bluuebunny/crossref_metadata_2025 huggingface dataset:
P0269 Examination of the safety and effectiveness of budesonide rectal foam for patients with Ulcerative Colitis: Final report of post-marketing surveillance in Japan
Authors: Omori T , Saruta M , Nagaki A , Kuramoto K , Suzuki Y
Published: January 2025

Background

Budesonide rectal foam (BF) was approved in Japan in September 2017 for the treatment of mild to moderate active ulcerative colitis (UC).

Post-marketing surveillance was conducted from February 2018 to evaluate the safety and effectiveness in clinical practice.

Methods

We conducted this as a prospective, multicenter, open-label, observational study of subjects with mild to moderate active UC who received BF between February 2018 and April 2019.

Patient background, BF dosing status, adverse drug reaction (ADR), effectiveness using Partial Mayo score (PMS), and current health condition using the Visual Analogue Scale (VAS) were evaluated.

Results

Of the 633 patients included in the safety analysis, 53.7% were men, the mean age was 45.6 years, and the mean duration of BF treatment was 55.0 days.

Prior to BF administration, 92.9% used other UC medications, and the use of topical preparations was 22.1%.

The concomitant use of other UC medications was 96.7%, of which 91.5% was concomitant use of oral 5-ASA preparations.

ADRs occurred in 27 patients (4.27%). Serious ADRs were cytomegalovirus enteritis and enteritis infectious in one case each, but both cases recovered.

Glucocorticoid-related ADRs were observed in 7 patients (1.11%), but all ADRs were non-serious and the outcome was reversible or remitted.

In the 503 patients included in the effectiveness analysis, PMS and subscores significantly decreased from baseline to week 2 (Wilcoxon test, p<0.0001 for all).

Clinical response and remission at week 6 were 72.8% and 72.1%, respectively.

The changes in VAS scores were significantly improved from baseline to week 2 (all p<0.0001 by t-test).

Conclusion

No new safety concerns were identified for the BF in Japanese patients with mild to moderate acute UC, and its effectiveness and improvements in health condition were confirmed in actual clinical practice.
P0270 Standardisation of Rapid TDM Assay with WHO International Reference Material for Anti-Infliximab Antibodies
Authors: Dähn O , Johnson J , Ricken B , Anchling L , Gerhold C B
Published: January 2025

Background

Point-of-care (POC) tests play a crucial role in therapeutic drug monitoring (TDM) for Inflammatory bowel disease (IBD) patients undergoing anti-TNF therapy. Infliximab (IFX), the first biologic used in IBD treatment, is a chimeric anti-TNF-alpha blocker. However, its composition can trigger an immune response in patients, leading to the production of anti-drug antibodies (ADAs). Consequently, regular monitoring for ADAs is essential during IFX therapy. Various assays are available to measure anti-IFX antibody levels, mainly based on ELISA technology. The recent introduction of an international reference material (IRM) for infliximab ADAs allows enhanced measurement traceability and enables harmonised standardisation and improved comparability across different assays. Furthermore, it is mandatory to standardise with an existing IRM for compliance with the in vitro diagnostic regulation (IVDR). This study focused on standardising the lateral flow based Quantum Blue® Anti-Infliximab assay (LF-ADIF) using the IRM and comparing its performance with the current standardisation material. Additionally, a method comparison to established ELISA assays was carried out.

Methods

The lateral flow assay was calibrated with both the currently used standardisation material and the new IRM. Blant-Altman analysis was performed to evaluate the comparability of both standardisation materials. To establish the cut-off, 105 healthy donor samples were measured. This cut-off will be used for discrimination of positive and negative results of the rapid test. Furthermore, a set of 30 patient samples was analysed for method comparison with established ELISA assays.

Results

The Blant-Altman analysis revealed that a IRM based calibration is feasible and IRM concentrations <100 IU/mL can be detected. A technical cut-off was established allowing the discrimination of positive and negative patient samples. Total agreement between the lateral flow assay and the ELISA assays was demonstrated in the method comparison.

Conclusion

To the best of our knowledge the here presented assay is the first IRM based and IVDR ready lateral flow assay for anti-infliximab. The total agreement of patient sample results between the Quantum Blue® Anti-Infliximab assay and commercially available ELISA assays revealed good comparability. IRM standardisation across all anti-IFX assays would further improve comparability between them.
P0272 Evaluation of Rectal Wall Thickness Measurement Sensitivity via Transabdominal Ultrasound to Assess Mucosal Activity in Ulcerative Colitis: Could This Be a Useful Non-Invasive Tool? A Preliminary Analysis.
Authors: Calabrese F , Pasta A , Marabotto E , Furnari M , Santamorena G , Giannini E , Bodini G
Published: January 2025

Background

Ulcerative colitis (UC) is a chronic inflammatory bowel disease where accurate assessment of disease activity is essential for patient management. Endoscopy is the gold standard for evaluating mucosal inflammation, but non-invasive alternatives, such as transabdominal ultrasound (TAUS), are garnering interest. This study aimed to evaluate the sensitivity of rectal wall thickness measurement using TAUS to assess UC activity, comparing to endoscopic and histological findings.

Methods

In a prospective, observational study, we enrolled consecutive adult patients with UC who were referred to our tertiary center from May to October 2024. Eligibility required a scheduled TAUS before 30 days of a staging colonoscopy, without intervening therapy adjustments. Exclusion criteria included technically inadequate TAUS readings (e.g., due to anatomical variations or excessive gas interposition). In all patients we evaluated rectal wall thickness and laboratory parameters such as C-Reactive Protein and fecal calprotectin. Disease activity was assessed by endoscopist (MAYO score). Histological status (active/inactive) and additional clinical data, including disease duration, extent, and UC treatment, were recorded.

