bluuebunny/crossref_metadata_2025_split huggingface dataset:
P0541 Placebo rates in randomised clinical trials of Ulcerative Colitis: An individual patient data meta-analysis
Authors: Solitano V , Hogan M , Singh S , Danese S , Peyrin-Biroulet L , Vuyyuru S , MacDonald J K , Zou G , Yuan Y , Sands B E , Panaccione R , Feagan B G , Hanzel J , Sedano R , Dulai P , Narula N , Ma C , Jairath V 
Published: January 2025

Abstract

Background
Information on placebo rates is important for designing clinical trials. We aimed to assess placebo rates and associated factors using individual patient data from multiple randomised clinical trials in ulcerative colitis.

Methods
We conducted a meta-analysis of individual participant-level data from nine randomised trials using Vivli and Yale University Open Data Access data-sharing platforms. Phase 2 and 3 placebo-controlled randomised clinical trials of advanced biologic therapies in adults with moderate-to-severe active ulcerative colitis published since 2010 were included. Pooled placebo rates and 95% CIs were estimated using one-stage and two-stage meta-analytical approach. Significant patient-level factors (P&lt;0.05) associated with placebo rates were identified using regression analyses. The pre-specified primary outcomes were placebo clinical response and remission.

Results
Outcome data were available for 1,703 patients from nine studies (three induction-only, one maintenance-only, and five including both phases). For induction trials, overall placebo response and remission rates were 33% (95% CI 29-38%) and 9% (95% CI 7-11%), respectively (Figure). Overall placebo response and remission rates in maintenance trials were 28% (95% CI 17%-41%) and 14% (95% CI 9-20%), respectively (Figure). A lower body mass index reduced odds of placebo response and remission, while higher baseline albumin levels and left-sided UC (compared to extensive) increased the odds of these outcomes. A one-point increase in the Mayo Clinic Score and adapted Mayo Clinic Score was associated with a 26% and 27% reduction in the odds of clinical remission. For induction trials, prior exposure to biologics or tumour necrosis factor antagonist therapy was associated with lower odds of both response and remission. Multi-centre trials have lower placebo effect than single-centre trials.

Conclusion
These results will enable future trials that include placebo to incorporate design elements that enable reduction of placebo rates as well as a precise benchmark for expected rates in clinical trials that do not include placebo.
P0544 Long-term evaluation of quality of life in inflammatory bowel diseases: results from a prospective cohort study
Authors: Marinica A , State R M , Miron M , Mateescu R B 
Published: January 2025

Abstract

Background
Inflammatory bowel diseases (IBDs), including Crohn’s disease (CD) and Ulcerative Colitis (UC) have a negative impact on patients’ well-being and quality of life. Dysfunctions usually affect daily activities, performance in school, ability to work, and social life. The Short Inflammatory Bowel Disease Questionnaire (SIBDQ), frequently used to apraise Health-related Quality of Life (HRQoL) among IBD patients, measures social, systemic, bowel and emotional status (score 10–70, poor to good HRQoL)[1]. Our aim was to observe the impact of IBD on the patients’ quality of life over time.

Methods
We conducted a retrospective descriptive observational cohort study, followed prospectively at the Colentina Clinic Hospital Bucharest. The 10 questions of the SIBDQ questionnaire were divided into 4 subdomains (social, emotional, bowel and systemic). The SIBDQ was administered to patients at each study visit, scheduled every 12 months or more frequent, in case of unscheduled visits (disease flare).

Results
We included in the final analysis 219 patients, 88 (40%) with CD and 131(60%) diagnosed with UC. The 128 (58%) male and 91 (42%) female patients were followed for a median duration of 24 months. Overall SIBDQ scores improved at follow up visits (median SIBDQ 49 at baseline vs. mean 54 after 12 months of surveillance, p&lt;0.05, Chi-square test). SIBDQ differs significantly according to both clinical and endoscopic activity (SIBDQ score 57 vs 43 for clinical remission/activity and 54 vs 50 for mucosal healing/endoscopic activity, p&lt;0.05, Chi-square test). All subdomains of QoL were equally affected at the baseline visit and median scores improved during the first 24 months of follow-up: social (10 vs 11 points), emotional (15 vs 16 points) , bowel (13 vs 15 points) and systemic (10 vs 11 points). At the univariate analysis, we detected in the systemic (p=0.046) and social (p= 0.032) subcategories a significant association between the screening visit and the 48 months visit).

