bluuebunny/crossref_metadata_2025 huggingface dataset:
P0421 Clinical validity of a seroproteomic index of endoscopic activity in pediatric Crohn’s disease
Authors: Orlansky Meyer E , Dotson J , Saeed S , Zitomersky N , Focht G , Rabizadeh S , Sockolow R , Griffiths A , Navas-López V M , Sladek M , Baldassano R , Otley A , Spencer E , Ho J , Dervieux T , Turner D , Dubinsky M
Published: January 2025

Background

A seroproteomic index (i.e. the serum index) corresponds to 13 protein markers, including CRP, combined as a multianalyte assay with a score range 0-100 where higher score is associated with higher probability of endoscopic activity in adult CD. We aimed to evaluate its performances in pediatric CD.

Methods

Children with CD were enrolled from two separate cohorts. Cohort 1 enrolled CD from multiple centers in the United States (n=118) and cohort 2, was multinational (n=160). A simple endoscopic score for CD (SESCD) was collected (<3 points indicate endoscopic healing) with a blood specimen. Clinical disease status was measured using the Harvey Bradshaw index (HBI, cohort 1) or pediatric CD activity index (PCDAI, cohort 2) (PCDAI<10 or HBI<5 indicate clinical remission). Fecal calprotectin (FC) was collected in 180 patients from both cohorts. Serum specimens were processed in Prometheus Laboratories, San Diego, CA. Statistical analysis consisted of linear regression analysis, calculation of receiver operating characteristics curves (ROC) with area under the curve (AUC), sensitivity, specificity, Odds ratio (OR).

Results

In the 278 enrolled children (median age 14 years [IQR: 12-16 years], 46% females), median SESCD was 5 points (IQR: 0-12 points, 63% with endoscopic active disease); median CRP was 2.5 mg/L (IQR: 0.3-8.4 mg/L), median FC was 592 µg/g (IQR: 135-1147 µg/g) and median serum index was 33 (IQR: 17-60 points). AUROC analysis yielded significantly better area under ROC curve (AUROC, 0.87±0.03) for FC than the serum index (0.78±0.04) and CRP (0.77±0.04) (p<0.05) in distinguishing endoscopic active disease from endoscopic healing. There was a 9-fold higher likelihood of endoscopic active disease with serum index above 32 points (OR= 8.95 [95%CI: 5.02,15.96] p<0.001) with 70% sensitivity and 79% specificity (PPV=85%; NPV=61% at 63% pretest) (Table).

In multivariate analysis EHI above 32 points (aOR= 3.00 [95%CI: 1.25, 4.76] p=0.043), active clinical disease (aOR= 2.01 [95%CI: 0.85, 4.76] p=0.114), FC>250 µg/g (aOR= 5.61 [95%CI: 2.4,13.09] p<0.01) and CRP above 3 mg/L (aOR=2.09 [95%CI: 0.9-4.85])(p=0.08) associated with active endoscopic disease) (Figure). In the subset with clinical remission (n=158), or CRP below 3 mg/L (n=136), or FC levels below 250 µg/g (n=116), EHI above 32 points was still associated with higher likelihood of endoscopic disease (OR=5.4 [95%CI: 2.6,11.1], OR= 6.8 [95%CI: 2.9,15.8], and OR=4.0 [95%CI: 1.3,12.8], respectively) (p<0.05) (Figure).

Conclusion

These data support the association of the serum index with endoscopic outcome in pediatric CD patients.
P0423 Anastomotic leakage after ileoanal pouch surgery: risk factors and salvage
Authors: Moojen T , Vlug M , Visser E , Reijntjes M , Lange J , Bislenghi G , Carvello M , Warusavitarne J , Hompes R , Stassen L , Faiz O , Spinelli A , D’Hoore A , Bemelman W
Published: January 2025

Background

Chronic anastomotic leakage (AL) is the most common cause of pouch failure after restorative proctocolectomy with ileal pouch-anal anastomosis for Ulcerative Colitis. This study aims to investigate the factors associated with AL and successful salvage of leaking anastomoses after ileoanal pouch surgery.

Methods

This multicentre retrospective cohort study included patients ≥18 years old with Ulcerative Colitis or unclassified Inflammatory Bowel Disease who underwent ileoanal pouch surgery between 2016 and 2021 in six European centres, with >12 months follow-up. The primary outcome was AL rate. Secondary outcomes included factors associated with the occurrence of AL, diagnosis, management and salvage of AL and stoma-free survival.

Results

411 patients were included, of which 13.6% (n=56) had a diagnosed AL with a significantly higher rate in low-volume centres. Of the 56 AL, 44 were diagnosed early and 12 late. Three-stage approach was associated with late diagnosis and treatment. AL were managed using various techniques. The overall AL salvage rate was 85.4%, 92% when diagnosed and treated early and 60% when diagnosed and treated late (p=0.010). Successful AL salvage was associated with long-term stoma-free status (p=0.002). The long-term stoma-free rate was 95.5% in patients with early diagnosed and treated leaks, but only 41.7% when diagnosed and treated late (p<0.001).

Conclusion

Early diagnosis and treatment of AL diminishes the negative effect of AL after ileoanal pouch surgery. Pro-active anastomotic assessment is mandatory to enable early diagnosis and management especially in patients at increased risk of silent leaks such as three-staged patients.
P0429 Endocytoscopy in real-time assessment of histological and endoscopic activity in ulcerative colitis
Authors: Chaemsupaphan T , Ali M S , Paramsothy S , Leong R W
Published: January 2025

Background

With 500-fold magnification, endocytoscopy (CF-H290ECI; Olympus Medical Systems Corporation, Japan; ARTG 121183) is a novel advanced imaging technology enabling real-time imaging of the intestinal mucosa. Endoscopic-histological remission assessment in ulcerative colitis (UC) has the potential to become the standard of care. Endoscopists, however, are uninvolved in the assessment of histology. Endocytoscopy might improve workflow and efficiency in the evaluation of UC activity.

