bluuebunny/crossref_metadata_2025_split huggingface dataset:
P0902 Development and validation of a novel model based on clinical characteristic variables to predict disease behavior progression in patients with stricturing Crohn's disease
Authors: Wang Y , Chen X , Liu Z , Gu Y , Mao R 
Published: January 2025

Abstract

Background
The risk factors for disease behavior progression in CD patients with strictures remain unclear. This study aims to construct a predictive model based on commonly used clinical indicators to identify high-risk CD patients with early progression.

Methods
We conducted a retrospective analysis of clinical data from stricturing Crohn’s disease patients at The First Affiliated Hospital of Sun Yat-sen University from October 2016 to October 2023. The disease behavioural progression was defined as progression to B3 classification or under surgery due to intestinal strictures. The data were split into a test set and an internal validation set in a 7:3 ratio. Classification models, including logistic regression (LR), random forest (RF) and extreme-gradient Boosting (XGB) Models, were constructed. Finally, all models were validated in an independent external validation cohort from Ruijin Hospital, Shanghai Jiaotong University School of Medicine.[Figure 1]

Results
The study included 341 patients, with 190 in the internal training set, 81 in the test set, and 70 in the external validation set. Obstructive symptoms, globulin (GLB), erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) are independent predictors of disease behavior progression. The areas under the receiver-operating characteristic curves (AUROCs) of the LR, RF, and XGB models were 0.861, 0.477 and 0.559, respectively. The logistic regression model achieved the highest AUROC value of 0.752 in the external validation. The further transformed nomogram has a similar prediction accuracy to the logistic regression.

Conclusion
In patients with stricturing CD, obstructive symptoms score, CRP, ESR and GLB were independent and validated predictors of disease behavior progression in stricturing Crohn's disease. We found no evidence of better performance of machine learning-based models in predicting disease behavior progression in stricturing CD. A nomogram based on the logistic regression model might aid in the management of stricturing CD patients.
P0904 Factors influencing postoperative bowel movement frequency following primary Ileo-Cecal resection in Crohn’s Disease patients
Authors: Naveh H , white I , wasserberg N , gurevich N , rozenstein Y 
Published: January 2025

Abstract

Background
Ileo-cecal resection is an effective treatment in Crohn’s patients, while diarrhea is a common postoperative negative outcome, with significant effect on patient’s quality of life. The aim of this study is to assess the effect of pre, peri and post-operative variables on the number of post-surgical bowel movements.

Methods
A retrospective cohort study of 168 Crohn’s patients undergoing primary ileo-cecal resection (2015–2023) at a high-volume center (Rabin Medical Center). Bowel movements were analyzed at three intervals (first check-up, 6–12 months, ≥2 years). We assessed the impact of multiple factors on post-operative number of bowel movements for both absolute and percentage change in bowel movements. Recurrent or concomitant resections were excluded

Results
168 patients who underwent primary ileo-cecal resection were included. The mean number of bowel movements raised from 2.77 pre-operative to 3.59 post-surgery (p=0.001). Longer resected bowel portions showed correlation at every follow up interval when examined as a percentage change (p=0.001 at first check up, p&lt;0.001, after 6-12M and after 2 years&lt;) or as an absolute number (p&lt;0.001 at each corresponding check up). Short resection (up to 50 cm) vs. long resection (51 cm&gt;) resulted in 62% more bowel movements in the short resection group at the two years follow up compared to pre-surgery, with the long resection group increasing by 164% (p&lt;0.001). Active smokers preoperatively has a statistically significant increase in the number of bowel movements vs. non-smokers at all follow up intervals, peaking at 2 years post-op with mean absolute number of bowel movements 5.28 vs. 2.81 (p=0.003) and percentage rise of 127% vs. 71% respectively (p=0.041). Patients receiving pre-surgical TPN nutrition suffered more compared to enteral nutrition (55% vs. 121% after 6-12 months P=0.009 and 64% vs. 148% after&gt; 2 years p=0.02). Patients with combined B2B3 disease behavior had an elevated number of bowel movements 2 years after the surgery compered to patients with B1/B2/B3 alone (P=0.02 for B2B3 vs. B1, P=0.03 for B2B3 vs. B2/B3). Patients treated with anti-diarrhea medications post-surgery had longer time from diagnosis to surgery compared with those without (P=0.049).