Conclusion
SIBDQ is a reliable tool for QoL assesement in IBD patients, correlated with clinical and endoscopic activity. In our cohort, long-term follow-up significantly improved QoL and patients achieved SIBDQ scores indicative of a good quality of life, in all subdomains (social, emotional, bowel and systemic).

References
[1]Jowett SL, Seal CJ, Barton JR, Welfare MR. The short inflammatory bowel disease questionnaire is reliable and responsive to clinically important change in ulcerative colitis. Am J Gastroenterol. 2001;96(10):2921-2928. doi:10.1111/j.1572-0241.2001.04682.x
P0555 Quantitative Assessment of Colon Motility in Ulcerative Colitis using Magnetic Resonance Enterography: Correlation with Endoscopic Disease Activity
Authors: Sarikhani M , Naim I , Torabi A , Amouei M , Vahedi H , Sima A R , Kolahdoozan S , Menys A , Radmard A R 
Published: January 2025

Abstract

Background
Changes in small bowel motility have been quantified by magnetic resonance enterography (MRE) in Crohn’s disease to assess disease activity, but there is no data about colon motility changes in ulcerative colitis (UC). The aim of this study was to examine the correlation between colon motility (bowel wall motion) and endoscopic and laboratory features of activity in patients with UC.

Methods
This prospective study included 33 adults with known UC (mean age 38 [SD: 12.9] years, 51% female) and 30 controls (mean age 46 [SD: 15.2] years, 73% female). Two board-certified radiologists, blinded to clinical and endoscopic information, assessed motility scores for each colonic segment from dynamic cine MRE sequences using FDA-approved software with higher GIQuant scores indicating greater motility. Mayo endoscopic scores (MES) were determined by two experienced gastroenterologists in a consensus for each segment. Colonoscopy and laboratory tests were performed within 14 days of MREs. We used a mixed-effects linear model to evaluate the correlation between MES and motility scores across the five segments per patient.

Results
UC group consisted of 12 (36%) and 21 (64%) patients with left-sided colitis and pancolitis, respectively. The median value of GIQuant score for all colonic segments was significantly lower in UC patients (1184, IQR 693 to 1675) than controls (1245, IQR 851 to 1693) (p= 0.006). There was a decreasing trend of motility from ascending colon to rectum in controls with the similar pattern in UC patients except for lower motility of sigmoid than rectum. Per segment analysis of UC cases revealed a weak negative correlation between GIQuant and MES only in sigmoid (r= -0.2, p= 0.01). The mixed-effects model in per patient analysis identified a significant negative association between MES and GIQuant, indicating that each one-score increase in MES corresponds to a 144.3-point reduction in GIQuant between the less and more-involved colonic segment (β = -144.30, SE = 33.19, p &lt; 0.001, 95% CI: -209.34 to -79.25). No significant correlation was found between the median GIQaunt score of all involved colonic segments and fecal calprotectin or serum CRP levels.

Conclusion
Higher endoscopic UC activity in each colonic segment is associated with lower motility compared to the less involved segments in each patient. Given the significant between-patient variability, colon motility should be assessed individually. MRE-based colon motility scores may provide an objective, transmural and physiological impression to complement endoscopy which may aid personalized assessment of UC activity.
P0556 A novel switching of artificial intelligence to generate simultaneously multimodal images to assess inflammation and predict outcomes in Ulcerative Colitis
Authors: Iacucci M , Zammarchi I , Santacroce G , Kolawole B B , Chaudhari U , Del Amor R , Meseguer P , Naranjo V , Puga-Tejada M , Capobianco I , Ditonno I , Buda A , Hayes B , Crotty R , Bisschops R , Ghosh S , Grisan E ,   PICaSSO group
Published: January 2025

Abstract

Background
Virtual Chromoendoscopy (VCE) is pivotal for assessing activity and predicting outcomes in Ulcerative Colitis (UC), though inter- and intra-observer variability and the need for expertise persist. Artificial intelligence (AI) has the potential to offer standardised VCE-based assessment. This study introduces a novel AI model to detect, generate and transition between various endoscopic modalities, enhancing AI-driven inflammation assessment and outcome prediction in UC.

