenter study was conducted between October 2023 and October 2024 at 2 tertiary IBD referral centers: the Fondazione Policlinico Universitario “A. Gemelli” in Rome, Italy, and the Crohn’s & Colitis Center at the University of Miami, USA. Consecutive patients with IBD indicated for a new ADT were enrolled. Each patient was systematically screened for inclusion and exclusion criteria across all actively recruiting phase 2b and 3 RCTs available at each center at the time of evaluation (6 RCTs in Rome: 4 UC and 2 CD; 5 RCTs in Miami: 3 UC and 2 CD).

Results

A total of 166 IBD patients (69 UC and 97 CD) were enrolled, with 129 patients from the Italian cohort and 37 from the American cohort. Among UC patients, only 16 (23.2%) met the eligibility criteria for at least 1 RCT, whereas 53 (76.8%) were deemed ineligible (p<0.001). In the CD group, just 10 patients (10.3%) were eligible for at least 1 RCT, compared to 87 (89.7%) who were not (p<0.001). The most common reasons for ineligibility among UC patients included: Modified Mayo score not within the required range of 5–9 (50.7%), absence of bowel urgency (63.8%), Mayo Endoscopic Subscore <2 (39.1%), failure to comply with ADT washout requirements (56.5%), insufficient number of prior ADT failures (39.0%), and recent use of topical 5-ASA or steroids within 4 weeks prior to screening (62.3%).
In CD patients, the most frequently unmet criterion was a CDAI between 220 and 450 (92.8%), followed by insufficiently liquid stool frequency (≥4 very soft or liquid stools/day; 75.3%), SES-CD<6 (39.2%), and the presence of CD-related complications such as strictures or fistulas (13.1%).

Conclusion

The majority of real-life IBD patients, particularly those with CD, are ineligible for participation in current RCTs—primarily due to relatively mild disease activity or ongoing need for concomitant therapies that are not permitted by trial protocols. Importantly, many real-world CD patients initiate new ADTs based on radiologic signs of disease activity, the presence of disease complications, or as prophylaxis for post-surgical recurrence, rather than clinical activity scores alone. Similarly, UC patients may require ADTs even in the context of corticosteroid dependence and low-grade disease activity. These findings underscore the need to revisit and broaden eligibility criteria in future RCTs to ensure greater external validity and alignment with the heterogeneity of real-life IBD population.

References

1. Turner D, Ricciuto A, Lewis A, D'Amico F, Dhaliwal J, Griffiths AM, Bettenworth D, Sandborn WJ, Sands BE, Reinisch W, Schölmerich J, Bemelman W, Danese S, Mary JY, Rubin D, Colombel JF, Peyrin-Biroulet L, Dotan I, Abreu MT, Dignass A; International Organization for the Study of IBD. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021 Apr;160(5):1570-1583. doi: 10.1053/j.gastro.2020.12.031. Epub 2021 Feb 19. PMID: 33359090.

Introduction

The safety and efficacy of mirikizumab (miri), an anti-IL-23p19 antibody, for moderately-to-severely active ulcerative colitis (UC) have been shown in Phase 3 trials (LUCENT-1 and -2; NCT03518086, NCT03524092). Extended induction with 3 additional intravenous (IV) doses of miri induced clinical response at Week (W)24 in more than 50% of patients who did not initially achieve clinical response to induction with miri at W12. Among the clinical non-responders, some had achieved partial response at W12 (Table 1). We assessed response over time in clinical non-responders at the end of induction who received extended induction with miri for an additional 12W.

Aims & Methods

In LUCENT-1, patients (N=1281) were randomly assigned 3:1 to receive miri 300mg or placebo IV at W0, W4, and W8. Patients not achieving clinical response with miri 300mg IV at W12 of LUCENT-1 (n=272) received extended induction treatment with open-label miri 300mg IV at W12, W16, and W20 (LUCENT-2). Symptomatic remission, symptomatic response, bowel urgency (BU) remission, and BU change from baseline at W16 and W20 are reported (definitions in Table 1) in addition to the previously disclosed outcomes at W24. For categorical variables, number and percentage of patients who are responders/remitters were presented. For continuous variables, mean change from baseline with standard deviation (SD) was used. Missing data were imputed as non-response.

Results

Among patients who were clinical non-responders to 12W of initial induction treatment (n=272), 53 (19.5%); 73 (26.8%); 101 (37.1%) achieved symptomatic remission and 144 (52.9%); 169 (62.1%); 197 (72.4%) patients achieved symptomatic response at W16, W20, and W24, respectively. Among miri induction non-responders with Urgency Numeric Rating Scale (NRS) score ≥3 at induction baseline (n=256), 10.9% achieved BU remission at W16, 14.8% at W20, and 19.9% at W24. There was a 1.8±2.4 (mean±SD) point reduction in Urgency NRS scores at W16, 2.1±2.5 reduction at W20, and 2.5±2.7 reduction at W24 (Table 1).