Methods

In this single-center, prospective cohort study at Concord Hospital, Sydney, UC participants consenting to colonoscopy and endocytoscopy for disease assessment were recruited. Methylene blue chromoendoscopy enhanced cellular imaging. Data collected were demographics, disease activity, Mayo endoscopic score (MES) and endocytoscopic activity based on crypt shape, inter-crypt distance, cellular infiltration, and extent of vascularization. Correlation against the MES and the Nancy histological index (NHI) was conducted and validation against the ErLangen Endocytoscopy in CoLiTis (ELECT) score, and the endocytoscopy score (ECSS) was performed using Kappa (κ) statistics and Spearman correlation coefficient (r). P value <0.05 was deemed statistically significant. Duration and adverse events data were recorded.

Results

A total of 61 colonic bowel segments from 15 UC patients were evaluated (endoscopic improvement 69%, histological remission 67%) (Table 1). Endocytoscopy correlated significantly with MES using both the ECSS (κ=0.60, P<0.001; r=0.78, P<0.001) and the ELECT (κ=0.88, P<0.001; r=0.81, P<0.001) scoring systems. Endocytoscopy correlated with NHI using both the ECSS (κ=0.47, P<0.001; r=0.69, P<0.001) and the ELECT (κ=0.88, P< 0.001; r=0.74, P<0.001) systems. The ELECT score demonstrated superior diagnostic performance in determining histological remission with sensitivity, specificity, and AUROC of 100%, 85%, and 0.90 (95% CI: 0.78-1.00), versus 68.3%, 85%, and 0.88 (95% CI: 0.75-1.00) with ECSS (Figure 1). No serious adverse events were reported, apart from temporary urinary discoloration from methylene blue excretion.

Conclusion

Instant simultaneous endoscopic and histological assessment of UC is possible using endocytoscopy, which was safe, accurate and well-tolerated. The ELECT score reflects histology significantly better than the ECSS.
P0439 Ultrasound transmural healing reduces the risk of relapse in Crohn’s disease patients with endoscopic mucosal healing: results of a prospective study
Authors: Yzet C , Brazier F , Derval E , Pricope D , Vaneslander P , Dejour V , Diouf M , Ollier A , Fumery M
Published: January 2025

Background

The STRIDE II guidelines recognize endoscopic healing as one of the main therapeutic targets in Crohn’s disease (CD). Nevertheless, transmural healing could reduce the risk of long-term complications. The aim of this study was to assess the risk of long-term complications in CD according to the degree of endoscopic and ultrasound healing.

Methods

We conducted a prospective study that included all patients with CD in clinical remission who underwent colonoscopy with endoscopic healing (CDEIS <4) and intestinal ultrasound (IUS) within 4 weeks between September 2019 and September 2022. IUS transmural healing was defined by a parietal thickness < 3 mm on all digestive segments (colonic and ileal) without colour doppler signal.

The primary endpoint was CD relapse, defined as the need for drug intensification, initiation of corticosteroid therapy, CD-related hospitalization, development of a perianal and luminal fistula or abscess, or the need CD-related bowel surgery. Patients were followed up at least every 6 months for two years.

Results

A total of 93 patients were included, the majority of whom were women (53%) with ileocolic location (43%). The median disease duration was 12 years (IQR, 4-19) and 71% patients were treated with anti-TNF. Ultrasound transmural healing was observed in 73% (68/93) of patients. After a median follow-up of 22.5 months [IQR, 19.3-23.7], relapse was significantly higher among patients without IUS transmural healing (48% vs. 18% p = 0.007). Relapse rate at 6 and 12 months were significantly higher among patients without IUS transmural healing (22% vs. 9% and 22% vs. 13%; p = 0.019). In multivariate analysis, the risk of relapse was 5 times higher without IUS transmural healing (HR 5.5 (2.1-14.2) p < 0.001).

Conclusion

IUS transmural healing was associated with a lower risk of relapse among patients with endoscopic healing and could be considered as a non-invasive therapeutic target in CD.
P0542 Systematic Liver Biopsies in IBD Surgery: A Unique Insight into Silent Hepatic Abnormalities
Authors: Elommal H , Koulali H , Elmqaddem O , Zazour A , ismaili Z , Kharrasse G
Published: January 2025

Background

Systematic liver biopsies during IBD-related surgeries are rare but provide a unique opportunity to uncover silent hepatic abnormalities. This study evaluates the utility of systematic biopsies, Fibroscan, and biochemical markers in detecting liver abnormalities in IBD patients.

Methods

A retrospective cohort of 31 IBD patients who underwent systematic liver biopsies was analyzed. Factors evaluated included age (>40 years classified as elderly), sex, disease type and activity, treatment status, inflammatory markers (CRP, hemoglobin, platelets), liver function tests (ALT, AST, Gamma-GT, bilirubin, alkaline phosphatase, albumin, TP), and nutritional status (BMI). Statistical analyses included Mann-Whitney U for group comparisons and logistic regression for predictive modeling.

Results: Biopsy Findings

35.5% of biopsies were abnormal, with two cases of cholangitis sclérosante primitive (CSP) diagnosed exclusively by biopsy.

CSP was silent, with no prior biochemical or clinical signs, and biochemical anomalies emerged months post-diagnosis.

Predictive Factors:

Age > 40 years: p = 0.091 (trend toward significance).

Platelet count: p = 0.060 (trend toward significance).

Anti-TNF therapy: p = 0.061.