Conclusion
Primary ileo-cecal resection increases bowel movements for all Crohn’s Disease patients, but especially in patients with extended resections, pre-op TPN, smokers, or B2B3 disease behavior. Although a statistically significant correlation between time from diagnosis to surgery and post-surgical bowel symptoms was not observed, we found that patients who waited longer for surgery were more likely to use anti-diarrheal medications, suggesting an advantage to earlier surgical intervention after diagnosis.
P0907 Health literacy and digital health literacy in Inflammatory Bowel Disease as conditions for individualized adapted digital health information
Authors: Maurud S , Lunde L , Moen A , Opheim R 
Published: January 2025

Abstract

Background
Digital health information appears inadequate of providing medical expertise and clinical guidelines in IBD, including optimized accessibility, relevance and understandability for effective self-management. This study examines IBD patients’ health literacy (HL) and digital health literacy (DHL) and their covariance with various patient characteristics as implications for a digital health information platform.

Methods
IBD patients at a Norwegian university hospital underwent a cross-sectional survey. Clinical data were extracted from EHR. Other data were reported via questionnaire with the following instruments: HL – Health Literacy Questionnaire; DHL – eHealth Literacy Questionnaire; Quality of Life (QoL) – EQ-5D-5L; Self-efficacy (GSE) - General Self-Efficacy Scale; Illness perception (IP) – Brief Illness Perception Questionnaire; Medication adherence (MA) – The OsloMet Adherence to medication Survey tool. Data underwent a canonical correlation analysis (CCA) followed by hierarchical clustering. Variables omitted from CCA underwent bivariate analyses and logistic regression to assess cluster affiliation.

Results
Of 380 patients, 173 had UC and 53 % were male. Mean age was 43.6 years. No diagnose-specific PROM differences were found. CCA demonstrated positive associations for GSE, IP and health status against having sufficient capability to understand, assess and act upon health information and digital health services (p &lt; .001). CCA also proved a negative association for age and actively engaging with digital health services (p &lt; .001). Two clusters were identified (p &lt;. 05). Cluster 1 embodied the oldest patients, lowest levels of HL, DHL, GSE, health status, IP and longest disease duration. Compared to Cluster 2, Cluster 1 significantly demonstrated lower MA (p &lt;.05), higher shares of unemployment (p &lt;.05), active disease (p &lt;.001), and more severe QoL problems in terms of mobility (p &lt; .05), usual activities (p &lt; .001), pain/discomfort (p &lt; .001) and anxiety/depression (p &lt; .001). Disease activity (p &lt;. 01) and biological treatment (p &lt; .001) proved to be the strongest factors for cluster affiliation in a logistic model.

Conclusion
Our results imply a relation between health status, age, self-efficacy, biological treatment, disease perception and disease activity for IBD patients with low HL and DHL. The findings are implicative for a targeted intervention addressing digital health information dissemination for IBD patients.
P0910 Evaluating Tryptophan as a Biomarker for Treatment Success in Ulcerative Colitis Patients Undergoing Mirikizumab Therapy
Authors: Hatem Y , Maaß C , Marquardt J , Solbach P 
Published: January 2025

Abstract

Background
The treatment of ulcerative colitis (UC) has advanced significantly with the introduction of targeted medications, such as IL-23-Inhibitors. However, treatment success in inflammatory bowel diseases (IBD) varies and requires reliable biomarkers to assess therapeutic efficacy. Tryptophan (Trp), an essential amino acid, plays a central role in gut metabolism and immune modulation. Recent studies have shown that Trp metabolism is associated with inflammatory processes and correlates with IBD activity.

Aim of the Study
We hypothesized that Trp can serve as a reliable marker for assessing treatment success in patients with UC undergoing Mirikizumab therapy. To test this, Trp levels were correlated with established laboratory parameters (leukocytes, C-reactive protein in serum (CRP), fecal Calprotectin (fCal), as well as clinical parameters (IBD Disc).

Methods
Laboratory and clinical parameters during induction and maintenance therapy of four patients with UC who were treated with Mirikizumab were analyzed. Using SPSS, the Spearman correlation coefficient was used to examine the correlations between Trp and established markers.

Results
A significant negative correlation between Trp and CRP (n = 18, rs = −0.75, p &lt; 0.001) suggests that lower Trp levels are associated with increased inflammatory activity. Correlations with leukocyte count (n = 18, rs = 0.27, p = 0.39), fCal (n = 10, rs = −0.33, p = 0.35), and the IBD Disk Score (n = 14, rs = −0.25, p = 0.40) were weak and not significant.