Results

We studied 29 patients (51.7% females, median age 55 years). The median UC duration was 10 years, and most patients had proctitis or left-sided colitis (37.9% each). Patients with an endoscopic MAYO score of 0 or 1 had a median rectal wall thickness of 4.7 mm (IQR 4.5-5.5), while those with a score of 2 or 3 had a median of 7.0 (IQR 5.3-7.4 mm, p=0.005). ROC analysis of TAUS rectal wall thickness revealed significant discriminatory capability for endoscopic activity (AUC: 0.833, CI 95%, 0.678-0.989), while the same figures for fecal calprotectin and C-Reactive Protein were 0.890 (CI 95%, 0.671-1.000) and 0.774 (CI 95%, 0.604-0.944), respectively. For histological activity, accuracy of rectal wall thickness, fecal calprotectin, and C-Reactive Protein were 0.796 (CI 95%, 0.620-0.972), 0.790 (CI 95%, 0.605-0.975), and 0.645 (CI 95%, 0.429-0.861), respectively.

Conclusion

This preliminary analysis showed that rectal wall thickness measured by TAUS has a high accuracy in identifying both endoscopic and histologic activities in patients with UC, positioning it as a promising tool to avoid endoscopy. Future studies with larger cohorts are needed to confirm these findings and further optimize the use of TAUS in this setting.
P0277 Skin tag excision in Crohn’s disease: first, do no harm?
Authors: Unal E , Lavryk O , Kanters A , Spivak A , Lipman J , Fulmer C , Falloon K , Qazi T , Cohen B , Holubar S
Published: January 2025

Background

Traditionally, perianal skin tag excision has been contraindicated in patients with Crohn’s disease (CD) owing to risk of non-healing wounds. However, little data exists on this topic. We aimed to review our institutional experience with outcomes after perianal skin tag excision in patients with CD. We hypothesized that perianal skin tag excision in CD would be associated with non-healing wounds.

Methods

We retrospectively reviewed adults with CD who underwent skin tag excision with or without limited excisional hemorrhoidectomy at our center between 2012 and 2024. Demographics, CD characteristics, medications, operative data, pathology, and postoperative outcomes were reviewed.

Results

Forty-five patients with CD underwent excision of skin tags (28, 62%) and/or limited excisional hemorrhoidectomy (20, 44%). Demographics, CD characteristics, and medications are detailed in Table 1. Short -term complications occurred in 2 (4.4%); 1 fistula and 1 wound dehiscence. Pathology results were available for 42 (93%) patients; the majority were benign (33, 78.5%) but a small subset (2, 5%) had anal intraepithelial neoplasms (Table 2). Long-term complications occurred in 11 (24.4%) patients (Table 2), of which 9 (81.8%) were managed [conservatively or with non-operative therapy. Complications included perianal fistula (4, 8.8%), anal stenosis (4, 8.8%), nonhealing wounds (2, 4.4%) and anal fissure (1, 2.2%). Of these patients, seven (63.6%) later had complete wound healing. Almost half of these patients had penetrating disease with perianal involvement (5, 45.5%).

At most recent follow-up, 41 (91.1%) patients had complete wound healing, and only one (2%) patient required proctectomy. Four patients (9%) had persistent non-healing wounds; 2 with history of perianal fistulae requiring surgery (one requiring diversion), 1 with fistula 4 years after skin tag excision, and 1 later diagnosed with perianal hidradenitis suppurativa. Three (75%) of these patients had prior surgery for perianal disease (one each: fissure, abscess, and stricture), and all were on biologic therapy (infliximab, 3; adalimumab, 1).

Conclusion

Perianal skin tag excision in carefully selected CD patients resulted in wound healing in the majority (91%) of patients and can be considered for lifestyle limiting symptoms. Pathology was typically benign but occasionally revealed actionable results, including neoplasia, and should encourage routine pathologic evaluation of specimens. The risk of long-term complications was low, but higher in the CD population compared to average, and the sequelae were mostly managed with non-operative therapy. Our data suggests that previous surgery for perianal Crohn’s may be a risk factor for non-healing wounds after perianal skin tag excision.
P0286 Assessment of clinical predictive factors for the development of short bowel syndrome in a cohort of patients with Crohn’s disease
Authors: Parisio L , Becherucci G , Pizzoferrato M , Del Gaudio A , Covello C , Di Vincenzo F , Iaccarino J , Petito V , Masi L , Turchini L , Amatucci V , Profeta F , Foscarini E , Coppola G , Puca P , Laterza L , Lopetuso L R , Pugliese D , Chieppa M , Mocci G , Covino M , Cammarota G , Gasbarrini A , Scaldaferri F , Papa A
Published: January 2025

Background

Short bowel syndrome(SBS)is a severe clinical condition occuring when,following multiple intestinal resections,the remaining small bowel in continuity is ≤200cm.SBS is associated with intestinal failure(IF)when the intestinal absorptive function is compromised,requiring intravenous nutritional or electrolyte supplementation.Crohn’s disease(CD)is one of adults’ most frequent causes of SBS.The aim of this study was to identify clinical predictive factors of SBS in CD pts

Methods

We performed a prospective study, enrolling consecutive CD outpatients (pts).Statistical univariate comparison for primary outcome was assessed for continuous variables by the Mann-Whitney U test and the Kruskal-Wallis ANOVA test.Categorical variables were compared using the chi-square test.We also assessed a multivariate logistic regression model to identify independent predictors of SBS

