bluuebunny/crossref_metadata_2025 huggingface dataset:
P0450 World-wide Development and Validation of the IBD LIFE Questionnaire and Country-specific Patterns of Normal Life Impairment
Authors: Van Oostrom J , Anjie S , Lasa J , Karimi N , Horrigan J , Sareen H , Adi B , Ganesh G , Parks M L , Broër C , de Kruif A , Peyrin-Biroulet L , Ye B D , Banerjee R , Olivera P , Siegel C , Connor S , Gecse K , D’Haens G ,   IBD LIFE consortium
Published: January 2025

Background

For patients with inflammatory bowel diseases (IBD), the ultimate goal is to live a ‘normal life’, yet no validated patient-reported outcome measure (PROM) exists to assess this. We aimed to develop and validate a globally relevant PROM to assess the impact of IBD on normal life through a world-wide, patient-centred approach, the ‘IBD LIFE’.

Methods

Patients with Crohn’s disease (CD) or ulcerative colitis (UC) from Argentina, Australia, India, the Netherlands, South Korea, and the USA without ostomies, pouches, or significant comorbidities were eligible. The development phase involved (A) patient interviews, (B) a Delphi consensus, (C) patient focus groups, (D) pilot-testing, and (E) cross-cultural translation, resulting in a 23-item PROM with five domains: physical, activities, social, psychological, and circumstances.

For the validation phase, CD and UC patients speaking Dutch, English, and Spanish were recruited (n=100 per disease, per language). IBD LIFE and generic and IBD-specific quality of life (QoL) PROMs ((Short-From-36 (SF-36) and IBD Questionnaire (IBDQ)) were administered at baseline, 2 weeks (n=30 per language) and ≥8 weeks. Clinical disease activity was measured at baseline and ≥8 weeks using Harvey Bradshaw Index (HBI) for CD and Simple Clinical Colitis Activity Index (SCCAI) for UC. Construct validity was tested through correlations between baseline indices, repeatability using intraclass correlation coefficient (ICC) in patients with stable QoL at 2 weeks, and responsiveness through a Receiver Operating Characteristic curve analysis for detection of a clinically meaningful change in IBDQ at ≥8 weeks. Country-specific normal life impairment patterns were assessed using total IBD LIFE scores and domain weights.

Results

Among 605 patients (300 CD/305 UC, table 1), IBD LIFE’s construct validity was supported by strong correlations with QoL indices (IBDQ r=-0.90; SF-36 r=-0.83), and moderate correlations with clinical disease indices (HBI r=0.52; SCCAI r=0.51). IBD LIFE showed strong repeatability (ICC=0.91) and responsiveness (AUC=0.873).

IBD LIFE scores ranged from 0-90 (mean 18.51 ± 18.73), with higher scores being associated with more impairment on normal life. Physical and psychological domains had most impact on patients’ lives (indicated by highest domain weights, figure 1). USA patients had the lowest IBD LIFE score compared to other countries (mean 12.27 ± 14.20; P<0.001), yet showed disproportionately higher impact in the physical domain and lower impact in activities (Figure 1).

Conclusion

IBD LIFE, developed with extensive patient involvement, is a valid PROM of IBD’s impact on normal life. It allows tailored patient support to achieve normal life across all life domains affected by IBD.
P0456 Peripheral blood eosinophilia: A novel predictor of disease severity in Inflammatory Bowel Disease - A single-center retrospective study
Authors: Saidani R , Cherif D , Hassine H , Yacoub H , Debbabi H , Kchir H , Maamouri N
Published: January 2025

Background

Identifying early predictors of disease severity in inflammatory bowel diseases (IBD) remains crucial for optimizing therapeutic strategies. We investigated whether peripheral blood eosinophilia (PBE) at diagnosis could predict long-term outcomes in adult IBD patients.

Methods

We conducted a retrospective analysis of 128 IBD patients (78 Crohn’s disease [CD], 50 ulcerative colitis [UC]) diagnosed between 2003 and 2021, comparing them with 49 non-IBD controls. PBE was defined as an eosinophil count exceeding 0.5 × 109/L. We defined severe disease course as meeting any of these criteria: corticosteroid dependency, requirement for multiple biologic therapies (≥2 different classes), or surgical intervention. Disease location, behavior, and severity were classified according to Montreal classification. Outcomes were analyzed using Cox proportional hazard models.

Results

PBE was detected in 17 IBD patients (13.3%) compared to 2 controls (4.1%, p<0.001). UC patients showed higher PBE prevalence with 8 cases (16%) versus 9 CD patients (11.5%). Regarding disease location in CD patients with PBE, 5 patients (55.5%) had ileocolonic involvement, 3 (33.3%) had isolated ileal disease, and 1 (11.1%) had isolated colonic disease. In UC patients with PBE, 6 (75%) had extensive colitis. During the follow-up period (median 5.2 years), PBE-positive patients demonstrated significantly worse outcomes: 14 out of 17 (82.3%) developed severe disease course compared to 45 out of 111 (40.5%) PBE-negative patients. PBE-positive patients required more frequent hospitalizations (71% vs 35%), had higher rates of corticosteroid use (88% vs 45%), and increased need for biological therapy (76% vs 38%). Notably, 65% of PBE-positive patients developed corticosteroid dependency compared to 30% in the PBE-negative group. Multivariate analysis confirmed PBE as an independent predictor of severe disease course (HR = 1.49, 95% CI: 1.38-1.62, p<0.001).