Conclusion
The significant correlation between Trp and CRP suggests that Trp could serve as a potential monitoring tool for assessing the inflammatory status in UC patients undergoing Mirikizumab therapy. However, Trp appears to have limited value as a standalone marker, and no cut-off levels have been established. Further prospective studies with larger sample sizes are necessary to confirm the clinical relevance of Trp as a biomarker for treatment response to Mirikizumab.

References
Harris, D. M. M., Szymczak, S., Schuchardt, S., Labrenz, J., Tran, F., Welz, L., Graßhoff, H., Zirpel, H., Sümbül, M., Oumari, M., Engelbogen, N., Junker, R., Conrad, C., Thaçi, D., Frey, N., Franke, A., Weidinger, S., Hoyer, B., Rosenstiel, P., … Aden, K. (2024). Tryptophan degradation as a systems phenomenon in inflammation-an analysis across 13 chronic inflammatory diseases. www.thelancet.com
Nikolaus, S., Schulte, B., Al-Massad, N., Thieme, F., Schulte, D. M., Bethge, J., Rehman, A., Tran, F., Aden, K., Häsler, R., Moll, N., Schütze, G., Schwarz, M. J., Waetzig, G. H., Rosenstiel, P., Krawczak, M., Szymczak, S., & Schreiber, S. (2017). Increased Tryptophan Metabolism Is Associated With Activity of Inflammatory Bowel Diseases. Gastroenterology, 153(6). https://doi.org/10.1053/j.gastro.2017.08.028
P0916 Lusvertikimab is efficacious in severe ulcerative colitis (UC) patients with high fecal calprotectin (FCP): results from the CoTikiS study
Authors: Reinisch W , Kierkus J , Corallo F , Bourreille A ,   CoTikiS
Published: January 2025

Abstract

Background
Fecal calprotectin (FCP) is an objective marker of inflammation in ulcerative colitis (UC) patients and may predict sustained clinical and endoscopic response. In the CoTikiS study (NCT04882007), 2 doses (450 mg or 850 mg) of OSE-127 Lusvertikimab (L) were administered for 10 weeks in patients with moderately or severely active UC. Additional analyses compared the effects of these 2 doses versus placebo on FCP and their efficacy in patients with high FCP at baseline.

Methods
Stool samples were collected at weeks 0 (w0), 2, 6 and 10 in all patients, frozen at -20°C and shipped to a central laboratory where FCP was measured using a validated analytical method. FCP values were analysed by treatment groups and by visit and the changes versus baseline were compared between each treatment group and placebo. A FCP value &gt; 250 µg/g is considered as a threshold of active inflammatory disease. The efficacy of L850 and L450 was compared to that of placebo in patients with FCP &gt; 250 µg/g at baseline.

Results
At baseline, FCP was not different between treatment groups: 1192 µg/g, 1088 µg/g, 1148 µg/g and 1459 µg/g for L850, L450, L850/450 and placebo (p=NS) respectively. At w10, FCP was significantly reduced in patients treated with L850 (p=0.018) and L450 (p=0.009).
FCP was analysed in patients with baseline values &gt; 250 µg/g, which represented 69.5% of the total population. There were no differences in demographics or disease characteristics between those subgroups. The corresponding baseline FCP values were 1713.1, 1673.9, and 1817.9 µg/g for L850, L450 and placebo, respectively). L450 and L850 significantly decreased FCP as compared to placebo.
FCP values were reduced below 250 µg/g at w10 in 45.2% and 38.1% of patients treated with L850 and L450 vs only 18.2% in the placebo group. In this subgroup of patients, the MMS was significantly improved versus placebo at w10: L850mg=-0.94, L450mg=-1.47 and L850/450=-1.16. UC Endoscopic Index of Severity (UCEIS) also markedly improved: L850mg=-0.74, L450 mg=-1.69, L850/450=-1.12 vs placebo.

Conclusion
Lusvertikimab, a pure IL-7 receptor antagonist, significantly decreased FCP after 10 weeks of treatment and achieved improvements in clinical and endoscopic outcomes in UC patients with active inflammation per FCP &gt; 250 µg/g at baseline. These data strengthen the overall results of the primary and key secondary endpoints from the CoTikiS study.
P0917 Corticosteroid sparing effects of treatment with guselkumab in patients with moderate to severely active Crohn’s disease: Phase 3 GALAXI 2/3 results through week 48
Authors: Panés J , Hisamatsu T , Armuzzi A , Terry N A , Salese L , Van Rampelbergh R , Yee J , Wan K Y , Yang Z , Pin S , Sands B E , Rubin D T 
Published: January 2025

Abstract

Background
GALAXI 2 & GALAXI 3 (G2 & G3) are identical 48-week (Wk), randomized, double-blind, head-to-head, placebo- and active-comparator (ustekinumab; UST) treat-through trials assessing the efficacy and safety of guselkumab (GUS), a dual-acting IL-23p19 subunit inhibitor, in participants (pts) with Crohn’s disease (CD). Here we report the corticosteroid (CS)-sparing effects of treatment with GUS vs UST from the pooled G2 & G3 studies through Wk48.