Fibroscan (kPa) and other liver markers (ALT, AST, bilirubin): non-significant.

Conclusion

Systematic liver biopsies revealed critical hepatic abnormalities that would have been missed by biochemical tests or Fibroscan. Biopsies should be considered in high-risk IBD surgeries, especially for elderly patients or those on anti-TNF therapy. Future research should explore broader implementation of this practice.
P0543 Impact of disease clearance on the disease course in Ulcerative Colitis patients in clinical remission over a ten-year follow-up
Authors: Telli P , Ataş O , Çelik A O , İstemihan Z , Nuriyev K , Rustamzada A , Genç Uluçeçen S , Dağcı G , Yağlı M A , Gurbanov A , Ağargün B F , Çavuş B , Çifcibaşı Örmeci A , Akyüz F , Demir K , Beşışık S F , Kaymakoğlu S
Published: January 2025

Background

Despite being in clinical remission, ulcerative colitis (UC) patients continue to have a risk of disease flare-ups. Although endoscopic and histological evaluations are considered the gold standard for follow-up, the value of histological inflammation in predicting disease flare-ups in clinically remitted patients is not clearly known. This study aimed to investigate the relationship between histological inflammation and disease flare-ups in UC patients in clinical remission.

Methods

Adult patients with UC, no history of colectomy, followed up in our outpatient clinic, and in clinical remission were included in the study (total Mayo score < 2). Biopsy reports from colonoscopies performed during clinical remission were examined for histological activity. The follow-up period was defined as 10 years, based on the last clinical remission recorded in the outpatient clinic records. The Nancy histological index (NHI) was used as the histological activity score. Patients with NHI < 2 were considered to be in histological remission. The temporal relationship between histological inflammation and the first clinical flare-up was evaluated using Spearman correlation analysis.

Results

A total of 53 patients, including 26 women and 27 men, with a diagnosis of UC in clinical remission were included in the study. The mean age of the patients was 51.5 years. While 28 patients were in endoscopic remission, 25 were followed up as endoscopically active. Among the 28 patients in endoscopic remission, 15 were in histological remission, and 13 were histologically active. Flare-ups were observed after a median of 18.0 months in patients with endoscopic remission and 10.0 months in those with endoscopic activity (p=0.07). Flare-ups were observed after a median of 96.0 months in patients with histological remission and 10.5 months in those with histological activity (p<0.05). A negative correlation was found between histological inflammation and disease flare-up (r=-0.381, p<0.05).

Conclusion

The risk of disease flare-ups is higher in patients who do not achieve disease clearance (i.e., those who are histologically active even in endoscopic remission).

References

1.Marchal-Bressenot A, Scherl A, Salleron J, Peyrin-Biroulet L. A practical guide to assess the Nancy histological index for UC. Gut. 2016;65(11):1919-1920.

2.Wang H, Fewings I, Bornman L, Shadbolt B, Fadia M, Subramaniam K. Histologic remission (NANCY Index) is superior to endoscopic mucosal healing in predicting relapse free survival in patients with ulcerative colitis in clinical and endoscopic remission. Journal of Clinical Gastroenterology. 2023;57(5):494-500.
P0551 Diagnostic Accuracy of Low-Cost Blood Test Inflammatory Markers in Severe Ulcerative Colitis
Authors: Sadek A , Salim A , Afifi A , Ibrahim N , Salem S
Published: January 2025

Background

Ulcerative colitis (UC) is a long-standing inflammatory disease with remission and exacerbation courses. Early detection of relapses, flares, disease activity changes, and treatment responses is key to optimising patient management. The evidence about the usefulness of low-cost blood test inflammatory markers concerning UC disease activity is still limited. This study aimed to evaluate the diagnostic accuracy of low-cost serum inflammatory markers in monitoring UC activity.

Methods

This cross-sectional study was conducted in the inflammatory bowel disease (IBD) clinic, Zagazig University Hospital, Egypt. Faecal calprotectin and low-cost serum inflammatory markers including C-reactive protein (CRP), C-reactive protein-albumin ratio (CAR), lymphocyte-monocyte ratio (LMR), mean platelets volume-lymphocyte ratio (MLR), mean platelets volume-platelets ratio (MPR), neutrophil-lymphocyte ratio (NLR), platelets-lymphocyte ratio (PLR), red cell distribution width-platelet ratio (RPR), and systemic immune-inflammation index (SII) were measured.

Results

The area under the curve (AUC) of CRP, CAR, Faecal calprotectin, LMR, SII, and MPR in the diagnosis of severe UC were 0.85, 0.85, 0.84, 0.81, 0.83, and 0.80 respectively (Figure I). CRP, CAR, Faecal calprotectin, NLR, LMR, SII, Albumin, MPR, and RPR were independent predictors for Mayo score grade 3 (Table I).

Conclusion

low-cost serum inflammatory markers such as CRP, CAR, LMR, SII, and MPR showed diagnostic accuracy in monitoring severe UC activity.
P0554 Machine Learning-Based Interpretation of Unstructured Radiology Reports for Objective Scoring of Inflammation and Stenosis in IBD: A Nationwide Study From the epi-IIRN
Authors: Badash Z , Gavrielov N , Hagopian T , Cytter Kuint R , Dotan I , Loewenberg Weisband Y , Ben-Tov A , Zacay G , Matz E , Focht G , Turner D , Freiman M ,   epi-IIRN study group
Published: January 2025

Background

Systematic interpretation and quantification of inflammation and stenosis in inflammatory Bowel Disease (IBD) from radiology reports of CT and MR enterography exams are challenging due to their unstructured nature, often leading to variability and reduced reproducibility. This study leverages data from the epi-IIRN nationwide cohort to develop and evaluate machine-learning-based scores for inflammation and stenosis derived from these unstructured radiology reports.