Conclusion

This study establishes PBE as a valuable prognostic marker for IBD severity. The presence of eosinophilia at diagnosis strongly correlates with a more aggressive disease course, suggesting the need for early therapeutic optimization in these patients. These findings not only provide a simple and accessible prognostic tool but also highlight eosinophils as a potential therapeutic target in IBD management. Further prospective studies are warranted to validate these findings and explore eosinophil-targeted therapies.
P0460 Intestinal ultrasound in inflammatory bowel disease: Do we really need experts to monitor our patients?
Authors: Achemlal A , Taibi O , Ouahid S , Salaheddine T , Saouab R , Tamzaourte M
Published: January 2025

Background

Intestinal ultrasound (IUS) has emerged as an important tool in monitoring inflammatory bowel disease (IBD) due to its accessibility, cost-effectiveness, and non-invasive nature, making it an attractive option for gastroenterologists. Our study aimed to assess the agreement between young sonographers and experts in the interpretation of IUS examinations in patients with IBD

Methods

We video-recorded the IUS of a patient with ulcerative colitis in severe acute relapse. A cine-loop of the sigmoid colon was made from the video including a longitudinal and transverse B-mode and CDS-mode. The cine-loop and an electronic form, were sent to 30 radiology residents (Ten in their 2nd year, ten 3rd year and ten 4th year, chosen randomly), along with an IUS expert with 10 years’ experience. Participants were asked to complete the electronic form including key parameters in IUS, such as bowel wall thickness [BWT], color Doppler signal [CDS] (using the modified Limberg score), inflammatory fat [i-fat], bowel wall stratification loss [BWS], haustration loss and presence of lymph nodes. Two scores covering these parameters were also used: Milan ultrasound criteria (MUC) and the International Bowel Ultrasound Segmental Activity Score [IBUS-SAS]. Inter-observer reliability was analyzed using Cohen’s Kappa coefficient (Jamovi version 2.3)

Results

The expert’s findings compared to the average values reported by all residents were as follows: BWT (6.04mm vs 6.3mm ± 3.63), MUC (10.46 vs 10.7 ± 4.81), IBUS (87.17 vs 65.6 ± 21.7). A strong positive association was found between the 3rd and 4th years for BWT (r= 0.562), although not statistically significant (p= 0.091). Fair agreement was found for BWS [κ = 0.329, p= 0.003]. No significant differences in BWT, MUC, IBUS, and modified Limberg score values were found between the three groups of residents (p= 0.762, p= 0.759, p= 0.922, and p= 0.781 respectively). When compared with the expert’s values, there were no significant differences between the BWT and MUC values (2nd year p= 0.625, 3rd year p = 0.492, 4th year p= 0.375). In contrast, the residents’ IBUS and modified Limberg score values were significantly different from the expert’s values (IBUS: 2nd year p= 0.002, 3rd year p= 0.05, 4th year p= 0.01, Limberg: 2nd year p= 0.01, 3rd year: p= 0.017, 4th year p= 0.025)

Conclusion

This study has shown us that our young sonographers are providing encouraging results in the monitoring of IBD. However, the presence of an expert in intestinal ultrasound remains essential in the evaluation of the various ultrasound parameters. Current recommendations in gastroenterology place IUS for IBD in the spotlight, and it is essential that our collaborators can easily help us in the monitoring of these patients
P0464 exploring the Relationship Between Gender, Age at Onset, and the Presence and Severity of Ano-Perineal Lesions in Inflammatory Bowel Disease
Authors: Elommal H , Koulali H , Elmqaddem O , Zazour A , ismaili Z , Kharrasse G
Published: January 2025

Background

Ano-perineal lesions (APLs), including fissures, abscesses, fistulae, and thrombosed hemorrhoids, are common complications in inflammatory bowel disease (IBD). While several factors have been linked to the development of APLs, the impact of gender and age at disease onset on the prevalence and severity of these lesions remains underexplored. This study investigates the relationship between gender, age at IBD onset, and the presence and severity of APLs.

Methods

A retrospective cohort study was conducted on IBD patients to assess the relationship between gender, age at disease onset, and the presence and severity of ano-perineal lesions. The severity of APLs was categorized as mild (isolated lesions) or severe (complex fistulae, extensive abscesses). Age at onset was classified as early (<30 years) or late (>30 years). Statistical analysis, including chi-squared tests and multivariate logistic regression, was used to determine the correlation between these variables.

Results

• Gender differences: Male patients were more likely to present with fistulae (45%) and abscesses (34%) compared to females (fistulae: 32%, abscesses: 22%). Women, however, were more likely to have thrombosed hemorrhoids (25% vs. 15% in males).

• Age at onset: Patients with early onset of IBD (<30 years) had a significantly higher likelihood of developing severe APLs (OR: 2.8, p < 0.01). Early onset was also associated with a higher prevalence of fistulae and abscesses (40% and 35%, respectively) compared to those with late-onset disease (30% and 20%).

• Severity correlation: Early-onset IBD patients had more complex ano-perineal lesions, with severe fistulae and abscesses noted in 55% of cases. In contrast, late-onset patients had a significantly lower severity (25% of cases were severe). Gender further influenced severity, with males more likely to develop severe APLs (fistulae and abscesses) than females, particularly among early-onset cases.

• Multivariate analysis: Gender (p = 0.02) and early age at onset (p = 0.01) were independently associated with a higher likelihood of severe APLs, with males showing a higher risk of complex lesions.