Results

We enrolled 169 CD pts(47.3% male,mean age 43.5 years[±14.1]).45.5% of them were smokers;extraintestinal manifestations(EIMs)were present in 45.5% of pts, and 67.5% of pts had bowel resections(26.6% of them with more than one surgical intervention).Median disease duration and median time between diagnosis and the first resection were 9y(IQR 4-17)and 6.5y(IQR 1-13),respectively.At baseline,101 pts were on anti-TNF therapy,and considering the course of the disease,overall,20.1% of the pts were exposed to ≥3 biologics.10% of pts had SBS and 5.3% IF.In univariate analysis,comparing patients with and without SBS,the following variables were statistically different:disease duration(p=0.000),upper gastrointestinal disease location(p=0.001),ileocolonic location(p=0.008),stenosing behavior(p=0.040),perianal disease(p=0.000)and time elapsing from CD diagnosis to start biological therapy(0.002).At multivariate analysis,disease duration(p=0.000),perianal disease(p=0.05)and time elapsing from CD diagnosis to start biological therapy(p=0.016)resulted independently associated with the development of SBS

Conclusion

Our data identify the clinical features that would allow the gastroenterologists to predict the risk of developing SBS in a cohort of CD pts.Further studies would be needed to confirm our findings.Funded by:2.1 “Rafforzamento e potenziamento della ricerca biomedica del SSN”,finanziato dall’Unione europea–NextGenerationEU, CUP C53C22001140007. 2022 PNRR Project “Changing the future of intestinal failure in intestinal chronic inflammation:towards innovative predictive factors and therapeutic targets”code:PNRR-MAD-2022-12376791
P0287 Mild Crohn´s Disease is associated with a low, but not negligible, rate of progression, over a 5-year follow-up period
Authors: Bárbara A , Bravo C , Abrantes D , Abreu B , Reves J , Palmela C , Gomes C , Torres J
Published: January 2025

Background

Currently, most studies aim to identify predictive factors for complicated phenotype in Crohn’s disease (CD). However, it is equally important to identify factors associated with a mild disease course, thereby avoiding unnecessary exposure of patients to the potential risks of medication.

Methods

This was a retrospective cohort study of incident CD cases between February 2015 and August 2023. Mild CD was defined as: 1) absence or minimal symptoms at diagnosis, 2) absence of deep ulcers on colonoscopy, 3) absence of complications (strictures, fistula, perianal disease), and/or 4) no need for surgery within three months of diagnosis. A composite outcome was defined by the need of steroids, therapeutic escalation, surgery, progression to fistulizing/penetrating disease, or perianal disease. Survival analysis was performed.

Results

We included 40 patients (55% male; median age of 44 years, IQR [34-56]), with a median follow-up of 63 months, IQR [35–111]. According to Montreal classification the majority were A2 (55%) with terminal ileum involvement (L1 72.5%, of which 80% had <10 cm of ileal involvement, L2 20%, L3 7.5%). At diagnosis, 55% started on 5-ASA, 35% oral budesonide, and 10% did not receive any treatment. The composite outcome occurred in 22.5% of cases (9/40), with a median time until the event of 30 months IQR [6.5-70]: perianal disease in 0.03% (1/40), development of stricturing phenotype in 0.03% (1/40), need for steroids in 17.5% (7/40) and need to escalate therapy also in 17.5% (7/40) patients.

Characteristics at baseline were not different between those who developed the composite outcome. Shorter ideal disease showed a trend toward a lower rate of disease progression (16%vs 23%, p=0.09) (table 1). In a multivariate cox regression, none of these variables were independent predictors of the need of corticotherapy, escalation of therapy or the development of the composite outcome.

Conclusion

Only a minority of patients with mild CD had disease progression, which was generally indolent. No factors associated with worse outcomes were identified in our cohort. Mild CD appears to represent a distinct phenotype that warrants further investigation to better characterize its disease course.
P0288 Translation and validation of the IBD-Disk as a tool for assessing the degree of disability in a cohort of Spanish-speaking patients with inflammatory bowel disease. TRAVIDI study.
Authors: González Muñoza C , Giordano A , Gely C , Gordillo Ábalos J , Bertoletti F , Roig C , Garcia Planella E
Published: January 2025

Background

Inflammatory bowel diseases (IBD), such as Crohn’s disease (CD) and ulcerative colitis (UC), impact patients’ quality of life, affecting them during both active periods and remission. Recently, tools have been designed to align therapeutic goals between patients and healthcare professionals, known as Patient-Reported Outcome Measures (PROMs). The Inflammatory Bowel Disease Disability Index (IBD-DI) measures disability in IBD patients, but its complexity limits its use. Alternatively, a simplified self-administered version, the IBD-Disk (IBDD), has been developed and validated in various languages, though not yet in Spanish. This study aims to translate and validate the Spanish version of the IBDD

Methods

This prospective study involved the translation and validation of the IBDD in a cohort of patients at a tertiary referral centre for IBD in Catalonia. Two phases were carried out: Phase 1 involved forward translation into Spanish, resolution of discrepancies by a bilingual expert (English and Spanish), and back translation into English to produce a final synthesised document tested internally with a group of 10 patients (not included in the final analysis) following the World Health Organization protocol. Phase 2 consisted of a prospective validation (at week 0 and week 24 ± 4 weeks) of the Spanish version of the IBDD, comparing it with the IBD-DI in IBD patients. Sociodemographic, clinical, and laboratory data were collected during both visits.

Results

A total of 102 patients were included (52 CD and 50 UC). The Spanish version of the IBD-Disk demonstrated high internal consistency (alpha 0.925, 95% CI: 0.902–0.945) and good test-retest reliability (intraclass correlation coefficient of 0.957). The correlation between the total IBDD and IBD-DI scores was excellent (R = 0.912; p < 0.001), confirming good concurrent validity. Seventy-two patients completed the questionnaire at week 24, showing good correlation with clinical evolution (measured by the Walmsley and Harvey-Bradshaw indices) and the IBDD.

