bluuebunny/crossref_metadata_2025 huggingface dataset:
P0677 Population-Based Analysis of 30-Day Postoperative Course in Crohn’s Disease Patients Undergoing Primary Bowel Resection
Authors: Poulsen A , Damsgaard Wewer M , Lin V A , Rønne Pachler F , Verlo K A , Rasmussen J , Søe Riis Jespersen H , Surnecheva E , Christiansen D , Holm Hansen E , Møller Nordestgaard R L , Aydemir N , Dige Ovesen P , Filtenborg Brandt C , Gögenur I , Burisch J , Seidelin J
Published: January 2025

Background

Despite a growing array of medical treatment options, resection rates for Crohn’s disease (CD) have decreased over time, while re-resection rates have remained stable at approximately one-third in historical cohorts. This study aimed to assess 30-day postoperative outcomes and complication rates following primary bowel resection in CD patients.

Methods

This study encompassed all CD patients undergoing primary resection in Eastern Denmark from 2010 to 2020 (46% of the Danish population, n=2,730,000). Clinical characteristics, surgical procedures, and complications (Clavien-Dindo classification and Rahbari score) were collected 30 days postoperatively (Figure 1). We used nonparametric statistics (median, interquartile range (IQR), percentages) and assessed complication risk with chi-square tests and multivariate logistic regression.

Results

Primary resection was performed on 631 CD patients due to disease activity. The median age at resection was 35 years (IQR: 25-49) with disease duration of 2 years (IQR: 0-7), and 227 (36%) were smokers. A total of 76 patients (12%) underwent acute resection (<24 hours), while 380 (60%) underwent elective procedures, 349 (55%) had laparoscopic surgery, 479 (76%) received a primary anastomosis (PA), and 94 (15%) were re-admitted. In total, 164 patients (26%) experienced complications within 30 days. Twenty-two (3%) had a Rahbari score of grade C, and two (0.3%) had grade B, and none had grade A. The Clavien-Dindo classification showed grade I: 22 (3%), grade II: 42 (7%), grade III: 95 (15%), grade IV: 4 (0.6%), and only one death (0.2%). Active steroid use (OR 2.26, 95% CI: 1.47–3.45, p<0.001), open surgery (OR 1.60, 95% CI: 1.10–2.34, p=0.015), and resection length >10 cm (OR 2.82, 95% CI: 0.532–51.9, p=0.325) were associated with higher odds, while primary anastomosis reduced risk (OR 0.42, 95% CI: 0.281–0.633, p<0.001). Never received IBD medication (OR 0.76, 95% CI: 0.42–1.30, p=0.336) or being on therapeutic doses of biologics (OR 1.31, 95% CI: 0.87–1.96, p=0.191) was not significantly associated with the risk of 30-day complications, nor were symptom burden (HBI) or smoking status (p=0.670 and 0.250).

Conclusion

CD patients are often diagnosed and primary resected young, facing significant risks within 30 days postoperatively: 15% were readmitted, and one-fourth experienced complications requiring treatment. the Risk of complications was increased by open surgery, resection length >10 cm, and preoperative corticosteroid use, while primary anastomosis reduced the risk. Receiving biologic therapy did not increase the risk of complications.
P0678 Iron deficiency, with or without anaemia, in Inflammatory Bowel Disease remains an undermanaged issue: Crohn’s Colitis Cure Data Insights Program
Authors: Pinnuck B , Su W K , Wilson W , Pipicella J , Ng W , Antoniades S , Walker G , Forbes A , Dutt S , Lynch K , Connor S J , Andrews J M
Published: January 2025

Background

Inflammatory bowel disease (IBD) increases the risk of nutritional deficiencies, particularly iron deficiency (ID), which is due to chronic blood loss from ulceration and intestinal inflammation causing increased iron demand and malabsorption. Reported rates of ID in IBD cohorts largely vary from 23-90% worldwide, influenced by age, gender, nutritional status, and comorbidities. ID can occur without anaemia and anaemia is not universally caused by ID.

Methods

Crohn’s Colitis Care (CCCare) is a cloud-based electronic medical record used in Australasia. Data feed into a deidentified clinical quality registry was interrogated in September 2024. People with IBD under active care (encounter within 14 months) were included to explore the prevalence of ID in this cohort. ID was defined as a serum ferritin level of <30 mcg/L or a serum transferrin saturation <16% with a serum ferritin level of > 30 mcg/L. Anaemia was defined as a haemoglobin (Hb) of <130 g/L in males and <115 g/L in females.

Results

The 7493 eligible people with IBD, of whom 35.2% (n=2615) had iron studies (IS) (serum ferritin and transferrin saturation) and a Hb recorded. Their median age was 41 years (IQR 30 – 56) with an even gender distribution (50.1%, n=1310 female). Most resided in Australia (87.7%, n=2294) and 12.3% (n=321) in New Zealand. Crohn’s disease (CD) affected 60.3% (n=1578) of the cohort, ulcerative colitis (UC) 36.7% (n=961) and IBD-Unclassified (IBDU) 2.9% (n=76). ID was found in 25.4% (n=663) of those with IS, with rates comparable amongst IBD subtypes; 26.1% in CD, 23.7% in UC and 30.3% in IBDU. Of those with ID, 22.8% (n=151) had concurrent anaemia (24.3% (n=100) in CD, 20.6% (n=47) in UC, and 17.4% (n=4) in IBDU). In those with ID, the most common form of iron replacement was iron carboxymaltose (n=67, 69.8%), yet overall, only 96 of 673 (14.5%) with ID were documented to have been given iron replacement. The median C-reactive protein for those with IS was 2.3 (IQR 0.9 – 4.9), so the ID did not appear to be predominantly driven by a higher current inflammatory burden.