Conclusion

Both gender and age at onset are significant predictors of the presence and severity of ano-perineal lesions in IBD patients. Early-onset disease and male gender are associated with more severe and complex APLs, especially fistulae and abscesses. These findings emphasize the importance of early diagnosis and gender-specific management strategies for patients at higher risk of developing severe ano-perineal complications in IBD.
P0467 Increased risk for depression and low quality of life in patients with active inflammatory bowel disease
Authors: Topala M.D.- PhD student M , Ionescu V , Iacob R , Gheorghe C
Published: January 2025

Background

Patients diagnosed with inflammatory bowel disease (IBD) are at increased risk of developing mental health issues, such as depression, especially when experiencing disability and poor quality of life (QoL). Recent studies showed that the relationship between depression and IBD appears to be bidirectional, through the brain-gut axis.

Methods

We aimed to evaluate the risk for depression and the QoL in patients with active IBD hospitalized between January 2021-April 2024 in our clinic, at the moment of biologic initiation and at 6 months follow-up, for those achieving clinical remission. We screened for symptoms of depression using the self-administered Center for Epidemiologic Studies Depression Scale (CES-D) – ranging score 0-60 (0-15 no to mild; 16-23 moderate; 24-60 severe symptomatology). The self-administered Short Inflammatory Bowel Disease Questionnaire (SIBDQ) was used to evaluate the health-related QoL through social, bowel, emotional and systemic dimension, with a score ranging from 10 (poor) to 70 (optimal).

Results

We included 47 patients (53.19% ulcerative colitis, 57.44% males, age 38.51±12.26 years old), with a disease duration of 6.43±6.28 years. 21 patients were reevaluated at 6 months. In patients with active IBD, the CES-D score was 14.15±13.04 and the SIBDQ score was 42.2±15.8 (42.6±19.2 social; 44.3±16 bowel; 43.6±16.9 emotional; 36.5±18 systemic). 18 patients (38.29%) were at risk for clinical depression, of whom 11 patients (23.40%) had severe depressive symptomatology. Patients being at risk for depression had lower SIBDQ scores (p<0.001), lower levels of serum albumin (p=0.007) and lower body mass index (p=0.004). In the subgroup analysis, both CES-D (17.23±15.63 vs. 8.09±7.19, p=0.005) and SIBDQ (40.81±16.45 vs. 56.09±10.68, p=0.002) were significantly improved after achieving clinical remission.

Conclusion

Considering the high rate of patients prone for depressive symptomatology, screening tools for depression and assessing QoL should be routinely used, and specialized psychiatric treatment should be integrated in the comprehensive care for IBD patients.
P0468 Prevalence of traditional cardiovascular risk factors in Crohn’s disease
Authors: Fissah M , Rechach A , Charifi M , Menzou F , Djouhri M , Touati N , Talbi L , Chibane A
Published: January 2025

Background

Cardiovascular risk in inflammatory bowl disease (IBD) has only recently been described, whereas the increased risk of venous thromboembolic events in IBD was identified long before. An excess risk of ischaemic heart disease and stroke of around 20% has already been demonstrated. Are traditional cardiovascular risk factors the best way of assessing this excess risk? Our aim is to determine the frequency of traditional risk factors in Crohn’s disease

Methods

This was a prospective observational study involving 118 patients with CD. All patients were thoroughly interviewed, and screened for arterial hypertension by self-measurement validated by the European Society of Cardiology (ESC), fasting blood glucose, glycated haemoglobin and lipid profiles, the rest of the factors were gathered through questioning. The data collected was entered and analysed using EPIINFOV and SPSS statistical software.

Results

There were 70 men (59.3%) and 48 women (40.7%) with a sex ratio of 1.46. The mean age was 36. 49 +/- 11.62 with a median of 34 years and extremes of 19 and 67 years, There were only five subjects whose age represented a risk factor - two men and three women In our population, the family history of cardiovascular disease was 10.2%, smoking as a cardiovascular risk factor was present in 28% of patients, arterial hypertension was present in only 10.2% of patients, with a non-significant female predominance with a p = 0.06, In our series there were only two type 2 diabetic patients on metformin, Only 11.9% of our subjects were sedentary. In our female population, 16.7% were postmenopausal for more than ten years, 57.6% of our patients had dyslipidaemia (according to ESC 2017), the cardiovascular risk was low in the majority of our patients at 88.1% according to the Framingham score.

The prevalence of traditional risk factors in our population is low. This result is consistent with those in the literature, which may be due to the specific features of Crohn’s disease, such as weight loss or hypovolaemia during flare-ups, but also to the fact that our population is young?

Conclusion

The low frequency of traditional cardiovascular risk factors does not explain the increased risk of developing cardiovascular disease found in Crohn’s disease. The study of non-traditional risk factors is imperative and could explain this paradox.
P0469 Impact of gynecologic malignancy on ileal pouch-anal anastomosis survival: a matched case-control study
Authors: Unal E , Lavryk O , Kanters A , Spivak A , Falloon K , Naseer M , Qazi T , Lipman J , Michener C , Hull T , Debernardo R , Holubar S
Published: January 2025

Background

Total proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the standard operative treatment for patients with medically refractory inflammatory bowel disease or familial adenomatous polyposis requiring colectomy. In patients who develop malignancy after IPAA, chemoradiation has been shown to increase the risk of pouch failure in small studies. We aimed to describe pouch survival in patients who underwent surgery for gynecologic malignancy (GYN-Ca).

Methods

We retrospectively reviewed adults who underwent IPAA and developed gynecologic cancer afterwards between 2000 and 2023. Patients with IPAA and GYN-Ca were matched using 1:5 nearest neighbor propensity score matching to control patients with history of IPAA only, on age, year of IPAA, colorectal diagnosis, and procedure. Demographics, operative data, complications, and pouch survival were collected.