Methods

We identified radiology reports for IBD-diagnosed patients within the nationwide epi-IIRN cohort, which encompasses data from Israel’s four HMOs, covering 98% of the population. Using our in-house HSMP-BERT natural language processing (NLP) platform, we extracted radiological indicators related to inflammation, stenosis, and location, including wall thickening, enhancement, lumen narrowing, and dilation across specified regions: jejunum, ileum, caecum, colon, sigmoid, and rectum.

We developed and evaluated a machine-learning model to predict both categorical (no, mild, and moderate or severe) and VAS (0-100) scores of global inflammation and stenosis, using physician-based scoring as the reference standard. A 5-fold cross-validation experimental setup was applied to assess model performance. Evaluation metrics included accuracy, F1 score, Cohen’s kappa, AUC, PPV, and NPV for categorical scores, and RMSE, r2 and MAE for VAS-like scores.

Results

The dataset included 9658 reports from 7389 patients with a mean age of 36.4±17.6 years, of whom 49% were male. In the annotated subset (500 reports), inflammation severity was distributed as approximately 37% no, 34% mild, and 29% moderate or severe, while stenosis severity was distributed as 72% no, 15% mild, and 13% moderate or severe.

Table 1 summarizes key metrics for inflammation and stenosis, including accuracy, PPV, NPV, F1, and Cohen’s kappa for categorical scores, and RMSE, r2, and MAPE for VAS-like scores, averaged over 5 folds with mean [95% CI].

Main results showed strong performance for both inflammation and stenosis predictions: for inflammation, mean accuracy/F1/kappa/AUC/NPV/PPV/r2/RMSE/MAE were 0.786/0.782/0.676/0.914/0.897/0.775/0.629/13.57/8.571, and for stenosis these values reached 0.912/0.906/0.793/0.955/0.959/0.837/0.760/8.431/3.270.

Figure 1 illustrates the joint distribution of predicted versus ground truth VAS-like scores, with both axes spanning the full range of 0 to 100 as defined by physician-based scoring.

Conclusion

This study demonstrates the feasibility of machine-learning models for mass scoring of inflammation and stenosis from unstructured radiology reports of IBD patients, enabling reliable mass tagging of CTE and MRE as well as determining disease phenotype in large populations.
P0635 Degree of interest in using a cognitive-behavioral therapy application for fatigue management and related factors among outpatients with inflammatory bowel disease
Authors: Tanaka M , Kawakami A , Wakai S , Takai M , Sakagami K , Ito H
Published: January 2025

Background

Fatigue is a common symptom in patients with inflammatory bowel disease (IBD) and is associated with a diminished quality of life. Previous research has demonstrated the effectiveness of fatigue management programmes that use cognitive behavioural therapy (CBT) or other psychotherapies. CBT is often face-to-face and individually time consuming, and there are personnel challenges in its implementation in real-world clinical settings. This study aimed to understand the needs of Japanese patients with IBD regarding fatigue management and explore the characteristics of those willing to use CBT applications (apps).

Methods

This study involved secondary analysis of data from 488 patients treated at a specialised IBD clinic in Japan. Patient characteristics, such as sex, age, disease duration, interest in CBT programmes, and interest in CBT apps for fatigue management (each assessed on a 7-point ordinal scale from 0 for not interested to 6 for very interested), and the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) scale score were included in the survey. Data on blood parameters and disease activity, as determined by Crohn’s activity index and the partial Mayo score, were obtained from medical records.

Results

Among the participants, 85% were in clinical remission, 58% had Crohn’s disease (CD), and 66% were male. Forty-five percent of the patients were affected by moderate or high levels of fatigue (FACIT-F score > 40). The mean score for interest in the CBT programme was 3.3 ± 1.9, with 69% expressing moderate or greater interest (scores ≥ 3). Interest in the CBT app averaged 2.5 ± 1.9, with 50% expressing a moderate level of interested or higher. Interest in the CBT programme was significantly higher among females and those with greater levels of fatigue (lower FACIT-F scores) or lower levels of emotional well-being. Significant factors associated with higher interest in the CBT app included female sex and greater levels of fatigue.

Conclusion

Interest in CBT for fatigue management among patients with IBD was moderate, with higher levels of interest observed in patients experiencing greater levels of fatigue, particularly among females. CBT apps offer a promising alternative for addressing fatigue, potentially enhancing accessibility and convenience in clinical settings. Future strategies incorporating CBT apps may help meet the needs of those with limited access to in-person therapies.
P0640 Development and characterization of LQ080, a novel extended half-life bispecific TL1A/IL-23 p19 single domain antibody for the treatment of IBD
Authors: Wan Y , Zhu M , Gai J , Huang Y , Hu Y
Published: January 2025

Background

Despite the effectiveness of current anti-TL1A treatments, unmet needs remain for effective therapeutics for IBD. Therapies simultaneously neutralizing TL1A and IL-23 might be better choices owing to their synergistic anti-inflammatory effects in the pathogenesis of IBD.

Methods

TL1A and IL-23 single domain antibodies (sdAbs) were selected from immunized sdAb Phage display libraries. A human whole blood-based assay measuring IFNγ secretion was used to assess functional blockade of TL1A. Mouse splenocytes based assay measuring mouse IL-17 release was used to evaluate functional blockade of IL-23. Dextran Sulfate Sodium (DSS) induced mouse bowel inflammatory model was used to judge the in vivo effect of anti-TL1A antibodies. Synergistic anti-inflammatory effect was evaluated in mouse dermatitis model. Half-life extension was measured via pharmacokinetic analysis in non-human primate (NHP) given a single bolus of LQ080 by subcutaneous administration.