Table 1. Clinical outcomes for the mirikizumab induction non-responder patient population
Outcomes for miri IV extended induction	W12 (W0 extended induction) Miri induction non-respondersa 300 miri IV, Q4W N= 272	W16 (W4 extended induction) Miri induction non-respondersa 300 miri IV, Q4W N= 272	W20 (W8 extended induction) Miri induction non-respondersa 300 miri IV, Q4W N= 272	W24 (W12 extended induction) Miri induction non-respondersa 300 miri IV, Q4W N= 272
Clinical responseb	0	n/a	n/a	146 (53.7)
Symptomatic remissionc	13 (4.8)	53 (19.5)	73 (26.8)	101 (37.1)
Symptomatic responsed	83 (30.5)	144 (52.9)	169 (62.1)	197 (72.4)
BU remissione(Nx= 256)	18 (7.0)	28 (10.9)	38 (14.8)	51 (19.9)
BU change from baselinef[mBOCF; mean (SD)]	-1.2 (2.2)	-1.8 (2.4)	-2.1 (2.5)	-2.5 (2.7)
Data reported as n (%) unless otherwise indicated. Abbreviations: BU=bowel urgency; IV=intravenous; mBOCF=modified baseline observation carried forward; miri=mirikizumab; N=patient population; n=patient subpopulation; Nx=number of patients with Urgency Numeric Rating Scale ≥3 at induction baseline; Q4W= every four weeks; SD=standard deviation; W=week aThe miri induction non-responder population only included patients who continued to the maintenance trial (LUCENT-2) bDefined as ≥2-point and ≥30% decrease in Modified Mayo Score from baseline; rectal bleeding =0 or 1 or ≥1-point decrease from baseline cDefined as stool frequency =0 or stool frequency =1 with ≥1-point decrease in Modified Mayo Score from baseline; rectal bleeding=0 dDefined as at least a 30% decrease from baseline in the composite clinical endpoint of the sum of stool frequency and rectal bleeding subscores eDefined as Urgency Numeric Rating Scale score=0 or 1 fChange from baseline in Urgency Numeric Rating Scale score; range 0 to 10; a lower score indicates less severe bowel urgency

Conclusion

Among patients who were clinical non-responders to induction at W12, more than 50% achieved clinical response after 3 additional induction doses with miri. A proportion of patients benefited earlier from extended induction at W16 and W20, respectively, regarding symptomatic response and remission, and BU outcomes. The results demonstrate continued symptomatic improvement and further support the potential benefit of extended induction treatment.

Disclosure

DR receives grants or contracts from Takeda, and discloses consultancy fees with Abbvie, Altrubio, Allergan, Inc., American College of Gastroenterology, Arena Pharmaceuticals, Athos Therapeutics, Bellatrix Pharmaceuticals, Boehringer Ingelheim, Ltd., Bristol-Myers Squibb, Celgene Corp/Syneos, Cornerstones Health, Inc. (non-profit), GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, GoDuRn, LLC, InDex Pharmaceuticals, Ironwood Pharmaceuticals, Iterative Scopes, Janssen Pharmaceuticals, Eli Lilly and Company, Materia Prima, Pfizer, Prometheus Biosciences, Reistone, Takeda and Techlab, Inc.
AC is on the advisory board of and/or a consultant for and/or receives educational grants from Abbvie, Eli Lilly and Company, Janssen, Pfizer, and Takeda.
VJ has received consulting/advisory board fees from AbbVie, Alimentiv Inc. (formerly Robarts Clinical Trials), Arena Pharmaceuticals, Asieris, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Fresenius Kabi, Galapagos, GlaxoSmithKline, Genentech, Gilead, Janssen, Merck, Mylan, Pandion, Pendopharm, Pfizer, Reistone Biopharma, Roche, Sandoz, Takeda and TopiVert, and speaker’s fees from AbbVie, Ferring, Galapagos, Janssen, Pfizer, Shire and Takeda.
JW has received consultancy or advisory board fees from Medtronic and Eli Lilly and Company.
KM, RM,SM, RE, SB are employees and minor shareholders of Eli Lilly and Company
LZ-P is an employee of HaaPACS GmbH and contractor for Eli Lilly and Company
TK has received lecture fees from Abbie GK, Activaid, Alfresa Pharma, Janssen Pharmaceutical, JIMRO, Kyorin Pharmaceutical, Mitsubishi Tanabe Pharma, Nippon Kayaku, Pfizer Japan, Takeda Pharmaceutical, Thermo Fisher Diagnostics and Zeria Pharmaceutical; research grants from Abbvie GK, Activaid, Alfresa Pharma, Bristol Myers Squibb, Eli Lilly Japan, Ferring Pharmaceuticals, Gilead Sciences, Janssen Pharmaceutical, JMDC, Mochida Pharmaceutical, Nippon Kayaku, Pfizer Japan and Takeda Pharmaceutical; scholarship contributions from Mitsubishi Tanabe Pharma, Nippon Kayaku and Zeria Pharmaceutical; study group sponsorship by Abbvie GK, EA Pharma, JIMRO, Kyorin Pharmaceutical, Mochida Pharmaceutical, Otsuka Holdings and Zeria Pharmaceutical; and advisory or consultancy fees from Abbie GK, Activaid, Alfresa Pharma, EA Pharma, Janssen Pharmaceutical, KISSEI Pharmaceutical, Kyorin Pharmaceutical, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Nippon Kayaku, Pfizer Japan and Takeda Pharmaceutical.