Methods
Pts with moderately to severely active CD (based on CDAI and SES-CD scoring) and inadequate response or intolerance to conventional or biologic (BIO-IR) therapy were eligible. Pts were randomized 2:2:2:1 to GUS 200mg IV q4w(x3)→200mg SC q4w, GUS 200mg IV q4w(x3)→100mg SC q8w, UST ~6mg/kg IV(x1)→90mg SC q8w, or placebo. Pts receiving oral CS upon entry (up to 40mg/day of prednisone-equivalent dose) were required to begin tapering their daily CS dose at Wk12, unless not medically feasible. CS use and 90-day CS-free clinical outcomes at Wk48 were assessed vs UST.

Results
The primary analysis (all pts) included 508 (G2) and 513 (G3) pts. Baseline (BL) characteristics were similar across trials: mean [SD] CDAI (G2: 295.0 [52.0], G3: 294.7 [53.8]), mean [SD] SES-CD (13.1 [7.3], 12.8 [7.3]), BIO-IR history (52.8%, 51.9%), BIO-naïve (41.9%, 41.5%), and oral CS use (37.4%, 36.1%). In analyses of pooled data (G2+G3), the proportion of pts receiving oral CS at BL was similar across treatment groups (GUS 100mg q8w: 38.1%; GUS 200mg q4w: 35.8%; UST: 37.5%). Greater proportions of pts receiving both GUS doses achieved 90-day CS-free Wk-48 outcomes of endoscopic response vs UST (100 mg q8w vs UST: ∆11.2%; 200 mg q4w vs UST: ∆14.5%), endoscopic remission (∆9.5%, ∆11.9%), the composite endpoint of clinical remission + endoscopic response (∆8.1%, ∆12.4%), the composite endpoint of clinical remission + endoscopic remission (∆8.0%, ∆10.9%), and clinical remission (∆4.1%, ∆5.3%) (Table 1). The 90-day CS-free outcomes vs UST in BIO-IR and BIO-naïve pts in the primary analysis were also assessed at Wk48 (Table 1).
Among all pts receiving oral CS at BL, greater proportions of GUS-treated pts (100mg q8w: 71.6%; 200mg q4w: 75.5%) were not receiving CS at Wk 48 vs UST (67.0%). Also, among all pts receiving oral CS at BL, greater proportions of GUS-treated pts achieved 90-day CS-free outcomes at Wk48 vs UST, including endoscopic response (41.3%, 42.5% vs 31.2%) and endoscopic remission (30.3%, 28.3% vs 20.2%), and similar proportions for clinical remission (52.3%, 54.7% vs 53.2%).

Conclusion
In CD, greater proportions of GUS-treated pts achieved CS-free endoscopic-based efficacy outcomes through Wk48 vs UST, regardless of prior biologic exposure status.
P0925 Risk of postoperative Crohn’s disease recurrence in patients smoking e-cigarettes and heat-not-burn tobacco products: a multicenter retrospective study
Authors: Parigi MD T L , Nardone O M , Lisa M , Gabbiadini R , innocenti T , Bertani L , Allocca M , D’Amico F , Furfaro F , Zilli A , Castiglione F , Dragoni G , Fiorino G , Armuzzi A , Danese S 
Published: January 2025

Abstract

Background
Tobacco is a known risk factor for Crohn’s disease (CD) recurrence after surgery. However, the impact of electronic cigarettes (or vape) and heat-no-burn tobacco products on post-operative recurrence is unknown.

Methods
We conducted a retrospective study across five centers in Italy. We included consecutive patients with CD who underwent ileocolic resections and endoscopic reassessment within 3 to 12 months after surgery, for whom smoking habit after surgery and before reassessment was known. Endoscopic recurrence was defined as a modified Rutgeerts score of i2b or higher. Recurrence rates were compared with Fisher’s exact test.