Methods
Endoscopic videos in high-definition white-light (HD-WLE), iScan2, iScan3 and NBI modalities from UC patients of the international PICaSSO iScan and Narrow-Band Imaging (NBI) cohort (302 and 54 patients, respectively) were used to develop a neural network (NN) able to identify the acquisition modality of each frame and for inter-modality image switching. 2535 frames were switched to different endoscopic modalities and used to train a deep-learning model for inflammation assessment using single and multimodal inputs on 169 videos of the iScan cohort. Subsequently, the model was tested on a subset of the iScan and NBI cohort (72 and 51 videos, 1080 and 765 frames, respectively). The model performance in predicting endoscopic and histological activity and outcomes and the agreement with experts were evaluated.

Results
Table 1 details the diagnostic performance of the AI model for the prediction of endoscopic and histological remission. The AI model efficiently classified and converted images across modalities (92% NN classifier accuracy). It showed excellent performance in predicting endoscopic and histological remission, with the multimodal assessment outperforming the unimodal one in both iScan cohorts (accuracy 91.67 [95% CI 82.74-96.88] and 88.89 [80.4-97.73]; AUROC 0.96 and 0.90 by Ulcerative Colitis Endoscopic Index of Severity (UCEIS) and Paddington International Virtual Chromoendoscopy (PICaSSO) score, respectively) and NBI cohort (accuracy 84.62 [95% CI 65.13-95.64] and 88.46 [69.85-97.55]; AUROC 0.92 by UCEIS and PICaSSO score, respectively). Moreover, it showed a remarkable ability to predict clinical outcomes in the iScan and NBI cohort (HR 3.18 [0.98-10.35] and 1.7 [0.7-4.11] by endoscopy; 5.75 [1.77-18-71] and 3.9 [1.15-13.28] by histology, respectively). Finally, the agreement with the assessment performed by endoscopists and pathologists was good.

Conclusion
Our multimodal "AI-switching" model innovatively detects, generates, and transitions between different endoscopic enhancement modalities and platforms, refining inflammation assessment, outcome prediction, and precise UC management by integrating model-derived images.
P0569 Inflammatory Bowel Disease nursing helpline trends in a large real-world Australasian cohort: Crohn's Colitis Cure (CCC) data insights program
Authors: Chan P , Su W K , Wilson W , Cabaero A , Antoniades S , Forbes A , Arnold K , Grafton R , Andrews J , Connor S 
Published: January 2025

Abstract

Background
The chronic nature of Inflammatory Bowel Disease (IBD) necessitates ongoing engagement between the healthcare team and patients with IBD. Dedicated nurse led helplines have been demonstrated to improve access to care, reduce healthcare costs and utilisation, and improves satisfaction. IBD nurses and helplines may not be widely available subject to resourcing. We analysed real world IBD-helpline usage across 10 Australasian sites to determine current trends.

Methods
Crohn’s Colitis Care (CCCare) is a cloud-based IBD-specific electronic medical record used increasingly in Australasia. The inclusion of a helpline augments the service through enabling encounter related documentation. De-identified data is made available from an associated, clinical quality registry (CQR). Helpline-associated data prospectively entered from September 2023 to September 2024 were analysed.

Results
In our cohort (n=7,493), 55.8% (n=4,181) had Crohn’s Disease (CD), 41.4% (n=3,101) had Ulcerative colitis (UC) and 2.8% (n=211) had IBD-Unclassified (IBDU). The median age was 42 years (IQR 31–56) and the cohort was evenly distributed in gender (49.0%, n=3,670 male). All patients resided in either Australia (73.1%, n=5,478) or New Zealand (23.6%, n=1,477). Three-quarters (75.2%) lived in metropolitan regions compared to regional/rural areas (24.8%). A total of 10,673 helpline encounters were documented, 75.5% (n=8,078) by email and 24.5%, (n=2,622) by phone. Email remained the predominant modality of communication across all age groups except those under 16. Those receiving advanced therapy (biologic or novel small molecule) formed 60% (n=3876) of the cohort but comprised 81.9% of the helpline utilisation likely reflecting increased complexity associated with their care. The most common reasons for helpline encounters related to administrative tasks (33.3%), medication-related issues (24.0%), and investigations/results (14.3%). Clinical concern and care only formed 14.3% of helpline contact encounters. This was consistent across most age groups, however a greater proportion of encounters were related to clinical concern or care in those under 18 (&gt;30%) and over 80 (&gt;20%).