Conclusion

The Spanish version of the IBD-Disk is a valid and reliable tool for assessing disability in Spanish-speaking IBD patients.
P0294 Functional outcomes after primary ileocecal resection for Crohn’s disease
Authors: Grellier N , Kirchgesner J , Chafai N , Nion-Larmurier I , Debove C , Bourrier A , landman C , Mclellan P , Sokol H , Beaugerie L , Lefèvre J H , Seksik P
Published: January 2025

Background

Ileocecal resection (ICR) is a common procedure in Crohn’s disease (CD). Increasing evidence suggests ICR may be considered a first-line treatment for localized ileal CD to maintain long-term remission, rather than starting biologics. However, removal of the ileocecal valve affects bowel transit and disabling symptoms may arise. The aim of our study was to prospectively assess the impact of primary ICR on daily digestive symptoms in CD patients.

Methods

We included patients who underwent primary ICR at Saint-Antoine Hospital between January 2017 and December 2022. Patients were assessed after a morphological evaluation (endoscopy or MRI) performed between 5 months and 1 year post-ICR. Digestive symptoms were prospectively and systematically collected using a dedicated database. The primary endpoint was the prevalence of a composite outcome, defined as at least 4 soft or liquid stools per day and/or a fecal urgency with inability to delay defecation for more than 15 minutes, and/or moderate to severe daily abdominal pain. Secondary endpoints included other digestive symptoms. Multiple logistic regression analysis was performed to assess predictive factors for the primary outcome.

Results

One hundred nine patients were included. Indications for ICR were fistulizing disease (n=61, 56%) and stenosis (n=41, 37.6%). Only 7 patients (6.4%) had surgery for uncomplicated inflammatory disease. Thirty-five patients (32.1%) had morphological recurrence, defined as i2b, i3, i4 score, deep ulcers, stenosis, or fistulas on MRI. The primary endpoint was met by 24 patients (22%), with 21.1% having at least 3 liquid stools per day. Diarrhea (soft to liquid stools daily) was observed in 56.9%, fecal urgency in 22.9%, and abdominal pain in 32.1% (Figure 1). The primary endpoint prevalence was 17.6% in patients without morphological recurrence and 31.4% in those with recurrence (p=0.17) (Table 1). Multivariate analysis showed that age >40 years at surgery (OR=3.58 [95%CI 1.06-12.8] p=0.04), disease duration >2 years (OR=5.67 [95%CI 1.69-23.0] p=0.008), sepsis (fever >38.3°C within 7 days before surgery) (OR=8.06 [95%CI 1.68-44.2] p=0.01), and small bowel resection length >40 cm (OR=9.50 [95%CI 2.35-45.8] p=0.003) were associated with poorer digestive quality of life as defined by the primary composite endpoint.

Conclusion

The prevalence of digestive symptoms after primary ICR for CD is notable, regardless of disease recurrence. Advanced age, long disease duration, sepsis at surgery, and resection length were associated with disabling digestive symptoms. These results suggest that ICR leads to frequent and disabling digestive symptoms for many patients, which should be considered when proposing ICR.
P0296 Comparison of clinical characteristics of Montreal classification group A3 patients with Crohn’s disease in Korea: Results from the Prospective and Retrospective CONNECT Study
Authors: Yoon J , Kim Y S , Ye B D , Cheon J H , Im J P , Joo Sung K
Published: January 2025

Background

The CONNECT study, a nationwide multicenter cohort study of Crohn’s disease (CD) in Korea, was designed to investigate the clinical characteristics and long-term prognosis of CD patients. Starting in 2009, the study enrolled patients in both a prospective cohort (patients diagnosed since 2009) and a retrospective cohort (patients diagnosed before 2009). Recent trends show an increase in elderly-onset CD (EOCD) in Korea, alongside cases in younger individuals; however, research focusing specifically on EOCD patients remains limited. This study aims to evaluate the clinical characteristics and long-term outcomes of EOCD patients using data from this nationwide, multicenter cohort in Korea.

Methods

We analyzed data both the prospective and retrospective CONNECT cohorts, which included 2,399 CD patients diagnosed between 1982 and 2019 (retrospective cohort of 1,224 patients, prospective cohort of 1,175 patients). Of these, 244 patients were identified as having Montreal classification A3 at diagnosis. Fifty-six EOCD patients (diagnosed at age 60 or older) were compared with 188 adult-onset CD patients (diagnosed at age 40-59) in aspects of baseline characteristics, medication use, and bowel resection rates.

Results

EOCD patients had a higher proportion of females (55.4%) compared to the adult-onset CD group (31.5%). Ileal involvement was the most common location of disease at diagnosis in EOCD patients (51.8%). Previous use of anti-tuberculosis medication was more frequent in EOCD patients than in the adult-onset CD group (29.6% vs. 16.3%, p = 0.047). Although there were no significant differences in disease behavior at diagnosis or ever use of medication between the groups, EOCD patients showed a significantly lower risk of bowel resection (p = 0.008).

Conclusion

EOCD patients in Korea appear to present with distinct clinical features and have a more favorable prognosis, as evidenced by a reduced need for bowel resection compared with adult-onset CD patients. Further research is essential to better understand the unique needs of EOCD patients, including the development of tailored therapeutic guidelines that address the complexities associated with aging and the management of CD.
P0297 Development of Red Flags Index for Crohn’s Disease in the Korean population
Authors: Kim O , Kim S H , Lee H J , Im J P , Kim B G , Kim J S , Koh S J ,   Gastroenterology
Published: January 2025

Background

The prevalence of Crohn’s disease (CD) is gradually increasing in South Korea, leading to various complications and negatively impacting quality of life, highlighting the need for early and non-invasive diagnosis. In 2015, the International Organization for Inflammatory Bowel Disease (IO-IBD) developed the Red Flags index for early detection of CD, but it requires validation or improvement for the Korean population. The aim of this study is to develop a Red Flags index tailored to the Korean population.