Results
In total 332 patients were retrieved, 65% male and 35% female, with an average age of 44, 55 (16.6%) with a history of other prior intestinal resections. (Table 1)
Of these, 64 (19.3%) patients were excluded for uncertain endoscopic outcomes or missing Rutgeerts score. Additionally, because we focused the analysis on the consumption of e-cigarettes, heat-not-burn tobacco products (ie. IQOS), and traditional tobacco cigarettes, 4 patients were excluded due to mixed smoking habits (e-cigarettes and conventional cigarettes), and 1 for smoking cannabis.
In the overall population, post-operative endoscopic recurrence was observed in 76% (13/17) of heat-not-burn tobacco smokers, 72% (51/71) of conventional cigarette smokers, 56% (9/16) of e-cigarette smokers, and 52% (82/159) of non-smokers. Figure A
To avoid the potential confounding effect of therapy, we restricted the analysis to patients who received immunomodulators, biologics, or advanced small molecules after surgery for prevention of post-op recurrence. In the 208 patients who received prophylaxis, recurrence rates were broadly similar, 80% (12/15), 73% (43/59), 58% (7/12), and 51% (62/122) for the respective groups. Figure B
Irrespective of post-operative treatment, recurrence rates were similar for heat-not-burn tobacco and traditional tobacco cigarettes (76% vs 72%, p=0.9; and 80% vs 73% p=0.7) and similar between e-cigarettes and non-smokers (56% vs 52% p=0.8; and 58% vs 51% p=0.7). Instead, as expected, tobacco increased the risk of recurrence compared to non-smoking (both p=0.005). Although not significant, a trend of progressively greater recurrence was observed from non-smoke, vape, tobacco, and heat-not-burning tobacco products.

Conclusion
In the first study on the impact of novel smoking habits on CD postoperative recurrence, vaping was not associated with higher recurrence rates compared to non-smoking, instead heat-not-burn tobacco products had recurrence rates similar to traditional cigarettes. A larger study is underway to confirm these results.
P0927 Surgery as a Treatment Option for CD: A Nationwide Cohort Study
Authors: Faye A , Axelrad J , Sun J , Halfvarson J , Soderling J , Olen O , Ludvigsson J 
Published: January 2025

Abstract

Background
Although surgery is often reserved for individuals with refractory Crohn’s disease (CD), recent data suggest that intestinal resection in select individuals may obviate the need for future CD-related treatment, particularly among older adults. Despite this, limited data characterizing these patients exist.

Methods
We performed a nationwide cohort study using the Swedish National Patient Register and the ESPRESSO (Epidemiology Strengthened by histoPathology Reports in Sweden) cohort to identify all individuals who underwent a first CD-related intestinal resection between 2007-2018 (allows for five years of follow-up among all individuals). Intestinal resection for dysplasia and/or malignancy were excluded in order to identify those with ongoing CD-related disease activity. Our primary outcome was the need for an IBD-related treatment (medical therapy, surgery, and/or IBD-related hospitalization) within the five years following intestinal resection; subgroup analysis was performed among older adults. Univariable and multivariable logistic regression were used to calculate odds ratios (ORs).

Results
Overall, there were a total of 1,760 individuals included. The average age at surgery was 41.4 years, and the median duration of disease prior to resection was 0.5 years (IQR: 0.0-2.1 years). At 5-years, 341 (19.4%) of individuals did not require an IBD-related treatment; of those who required treatment, 2.3% had another intestinal resection, 15.8% had an IBD-related hospitalization, and the majority required corticosteroids, an immunomodulator, and/or an advanced therapy. On multivariable analysis, longer disease duration (aOR 1.07, 95%CI 1.01-1.15), the absence of COPD (suggesting no smoking: aOR 4.35, 95%CI 1.32-14.3), and being bio-naïve (aOR 2.97, 95%CI 1.11-8.00) prior to surgery increased the odds of remaining IBD-treatment/hospitalization free for 5-years post intestinal resection (Table 1). On subgroup analysis among adults ≥ 50 years-old (given data suggest this group may derive the most benefit from elective surgery), longer disease duration (aOR 1.10, 95%CI 1.00-1.22), as well as the absence of COPD (aOR 4.76, 95%CI 1.43-16.70) were associated with a higher odds of remaining IBD-treatment/hospitalization free.

Conclusion
Individuals with CD who have a longer disease duration, do not smoke, and are bio-naive, may be more likely to remain treatment free in the five years following intestinal resection; similar results were observed among older adults with CD. These data can help identify individuals in which surgery may obviate the need for future CD-therapy, though future studies should assess whether earlier surgery among these individuals can improve long-term clinical outcomes.