Results

The TL1A sdAb, which binds to both soluble and membrane-bound TL1A in a pH dependent pattern, potently blocked TL1A/DR3 while leaving the TL1A/DcR3 binding undisturbed and illustrated better IFNγ release in human whole blood induced by TL1A than RVT-3101 and PRA023. In DSS model, the TL1A sdAb also demonstrated better anti-inflammation effect than RVT-3101. The TL1A/IL-23 p19 biparatropic sdAb, LQ080, showed better IFNγ secretion inhibition than RVT-3101 and PRA023, and better inhibition of mouse IL-17 induction than Risankizumab and Guselkumab. Synergistic effects were found using LQ080 in both IFNγ release inhibition in human PBMCs induced by IL-23 and TL1A and in the mouse dermatitis model. The half-life of LQ080 significantly extended of 2-3 folds in non-human primate (NHP) compared to that of RVT-3101. Besides, LQ080 did not form large immune complex in vitro when mixed with TL1A and IL-23. Moreover, LQ080 did not stimulate the release of pro-inflammatory cytokines in the cytokines release assay.

Conclusion

The TL1A sdAb demonstrated better bioactivity than RVT-3101 and PRA023. LQ080, a TL1A/IL-23 p19 biparatropic sdAb, illustrated synergistic anti-inflammation effect both in vitro and iv vivo for its simultaneous neutralization of TL1A/DR3 and IL-23/IL-23R pathways, which would greatly improve the clinical results of IBD patients. The pH dependent TL1A binding makes LQ080 very different from other anti-TL1A mAbs. LQ080 demonstrated extended half-life in NHP making infrequent dosing possible for IBD treatment. No large immune complex formation when mixed with TL1A and IL-23 would make LQ080 safer when administrated by SC route. Overall, LQ080 is a promising TL1A/IL-23 p19 sdAb for IBD treatment.
P1101 Real-world effectiveness and safety of Risankizumab in Crohn’s Disease
Authors: McShane C , Olivera Sendra P A , Kim J , Milgrom R , Stempak J , Nguyen G , Weizman A V , Croitoru K , Gallinger Z , Huang V , Steinhart H , Targownik L , Lee S H , Silverberg M
Published: January 2025

Background

Data on real-world therapy outcomes for the use of risankizumab in Crohn’s Disease (CD) remain limited. We aimed to assess the real-world effectiveness and safety of risankizumab therapy in CD.

Methods

A retrospective study was carried out at a tertiary referral centre on patients started on risankizumab for CD between February 2019 and November 2024. Primary outcomes included: rates of clinical response and clinical remission at weeks 12, 28, and 52, and rates of endoscopic improvement by week 52. Clinical response was defined as a treatment response recorded in the chart as “complete response” or “partial response”, clinical remission was defined as remission status recorded as “in remission”, and endoscopic improvement as an endoscopic assessment of normal, inactive or mild disease. Secondary outcomes included treatment persistence (patients who did not discontinue treatment during follow-up), changes in Harvey Bradshaw Index (HBI), SES-CD score, CRP, faecal calprotectin, and adverse events. Kaplan-Meier analysis was used for survival probabilities, and Mann-Whitney test compared group differences.

Results

The study cohort included 122 patients. The median duration of follow-up was 38.7 weeks (IQR 24.4-61.5). Clinical response rates at week 12, 28, and 52, were 78%, 69%, and 77% respectively. Clinical remission rates at week 12, 28, and 52 were 32%, 38%, and 37% respectively. Endoscopic improvement by week 52 was seen in 26% of patients who underwent endoscopy (n=35). There was no difference in rates of treatment persistence in the ustekinumab exposed group (n=45). In the overall cohort, there was no difference in median HBI score at baseline and the pre-defined time points. Median SES-CD score reduced from baseline (8 [IQR 6-11]) to week 12 (3 [0-3], p=0.009) and week 28 (6 [3-7], p=0.015). No differences between baseline SES-CD score and week 52 were seen. Median faecal calprotectin levels reduced from baseline (766μg/mg [IQR 318-1500]) to week 12 (427μg/mg [232-1096], p=0.04), week 28 (332μg/mg [59-1435], p=0.04), and week 52 (200μg/mg [54-900], p=0.048). There was a non-statistical trend towards reduction of CRP over the same time period. 13% (n=16) discontinued therapy in the follow-up period, 11 due to therapy failure, 3 due to adverse events and, 2 due to patient preference. There were 39 reported adverse events; 6 disease-related, 15 infectious (1 serious). There were 2 pregnancies during the follow-up period, with one early-term delivery and the second ongoing.

Conclusion

In a real-world setting risankizumab is an effective and safe therapeutic option in CD. Clinical effectiveness is comparable to other biologic therapies for CD. No new significant adverse events were identified.
P1111 Infliximab is not Superior to Vedolizumab for the Treatment of Moderately to Severely Active Ulcerative Colotis with PR3-ANCA Positive : A Retrospective Multicentre Real-World Study
Authors: Yu Q , Yiyu C , Chen Y , Zhu L
Published: January 2025

Background

Current literature presents conflicting findings about the efficacy of Infliximab (IFX) versus vedolizumab (VDZ) in patients with moderately to severely active ulcerative colitis (UC). Patients with UC who are positive for anti-neutrophil cytoplasmic antibodies(ANCA) are known to respond poorly to IFX1-3 and VDZ4. We aimed to evaluate the comparative efficacy and safety of IFX versus VDZ in moderately to severely active UC patients with Proteinase 3-ANCA(PR3-ANCA) positive.