Methods

A total of 126 CD patients receiving treatment at Seoul National University Hospital were recruited for the study. These patients were compared with two control groups: Group A (111), consisting of individuals with non-CD conditions, such as irritable bowel syndrome, and Group B (60), comprising high-risk individuals who had not yet been diagnosed with CD but were either first- degree relatives of IBD patients, ASCA-positive or had spondyloarthritis. Patients answered 15 questions selected from the IO-IBD study. Chi-square test and multiple logistic regression were used consecutively to select items for the Red Flags index. To evaluate the diagnostic value of the Red flags index as a tool, ROC analysis was performed. Additionally, fecal calprotectin levels were measured in the study participants and diagnostic accuracy of combining fecal calprotectin with the Red flag index was analyzed.

Results

The Red flags index was developed for non-CD subjects and high-risk subjects, respectively. When comparing the area under the curve (AUC), the index constructed from high-risk subjects (Control Group B) showed a larger AUC of 0.909. Notably, the AUC increased when the Red Flag index was used in combination with fecal calprotectin, indicating improved diagnostic accuracy with the combined approach.

Conclusion

We developed the Red Flags index for the Korean population, designed to predict the diagnosis of CD in patients presenting with gastrointestinal symptoms. This index offers a simple, effective tool for the early CD detection.

References

1.Allocca M, Fiorino G, Bonifacio C, et al. Validation of the Red Flags Index for Early Diagnosis of Crohn’s Disease: A Prospective Observational IG-IBD Study Among General Practitioners. J Crohns Colitis. 2020;14(4):512-518.

2.Peyrin-Biroulet L, Sandborn W, Sands BE, et al. Development of Red Flags Index for Early Referral of Adults with Symptoms and Signs Suggestive of Crohn’s Disease: An IOIBD Initiative. J Crohns Colitis. 2015;9(8):601-606.

3.Furfaro F, Biamonte E, Vero V, et al. The Earlier You Find, the Better You Treat: Red Flags for Early Diagnosis of Inflammatory Bowel Disease. Diagnostics (Basel). 2023;13(20):3183.

4.Kim JW, Cho YE, Kim JH, et al. Clinical significance of anti-Saccharomyces cerevisiae antibody (ASCA) in Korean patients with Crohn’s disease and its relationship to the disease clinical course. Dig Liver Dis. 2007;39(7):610-616.
P0298 Revolutionizing Diagnostics: Evaluating ChatGPT-4’s Performance in Ulcerative Colitis Endoscopic Assessment
Authors: Levartovsky A , Albshesh A , Grinman A , Shachar E , Lahat A , Eliakim R , Kopylov U
Published: January 2025

Background

The Mayo Endoscopic Subscore (MES) is a widely utilized measure for assessing endoscopic disease activity in ulcerative colitis (UC). This assessment has a key role in clinical practice as endoscopic remission is a long-term therapeutic objective. Artificial intelligence has emerged as a promising tool for enhancing diagnostic precision and addressing inter-observer variability among endoscopists. This study aims to evaluate the diagnostic accuracy of ChatGPT-4, a multimodal large language model (LLM), in identifying and grading endoscopic images of UC patients using the MES as a reference standard, without prior configuration or fine-tuning.

Methods

Real-world endoscopic images of UC patients were obtained for severity assessment and reviewed by an expert consensus board. Each image was classified by severity grade (0-3) based on the MES. Only images that were uniformly graded by the consensus board were subsequently provided to three IBD specialists and ChatGPT-4 in three separate sessions. Severity gradings of the IBD specialists and ChatGPT-4 were compared with assessments made by the expert consensus board.

Results

Fifty endoscopic images were initially evaluated by the expert consensus board. Of those, 30 images (60%) were graded with complete agreement of MES among the experts. Compared to the consensus board, ChatGPT4’s MES gradings were accurate in 26/30 (86.7%), 21/30 (70%) and 24/30 (80%) with a mean accuracy rate of 78.9%. The IBD specialists gradings were accurate in 24/30 (80%), 24/30 (80%) and 25/30 (83.3%) with a mean accuracy rate of 81.1% (figure 1). There was no statistically significant difference in mean accuracy rates between the two groups (p = 0.71).

Conclusion

ChatGPT-4 has the potential of assessing mucosal inflammation severity from endoscopic images of UC patients, without prior configuration or fine-tuning. Performance rates were comparable to IBD specialists. Further research and validation are warranted to explore the broader applications of LLMs and their integration into diagnostic workflows.
P0313 Bowel wall thickness is not inferior to intestinal ultrasound scores in detecting endoscopic activity in Ulcerative Colitis
Authors: Elkot A , Maher M , Omran E , Eldesoky A E
Published: January 2025

Background

Several intestinal ultrasound (IUS) scores have been proposed to assess disease activity in ulcerative colitis (UC) combining different intestinal ultrasound parameters. However, it is not known if these scores are superior to solely measuring bowel wall thickness (BWT), the IUS parameter most strongly correlated with disease activity and showing a near perfect inter-rater agreement. This study aimed to compare the performance of BWT and 2 validated IUS scores, Milan US criteria (MUC), and the IUS-UC index in identifying active endoscopic disease.