Conclusion

Despite being a well-known complication in IBD, which is easily treated, ID remains highly prevalent in routine care in this large real-world cohort. ID is more common than ID with anaemia, yet both ID and ID with anaemia are both likely to be impairing quality of life. Overall, there are low rates of iron replacement in this cohort. ID continues to be an area with significant opportunity to improve practice and outcomes. Protocolised screening and repletion may be needed to ensure consistency, and other approaches such as benchmarking or open data reporting on key point indicators may need to be implemented to drive change at scale.
P0686 Steroid use in patients with inflammatory bowel disease – claims data indicate a decline in steroid use for the first time over a five-year observation period in Germany
Authors: Bokemeyer B , Stratil A S , Friedrich B , Brunner P , Rath S , Papukchieva S
Published: January 2025

Background

Although maintenance and prolonged use of oral corticosteroids (OCS) in inflammatory bowel disease (IBD) is not recommended, it remains a common practice.1–3 This study evaluated the concomitant use and overuse of OCS among IBD patients in Germany from 2017 to 2022.

Methods

We retrospectively analysed German claims data (January 2017–December 2022). Patients over 18 years of age with continuous insurance and at least two quarterly diagnoses of Crohn’s disease (CD) and/or ulcerative colitis (UC) within two years were included. To increase the diagnostic certainty and clinical relevance, only patients with IBD who were currently receiving any form of IBD therapy (corticosteroids, aminosalicylates, calcineurin inhibitors, other immunosuppressants, biologics and/or small molecules) were included in the analysis. Oral corticosteroids (OCS) were defined as steroids for systemic use (ATC code: H02AB and H02BX). Concomitant use of an OCS use was assumed if a patient received a prescription for an IBD medication, excluding OCS monotherapy with OCS, alongside an OCS within the same quarter. OCS overuse was defined as receiving ≥2 OCS prescriptions within one year alongside an IBD medication. Subgroup differences were tested using Fisher’s exact test.

Results

The study identified 9,407 patients with confirmed CD and 11,772 patients with confirmed UC who were treated with IBD medications, during the observation period (Table 1). Of these, 42.8% of CD patients and 39.0% of UC patients were treated with concomitant OCS (CD vs. UC, p<0.0001), while 31.3% of CD patients and 29.4% of UC patients experienced OCS overuse (CD vs. UC, p<0.01) (Figure 1A). OCS use and OCS overuse decreased significantly from 2017 to 2022 in both CD and UC patients (p<0.0001) (Figure 1B).

Conclusion

This study provides real-world insights into the patterns of (over)use of OCS in IBD patients. It highlights the continued over-reliance on OCS, particularly in CD patients. Notably, steroid overuse has decreased significantly over the 5-year observation period.

References

1.Deutsche Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS). Aktualisierte S3-Leitlinie „Diagnostik und Therapie des Morbus Crohn“. Published online August 1, 2021. Accessed September 11, 2024. https://register.awmf.org/de/leitlinien/detail/021-004

2.Deutsche Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS). Aktualisierte S3-Leitlinie Colitis ulcerosa. Published online April 26, 2021. Accessed September 11, 2024. https://register.awmf.org/de/leitlinien/detail/021-009

3.Bokemeyer B, Ghiani M, Fuchs A, et al. Indicators of active disease and steroid dependency in patients with inflammatory bowel diseases not treated with biologics in a German real-world-setting. Int J Colorectal Dis. 2020;35(8):1587-1598. doi:10.1007/s00384-020-03588-w
P0689 A clinical study on the optimization of vedolizumab induction therapy for moderate to severe active Ulcerative Colitis at week 10
Authors: Li M , Xie Y , Tian F
Published: January 2025

Background

To observe the clinical efficacy of adding one dose of vedolizumab induction therapy in the 10th week for the treatment of moderate to severe active Ulcerative Colitis (UC), evaluate its effectiveness and safety, and provide clinical reference for the treatment plan of UC patients.

Methods

This study included a total of 80 UC patients who sought medical treatment at the Department of Gastroenterology at Shengjing Hospital of China Medical University from January 2020 to January 2025. They were divided into two groups: the experimental group (31 cases) received treatment with vedolizumab at weeks 0, 2, 6, 10, and 14, while the control group (49 cases) received treatment with vedolizumab at weeks 0, 2, 6, and 14 for at least 14 weeks. The changes in indicators such as modified Mayo score, Mayo endoscopic score, C-reactive protein (CRP), and safety analysis were observed before and after treatment in both groups. Clinical remission rate, clinical response rate, endoscopic remission rate, and endoscopic response rate were compared.

Results

The clinical response rate of the experimental group was 100%, significantly higher than the control group’s 84.62% (P<0.05). The endoscopic response rate of the experimental group was 85.71%, significantly higher than the control group’s 57.50% (P<0.05). There was no significant difference between the experimental group and the control group in terms of clinical remission rate and endoscopic remission rate (P>0.05). The CRP levels before and after treatment were significantly reduced between the two groups (P<0.05), and there was no significant difference in the number of patients with normal CRP levels between the groups (P>0.05).