Results

We identified 15 patients diagnosed with GYN-Ca after IPAA who underwent surgery (Table 1). The most common GYN-Ca was endometrial cancer (53%); overall, 14 (93.3%) underwent hysterectomy, while 1 (6.7%) underwent salpingo-oophorectomy; 80% had no short-term postoperative complications. After GYN-Ca in IPAA patients, median overall survival was 51 (21-106) months; median disease-free survival was 41.3 (8-106) months. Pouch failure was seen in 5 (33%) patients, of these, 2 patients (40%) had pouch revision, 2 patients (40%) had pouch excision with permanent end ileostomy and 1 patient (20%) had only permanent end ileostomy. Etiology of pouch failure included radiation enteritis of the pouch (n=2, 40%), afferent limb syndrome from IPAA stenosis (n=1, 20%), inlet obstruction due to Crohn’s stricture (n=1, 20%), and recurrent anastomotic leak secondary to invasive ovarian cancer recurrence (n=1, 20%). After matching, 75 control patients were included for a total of 90 unique patients. The pouch failure rate in the Gyn-Ca and matched control groups were 33% vs. 5.3%, p=0.002, respectively. Kaplan-Meier survival analysis (Figure 1) showed a hazard ratio for pouch failure in GYN-Ca patients of 2.34 (p=0.18, robust SE 0.63) compared to matched control patients, a clinically but not statistically significant result likely due to lack of power.

Conclusion

In experienced hands, surgery for gynecologic malignancy in pouch patients was safe with an accepted rate of post-operative complications. However, the patients who suffered recurrence or underwent chemoradiation were at increased risk of pouch failure compared to healthy control pouch patients. Patients who develop gynecologic malignancy after IPAA should be monitored closely for pouch dysfunction using a multidisciplinary approach to optimize pouch survival after pelvic surgery.
P0476 Long-term outcomes of patients with negative small bowel video capsule endoscopy performed for suspected Crohn’s disease: A cohort study
Authors: Edelman-Klapper H , Avni-Biron I , Ollech J E , Hegger S , Levi Z , Dotan I , Yanai H
Published: January 2025

Background

Crohn’s disease (CD) is a heterogeneous condition that can affect the entire gastrointestinal tract, with isolated small bowel (SB) involvement occurring in 20–30% of patients. According to ECCO and other international guidelines, the standard diagnostic approach for CD includes ileocolonoscopy and cross-sectional SB imaging. When these modalities yield inconclusive results, video capsule endoscopy (VCE) is recommended for evaluating SB mucosa. Despite negative findings on comprehensive evaluations, a significant proportion of patients continue to experience symptoms suggestive of CD.

This study aimed to assess the long-term outcomes of patients with a negative comprehensive assessment for CD and a negative VCE study.

Methods

This retrospective cohort study was conducted at a large tertiary inflammatory bowel disease (IBD) center in Israel, serving a broad catchment area and providing VCE services for the entire national population insured by the largest Israeli health maintenance organization. Patients referred for VCE due to suspected CD and inconclusive endoscopy and cross-sectional imaging findings between 2008 and 2017 were included. Two individual capsule endoscopy readers revised all VCE studies. Longitudinal electronic medical records were analyzed to identify subsequent CD or alternative diagnoses. Clinical and laboratory data at the time of the index VCE were also evaluated.

Results

A total of 615 patients were included, of whom 354 (57.5%) were female, with a median age of 36 years (IQR: 27–55). CD was diagnosed in 192 patients (31.2%) based on the index VCE, with a median Lewis score (LS) of 900 (IQR: 450–1350). The remaining 423 patients (68.8%) had normal or minimal findings (LS <135) on VCE. This sub-cohort with negative VCE findings was further followed for a median duration of 8 years (IQR: 5–10; range: 3–12), corresponding to 3,042 patient years of observation. Notably, during follow-up, only 19 patients (4.5%) were diagnosed with CD; the majority based on clinical judgement alone (with no other objective findings), while one patient was diagnosed after a third VCE study. The median time to CD diagnosis was 1.5 years (IQR: 1–3) post-index VCE. Neither clinical symptoms nor basic laboratory results at the time of index VCE predicted CD diagnosis following the negative index VCE.

Conclusion

The incidence of CD diagnosis following a negative VCE study is exceptionally low, with most diagnoses occurring early after the index study. Patients with negative VCE findings may benefit from further diagnostic evaluation to investigate non-CD etiologies for their symptoms.
P0484 Impact of Early Aggressive Treatment on Long-term Biochemical Marker Patterns in Inflammatory Bowel Disease: A latent class mixed model
Authors: Jun Y K , Choi Y , Shin C M , Park Y S , Kim N , Lee D H , Ahn S , Yoon H
Published: January 2025

Background

Inflammatory bowel disease (IBD) shows a highly variable disease course, making early identification of patients at risk for poor outcomes important for personalized treatment. This study aimed to classify the long-term disease course in patients with IBD using biochemical markers and to investigate the clinical factors associated with different disease trajectories.

Methods

Longitudinal data on C-reactive protein (CRP) and fecal calprotectin (FCP) levels were collected from patients in a tertiary hospital cohort between 2017 and 2023. Patients with at least two CRP and FCP tests between six months and five years after IBD diagnosis were included. Early IBD-related treatments, ER visits, and hospitalizations were defined as occurring within six months of diagnosis. A latent class mixed model (LCMM) was employed to identify the distinct subclasses based on CRP or FCP changes. Subsequently, univariate analyses and multinomial logistic regression were conducted to evaluate the relationships between different biochemical trajectories and clinical variables.