Methods

This retrospective multicentre real-world study was conducted in three centers in Hubei, China. Patients with moderate to severe active ulcerative colitis (UC) who are positive for PR3-ANCA were allocated to either the Vedolizumab (VDZ) group (n=19) or the Infliximab (IFX) group (n=26) depending on the biologics they received. The endpoints assessed at week 22 included clinical remission(primary endpoint), clinical response, endoscopic response, and endoscopic remission. Inverse probability of treatment weighting (IPTW) was employed to ensure the reliability and robustness of the clinical outcomes.

Results

In the original cohort, IFX was not superior to VDZ in terms of clinical remission (23.08% vs. 42.11%, P=0.173), clinical response (65.38% vs. 63.16%, P=0.878), endoscopic response (57.69% vs. 63.16%, P=0.712), and endoscopic remission (11.54% vs. 26.32%, P=0.253). Additionally, similar outcomes were observed in the IPTW cohort: for clinical remission (23.26% vs. 35.89%, P=0.384), clinical response (68.68% vs. 60.29%, P=0.583), endoscopic response (58.48% vs. 60.29%, P=0.912), and endoscopic remission (14.18% vs. 22.75%, P=0.494) when comparing IFX to VDZ.

Conclusion

IFX is not superior efficacy compared to VDZ in moderately to severely active UC patients with PR3-ANCA positive.

References

1.Yoshida A, Matsuoka K, Ueno F, Morizane T, Endo Y, Hibi T. Serum PR3-ANCA Is a Predictor of Primary Nonresponse to Anti-TNF-α Agents in Patients with Ulcerative Colitis. Inflammatory intestinal diseases. May 2021;6(2):117-122. doi:10.1159/0005153612.

2.Ferrante M, Vermeire S, Katsanos KH, et al. Predictors of early response to infliximab in patients with ulcerative colitis. Inflammatory bowel diseases. Feb 2007;13(2):123-8. doi:10.1002/ibd.200543.

3.Jürgens M, Laubender RP, Hartl F, et al. Disease activity, ANCA, and IL23R genotype status determine early response to infliximab in patients with ulcerative colitis. The American journal of gastroenterology. Aug 2010;105(8):1811-9. doi:10.1038/ajg.2010.954.

4.Liefferinckx C, Minsart C, Cremer A, et al. Early vedolizumab trough levels at induction in inflammatory bowel disease patients with treatment failure during maintenance. European journal of gastroenterology & hepatology. Apr 2019;31(4):478-485. doi:10.1097/meg.0000000000001356
P1118 Advanced Combination Therapy with Biologics and Upadacitinib in Refractory Inflammatory Bowel Disease: A Retrospective Study from Taiwan
Authors: Meng M J , Le P H , Kuo C J , Lai M W , Chiu C T
Published: January 2025

Background

While biologics have significantly improved outcomes in inflammatory bowel disease (IBD), remission rates in refractory cases remain suboptimal. Advanced combination therapy (ACT) presents a potential strategy to overcome this therapeutic ceiling in refractory IBD. Upadacitinib (UPA), an oral selective Janus kinase inhibitor, offers rapid action and low immunogenicity, showing promise in IBD management. However, no studies have evaluated the safety and efficacy of ACT combining biologics and UPA in Asia. This preliminary study aims to address this gap with data from Taiwan.

Methods

This retrospective study included all IBD patients who received ACT with biologics and UPA, followed up at the Chang Gung Inflammatory Bowel Disease Center from July 2020 to August 2024. The primary outcome was clinical response and remission rates at week 4. Secondary outcomes included clinical response and remission rates at weeks 12 and 24, along with safety profiles during the follow-up period. Continuous data were presented as medians with interquartile ranges (IQRs), while categorical data were expressed as frequencies and percentages. Analyses were conducted using IBM SPSS Statistics version 26.

Results

Sixteen IBD patients (7 Crohn’s disease, 9 ulcerative colitis) with prior biologics exposure were enrolled. The median disease duration was 4.5 years [IQR 2.25-9.50]. The most common UPA-based ACT regimen was Ustekinumab (63%), followed by Vedolizumab (25%), Risankizumab (6.25%), and Adalimumab (6.25%) (Table 1). Clinical response rates at weeks 4, 12, and 24 were 88%, 83%, and 100%, respectively. Clinical remission rates at weeks 4, 12, and 24 were 31%, 50%, and 80%, respectively (Figure 1). One patient (6.25%) experienced a minor adverse event (acne), with no major adverse events such as herpes zoster reactivation or major adverse cardiac events reported.

Conclusion

This study is the first in Asia to demonstrate that UPA-based ACT is effective and safe in refractory IBD. However, larger studies are needed to identify predictors of efficacy and assess long-term outcomes of UPA-based ACT.
P1135 Comparing Hypophosphataemia Risk and Complications Between Ferric Carboxymaltose and Other IV Iron Formulations in General and Inflammatory Bowel Disease Populations
Authors: Odah T , Farraye F A
Published: January 2025

Background

Iron deficiency is common in patients with inflammatory bowel disease (IBD), where poor absorption or prior surgery often renders oral iron supplementation ineffective, necessitating intravenous (IV) iron therapy. Hypophosphataemia, particularly associated with ferric carboxymaltose via fibroblast growth factor 23 dysregulation, is a recognized complication of IV iron therapy. It can result in severe outcomes such as rhabdomyolysis, osteomalacia, fractures, and convulsions. This study evaluates the risk of hypophosphataemia between ferric carboxymaltose and other IV iron formulations and its association with complications.

Methods

This retrospective propensity-matched study utilised the TriNetX database, a global repository of de-identified electronic health records. The first analysis compared ferric carboxymaltose to other IV iron formulations (iron sucrose, sodium ferric gluconate, ferumoxytol, ferric derisomaltose), matched on demographics (age, gender, ethnicity) and comorbidities (vitamin D deficiency, malnutrition, malabsorption, diabetes, CKD by stage, alcohol abuse, hyperparathyroidism, corticosteroid, diuretic, antacid, and bisphosphonate use) to assess hypophosphataemia risk. The second and third analyses evaluated hypophosphataemia-related complications in ferric carboxymaltose versus other formulations, both in the general population and in patients with IBD.