Conclusion
IBD helplines play an essential role in augmenting the routine care provided to people with IBD, however it is limited by resource allocation, along with the burden of non-clinical and administrative tasks. Digital delivery of the IBD nursing helpline is utilised preferentially across all demographics in our cohort and signals an opportunity for innovative digital solutions to streamline care, reduce administrative burden, and improve overall patient care and satisfaction.

Figure 1. Helpline encounter reasons by age groups.
P0574 Correlations Between Inflammatory Biomarkers and Hematological Parameters in Assessing Disease Activity in IBD
Authors: Andronic A M , Andronic C , Toader E 
Published: January 2025

Abstract

Background
Monitoring ulcerative colitis (UC) and Crohn's disease (CD) involves assessing inflammatory and hematological biomarkers to evaluate disease activity, treatment response, and the impact of inflammation on overall health. The aim of this study was to assess if hematological and inflammatory biomarkers along with clinical parameters correlate with IBD inflammatory activity and severity.

Methods
The study retrospectively analyzed 100 IBD patients, of which 72 patients with UC and 38 patients with CD. Age, hematological parameters (hemoglobin, iron and ferritin), inflammatory biomarkers (CRP, fibrinogen and fecal calprotectin) and clinical scores such as Truelove and Witts for UC and UCDAI for CD were analyzed. Pearson's correlation coefficient demonstrated relationships between hematological and inflammatory biomarkers, while the Kruskal-Wallis test evaluated associations between these biomarkers and clinical scores.

Results
The mean age was 44.02 years, with UC patients averaging 43.03 years and CD patients 49.3 years, reflecting a slightly older demographic for CD. Age was negatively correlated with iron (-0.93) and positively with ferritin (0.88), indicating that older individuals have less iron deposits. Hemoglobin levels (mean 11.81 g/dL) were reduced across both diseases and exhibited significant negative correlations with CRP (-0.93) and fecal calprotectin (-0.91). Systemic (CRP) and intestinal (fecal calprotectin) inflammation can diminish hemoglobin levels in IBD patients, causing inflammatory anemia. Iron levels were lowest in CD (61.78 µg/dL) and correlated negatively with CRP (-0.93) and ferritin (-0.99) during active systemic inflammation, while ferritin levels (107.89 ng/mL) were elevated, particularly in active inflammation in CD group. Intestinal inflammation impacts iron status (-0.40), while ferritin and CRP are positively correlated (0.96), showing that systemic inflammation enhances iron storage. Fecal calprotectin emerged as a particularly sensitive marker of intestinal inflammation, showing the highest levels in UC patients (517.18 µg/g) and significant correlations with clinical activity scores (p = 0.02) for both Truelove-Witts and UCDAI. Hemoglobin was the only parameter that showed a weak trend of correlation with clinical scores (p=0.06), without statistical significance.

Conclusion
Hematological and inflammatory biomarkers along with clinical parameters correlate with IBD inflammatory activity and severity of the inflammatory process. The results highlight the effectiveness of biomarker evaluation in the personalized management of patients, enabling the adaptation, configuration, or establishment of monitoring schedules and therapeutic optimization based on the inflammatory profile.
P0575 Bronchiectasis in patients with inflammatory bowel disease – prevalence, predictors, and clinical characteristics
Authors: Freund O , Bar-Shai A , Alkhazov A , Stav D , Hadad Y , Perluk T M , Sror N , Hirsch A , Ron Y , Thurm T , Herling A , Leibovitzh H , Maharshak N , Cohen N A 
Published: January 2025

Abstract

Background
Inflammatory bowel diseases (IBD) are known to be associated with bronchiectasis (BE). However, data detailing the prevalence of BE among patients with IBD (IBD-BE), its risk factors, and clinical characteristics are limited.

Methods
This was a single center retrospective study including patients who visited an IBD unit at a tertiary center between 2022 and 2023. Data on prior chest CT scans was extracted. Radiologists blinded to clinical data analyzed all chest CT scans for BE. The overall prevalence of IBD-BE was estimated using multiple imputation analysis. Risk factors were analyzed in the whole cohort and after matching.