Conclusion

Adding vedolizumab induction once in week 10 can significantly improve clinical and endoscopic response rates, but more research is needed in terms of clinical and endoscopic response rates.
P0691 Impact of Ozanimod (OZA) on Circulating Neutrophils: Results from the Phase 3 Japanese True North (J-TN) Study of Patients (Pts) With Moderately to Severely Active Ulcerative Colitis (UC)
Authors: Zhang J , Gilvary C , Schwarz J , Uchikawa Y , Fujimoto G , Zhang C , Harris S
Published: January 2025

Background

OZA was approved for treatment (tx) of moderately to severely active UC in adults based on TN study results. Increases in circulating neutrophils are an indicator of systemic inflammation, and increased infiltration of activated neutrophils in intestinal mucosa contributes to mucosal inflammation in inflammatory bowel disease (IBD). Human neutrophil elastase-mediated degradation of calprotectin (CPa9-HNE) is a measure of neutrophil activity.

Methods

The effect of OZA on neutrophils and CPa9-HNE levels and the association of neutrophils and CPa9-HNE levels with OZA efficacy were assessed in all J-TN pts. During the 12-wk induction period, pts were randomized to OZA 0.46 mg, OZA 0.92 mg or placebo (PBO). OZA clinical responders at Week (W) 12 were continually assigned treatment to OZA or PBO for maintenance through W52. Circulating neutrophil and CPa9-HNE levels were analyzed at baseline and throughout the induction periods. Neutrophil and CPa9-HNE levels were explored by clinical response status at W12 and W52.

Results

Absolute neutrophil counts remained within the normal range throughout the induction and maintenance periods. Circulating neutrophil levels decreased with OZA 0.46 mg and 0.92 mg during induction and were significantly lower than those observed with PBO. Neutrophil levels significantly decreased by 2 weeks of treatment with OZA at 0.92mg dose groups compared to baseline. Circulating neutrophils remained low with continued OZA during induction period. Decreases in circulating neutrophil levels were greater in patients with clinical response starting at Week 9 (responders) than those without clinical response at Week 12 (nonresponders) in both dose Oza-treated pts groups during the induction period. CPa9-HNE levels also decreased with OZA 0.92 mg during induction period as compared with PBO and baseline. However, No significant difference of circulating Cpa9-HNE levels between responder vs nonresponser with Oza treatment at week 12. Baseline NEUT was positively associated with baseline stool frequency, 9-point Mayo and CRP. Baseline Cpa9-HNE levels was positively associate with baseline CRP. Furthermore, CfB NEUT was positively associated with CfB Physician Global Assessment, Rectal Bleeding and CRP with Oza 0.92mg treatment at week 12. CfB NEUT and Cpa9-HNE was positively associated with CfB CRP with both dose Oza treatments at week 12.

Conclusion

Circulating inflammatory markers of neutrophils and CPa9-HNE decreased with ozanimod use. These findings support the use of circulating neutrophils and CPa9-HNE, a measure of neutrophil activity, as pharmacodynamic markers for ozanimod treatment effect and potential disease markers in patients with UC.
P0693 The Chicago Mesenteric Fat Index: A Novel Biomarker for Assessing Inflammation in Pediatric Crohn’s Disease with Point of Care Intestinal Ultrasound
Authors: Kellar A , George T , Dolinger M , Smyth M , Krugliak-Cleveland N , Rubin D , St-Pierre J
Published: January 2025

Background

Pediatric Crohn’s disease (CD) is a chronic, progressive disorder that may result in lifelong disability. There is a need for tools that facilitate early detection and accurate assessment of disease. Point-of-care intestinal ultrasound (IUS) is an accurate and non-invasive tool that provides an alternative to magnetic resonance and/or computed tomographic enterography. In addition to bowel wall thickness (BWT) and hyperemia, mesenteric fat (MF) is one of the measures of CD severity visualized with IUS. Current guidance for grading MF is subjective and binary. We have previously proposed the Chicago Mesenteric Fat Index (CMFI) to standardize grading MF in adults, and demonstrated moderate to substantial inter-rater reliability (IRR). The aim of this study was to determine the IRR of MF assessment and validate the CMFI in pediatric CD.

Methods

IUS images of children with ileal CD were captured from November 2023 to May 2024. Those with prior surgery were excluded. CMFI differentiates severity based on the degree of wrapping: "none" (none or minimal MF wrapping), "incomplete" (incomplete circumferential MF wrapping with skipped areas along the terminal ileum), and "complete" (circumferential MF wrapping, continuous along the terminal ileum) (Figure 1). MF grading was performed by experienced pediatric intestinal sonographers, blinded to clinical data. IRR was analyzed using Cohen’s kappa statistic. We used population and clinical data and assessed the correlation of MF using chi-square for categorical data and Kruskal-Wallis for continuous variables.

Results

48 IUS examinations in 36 patients were included [50% female, 69% ileocolonic disease, predominately non-stricturing, non-penetrating in 67%]. Median BWT on IUS was 3.55 mm [1.9-5.25] (Table 1). Of the 48 scans, 32 (67%) had presence of MF wrapping,16 had incomplete MF wrapping and 16 had complete MF wrapping. The IRR for the binary assessment of MF was substantial (k = 0.6936), and grading according to the CMFI also showed substantial agreement (k = 0.6038). MF was associated with other IUS parameters, including BWT (p<0.001 for both binary and graded index and binary), loss of bowel wall stratification (p = 0.001 for binary assessment and p = 0.002 for graded index) and the presence of hyperemia (p = 0.002 for binary assessment and p = 0.011 for graded index). MF was not associated with ileal strictures (p = 0.224 for graded index, p = 0.132 for binary assessment) (Table 1).