Methods

Consecutive UC patients (Age ≥ 18 y) scheduled for colonoscopy or sigmoidoscopy in a single center underwent IUS within 3 weeks of the procedure, with disease activity graded using the Mayo endoscopic subscore (MES). IUS parameters assessed included BWT, color doppler signal (CDS), haustral pattern (HP), wall layer stratification (WLS), and fat wrapping. Correlations between MES and all IUS parameters, IUS-UC index, and MUC were assessed using Spearman’s rank correlation coefficient. The area under the receiver-operating characteristic (ROC) curves for detecting endoscopic activity (MES ≥ 1) for BWT, IUS-UC index, and MUC were compared.

Results

A total of 57 UC patients (undergoing 60 examinations) were enrolled (median age 34.8 years, 34.3% male). Twenty-five percent of patients were in clinical remission, defined by simple clinical colitis activity index SCCAI < 3. In comparison, 16.3% of patients had endoscopic remission (MES 0), and 33.3% had MES ≤1. The median interval between IUS and colonoscopy was 5 days. The median (IQR) BWT was 1.4mm (1.3-1.7) for MES 0, 2.1mm (1.7-2.7) for MES 1, 3.5mm (2.8-4.3) for MES 2, and 4.4mm for MES 3 (3.9-5.4). BWT, abnormal HP, CDS, IUS-UC index, and MUC showed strong correlation with endoscopic activity. The Pearson correlation coefficients were 0.834, 0.820, 0.757, 0.876, and 0.882, respectively, with all p values <.001. Fat wrapping showed moderate correlation (r = 0.666, p<.001), while loss of WLS showed a weak correlation (r = 0.391, p<.001). There was no significant statistical difference in the area under the receiver-operating characteristic curve for BWT, IUS-UC index, and MUC in differentiating endoscopic remission from endoscopic activity (MES≥1) (figure 1). The optimal cutoff values are presented in Table 1.

Conclusion

IUS-index and MUC are both sensitive and specific in detecting even mild endoscopic activity, however they didn’t show superiority over using BWT as a single parameter. Our study suggests that BWT alone is as effective as more complex IUS scores in detecting active endoscopic disease in UC. BWT may be used as a practical primary IUS parameter for the routine assessment of UC activity.
P0326 Environmental factors, genetic predisposition and subclinical inflammation in the development of perinuclear-antineutrophil cytoplasmic antibody (P-ANCA)-positive ulcerative colitis: A European twin study
Authors: Bergemalm D , Amcoff K , Pierik M J , Colombel J F , Vermeire S , Bodin L , Halfvarson J
Published: January 2025

Background

Perinuclear-antineutrophil cytoplasmic antibodies (P-ANCAs) have been identified in familial ulcerative colitis (UC), but the precise mechanism underlying their expression remains elusive. We assessed the role of genetic predisposition, environmental factors and systemic subclinical inflammation in the development of P-ANCA in a twin cohort with UC.

Methods

A total of 48 twin pairs (Leuven, Belgium n=4, Maastricht, The Netherlands n=6 and Örebro, Sweden n=38) with UC were included. Among these, 18 were monozygotic (3 concordant and 15 discordant for UC) and 30 were dizygotic (1 concordant and 29 discordant for UC). P-ANCA was detected through standardised ELISA, an indirect immunofluorescence assay and DNase treatment. In addition to high sensitivity C-reactive protein (hs-CRP), 92 inflammatory protein markers were measured in serum by proximity extension assay (Olink proteomics).

Results

P-ANCA was present in 16/52 (31%) of UC twins vs. 4/44 (9%) healthy twin siblings (p=0.01). No agreement in the presence of P-ANCA or their levels was observed between twin siblings in monozygotic pairs discordant for UC [intraclass correlation coefficient (ICC)=0.09] or dizygotic pairs (ICC=-0.20). Female sex was associated with an increased likelihood of P-ANCA (odds ratio, OR 5.49; 95% confidence interval, CI 1.47-20.57) and higher ANCA levels (ratio of geometric means 1.80; 95% CI 1.12-2.88). Active smoking was associated with lower concentrations of ANCA (ratio of geometric means 0.33; 95% CI 0.15-0.75) and potentially reduced the likelihood of P-ANCA (OR 0.23; 95% CI 0.02-2.21) in twins with UC but not in their healthy siblings. In twin siblings without UC, significant correlations between ANCA levels and hs-CRP, CDCP1, IL17A, CXCL9 and IL5 (correlation coefficients 0.36-0.41, p-values <0.05) were observed.

Conclusion

Female sex and tobacco smoking outweighed genetics regarding the generation and levels of P-ANCA and ANCA antibodies. The correlations between ANCA levels and inflammatory markers in healthy twin siblings suggest that P-ANCA may result from subclinical inflammation in these healthy siblings.
P0327 Histologic remission predicts endoscopic remission in patients with ulcerative colitis
Authors: Aouroud H , Lairani F E , Aouroud M , Nacir O , Ait Errami A , Oubaha S , Samlani Z , Krati K
Published: January 2025

Background

In 2015, the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) committee proposed a treat-to-target (T2T) approach and recommended that the therapeutic target in UC should be both clinical and patient-reported outcomes (PRO) as well as the histological remission is also considered to be a treatment target. The aim of this study was to evaluate whether histologic activity can predict the maintenance of endoscopic remission in UC pa- tients with Mayo endoscopic subscore (MES) 0 or 1

Methods

This was a retrospective study conducted over a period of 18 months (January 2023 to June 2024) at a our tertiary hospital center. Patients diagnosed with UC who had been in clinical remission (n=56) for at least 6 months were evaluated for endoscopic remission. Those in endoscopic remission (Mayo score ≤1;23/56, 41%) were subjected to multiple biopsies from the rectosigmoid region and histological remission, which was then defined as grade 0/1 as per the Geboes criteria: Patients were divided into two groups based on their histologic activity: histologic remission and active.