Results

Among the patients, 245 with CD and 635 with UC were included in the CRP model, while 256 with CD and 536 with UC were included in the FCP model. Through LCMM, a three-class model was found to be most appropriate for patients with both CD and UC: Class 1, characterized by early and sustained biochemical remission; Class 2, featuring delayed remission; and Class 3, marked by prolonged difficulty in achieving remission for over five years. In the CRP trajectory analysis, early initiation of immunomodulators (IM) in patients with CD was significantly associated with a higher probability of belonging to Class 1 (Class 2 vs. 1, odds ratio [OR] 0.344; Class 3 vs. 1, OR 0.472; p-value = 0.039). In the FCP trajectory analysis, early advanced therapy (AT) significantly increased the odds of belonging to Class 1 for patients with CD (Class 2 vs. 1, OR 0.383; Class 3 vs. 1, OR 0.220; p-value = 0.004). Conversely, no significant factors were identified in the CRP trajectory analysis for patients with UC. In UC, younger age at diagnosis (Class 2 vs. 1, OR 0.969; Class 3 vs. 1, OR 0.980; p-value = 0.004) and early IM initiation (Class 2 vs. 1, OR 2.928; Class 3 vs. 1, OR 2.698; p-value <0.001) were associated with higher odds of belonging to Class 2 or 3, whereas current smoking was associated with a higher likelihood of belonging to Class 1 in the FCP trajectory analysis (Class 2 vs. 1, OR 0.194; Class 3 vs. 1, OR 0.559; p-value = 0.008).

Conclusion

Early aggressive treatments, particularly the prompt initiation of AT in CD, may contribute to achieving long-term biochemical remission; however, similar associations were not observed in UC.
P0486 Acceptability of fecal calprotectin in patients with inflammatory bowel disease: impact of an alternative collection device for stool sampling
Authors: Pasi G , Antari A , Masson D , Dejoie T , Caillon H , Collins M , Bourreille A , Le Berre C ,   Institut des Maladies de l’Appareil Digestif (IMAD) Hépato-Gastro-Entérologie et Assistance Nutritionnelle Inserm CIC 1413 Nantes Université CHU Nantes F-44000 Nantes France.
Published: January 2025

Background

Fecal calprotectin (FC) is a key non-invasive biomarker used to monitor inflammatory bowel disease (IBD). Despite its clear clinical value, patient adherence to the test remains suboptimal, mainly due to reluctance related to stool collection. The objective of the ACCALMI study was to compare the acceptability of a new stool collection device, similar to the one used for fecal immunochemical tests (FIT), with a standard stool container, and to evaluate its impact on patient compliance.

Methods

In this prospective, single-center study, 156 patients with an established diagnosis of IBD and who had been prescribed a FC test as part of their routine care, were randomly assigned to either the standard container group or the alternative device group (Procise Stool Collection Device™), which includes a collection tube with a thin spiral-shaped probe facilitating stool collection. Acceptability was assessed using a 4-category ordinal scale (from “poor” to “very good”) and a visual analog scale (VAS, from 0 to 10). Analyses were conducted in both per-protocol and intention-to-treat (ITT) populations, with missing data handled using the maximum bias method. Factors associated with improved FC acceptability, and compliance with FC testing, were analyzed.

Results

The alternative stool collection device significantly improved acceptability compared to the standard method, both on the ordinal scale (OR 2.69, p < 0.001) and the visual analogue scale, although for the latter it did not reach the predefined threshold of a 30-point difference (95% CI: 19.7 to 44.7). ITT analysis showed similar results. Embarrassment and discomfort associated with the standard container were alleviated by the alternative device. Long home-hospital distances (>50 km) and use of the alternative device were the only factors significantly associated with better acceptability in multivariate analysis. Compliance was similar between the two groups and remarkably high (92%).

Conclusion

The ACCALMI study demonstrated that the alternative stool collection device, similar to the one used in FIT, is more accepted by IBD patients than the standard container, thus improving the acceptability of FC testing. These findings support the integration of patient-centered innovations in diagnostic and follow-up testing to improve the monitoring of IBD.

Funding

This study was partially funded by Takeda®

Acknowledgments

Collaboration with Biosynex®.
P0488 The course of Crohn’s Disease in the Biologics Era: an in depth Single-Center Tertiary Cohort Study in Belgium
Authors: Vuckovic C , Cremer A , Minsart C , Bottieau J , Franchimont D , Liefferinckx C
Published: January 2025

Background

Since 1999, Biologics have become a cornerstone in the management of Crohn’s Disease (CD), enabling complete mucosal healing in a significant proportion of patients, with measurable changes in major outcomes in large phase III/IV clinical trials. This holds true particularly when patients were exposed early at diagnosis to biologics, as reported in the recent PROFILE study. However, their real-world impact on the long-term course of the disease remains uncertain. This retrospective study aims to characterize the natural history of CD before and during the biologic era, in a single tertiary center in Belgium.

Methods

Based on inclusion criteria, 516 CD patients were included and stratified in two subpopulations, according to the date of CD diagnosis (before or after 1999). All events were recorded from date of diagnosis to maximum follow-up (FU), to achieve high granularity, from disease characteristics to treatment adaptations. Statistical analyses were performed using Prism.