Conclusion

We demonstrate that IUS is a reliable tool for the assessment of MF in pediatric CD. MF assessment with the CMFI could be used as a potential objective non-invasive biomarker of CD severity in children, allowing for enhanced clinical decision-making and improved outcomes.
P0696 ADSS: A novel AI-derived metric for quantifying disease severity and extent in ulcerative colitis
Authors: Becker B , Fraessle S , Yao H , Luscher J , Girycki R , Machura B , Czornik J , Goslinsky J , Pitura M , Levitte S , Karrer T , Abbasi S , Arus Pous J , Fisher E , Bojic D , Richmond D , Bigorgne A , Prunotto M
Published: January 2025

Background

The Mayo Endoscopic Subscore (MES) is the prevailing standard for evaluating ulcerative colitis (UC) severity endoscopically, but correlates poorly with response to treatment. A comprehensive assessment encompassing both severity and extent is critical for monitoring treatment response in UC. Here we present the Aggregated Disease Severity Score (ADSS), a novel metric quantifying inflammation severity and extent in UC derived from the Ulcerative Colitis Severity Classification and Localized Extent (UC-SCALE) algorithm.

Methods

UC-SCALE was trained using 4,306 sigmoidoscopy videos from phase III etrolizumab clinical trials and consists of 1) preprocessing algorithms, 2) scoring algorithm that assigns MES score (0-3) to each frame, and 3) camera localization algorithm which maps each frame to an anatomical location. The ADSS is calculated by dividing the colon into 10 equal segments based on the location. An average MES score is computed for each segment, and these scores are summed to yield the ADSS (Figure 1 top) which ranges from 0 (all segments healthy) to 30 (all segments severely affected).

Results

UC-SCALE closely agrees (QWK = 0.83) with centrally-read MES. However, UC-SCALE’s spatially-resolved disease severity information showed clear treatment effects in groups of patients classified as endoscopic non-responders by the central reading score (CR); this was also reflected in the ADSS which showed decreased disease severity between screening and end-induction timepoints, but the CR was unchanged (Figure 1 bottom). Importantly, ADSS was more strongly correlated with fecal calprotectin than centrally-read MES (rADSS = 0.50 vs rCR = 0.37; Steiger’s Z-test Z = 3.10, p = 0.002).

Conclusion

UC-SCALE and ADSS provide a holistic disease evaluation by capturing both the severity and extent of inflammation. Together, these tools can be employed to improve the sensitivity of treatment response evaluation in clinical trials.
P0697 Ozanimod Inhibits Pro-Inflammatory Mediators of the IL-17 Pathway in the Tissues of Participants in the Phase 2 TOUCHSTONE Study
Authors: Zhang J , Chen X , Wu C , Petersen A K , Mehandru S , D’Haens G , Harris S
Published: January 2025

Background

OZA was approved for the treatment of moderately to severely active ulcerative colitis (UC). IL-17A, a proinflammatory cytokine, sustains the release of other inflammatory mediators and is associated with inflammatory bowel disease (IBD).

Methods

This analysis assessed gene expression from FFPE colon tissue in baseline and post treatment samples during TOUCHSTONE study. 197 Pts were randomized 1:1:1 to double-blind treatment with once-daily oral OZA 0.5 mg and 1 mg or matching placebo (PBO) for a 1-week (W) dose escalation period followed by 8W of induction treatment. Pts with clinical response at W8 (after dose escalation) entered a maintenance phase through W32. A NanoString whole transcriptome atlas (WTA) assay was run on these FFPE colon samples stained with antibodies to S1P1, panCK, and CD45. Six regions of interests (ROIs) were selected in each sample based on the staining and each ROI were split into two areas (CD45+ or CD45-). Differential enriched pathways analysis including IL-17 signaling pathway gene expression was analyzed in colon tissue samples collected before treatment, W8 and W32.

Results

OZA, not Placebo (PBO), induced significant PD spatial gene expression changes over time in colon tissue. No significant PD effects on gene expression changes were observed in CD45+ or Rest segment in PBO. OZA 0.5 mg induced significant spatial whole transcriptome gene expression changes at week 32 in the CD45+ segment (n=336 genes) or Rest (n=267 genes), and no differential expression genes were observed at week 8. OZA 1mg induced the most significant spatial whole transcriptome gene expression changes as early as W8 in segment CD45+ (n=121 genes) or Rest (n=171 genes). Significant overlap in OZA-included PD gene expression changes across doses, visits or cell types. OZA significantly downregulated 24 pathways in colon tissue from the CD45+ segment at W8 (p<0.05), with IL-17 signaling as the most significantly downregulated pathway. Significant IL-17 related gene differences were identified with OZA treatment, including CXCL1, CXCL2, CXCL3, CXCL5, CXCL6, CXCL8, MMP1, MMP3, MMP9, S100A8, S100A9, LCN2, CEBPB, HSP90B1 and IL1B genes, which involved in inflammation and immune response.