Results

Over 23 patients in endoscopic remission the majority had E1 (proctitis) disease (45.6%) followed by E2 (39.1%) and E3 disease (pancolitis) (15.2%) at baseline. Histological remission was noted in 47% of the patients, while 52% still retained the histologically active disease in the form of infiltration of the lamina propria by eosinophils and neutrophils (86.6%), cryptitis (93.3%), and crypt abscesses (8/15, 53.3%). On follow-up, after 1 year, 79.1% of the patients who had been in histological remission remained clinically asymptomatic, while 20% had relapsed. Among the histologically active patients, 36.6% remained in clinical remission, while 63.3% had relapsed.

Conclusion

The patients who achieve histologic remission are more likely to maintain endoscopic remission compared to those with histologic activity.
P0328 Faecal calprotectin and MRI are complementary tools for assessing treatment efficacy and predicting the risk of bowel damage progression in Crohn’s disease: results of the IZNOGOUD study
Authors: Buisson A , Guilmoteau T , Allimant C , Pereira B
Published: January 2025

Background

Faecal calprotectin (Fcal) and magnetic resonance imaging (MRI) could be used as non-invasive tools to monitor mucosal and transmural healing, respectively, in Crohn’s disease (CD).

We assessed the agreement between Fcal and MRI in detecting active CD and to explore the complementarity of these tools in predicting long-term CD outcomes.

Methods

Using pooled data from two prospective studies, we included patients with CD who underwent both MRI and Fcal testing within 7 days. MRI was performed without bowel cleansing or enema but with 0.5–1L of PEG for bowel distension. MRI included a segmental assessment of jejunum, non-terminal ileum, terminal ileum (last 30 cm), right colon, transverse colon, left colon/sigmoid colon, and rectum.

Transmural healing on MRI was defined as a C-score <0.5 in all segments.

Patients were classified into four groups: transmural healing (both normal), MRI healing (Fcal >100 μg/g but normal MRI), biochemical healing (Fcal <100 μg/g but abnormal MRI), and no healing (both Fcal and MRI abnormal).

The endpoints were the time to bowel damage progression and the time to relapse-related drug discontinuation.

Survival analyses were performed using the log-rank test (univariate) and Cox models (multivariate). Results were expressed as hazard ratios (HR) with 95% confidence intervals.

Results

Among the 112 patients included, 6.2% (7/112), 11.6% (13/112), 18.8% (21/112), and 63.4% (71/112) achieved transmural healing, MRI healing, biochemical healing, and no healing, respectively.

No significant differences were observed between the four groups. At baseline, 42% (47/112) of patients were symptomatic according to PRO-2.

The agreement between IUS and Fcal for detecting active CD was low (69.6%, κ coefficient = 0.10±0.09).

A total of 57 patients experienced progression of bowel damage during follow-up. Transmural healing, MRI healing (HR = 0.13[0.04-0.43]), or biochemical healing (HR = 0.24 [0.07-0.77]) were associated with a reduced risk of bowel damage progression compared to no healing (p <0.0001), with a non-significant trend favoring transmural healing over MRI or biochemical healing (Figure 1).

Of the 94 patients who discontinued treatment due to relapse during follow-up, transmural healing was associated with a lower risk of treatment discontinuation compared to biochemical healing (HR = 0.29[0.02-0.45], p = 0.003), MRI healing (HR = 0.45[0.02-0.60], p = 0.001), or no healing (HR = 0.11[0.018-0.04], p = 0.002).

Conclusion

Transmural healing, as assessed by two non-invasive tools, MRI and fecal calprotectin, appears to be associated with a reduced risk of bowel damage progression in patients with Crohn’s disease, suggesting an interesting complementarity of these tools in daily clinical practice.
P0329 Clostridium difficile infection associates with the need for biologics: a retrospective long-term analysis in a cohort of 102 ibd patients
Authors: Spagnuolo R , Scarlata G G M , Morano D , Imoletti F , Suraci E , Marasco R , Imeneo M G , Pavia G , Pantanella M , Calabretta M V , Marascio N , Quirino A , Trecarichi E M , Russo A , Abenavoli L , Matera G , Luzza F
Published: January 2025

Background

Gastrointestinal Infections (GIs) pose a significant challenge in patients with inflammatory bowel diseases (IBD), complicating its management and triggering IBD relapses. The overlap in clinical symptoms makes complex differentiating GIs from IBD flares, impacting therapeutic decisions. This study aims at evaluating the long-term impact of GIs in IBD patients.

Methods

From January 2020 to September 2024, 102 IBD patients (mean age 45±16 yrs; 78 ulcerative colitis, UC and 24 Crohn’s disease, CD) experiencing a clinical relapse according to ECCO guidelines, were retrospectively evaluated. GIs were established via stool immunochromatography and multiplex molecular assay. Demographic, clinical and laboratory findings along with the treatment were noticed at the time of flare, 6 and 12 months later. Statistical analysis was performed by Mann-Witney and chi-square test as appropriate (p<0.05).

Results

Nineteen patients tested GIs positive (GIs+): 14 out of 78 (18%) UC and 5 out of 24 CD (21%) patients. Clostridium difficile infection (CDI) was found in 11 patients while non-CDI enteric pathogens (EP+) in the remaining 8 patients. All CDI patients received a first-line antibiotic treatment while no treatment was offered to EP+ patients. By stratifying for GIs at the flare time, there were no differences between GIs+ and GIs- patients with regard to age (45±16 vs46±17 yrs, p=ns), disease duration (11±9 vs 12±10 yrs, p=ns), disease activity score (Mayo score 5±2 vs 5±2, p=ns and Harvey Bradshaw index 8±4 vs 8±4, p=ns) and inflammation biomarkers (C-reactive protein 21±41 vs 22±42 mg/dl, p=ns and fecal calprotectin 1446±1751 vs 1452±1714 mcg/gr, p=ns). At 12 months after flare, the number of patients being treated with biologics increased only in GIs+ IBD patients, from 3 out 19 (16%) to 10 out 19 (53%) (Figure 1). All the 7 IBD patients who have got biologics were CDI+.