Results
1637 patients with IBD were included, 254 had prior chest CT scans, of these, 30 (1.8% of the cohort) had BE. The estimated overall prevalence of IBD-BE was 4.7% (95% CI 3.6-5.8%). Demographic and clinical characteristics are detailed in Table 1. In a multivariate logistic regression analysis, older age (adjusted odds ratio (aOR) 1.04, 95% confidence interval (CI) 1.02-1.06 for every additional year, p&lt;0.001), UC diagnosis (aOR 2.31, 95% CI 1.08-4.92, p=0.029), and IBD-related surgery (aOR 2.71, 95% CI 1.23-5.96, p=0.013) remained independent predictors for IBD-BE. The IBD-BE group also had more extraintestinal manifestations (EIMs) in general (57% vs. 31%, p=0.01), and specifically arthritis (33% vs. 14%, p=0.02) and non-arthritis (33% vs. 19%, p=0.1) involvement. Radiological and clinical features of patients with IBD-BE are detailed in Figure 1. Interestingly, of patients with IBD-BE, 63% had evidence of BE in the chest cuts of their prior abdominal CT scans, and 70% had relevant respiratory symptoms. Despite this, most did not see a pulmonologist nor receive BE-related therapy. Clinical characteristics and outcomes of IBD-BE were similar to those of patients with non-IBD-related BE.

Conclusion
This study shows a minimal prevalence of 1.8% and an estimated 4.7% overall prevalence of BE in patients with IBD. Risk factors associated with IBD-BE included older age, a diagnosis of UC, IBD-related surgery and the presence of EIMs. The low rates of BE-directed therapy and pulmonology referral indicate the need for a higher degree of suspicion and timely referral.
P0586 Nationwide population-based cohort study on the use and persistence of infliximab (IV and SC) in France: the Riposte IBD study
Authors: Kirchgesner J , Quiles N , Foulley L , Habauzit C , Benkhalifa S , Prati C 
Published: January 2025

Abstract

Background
Subcutaneous infliximab (IFX-SC) is available in France since 2021. Beyond the pivotal trials, real-life data is needed. The aim of the RIPOSTE study is to evaluate the real-life use of IFX-SC in France at a nationwide level.

Methods
Patients affiliated to the French national health insurance with at least one IFX-SC or intravenous (IV) delivery between February 1, 2021, and December 31, 2022, were included, regardless of therapeutic indication. Three patient groups were defined: patients treated solely with IFX-IV (control group); patients who had received less than 3 infusions of IFX-IV before initiating IFX-SC (initiation group); patients who had received at least 3 infusions of IFX-IV before initiating IFX-SC (switch group). Patients were followed from the first IFX infusion until IFX discontinuation, initiation of another advanced therapy, death, or December 31, 2022. Discontinuation of infliximab was defined by a period of at least 3 months after the last day of estimated exposure without any new treatment delivery. Persistence of IFX-SC was assessed by the Kaplan-Meier method. Concomitant exposure of immunosuppressant (IS) and the occurrence of serious adverse events were also assessed.

Results
A total of 45664 patients received at least one IFX delivery (fig.1), 30842 treated solely with IFX-IV and 12480 patients treated with IFX-SC. Overall, 7467 (59.8%) and 2982 (23.9%) were diagnosed with Crohn’s disease (CD) and ulcerative colitis (UC), including 1449 (19%) and 664 (22%) in the initiation group, respectively. In the initiation group, 129 (8.9%) and 59 patients (9.2%) with CD and UC had not received IFX-IV at induction. The mean age at cohort entry was 40 years (SD, 14.49) in CD and 43 years (SD, 15.73) in UC, with 49% and 53% of men respectively. At 6 months, an IS was associated with IFX-SC in 39% of CD and 34% of UC patients in the initiation group compared to 16% and 17% of CD and UC patients in the switch group. Median patient follow-up for both diseases was 0.92 years, (Q1-Q3; 0.50-1.25). At 6 months, 84% of CD patients (CI [0.82-0.86]) and 80% (CI [0.76-0.83]) of UC patients were still on IFX-SC in the initiation group. Among patients in the switch group, persistence was 90% (CI [0.9-0.91]) for both CD and UC (CI [0.89-0.91]). Switch-back to IFX-IV in patients exposed to IFX-SC during follow-up occurred in 33 CD (2.3%) and 13 UC patients (2.0%) in the initiation group compared to 203 CD (3.4%) and 77 UC patients (3.3%) in the switch group. No new safety signals were identified (Table 1).

Conclusion
Based on a nationwide population-based cohort, over 80% of patients initiating IFX-SC and over 90% in maintenance with IFX-SC remained on treatment at 6 months. These data are consistent with previously published data.