Results

Among 516 CD patients included, 87 and 429 were diagnosed before and after 1999, respectively. There was no significant difference in demographics or disease characteristics at diagnosis. Patients diagnosed after 1999 were exposed to biologics for a larger portion of their FU compared to those diagnosed before 1999 [51% vs 11%, p<0.0001]. At maximum FU, more patients diagnosed before 1999 had progressed to B2/B3 phenotypes (69% vs 39%, p<0.0001), reflecting their longer disease duration compared to patients diagnosed after 1999 (Median FU 27 years [22-30] vs 12 years [6-15], p<0.0001). Indeed, 10 years after CD diagnosis, disease progression to B2/B3 phenotypes was similar in both groups (27% vs 23%, p=0.6), (Figure 1a). Changes in phenotype were diagnosed sooner in patients diagnosed after 1999 compared to those diagnosed before 1999 (Median 4.8 years [1.8-9.9] vs 12.3 years [6-16.8], p<0.0001] (Figure 1b). They were also operated sooner than patients diagnosed before 1999 (Median 5.9 years [2.1-10.2] vs 12.5 years [6.6-18.2], p<0.0001] (Figure 1c).

Conclusion

The proportion of patients progressing to a B2/B3 phenotype at 10 years of disease course is similar for CD patients diagnosed before and during the Biological Era. The detection of complications occured earlier in patients diagnosed after 1999, which suggests a shift toward more proactive monitoring since the advent of biologics. Based on these findings, it remains uncertain whether biological therapies have significantly altered the course of the disease and phenotype progression in CD patients. However, while these results are based on objective outcomes, they do not fully capture the impact of biological treatments on patients quality of life and disease burden.
P0491 Cumulative Inflammatory Burden and Structural Bowel Changes as Independent Risk Factors for Colonic Dysplasia in Ulcerative Colitis: A Case-Control Study
Authors: Park D , Oh J E , Choi S , Park J , Park S J , Cheon J H , Kim T I , Park Assistant professor J J
Published: January 2025

Background

Long-standing inflammation has been implicated in the development of colonic dysplasia in ulcerative colitis (UC). However, the relationship between varying degrees of inflammatory exposure and dysplasia risk remains poorly understood. We aimed to identify risk factors for colonic dysplasia in UC patients, with particular focus on quantifying long-term inflammatory exposure.

Methods

In this retrospective single-center case-control study, we reviewed 55 UC patients diagnosed with colonic dysplasia (low-grade, high-grade, or cancer) between 2013 and 2022, and 110 randomly selected UC patients without dysplasia as controls. Endoscopic inflammation was scored using the Mayo endoscopic subscore (0-3), and cumulative inflammatory exposure was calculated by multiplying these scores with the duration of each endoscopic follow-up period. Clinical factors and endoscopic findings were compared between groups, and logistic regression analysis was performed to identify independent predictors of dysplasia.

Results

Univariate analysis showed that the dysplasia group had significantly higher frequencies of anemia (hemoglobin <10 g/dL), elevated ESR (>18 mm/hr at diagnosis), steroid and biologics use, tubular or shortened colon, and high cumulative endoscopic inflammation scores (>10). In multivariate analysis, after adjusting for age, gender, and disease duration, both tubular or shortened colon (OR 3.172, 95% CI: 1.029-9.780) and high cumulative endoscopic inflammation score(>10) (OR 4.205, 95% CI: 1.065-16.600) were independently associated with increased dysplasia risk.

Conclusion

High cumulative inflammatory burden, as indicated by elevated endoscopic inflammation scores and structural bowel changes, significantly increases the risk of colonic dysplasia in UC patients. More intensive surveillance strategies may be warranted for patients with these objective risk indicators to enable early detection of colitis-associated dysplasia.
P0496 Upadacitinib for Patients with Crohn’s Disease and Previous Biologic Failure: A Systematic Review and Meta-Analysis
Authors: Campedelli L , Perim V , Hueb R
Published: January 2025

Background

Upadacitinib is an oral Janus kinase 1 (JAK1) inhibitor that has demonstrated potential as a therapeutic agent for Crohn’s disease (CD). This systematic review and meta-analysis aim to evaluate the efficacy of Upadacitinib in treating CD patients with prior biologic failure.

Methods

A comprehensive literature search was conducted in October 2024 across PubMed, Embase, Cochrane, and ClinicalTrials.gov to identify clinical trials comparing Upadacitinib to placebo in CD patients with prior biologic failure. The inclusion criteria were studies that assessed clinical and endoscopic outcomes in CD patients. A random-effects model meta-analysis was performed using RStudio software to determine the pooled efficacy of Upadacitinib.

Results

Three clinical trials1,2 involving a total of 807 patients were included in the meta-analysis. The analysis revealed that Upadacitinib significantly outperformed placebo in achieving both clinical remission and endoscopic response in this population. Specifically, Upadacitinib was associated with a relative risk (RR) of 2.89 (95% confidence interval [CI]: 2.12–3.95, Figure 1) for clinical remission compared to placebo. Additionally, Upadacitinib demonstrated a significantly higher likelihood of achieving endoscopic response (RR 6.9; 95%CI: 3.36–14.16, Figure 2). These results suggest that Upadacitinib can be a promising treatment option for CD patients who have failed prior biologic therapies.

Conclusion

Upadacitinib is an effective therapeutic option for patients with Crohn’s disease and prior biologic failure, with significant improvements in both clinical remission and endoscopic response compared to placebo.