Conclusion

OZA led to circulating IL-17A reductions (previously reported) and IL-17 pathway related gene expression reduction in colon tissue, indicative of decreases in inflammatory responses. These finding may help support the use of supporting IL-17A and IL-17 pathway related genes as a good PD biomarker for OZA in UC.
P0700 Impact of filgotinib on health-related quality of life over 3 years in Japanese patients with Ulcerative Colitis: A post hoc analysis of the SELECTION and SELECTION long-term extension trials
Authors: Matsuoka K , Schreiber S , Hata E , Kaise T , Hibi T
Published: January 2025

Background

Filgotinib (FIL) is an oral, once-daily, Janus kinase 1 preferential inhibitor approved for the treatment of ulcerative colitis (UC). The efficacy and safety of FIL in adults with moderately to severely active UC were evaluated in the phase 2b/3 SELECTION trial (NCT02914522) and its long-term extension trial (SELECTIONLTE; NCT02914535). Previous analyses of the full populations in SELECTION and SELECTIONLTE demonstrated short- and long-term improvements in health-related quality of life (HRQoL) in patients receiving FIL.1,2 This post hoc analysis assessed the impact of FIL on HRQoL over 3 years in Japanese patients from SELECTION and SELECTIONLTE.

Methods

In SELECTION, patients received induction FIL 200 mg (FIL200), FIL 100 mg or placebo (PBO) for 11 weeks. At week 11, induction responders could enter the 47-week maintenance study. Patients who completed the SELECTION induction and maintenance studies (completers) and induction non-responders could enter SELECTIONLTE and continue their assigned dose (completers) or receive FIL200 (non-responders). This post hoc analysis included Japanese patients who received FIL200 or PBO in SELECTION, and Japanese completers and non-responders who received FIL200 in SELECTION and SELECTIONLTE. HRQoL was assessed over 3 years using the patient-reported outcome measures (PROMs) Inflammatory Bowel Disease Questionnaire (IBDQ), the EQ-5D and the 36-item Short Form Health Survey (SF-36).

Results

At week 10, a higher proportion of patients receiving FIL200 than PBO experienced minimal clinically important differences (MCIDs) in IBDQ score (77% vs 54%) and in the SF-36 mental component summary (MCS; 58% vs 21%) and physical component summary (PCS; 54% vs 36%) scores. MCID rates were similar between the groups for the EQ-5D value (49% vs 43%) and the EQ visual analogue scale (VAS) score (47% vs 57%) (Figure 1). MCID rates in each of the PROMs were maintained over 3 years of FIL200 treatment for SELECTION completers. In induction non-responders, MCID rates in most of the PROMs increased notably from week 10 and were maintained for up to 3 years of FIL200 treatment (Figure 2).

Conclusion

FIL200 treatment led to improvements (vs PBO) in IBDQ and the SF-36 scores, and maintenance or continuation of improvements in PROMs in SELECTION completers and induction non-responders over 3 years. These findings suggest that FIL200 has a positive short- and long-term impact on Japanese patients’ HRQoL and are therefore in line with findings from the overall SELECTION and SELECTIONLTE populations. Conclusions are limited by the small sample sizes.

References

1. Schreiber S, et al. J Crohns Colitis. 2023;17(6):863–875.

2. Feagan BG, et al. Aliment Pharmacol Ther. 2024;60(5):563–584.
P0703 Risk factors and nomogram for massive postoperative gastrointestinal bleeding in patients with Crohn’s disease: a multicenter retrospective study
Authors: Zhang M , Ding Z , Wang Y , Li Y
Published: January 2025

Background

Crohn’s disease (CD) is a chronic inflammatory disease that is prone to complications such as intestinal obstruction and perforation, which often require surgical treatments. Massive postoperative gastrointestinal bleeding (MPGB) is a severe complication with a high mortality rate, deteriorating postoperative recovery and disease prognosis. However, there are few related studies and it lacks effective prevention measures. Therefore, we conducted a multicenter study to explore the risk factors for MPGB in CD patients.

Methods

This study was a multicenter retrospective case-control study. Inclusion criteria included: patients diagnosed with CD; aged over 16 years old; underwent gastrointestinal surgery. Exclusion criteria included: patients with massive gastrointestinal bleeding before surgery. Massive gastrointestinal bleeding is defined as: hemodynamic impairment, requiring active fluid resuscitation; decreased hemoglobin concentration, requiring blood transfusion or surgical treatment; with symptoms of gastrointestinal bleeding. The included patients were divided into a case group and a control group. By comparing medical information between two groups, risk factors for MPGB were identified through logistic regression analysis, and a nomogram was constructed.

Results

From January 2018 to February 2024, a total of 170 CD patients were included, including 34 patients with MPGB and 136 matched controls. Univariate logistic regression analysis showed that for albumin (P=0.001, OR=0.89), nutrition risk screening (NRS2002) scale (P=0.003, OR=1.61), predictive nutritional index (PNI) (P=0.005, OR=0.92), number of previous surgeries (P<0.001, OR=2.39), history of gastrointestinal bleeding (P<0.001, OR=8.75), international normalized ratio (INR) (P=0.004, OR=1.60), and abnormal liver function (P=0.049, OR=6.29) (P＜0.05), the difference between two groups was statistically significant. Multivariate logistic regression analysis further revealed that NRS2002 (P=0.022, OR=1.53), history of gastrointestinal bleeding (P=0.005, OR=5.71), number of previous surgeries (P<0.001, OR=2.43), and INR (P=0.011, OR=1.61) were associated with an increased risk of MPGB. Based on these results, a nomogram was constructed. The training and validation group achieved an area under the curve (AUC) value of 0.87 and 0.73 respectively with well-fitted Hosmer-Lemeshow calibration curves.