Results

We compared 115,242 ferric carboxymaltose patients to those on other IV iron formulations. Ferric carboxymaltose was associated with higher odds of severe (OR: 2.84, 2.22–3.64, p<0.0001) and moderate (OR: 1.37, 1.29–1.46, p<0.0001) hypophosphataemia but lower odds of mild hypophosphataemia (OR: 0.84, 0.79–0.88, p<0.0001). Among 25,586 hypophosphataemic patients, those on ferric carboxymaltose had lower odds of acute complications within 3 months, including muscle weakness (OR: 0.57, 0.47–0.70, p<0.0001), rhabdomyolysis (OR: 0.38, 0.20–0.75, p=0.003), disorientation (OR: 0.53, 0.46–0.61, p<0.0001), convulsions (OR: 0.59, 0.48–0.73, p<0.0001), cardiac arrhythmias (OR: 0.61, 0.54–0.69, p<0.0001), and respiratory failure (OR: 0.57, 0.50–0.64, p<0.0001). Over 2 years, chronic complications such as osteomalacia and fractures (23,508 patients each) showed no differences. In patients with IBD, no significant differences were observed in acute (2,688 each) or chronic complications (2,541 each) between cohorts.

Conclusion

Ferric carboxymaltose was linked to higher odds of severe and moderate hypophosphataemia but fewer acute complications than other IV iron formulations. The reasons for these differences remain unclear and warrant further research to understand the relationship between IV iron, hypophosphataemia, and clinical outcomes.
P1185 Preoperative bowel preparation in Crohn’s disease patients: final results of the prospective observational study
Authors: Iesalnieks I , Bercher M , Schmitz A
Published: January 2025

Background

Mechanical bowel preparation (MBP) in combination with oral antibiotics (OA) might decrease the risk of postoperative morbidity in colorectal surgery. However, there is a lack of data regarding the impact and safety of MBP in Crohn’s disease patients. MBP could even increase the morbidity by causing obstructive symptoms.

Methods

Patients with Crohn’s disease undergoing ileocolic or colorectal resections which were concluded by formation of an anastomosis were included in this prospective observational study. Exclusion criteria were: emergency surgery, no preoperative MBP, presence of colorectal malignancy, mere small bowel resection, simultaneous fecal diversion. The primary endpoint of the study was the occurrence of anastomotic complications (i.e., anastomotic leak, perianastomotic abscess, peritonitis or fistula). Secondary endpoint was occurrence of intraabdominal septic complications. “Incomplete MBP” was defined as an inability to drink the whole amount of scheduled 2 L of polyethylene glycol solution.

Results

284 patients were included. Side effects of MBP (nausea, vomiting, abdominal pain) occurred in 78 patients (29%). Fifty-three patients (19%) were not able to complete MBP. Female sex, emergency hospitalization, decreased hemoglobin level and scheduled ileocolic resection were associated with an incomplete MBP (p<0.05). The incidence of anastomotic complications was 5%, intraabdominal septic complications occurred in 7% of patients. An incomplete MBP was not associated with anastomotic complications or intraabdominal septic complications.

Conclusion

Preoperative MBP is associated with a considerable incidence of side-effects in Crohn’s disease patients. However, intake of lesser amounts of MBP-solution than scheduled was not associated with an increased risk of postoperative morbidity.
P1192 Use of a mobile application for monitoring and communicating with Inflammatory Bowel Disease patients
Authors: Lobato Matilla M E , Chamorro de Vega E , Romero Jiménez R , Ferris Villanueva M , Menchén Viso L A , Marín Jiménez I , Miranda Bautista J , Martinez Lozano H , Herranz Alonso A , Sanjurjo Sáez M
Published: January 2025

Background

Biological therapies and small molecules for patients with Inflammatory Bowel Diseases (IBD) have increased the effectiveness, but also adverse effects (AE) or problems in their administration. In addition, patients have greater formation and communication needs. In 2020, we developed a mobile application (app) to improve communication and monitoring of IBD patients.

Aim and objectives

To assess the implementation of an app for communication and remote monitoring with IBD patients.

Methods

A multidisciplinary group composed of pharmacists, dermatologists, rheumatologists, gastroenterologists, and nurses designed an app for immune-mediated inflammatory diseases (IMID) patients in a tertiary hospital. The app consists of the following modules: Medication, Questionnaires, Adverse Events, Useful Information, Messages, and Patient Profile.

We offered the app to patients who initiated a new biological or small molecule therapy. We performed an observational, longitudinal study to assess the app's impact on medication adherence, safety, and communication. The inclusion period was from December 2020 to May 2024. The inclusion criteria were age ≥ 18 years, diagnosis of IBD, and ownership of a smartphone. Patients with language barriers were excluded.

Results

183 patients were included (median age: 42 years [IQR: 29,5-52,1] and 47.5% were female). Concerning the type of IBD, 73.7% of patients had Crohn's Disease (CD) and 26.3% Ulcerative Colitis (UC). The median follow-up time for app use was 446 (243,5-626,5) days. In the Medication module, 100% of patients registered their biological therapy and 39 % also used this module to record each dose of medication administered. 95,1% adherent according 4-item Morisky Medication Adherence Scale (MMAS-4).