Conclusion

This study confirms that distinguishing a disease flare from the presence of superimposed GIs remains challenging. Notably, only in patients with CDI there was an increased use of biologics later after the flare onset. This suggest that CDI may serve as a marker of a more aggressive disease course in IBD patients.
P0331 Insights from the Polish Registry of Microscopic Colitis. The Overlapping Symptoms of Microscopic Colitis and Irritable Bowel Syndrome
Authors: Bielski A , Marlicz W , Małecka-Wojciesko E , Reguła J , Mróz A , Zwolińska-Wcisło M , Waśko-Czopnik D , Eder P , Daniluk J , Rosołowski M , Rydzewska G
Published: January 2025

Background

Microscopic colitis (MC) is a chronic inflammatory bowel disease (IBD), characterized by chronic watery diarrhea without blood, fecal urgency and distninct histological features. Symptoms of MC resemble those of irritable bowel syndrome (IBS), which can delay accurate diagnosis and effective treatment. The potential overlap in symptoms may impede to select effective management strategies.

Methods

The purpose of establishing the Polish Registry of Microscopic Colitis was to understand the clinical characteristics of patients and to improve diagnosis and treatment effectiveness. We present retrospective and prospective data from the cohort of 213 patients, collected across 9 reference gastroenterology centers in Poland.

Results

The median age at MC diagnosis was 56 years. MC occurred 3.5 times more frequently in women. On average, patients waited about 3 years for a proper diagnosis after the onset of symptoms. The lymphocytic subtype was diagnosed much more frequently than the collagenous subtype (68.4% vs 23.3%). Predominant symptoms at the diagnosis of MC were watery diarrhea (88.7%) and fecal urgency (68.1%). Patients also reported symptoms more typical of IBS: abdominal pain (59.2%), bloating (60.1%) and incomplete evacuation (40.8%). Notably, one-third of the patients met the Rome IV criteria for IBS during medical interviews (figure 1). Nearly half of the patients had COVID-19 diagnosis confirmed by an authorised test.

The most effective treatment was budesonide MMX, with a 93.2% improvement rate. 54% of patients using rifaximin and almost 40% of patients using probiotics reported improvement in intestinal symptoms, although these are not recommended therapies in MC. The effectiveness of various treatments is presented in table 1. Five patients with severe MC were successfully treated with biologics (three with adalimumab and two with vedolizumab). Unfortunately, one patient lost response to adalimumab after 8 months treatment and one patient showed no improvement with adalimumab.

Conclusion

The similarity of the symptoms of MC and IBS delays an accurate diagnosis. The results from the Polish Microscopic Colitis Registry emphasize a potential overlap of symptoms between MC and IBS. One possible reason for the frequent occurrence of IBS symptoms among patients with MC may be COVID-19 pandemic. The overlap in symptoms, necessitate a comprehensive clinical evaluation to select appropriate treatment and avoid unnecessary escalation of immunosuppressive therapy.

The much more frequent diagnosis of the lymphocytic subtype than the collagenous subtype indicates the need for discussion with pathologists about the potential underdiagnosis of collagenous colitis in Poland.
P0335 Development of an entrustable professional activity for intestinal ultrasound in North America
Authors: Aronskyy I , Spencer E , Yen E , Chugh R , Winter M , Jacobs J , Wahbeh G , Debruyn J
Published: January 2025

Background

Intestinal ultrasound (IUS) has emerged as an effective tool to evaluate and monitor inflammatory bowel disease (IBD) with rapidly expanding use worldwide. Concurrently, entrustable professional activities (EPAs) have become an essential and foundational element of competency-based medical education. Together, this arose a need to define and standardize IUS-specific tasks required to achieve competency in clinical practice. The Intestinal Ultrasound Group of the United States and Canada (iUSCAN) aimed to develop an EPA to inform current and future IBD specialists and training programs on the skills and responsibilities necessary to effectively achieve competency in IUS among IBD specialists.

Methods

The iUSCAN Education Committee established a multi-step process for EPA development (Figure 1). Step 1: A comprehensive literature review was conducted to identify the key competencies required for performing and interpreting IUS across various IBD presentations. Step 2: A focus group, organized by the iUSCAN Education Committee and consisting of adult and pediatric gastroenterologists with extensive IUS experience (each with >300 IUS scans), was formed to refine these competencies. Using a modified nominal group technique, the focus group evaluated, critiqued, and iteratively refined the identified competencies. This process resulted in the initial selection of 28 essential components necessary for performing consistent, high-quality IUS examinations and interpretations. Step 3: The revised competencies were then circulated for further feedback, adjustments, and expansion. Step 4: Finally, the committee utilized the Knowledge, Skills, and Attitudes framework to finalize this EPA into 34 associated milestones. The iUSCAN Education Committee, Executive Committee, and Steering Committee Chairs reviewed and approved the final version of the EPA.

Results

The Knowledge, Skills, and Attitudes components of an EPA on performing and interpreting IUS are shown in Table 1.

Conclusion

We present the development of an EPA that defines the competencies necessary to effectively perform, interpret, and integrate IUS into the care of patients with IBD. This IUS EPA is designed to serve as a lasting framework for foundational IUS competencies performed by IBD specialists. As IUS continues to advance with innovative and specialized techniques, this EPA will require further updates to incorporate new modalities and skillsets into standard competencies.