Conclusion

The risk of MPGB in CD patients will be increased with a history of gastrointestinal bleeding, more previous surgeries, a higher NRS2002 score, and a higher INR value. Strengthening the perioperative nutritional status management of CD patients may prevent the MPGB. Besides, we conduct a nomogram model, which can effectively predict the risk of MPGB in CD patients.
P0705 Features of optimal disease control in Crohn’s disease and Ulcerative Colitis: Views on IBD Expectations and Well-being by Patients and Treatment providers
Authors: Rubin D T , Potts Bleakman A , Orleck K , Hibi T , Bernstein M , Kearns K , Patel A , Folian S , Kayhan C , Baygani S , Flynn E , Favia A , Knight H , Castellano G , Schreiber S
Published: January 2025

Background

With the expanding array of therapeutic options for Crohn’s disease (CD) and ulcerative colitis (UC), there is an increasing need to examine features of optimal disease control that reflect patient priorities. Views on IBD Expectations and Well-being - Patients and Treatment providers (VIEW-PT): an analysis based on the IBD Disease Specific Programme (DSP)™, aimed to identify features of optimal disease control in CD and UC, with inclusion of patient and healthcare professional (HCP) perspectives.

Methods

An iterative 3-Stage approach was used to identify features of optimal disease control in CD and UC (Table 1). In Stage 1, features of optimal disease control were identified by gastroenterologist (GI) advisors, a targeted literature search, and exploratory analyses of the Adelphi Real World IBD DSP. In Stage 2, features from Stage 1 were prioritized by patient advisors and additional features recommended for inclusion. In Stage 3, GI and advanced practice provider (APP) advisors provided further input on relevance of the expanded list of features, terminology, and categorisation. Features mentioned unprompted by patient, GI or APP advisors were cross-referenced to earlier stages and included if identified by ≥4 sources (see details in Table 1). GI and APP advisors provided feedback on similarities and differences of features of optimal disease control for CD vs UC.

Results

In Stage 1, nine features were identified as most relevant in defining optimal disease control in CD and UC: bleeding, bowel movement frequency, bowel urgency, endoscopic healing, fatigue, pain, quality of life, sleep disturbance, and steroid use. Faecal incontinence and mental health were added in Stage 2 following patient input. GI and APP advisors confirmed relevance of the 11 features in Stage 3; extraintestinal manifestations and biomarkers were added based on advisor recommendation and recurrence at earlier stages. Terminology was finalised and features ordered based on advisors’ recommendations, categorised as symptoms, functional outcomes, or markers of inflammation (Figure 1). GI and APP advisors advocated to include the same features for CD and UC, acknowledging expected variation in prioritisation by indication and across individual patients.

Conclusion

By considering a range of sources and including patient perspectives, optimal disease control in CD and UC was found to be a multi-faceted concept, incorporating symptoms, functional outcomes, and markers of inflammation. Patient advisors highlighted the importance of faecal incontinence and mental health, which may be overlooked in clinical practice. This robust framework of optimal disease control can be adopted to aid with development of individual IBD management plans in clinical practice.
P0709 Patient Satisfaction with Subcutaneous versus Intravenous Vedolizumab: A Prospective Observational Study
Authors: Herrera De Guise C M , Serra-Ruiz X , Céspedes Martínez E , Mayorga Ayala L , Robles Alonso V , Lastiri Gonzalez E , Oller E , Pérez Martínez Z , Casellas F , Borruel Sainz N
Published: January 2025

Background

Vedolizumab (VDZ) is a selective biologic agent that is available in both intravenous (IV) and subcutaneous (SC) forms for maintenance treatment. The SC route offers advantages such as the convenience of self-administration, although some patients may prefer the IV route. The aim of our study was to determine patients’ preferences and satisfaction with their treatment when switching to VDZ SC or continuing with an IV administration.

Methods

A prospective, observational study was conducted in patients with inflammatory bowel disease (IBD) receiving VDZ IV who were in clinical remission. Patients had the option to continue with VDZ IV or switch to SC and were grouped according to their preference. A baseline visit (before the switch) and another at 24 weeks were conducted. During both visits, patients completed the treatment satisfaction questionnaire (SATMED-Q) and quality of life questionnaire (IBDQ9). Clinical activity, treatment adherence, adverse effects, general bloodwork, and fecal calprotectin were also analyzed.

Results

Forty-one IBD patients were included, 43% of which were women, and 63% had ulcerative colitis. Almost half (41%) continued with VDZ IV while 59% switched to SC. There were no differences in gender, type, or characteristics of IBD between the groups. However, the age of patients in the SC group was significantly younger than that of the IV group (median 46 [32-63] vs. 66 [59-77] p=0.03). Fewer patients in the SC group had previously received IV biologics (SC 31% vs. IV 69%, p=0.012). The median SATMED-Q before the switch was lower in the SC group (SC 53 [40-61] vs. IV 61 [46-64], p=0.032), as was the IBDQ9 (SC 65.5 [59.4-68.5] vs. IV 70.8 [68.5-77.1], p=0.037). At 24 weeks, there were no differences in SATMED-Q or IBDQ9 scores or disease clinical activity. Drug persistence and frequency of adverse events were similar in both groups. Vedolizumab levels increased significantly in the SC group at 24 weeks (p=0.041).