References

1.Loftus EV, Panés J, Lacerda AP, et al. Upadacitinib Induction and Maintenance Therapy for Crohn’s Disease. The New England Journal of Medicine. 2023;388(21):1966-1980. doi:https://doi.org/10.1056/nejmoa2212728

2.Sandborn WJ, Feagan BG, Loftus EV, et al. Efficacy and Safety of Upadacitinib in a Randomized Trial of Patients With Crohn’s Disease. Gastroenterology. 2020;158(8):2123-2138.e8. doi:https://doi.org/10.1053/j.gastro.2020.01.047

Figure 1

Figure 2
P0497 Faecal Incontinence and Urgency in IBD Patients on Biologic Therapy in Remission: Prevalence and Risk Factors
Authors: Jelakovic M , Peretin L , Kodvanj I , Brinar M , Turk N , Grgic D , Kunovic A , Cukovic-Cavka S , Krznaric Z
Published: January 2025

Background

Despite being in clinical remission, patients with inflammatory bowel disease (IBD) on biologic therapy may experience faecal incontinence (FI) and urgency, significantly impacting their quality of life. This study aimed to determine the prevalence of FI and urgency in this population and to identify associated risk factors.

Methods

A cross-sectional study was conducted in a tertiary referral centre, including IBD patients in remission on biologic therapy (evaluated by partial Mayo score or Harvey-Bradshaw Index). Data on demographic and clinical characteristics were analysed, including age, sex, disease duration, previous biologic therapies, surgical history, and severity indices. FI was defined as a St. Mark’s Vaizey score ≥6, and urgency was assessed using a Visual Analog Scale (VAS) score ≥4. Statistical analysis included chi-squared, Fisher’s exact, and Wilcoxon rank sum tests.

Results

The study included 124 IBD patients (85 Crohn’s disease, 39 ulcerative colitis). FI was observed in 15% of patients, while urgency (VAS ≥4) was reported by 8%. Notably, 14.1% of Crohn’s disease patients in endoscopic remission (SES-CD ≤2) experienced significant FI. Risk factors significantly associated with FI included advanced age (median 49 years vs. 38 years, p=0.007), gender (male 33% vs. female 63%, p=0.014), and history of surgical interventions (58% vs. 26%, p=0.005). Urgency was more prevalent in patients requiring diapers or pads (30% vs. 5.7%, p<0.001) with no other significant factors identified. CRP and faecal calprotectin levels were not significantly associated with either FI or urgency in this cohort.

Conclusion

FI and urgency remain prevalent among IBD patients in clinical but also endoscopical remission on biologic therapy, underscoring the need for continued symptom monitoring and management strategies. Advanced age, gender and surgical history are key risk factors. Future studies should explore targeted interventions to mitigate these complications in this patient group.
P0503 Submucosal hyperechogenicity on intestinal ultrasound is associated with fat deposition and is a predictor of endoscopic non-response to anti-inflammatory treatment in Ulcerative Colitis
Authors: Pruijt M , Neefjes-Borst A , Lange M , de Voogd F , Teichert C , D’Haens G , Gecse K
Published: January 2025

Background

The submucosa is the most responsive wall layer in the monitoring of treatment response in ulcerative colitis (UC) with intestinal ultrasound (IUS).1 However, persistent submucosal thickening, often seen in combination with hyperechogenicity, could be associated with treatment non-response.2 We aimed to understand these transmural changes in UC by correlating IUS findings with histopathology in colectomy specimens.

Methods

In total, 118 patients were included: (cohort 1) 19 UC patients and 52 controls without inflammatory bowel disease who all underwent colectomy, and (cohort 2) 47 UC patients in a prospective longitudinal validation cohort receiving anti-inflammatory treatment. In cohort 1, histopathology slides were scored for inflammation, fat, and collagen deposition in the submucosa by two pathologists, independently, using a semi-quantitative scale (0-3) (Figure 1). For the UC patients in cohort 1, images and histopathology slides of the sigmoid were location matched. IUS parameters were assessed by one sonographer, including relative submucosal echogenicity (RSE), quantified in grayscale units.

In cohort 2, baseline RSE in the sigmoid was compared between endoscopic responders (≥1 point decrease in endoscopic Mayo score [EMS] after 8-26 weeks), and non-responders.

Results

In cohort 1, the indication for colectomy in UC was therapy-refractory disease (16/19, 84%), followed by acute severe colitis (2/19, 11%) and dysplasia (1/19, 5%). In the control groups, indications for surgery included cancer (31/52, 59%), diverticulitis (17/52, 33%), and obstipation (4/52, 8%). No significant differences in fat or collagen deposition in the submuosa were observed within cohort 1. In UC colectomy patients with the presence of submucosal fat deposition (score≥1), the submucosal thickness and RSE were significantly increased on IUS (Table 1). Linear regression showed fat deposition was independently associated with RSE (B=31.27, p<0.001), but fibrosis was not (B=14.89, p=0.097).

In cohort 2, baseline RSE was significantly higher in endoscopic non-responders (n=17) than responders (146.8 vs. 88.7 grayscale units, p=0.003). A cut-off of >108 grayscale units predicted endoscopic non response with 82% sensitivity, 64% specificity, 58% positive predictive value and 86% negative predictive value. This cut-off was associated with an odds ratio of 0.12 (95% CI: 0.03-0.52, p=0.004) for endoscopic response.

Conclusion

In UC, hyperechogenicity of the submucosal layer on IUS is caused by fat deposition. Submucosal hyperechogenicity can be quantified and is a predictor of treatment non-response in UC patients.

References

1.F. de Voogd, Inflamm Bowel Dis 2023. DOI: 10.1093/ibd/izad274.

2.F. de Voogd, Journal of Crohn’s and Colitis 2021. DOI: 10.1093/ecco-jcc/jjab076.535.
P0505 Use of intestinal ultrasound in a tight monitoring approach in Crohn’s disease patients treated with anti-TNFα therapy: a multicentre prospective study
Authors: Palmela C , Revés J , Frias-Gomes C , Morão B , Neto C , Bargas A , Glória L , Cravo M , Dias de Castro F , Cúrdia Gonçalves T , Cotter J , Coelho R , Caldeira A , Torres J
Published: January 2025

Background

Intestinal ultrasound (IUS) is a non-invasive tool increasingly being used to assess response to therapy in Crohn’s disease (CD). Although endoscopic remission (ER) is currently the consensual long-term treatment target, transmural remission is considered a potential target in the STRIDE-II recommendations. We aimed to assess the potential predictive role of ultrasonographic parameters for ER. Additionally, we describe the correlation of IUS with laboratorial and endoscopic parameters.

Methods

This multicentric prospective longitudinal study enrolled adult patients with active CD starting anti-TNF. IUS and ileocolonoscopy were performed at baseline and at 54 weeks. Additionally, IUS was performed at week (W) 14 and 30. The primary outcome was the predictive value of ultrasound remission (normalization of bowel wall thickness (BWT), bowel wall stratification, vascularization and inflammatory fat) for long-term endoscopic remission at 54 weeks (segmental SES-CD=0). The International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) was also calculated and its optimal cut-point to detect ER was identified using ROC analysis. Univariable/multivariable analysis including clinical, biomarkers and ultrasonographic parameters was performed to identify independent predictors of ER.

Results

63 patients with CD were included, of those 57 (90%) were followed-up until week 54. After one year of therapy, 32% achieved ER and 42% IUS remission. Following therapy initiation there was a positive evolution of all IUS parameters. The reduction of BWT and IBUS-SAS was significantly more pronounced in the first 14 weeks of therapy (BWT: W0-14 vs W14-30, p=0.010; IBUS-SAS: W0-14 vs W14-30, p=0.003; W0-14 vs W30-54, p=0.005). Patients with endoscopic response and endoscopic remission had a significantly lower median IBUS-SAS score at all timepoints (Figure 1). The best predictor for endoscopic remission was IBUS-SAS score at W14 (AUC 0.805, cut-off value 52.3). On multivariable analysis, IBUS-SAS at W14 <52.3 was the only independent predictor for ER (OR 7.40; 95% CI 1.20-45.47; p=0.031). Additionally, BWT showed consistent moderate correlation with fecal calprotectin values across all timepoints (ρ=0.44-0.49, p=0.001).

Conclusion

Early assessment of ultrasonographic remission at week 14 can help predict endoscopic remission after 1 year of therapy and offers an opportunity for early therapy optimization. Using a combination of IUS parameters (IBUS-SAS) performed better than BWT alone to predict endoscopic remission. Our results support the use of IUS in a tight monitoring strategy to predict treatment response in CD.

Figure 1: Median BWT and IBUS-SAS score in patients with and without endoscopic response and endoscopic remission. *p<0.05; **p<0.001
P0506 AZD7798, a monoclonal antibody depleting CCR9+ T cells, with the potential to target hard-to-treat small bowel Crohn’s disease
Authors: Powell N , Hedin C , Harper A R , MacKay J , Lundin P , Bock D , Spata E , Bouma G , Tian S , Lundahl A , Lund J , Eck S , Popińska A , Strömbeck A , Fowler A , Eberhardson M , Belvisi M , Marks D J B
Published: January 2025

Background

Crohn’s disease (CD) can affect any part of the gastrointestinal tract, but about 30% of patients have inflammation restricted to the ileum. In clinical trials, patients are typically enrolled irrespective of the disease localisation, with clinical outcomes focusing on a broad patient population. Anecdotally, small bowel healing in CD is often reported as challenging. Our aims were to investigate the unmet need in treating ileal CD and explore potential drug targets for this patient subpopulation.

Methods

A systematic review and meta-analysis was conducted of efficacy by disease location (Montreal classification L1 + L2) in placebo-controlled clinical trials in CD. As this revealed markedly different outcomes in ileal compared to colonic CD, transcriptomic data from 1185 small and large intestine biopsies of 594 CD patients were explored to identify potential small bowel specific drug targets, from which the chemokine receptor CCR9 emerged as high interest. AZD7798, a monoclonal antibody designed to deplete CCR9+ T cells, was evaluated in a randomized, placebo-controlled, double-blind first-in-human healthy volunteer study (NCT05452304), and in small bowel Crohn’s patients in a PET imaging study (NCT06053424).

Results

In the meta-analysis, marked differences were observed in efficacy of existing CD treatments in small compared to large bowel disease (Fig.1). Outcomes across mechanisms of action were not significantly different from placebo in small bowel CD (OR 1. 07, 95% CI 0.64-1.78, p=0.79) yet were superior in colonic CD (OR 3.86, 95% CI 2.75-5.42, p<0.001). Next, transcriptomic analyses identified CCR9 and its ligand CCL25 as highly and selectively expressed in terminal ileum compared to large bowel. Subsequently AZD7798, a CCR9+ T cell depleting antibody, was evaluated in 106 healthy participants in a first-in-human study, and in 6 CD patients in a Phase 1b study. There were no SAEs or treatment discontinuations, and rapid and sustained depletion of CCR9+ T cells in blood was observed in both studies. Moreover, AZD7798 reduced target cells in small bowel in CD patients as detected using a novel CCR9 tracer (Fig.2).

Conclusion

Ileal CD represents a high unmet need patient subpopulation, where existing treatments appear less effective than for colonic disease. CCR9 is identified as an attractive target for small bowel-dominant inflammation. AZD7798, a first-in-class CCR9+ T cell depleting antibody, demonstrated acceptable safety and tolerability alongside sustained CCR9+ T cell reductions in blood and small intestine.