A total of 98 AE were registered. 16,39% of patients registered at least 1 AE. The most frequent AEs were fatigue (28.6%), injection site reaction (16.3%), headache (13.3%), and diarrhea (8.2%). 27,3% of patients used the messages module to communicate with healthcare professionals. The most frequent messages concerned gratitude (34%), logistical and citation issues (20%), doubts about administration (14%), doubts about managing AEs (12%), and drug interactions (8%).

Conclusion

Our app reminds patients to take medication, enables them to record AEs, and helps them communicate with healthcare professionals. More than a third of the patients registered the administration of the biological therapies and 16,39% registered at least 1 AE. The most used functionality was communication with health professionals.
P1195 Ecological momentary assessment of fatigue and depressive symptoms reveals significant daily variability in IBD
Authors: Atanasova K , Bredensteiner M , Starrmann A , Ebert M , Thomann A , Lis S , Reindl W
Published: January 2025

Background

In inflammatory bowel disease (IBD), symptoms of depression and fatigue overlap to great extent, making it difficult for medical practitioners to differentiate between these symptoms and provide patients with proper treatment options. In this study, we prospectively monitored multiple factors including mood, sleep, physical and psychological wellbeing, quality of life and stress perception, and explored the effects of these factors on symptoms of depression and fatigue in IBD. Our aim was to define specific combinations of symptoms helping to better distinguish between depression and fatigue in IBD populations.

Methods

Sixteen patients with IBD provided daily indices of sleep duration and quality as well as ratings of depressive symptoms, fatigue, stress perception, mood and IBD-related symptoms 6 times per day for 7 consecutive days of ecological momentary assessment (EMA) monitoring. Additionally, participants were provided with a series of questionnaires, stool samples were collected, as well as ambulatory physiological monitoring was performed. Multiple linear regression analyses were computed to explore how these specific factors can predict depression and fatigue in IBD. Network analyses were applied to identify and analyse distinct patterns of statistical associations related to depression and fatigue in IBD.

Results

Self-reported sleep quality (pFDR = .034) and feelings of sadness (pFDR = .045) significantly predicted symptoms of depression in IBD, while fatigue could only be predicted by poor sleep quality (pFDR = .030). Network analyses revealed two distinct patterns: symptoms of depression were associated with less positive (pFDR = .024) and more negative affect (pFDR = .012), as well as stronger feelings of tiredness (pFDR = .014) in daily life. Fatigue was characterized by an inability of feeling relaxed (pFDR = .002), more severe tiredness (pFDR = .013) and exhaustion (pFDR = .022).

Conclusion

Our preliminary results indicate that depressive symptoms are associated with the experience of negative emotions in daily life, which could affect patients‘ motivation to engage in activities and social interactions and thus, resulting in a stronger perception of tiredness. In contrast, the manifestation of fatigue in IBD is characterised by a stronger perception of tiredness and exhaustion, but not with the experience of negative affect. Additionally to the improvement of patient’s sleep quality, treatment of depressive symptoms should focus on fostering daily activities linked to positive emotions, while relaxation techniques and regular amount of moderate exercise can be a good treatment option for fatigued patients, if these associations could be found in larger studies as well.
P1208 High Prevalence of Perianal Crohn’s Disease and Distinct Advanced Therapy Persistence in an Arab IBD cohort
Authors: Alahmad M A , Ahmed H A , Alzaabi M N , Omar N M , Ahmed E F , Quraishi M N
Published: January 2025

Background

Perianal Crohn’s disease (PACD) is an aggressive phenotype associated with greater morbidity and treatment complexity. Data on PACD from emerging IBD nations including those in the Middle East are lacking. This study assesses the prevalence, clinical features, prescribing patterns, and treatment persistence of PACD versus non-PACD patients in a cohort of Arab IBD patients.

Methods

An observational analysis of Crohn's disease patients under active follow-up was conducted using the SSMC IBD registry, covering 15 years (prospective data since 2022). Analysed data included disease characteristics and advanced therapy (AT) use. Kaplan-Meier survival analysis compared therapy persistence between groups, and logistic regression identified factors independently associated with PACD.

Results

Among the 206 patients with Crohn’s disease, 74 (35.9%) had perianal Crohn’s disease (PACD), highlighting its significant prevalence in this cohort. Patients with PACD had similar male to female gender ratios and were diagnosed at a slightly younger median age (22 years, IQR: 17–30.75) compared to non-PACD (25 years, IQR: 18–38), though the median age at analysis was similar between the groups. PACD patients were more likely to have ileocolonic disease (64.9% vs. 56.8%) and penetrating behaviour (24.3% vs. 13.6%) but less likely to present with isolated ileal involvement. The mean total advanced therapy (AT) exposure was 1.64 therapies (SD 1.28) in PACD compared to 1.45 therapies (SD 1.24) in non-PACD. First-line anti-TNF therapy, was significantly more common in PACD (64.9% vs. 47.7%), with infliximab alone used in 43.2% of PACD patients compared to 31.1% in non-PACD. Logistic regression analysis identified positive associations between PACD and penetrating behaviour (p=0.032), and first-line anti-TNF therapy use (p=0.02) and negative association younger age at diagnosis (p=0.026). No association was observed with disease location or immunomodulator use. Kaplan-Meier survival analysis revealed showing superior persistence of infliximab in PACD patients compared to non-PACD (log-rank p = 0.021) but not with other ATs, independent of concomitant immunomodulator use.

Conclusion

Perianal Crohn’s disease is common, affecting over a third of our Arab Crohn’s disease patient cohort, with earlier onset, more penetrating behaviour, and increased use of first-line anti-TNF therapies. Infliximab showed better persistence in PACD than non-PACD, highlighting its importance in managing this difficult phenotype. These results stress the necessity for targeted, aggressive treatments to improve PACD outcomes in Arab populations, where data on prescribing practices and therapy efficacy are limited.