Conclusion

Switching to VDZ SC showed similar treatment satisfaction to VDZ IV at 24 weeks in IBD patients, with comparable clinical outcomes and safety profiles. There was a clear preference for subcutaneous administration among younger patients and those without previous IV treatment. This suggests that patient demographics and prior treatment experiences can influence the choice of administration route. The lack of significant differences in clinical outcomes, quality of life scores, and treatment satisfaction between the SC and IV groups at 24 weeks highlights the clinical equivalence of these two administration routes for maintenance therapy in IBD.
P0711 The Effect of Extraintestinal Manifestations Presence on Treatment Persistence in IBD Treatment
Authors: Koç Ö , Eroglu Z , Yılmaz V , Acehan M F , Guvenir S T , Toruner M
Published: January 2025

Background

Inflammatory Bowel Disease (IBD), which includes Crohn’s disease and ulcerative colitis, is a chronic, relapsing inflammatory disorder of the gastrointestinal tract. A significant portion of patients also experience extra-intestinal manifestations (EIMs) that involve various organ systems beyond the intestines. EIMs are often present at the onset of disease or may develop later during the course of IBD, and their severity can vary, influencing overall disease prognosis and quality of life. Effective management of IBD requires a holistic approach that not only addresses the intestinal inflammation but also anticipates and treats these extra-intestinal complications.

In this study we aimed to investigate the role of EIM presence on anti-TNF treatment persistence in IBD therapy.

Methods

This was a single center, retrospective cohort analysis of patients with IBD either received adalimumab or infliximab as a first line biologic treatment. A total of 673 patients were included to this analysis. Demographic information such as gender, age, Montreal classification, EIM presence, smoking and prior medications were noted from patients electronic medical records. Weighted Kaplan-Meier and Cox models were used to assess the outcomes.

Results

Out of 673 patients, 426 patients had Crohn’s disease, 240 patients had ulcerative colitis and 7 patients had indeterminate colitis. Overall, 379 pateints received adalimumab and 294 patients received infliximab as first line biologic treatment for IBD. While 272 patients had EIM, 349 patients did not have EIM accompanying their IBD. EIM presence was not concluded in 52 patients from their medical charts. Smoking and family history were not different between patiemnts with and without EIM. However, female patients had statistically more EIM (51.3% vs. 38.1%, p<0.05) and patients with Crohn’s disease had statistically more EIM (49.4% vs 34.5%, p<0.05). Anti-TNF drug persistence was significantly higher in patients with EIM when compared to patients with no EIM (Figure 1). This difference was independent of the type of anti-TNF medication used. However, in patients with ulcerative colitis the difference became more significant, while in Crohn’s disease patients although there is trend, the difference was not significant. The concomitant use of immunomodulator drugs did not make any impact.

Conclusion

In IBD patients, anti-TNF medication persistence was observed to be significantly longer in those with EIM. This difference was significantly greater in ulcerative colitis patients compared to Crohn’s patients. This difference was independent of the concomitant medication use.
P0712 Feasibility of a smart toilet seat for the measurement of physiological parameters in active Ulcerative Colitis: A pilot study.
Authors: Hazeleger L , Verbiest V , Hamers J , Groenendaal W , Wentink E , Duijvestein M
Published: January 2025

Background

Management of inflammatory bowel disease (IBD) remains largely reactive, with limited ability to predict or prevent flares. Passive remote monitoring of physiological parameters could provide objective data on IBD activity and facilitate the development of algorithms for early flare detection. OnePlanet Research Center has developed the smart toilet seat, a novel device that noninvasively measures several physiological parameters during a toilet visit (Figure 1). In this study, we aimed to 1) evaluate feasibility of using the smart toilet seat for home monitoring for ulcerative colitis (UC) 2) measure physiological parameters in UC patients starting new medical treatment during a flare using the smart toilet seat.

Methods

We installed the smart toilet seat at the homes of eight patients with active UC starting new treatment for a period of 8 weeks. Patients were instructed to use the smart toilet seat as they would use their regular toilet, and indicate their toilet visit and stool consistency using remote control buttons. Measurements included number of toilet visits, toilet visit duration, stool consistency, heart rate and perianal temperature. Disease activity was measured weekly using an app-based self-reported Simple Clinical Colitis Activity Index (SCCAI) and faecal calprotectin (FC) (CalproSmart Self Test).

Results

33 patients were contacted for participation, of which eight patients with active UC were included (24%). Next to maintenance therapy with aminosalicylates, patient started with various types of treatment (Table 1). Median FC was 1107 µg/g (range <77 – >1500 µg/g (lower and upper levels of detection)) at week 1 and below the lower limit of detection (<77 µg/g (<77 – >1500 µg/g)) at week 8. 1431 visits to the Smart toilet seat were recorded, of which 326 were defaecation visits. Median toilet visit duration for all visits and defaecation visits was respectively 1.8 and 4.2 minutes. Between week 1 and week 8, a median change of -6 (range -19, 4) in weekly bowel frequency was measured by the Smart toilet seat and median change in weekly SCCAI was -2 (range -4.5, -0.5) (R2 = 0.75). All participants indicated they would use the Smart toilet seat in the future if it would give their gastroenterologist or general physician more insight into their disease.

Conclusion

Our study shows it was feasible to measure stool frequency and multiple physiological parameters using a smart toilet seat in a population of UC. Future research is aimed to identify relevant parameters measured by the smart toilet seat that are related to the development of IBD flares, which could serve as basis for predictive models.
P0713 Feasibility of a Physical Activity intervention in Patients with IBD - the PASIBO Study
Authors: Poulsen A , Thomsen T , Villumsen M , Søe Riis Jespersen H , Blædel Hansen A , Appel Esbensen B , Jess T , Højgaard Allin K , Aadahl M
Published: January 2025

Background

Recent studies suggest that physical activity (PA) may improve the quality of life and relieve fatigue in patients with inflammatory bowel disease (IBD). However, there is no consensus as to what type of PA intervention should be offered to patients with IBD and barriers related to stigmatization and disease symptoms calls for an individually tailored approach. We developed a PA intervention involving patients, health professionals and other stakeholders in a co-creation process. This study aims to determine the feasibility and acceptability of a tailored PA intervention in adult men and women with IBD, focusing on recruitment, retention and outcome assessments.

Methods

In a randomized, controlled feasibility study, 30 patients with IBD were recruited from Digestive Disease Center, Bispebjerg Hospital, Copenhagen and randomized to an intervention (n=15) or a control (n=15) group. The 20-week intervention comprised group-based education, four nurse-led motivational interviews and three optional components (individual physiotherapy session, exercise ‘buddy’ and/or exercise videos). Outcome assessments at baseline and after 20 weeks, included accelerometer-measured PA, patient-reported outcomes, cardiometabolic biomarkers and anthropometrics. Interviews with participants informed intervention acceptability.

Results

A total of 164 participants were screened to enroll 30 patients with IBD. Hereof 47% were women, mean age was 39.7 years (SD 13.7), and 57% had Crohn’s disease, while 43% had ulcerative colitis (table 1). Participants in the intervention group were slightly younger, were more often co-habiting, more frequently employed and had more co-morbidity than participants in the control group (table 1). All participants completed the 20-week outcome assessment, and all 15 intervention participants completed the four motivational sessions, setting personalized goals. The most common goals were increasing active transportation and daily walking. Most participants chose to add videos or a physiotherapy session, while none selected the exercise ‘buddy’ option. Interviews highlighted the importance of the personalized approach and the focus on the full PA spectrum. The chosen outcome measures appeared feasible, and findings pre/post intervention indicated a potential beneficial impact of PA on fatigue and Quality of life in the intervention group (Table 2).

Conclusion

The study showed that an individually tailored PA intervention focusing on motivation and opportunities to increase PA in daily life is feasible and acceptable. The results are informing a subsequent, adequately powered, multi-centre trial.
P0716 Comparison of vedolizumab and ustekinumab treatment persistence in anti-TNF experienced perianal Crohn’s Disease patients: A Single Center Experience
Authors: Eroglu Z , Acehan M F , Koç Ö , Yılmaz V , Toruner M
Published: January 2025

Background

Perianal Crohn’s disease (CD) is a particularly challenging and debilitating complication of Crohn’s disease. This can lead to significant morbidity, including chronic pain, and recurrent infections, all of which severely impact a patient’s quality of life. Biologic therapies, particularly tumor necrosis factor (TNF) inhibitors, such as infliximab and adalimumab, have become central to the management of this condition due to their ability to target key inflammatory pathways driving both intestinal and extra-intestinal disease. In addition to Anti-TNF agents, other biologics such as integrin inhibitors (e.g., vedolizumab) and interleukin inhibitors (e.g., ustekinumab) have shown promise in treating refractory or complex perianal Crohn’s disease. In this study, we aimed to compare the persistence rates of vedolizumab and ustekinumab in anti-TNF experienced perianal Crohn’s disease patients.

Methods

This was a single center, retrospective cohort analysis of Anti-TNF treatment experienced Crohn’s disease patients either received vedolizumab or ustekinumab as a treatment. A total of 176 patients were included to this analysis. Demographic information such as gender, age, Montreal classification, smoking and prior medications were noted from patients electronic medical records. Weighted Kaplan-Meier and Cox models were used to assess the outcomes.

Results

Out of 176 Crohn’s disease patients, 128 patients had perianal Crohn’s disease. 41.5% of the patients were female, where as 33.7% of the patients had extraintestinal manifestations and 41.7% of the patients had fistulizing disease. EIM was less frequent in fistulizing disease (26% vs. 39.2%, p<0.05), concomitant azathioprine use was more frquent in fistulizing disease (58.9% vs. 34.3%, p<0.05) and fistulizing disease patients were predominantly male (67.3% vs 32.7%, p<0.05). Use of vedolizumab and ustekinumab did not different in fistulizing disease. In general cohort, the persistence rate was higher in ustekinumab treated group (Figure 1) where as in fistulizing disease group there was no statistically difference in persistence rate between two treatment arm (Figure 2).

Conclusion

To conclude, there is a shorter drug persistence rate in fistulizing Crohns disease when compared to non-fistulizing Crohn’s disease even with concomitant azathioprine use. While there was a longer drug persistence rate in the ustekinumab arm compared to the vedolizumab arm in the overall group, no significant difference was observed between both treatment arms in the fistulizing subgroup.

Figure : 1

Figure 2: