bluuebunny/crossref_metadata_2025_split huggingface dataset:
P0390 Development, internal, and external validation of a novel endoscopic activity score for evaluation of Crohn’s disease (EASE-CD)
Authors: Ma C , Khanna R , Maguire B R , Zou G , Bressler B , Hindryckx P , Mosli M , Sparrow M P , Hart A L , Leong R W , Rubin D T , Rémillard J , Shackelton L M , D’Haens G R , Danese S , Peyrin-Biroulet L , Sands B E , Panaccione R , Feagan B G , Jairath V 
Published: January 2025

Abstract

Background
Endoscopy is essential for measuring luminal disease activity in Crohn’s disease (CD). Current endoscopic indices for evaluating CD activity are limited: they are only modestly correlated with disease activity, contain items that are ambiguously defined and have poor inter-observer reliability, and lack validated definitions for clinically relevant change. We aimed to develop and internally and externally validate a reliable and responsive endoscopic CD activity index.

Methods
In this multi-part study, candidate endoscopic items for index development with face validity derived from a prior RAND/UCLA appropriateness exercise were assessed by blinded central readers using ileocolonoscopy videos from the phase 3b adalimumab EXTEND (NCT00348283) and phase 2 risankizumab (NCT02031276) trials. Acceptable item-level operating properties for further consideration as covariables in regression for model building included at least moderate inter-rater reliability (intraclass correlation coefficient [ICC]≥0.41), and medium responsiveness defined as the probability of a patient receiving active treatment having a better endoscopy score than a patient receiving placebo or win probability (WinP) ≥0.56. Model development and internal validation with bootstrapping utilised data from 112 paired baseline and post-treatment videos from the adalimumab trial. External model validation utilised data from 108 video pairs from the risankizumab trial.

Results
The Endoscopic Activity Score for Evaluating CD (EASE-CD) is comprised of ulcer size, presence of deep ulcer(s), and percentage of ulcerated surface with each item evaluated and averaged across visualised bowel segments (Table 1). Total scores range from 0-100 (higher scores indicate greater endoscopic activity). EASE-CD demonstrated almost perfect inter-rater reliability (ICC 0.820 [95% CI: 0.662-0.906]) and a large degree of responsiveness (WinP 0.769 [95% CI: 0.658-0.851]). A 10-point reduction in EASE-CD had 87.8% specificity and 60.9% sensitivity for endoscopic response defined by the Simple Endoscopic Score for CD (SES-CD)/CD Endoscopic Index of Severity (CDEIS). Ulcer-free endoscopic remission results in EASE-CD=0.

Conclusion
EASE-CD is a novel, validated, continuous measure of endoscopic CD activity constructed using modern principles of index development, that is reliable, responsive to treatment, and linearly correlated with disease activity. EASE-CD does not include “narrowing” (which cannot be reliably evaluated between observers) or “affected area” (which is ambiguous in meaning, poorly reliable, and not independently associated with disease activity). EASE-CD is based only on ulcer-related items, the hallmark lesion in CD.
P0392 Prospective endoscopy of pan-enteric mucosal, transmural and biochemical dynamics in the first year of biological treatment in Crohn’s disease - a prospective MILESTONE study
Authors: Ukashi O , Lahat A , Ungar B , Levy H , Zlotnik A , Ben-Horin S , Eliakim R , Kopylov U 
Published: January 2025

Abstract

Background
Crohn’s disease (CD) complications affect 25% of patients at diagnosis and may progress to over 70% within ten years, often evolving into more complex forms. Controlling inflammation is essential to prevent disease progression, with biologics playing a central role. Video capsule endoscopy (VCE) and intestinal ultrasound (IUS) have proven effective in monitoring CD and predicting future complications. However, prospective data on pan-enteric mucosal inflammation and transmural healing in CD remain limited.

Methods
This prospective observational study included patients with CD who started on first-line biologics. Patients were followed at baseline, 14 weeks, and 52 weeks with assessments including CD Activity Index (CDAI), C-reactive protein (CRP), fecal calprotectin (FCP), pan-enteric VCE after confirming small-bowel patency via patency capsule (PC) ingestion, and IUS. The primary outcome was the continuation of biologic therapy after one year. Biochemical, endoscopic, and ultrasonographic remission were defined as follows: FCP&lt;150 µg/g, Lewis score (LS)&lt;135 or Eliakim score (ES)&lt;4, and terminal ileum-bowel wall thickness (TI-BWT)&lt;3 mm.

Results
Seventy-eight patients were screened, with 59 enrolled (median age: 30 [23-43] years; male: 31/59 [52%]; B2/3 disease phenotype: 12/59 [20.3%]), and 19 excluded (Figure, A). The patients started vedolizumab (21/59, 35%), infliximab (11/59, 19%), adalimumab (24/59, 41%) and ustekinumab (3/59, 5%). Eight patients were dropped out before the 14-week time point (Figure, A). At 52 weeks, 34/59 (58%) patients continued their biologics. Among patients with abnormal baseline biochemical, endoscopic, and ultrasonographic measures, 11/42 (26.2%) achieved biochemical normalization, 7/52 (13.5%) achieved small-bowel mucosal healing (MH), 6/38 (15.8%) achieved pan-enteric MH, and 8/28 (28.6%) achieved transmural healing at 14 weeks (Figure, B). Seventeen patients discontinued the study between the 14-week and 52-week time points (Figure, A). At 52 weeks, 17/42 (40.5%) of patients achieved biochemical normalization, 9/52 (17.3%) achieved small-bowel MH, 12/38 (31.6%) achieved pan-enteric MH, and 10/28 (35.7%) achieved transmural healing (Figure, B).All median study indices significantly improved during follow-up: CDAI: 103→64→63 (p=0.08); CRP (mg/dL): 6.6→5.0→4.1 (p=0.016); FCP (μg/g): 678→190→101 (p=0.009); LS: 750→225→225 (p&lt;0.001); ES: 11→4→2 (p&lt;0.001); TI-BWT (mm): 3.8→ 3.3→2.3 (p&lt;0.001) (Figure, C).

Conclusion
First-line biologics significantly improve pan-enteric MH rates, along with clinical, biochemical, and ultrasonographic indices, in patients with CD over one year, with more than half of patients remaining on therapy during this period.
P0398 Point of Care Intestinal ultrasound – is it the key to reducing the carbon footprint of IBD Care?
Authors: Nwaezeigwe M , Hanley M , Lakshman K , Sheridan J , Cullen G , Doherty G 
Published: January 2025

Abstract

Background
Sustainability of IBD care has been identified as a key priority for the coming years by ECCO as part of the REACH strategy.
Additionally, the Irish Health Service Climate Action Strategy aims to achieve net-zero emissions by 2050 and provide healthcare that is environmentally and socially sustainable.
The STRIDE II consensus discusses new treatment goals in the care of IBD such as endoscopic healing which would require more frequent monitoring. However this poses an environmental burden as one MRI generates approximately 20kg CO2e, 3 times more than a CT scan (7kg CO2e), and 20 times more than an ultrasound (1kg CO2e) and 1 colonoscopy is estimated to generate between 28-55kg CO2e. Decontamination of the endoscope generate a further 11.19 kg CO2e.
Point of Care Intestinal ultrasound (POC-IUS) offers a low carbon alternative compared to CT, MRI and endoscopy for disease assessment and monitoring.

Aim
To calculate the potential reduction in Greenhouse Gas (GHG) emissions from the use of POC-IUS for disease monitoring.

Methods
A retrospective analysis of all POC-IUS performed over a 12mth period was conducted.
We focused on the impact of utilising IUS in the IBD clinic instead of interval MRE or colonoscopy to assess disease activity.
The immediate carbon emissions saved as a result of utilising IUS alone was calculated.
The long term reduction of carbon emissions over a three year period from using IUS as an alternative tool for disease monitoring was also calculated.
Data on patient travel, investigations and associated emissions were collected from the patient health record and calculated on ecotree.green.

Results
259 patients were identified who underwent IUS, 92% had Crohns disease.
20% (n=52) of patients had active disease which was followed up by POC-IUS alone. Mean F.Calpro was 495.
Consequently, 14 fewer colonoscopies and 43 fewer MRE were performed over the 12mth period due to the immediate assessment offered by IUS corresponding to at least 5460km reduction in travel to and from appointments with an overall reduction in GHG emission of 1,485kg CO2e. Overall, the use of POC-IUS instead of MRE and/or colonoscopy led to an estimated reduction in GHG of 3269kg CO2e.
Projecting these results over an interval period where IUS is used as the only primary monitoring tool to assess disease activity showed potential carbon emission savings of 36,531kg C02e.This is equivalent to 15 Round-Trip Flights from New York to London.

Conclusion
The findings emphasise the role IUS delivered within the IBD clinic might play in reducing the carbon footprint of IBD care.
POC-IUS is a low carbon alternative and is a tool in providing a lean care system which are two key principles of delivering a sustainable clinical practice.
P0403 The relationship between liver stiffness and disease duration in Crohn’s Disease: A prospective cohort study of hepatic manifestations in inflammatory bowel disease
Authors: Moon W , Park H J , Seo K I , Park J H 
Published: January 2025

Abstract

Background
Intestinal mucosal injury is known to contribute to liver disease, and abnormal liver profiles are frequently observed in inflammatory bowel disease (IBD) patients. This study aimed to investigate the hepatic manifestations of IBD in Korea.

Methods
A prospective cohort to evaluate hepatic abnormalities in IBD was established at Kosin University Gospel Hospital in 2018. From December 2018 to September 2024, patients diagnosed with IBD were consecutively enrolled and underwent abdominal ultrasonography and transient elastography-controlled attenuation parameter (TE-CAP), and laboratory tests including liver function tests, lipid profiles, and fecal calprotectin.

Results
A total of 383 patients were enrolled, including 218 with ulcerative colitis (UC) and 165 with Crohn’s disease (CD). The mean age was 45.8 (±15.2) years for UC patients and 37.6 (±16.3) years for CD patients. Among the participants, 250 were male, and 133 were female. The mean BMI was 23.1 (±3.49) for UC patients and 22.0 (±4.11) for CD patients. HBsAg was positive in 14 (3.7%) patients, Anti-HBc IgG in 76 (19.8%) patients, Anti-HCV Ab in 6 (1.6%) patients. The proportion of patients with a disease duration more than one year was 123 (56.4%) for UC and 90 (54.5%) for CD. The mean CAP (dB/m) score was 220.0 (±54.5) [UC 230.5 (±52.6), CD 209.4 (±53.5)]. The mean E (kPa) value was 4.71 (±1.94) [UC 4.70 (±1.98), CD 4.65 (±1.80)]. Mean fecal calprotectin levels was 1146.6 (±17.27.7) in UC and 1075.8 (±1720.6) in CD. (Table 1) In total population, CAP score was significantly associated with BMI (r=0.616, P&lt;0.001), triglyceride (TG) (r=0.273, P&lt;0.001). In UC patients, CAP score was significantly associated with BMI (r=0.527, P&lt;0.001) and TG (r=0.285, P&lt;0.001). In CD patients, CAP score was significantly associated with BMI (r=0.660, P&lt;0.001), albumin (r=0.400, P&lt;0.001), total cholesterol (r=0.288, P&lt;0.001), TG (r=0.271, P&lt;0.001) and inversely with fecal calprotectin (r=－0.329, P&lt;0.001). The E value was significantly associated with total bilirubin (r=0.348, P&lt;0.001), ALT (r=0.495, P&lt;0.001) and disease duration (r=0.333, P&lt;0.001). In CD patients with a disease duration of more than one year (n=75), E value was observed to increase gradually as the disease period lengthened (r=0.496, P&lt;0.001). (Figure 1)

Conclusion
In CD patients, liver stiffness is associated with a longer disease duration. In both UC and CD patients, abnormal lipid profiles are related to the development of fatty liver.
P0405 Evaluation of penetrating Crohn’s disease: course of complicated disease and risk factors associated with progression to penetrating complications
Authors: Pekmezci A , Bakkaloglu O K , Atay K , Erzin Y , Celik A F , Hatemi I 
Published: January 2025

Abstract

Background
This study aimed to identify the risk factors for developing penetrating Crohn’s disease (CD) and to evaluate clinical course of patients with penetrating CD at the time of diagnosis and those who subsequently evolved to penetrating CD during follow-up.

Methods
CD patients with penetrating complications followed between 1986 and 2022 were retrospectively evaluated. Patients who developed penetrating CD were compared to a control group of who did not. Also, patients developing penetrating CD on follow-up were compared to patients presenting with penetrating CD at the time of diagnosis.

Results
From a cohort of 1,404 CD patients, penetrating complications were identified in 312 (22.2%). A total of 198 patients were excluded due to insufficient data and 114 patients with penetrating CD were included in the analyses. Among them, 36 (31.6%) had penetrating complications at diagnosis and 78 (68.4%) developed penetrating complications during follow-up. The patients who developed penetrating complications during follow-up were compared with a control group (n:78) of CD patients who did not develop any penetrating complications. In-between these groups; The age at the diagnosis in the penetrating group was 25.5±9.03 years and was lower than in the control (33.0 ± 11.41); The need for steroids was higher and the rate of hospitalizations was more common in the penetrating group (p=0.022 and 0.002, respectively). The proportion of patients who underwent biologic treatment (78.2%) and was unresponsive to biologics (26.4%) were higher in the penetrating group. The frequency of endoscopic remission was higher in the control group (44.9% vs. 33.3%; p=0.03). Additionally, cross-sectional imaging revealed significantly more frequent instances of regressed disease in the control group (54.8% vs. 23.8%; p=0.006). Further, clinical follow-up of patients with penetrating CD were evaluated. Patients who presented with penetrating CD and those who developed penetrating complications subsequently during follow-up had similar rates of surgical intervention and resection related to penetrating CD (28.3% vs. 71.7%; 50.0% vs. 51.3%; respectively). The presence of an obstructive area before the development of penetrating complications was less common in the group with penetrating disease at diagnosis compared to the group who developed penetrating disease at follow-up (13.9% vs 61.5%, p&lt;0.001).

Conclusion
Age, treatment response and previous active clinic are identified risk factors for developing penetrating disease in initially non-penetrating CD. The clinical course of patients with penetrating disease at diagnosis and those who developed penetrating disease at the follow-up seems similar.
P0410 Clinical outcomes of endoscopically confirmed immune checkpoint inhibitor-induced colitis: A multicentre retrospective study
Authors: Ibraheim H , D’arienzo P , Dean N J , Aboulela M , Anderson K , Manickavasagar T , Vadera S , Symington J , Mullings S , Olsson-brown A , Young K , Powell N 
Published: January 2025

Abstract

Background
Immune checkpoint inhibitors (CPIs) have transformed cancer outcomes, but frequently trigger CPI-induced colitis (CPI-c) leading to significant morbidity and prolonged immunosuppression. This study characterises CPI-c patients (pts) using robust definitions. Additionally, the impact of macroscopic inflammation (endoscopic and histological evidence) compared to microscopic inflammation (histological only) on clinical outcomes remains unclear.

Methods
Retrospective outcome data were obtained from consecutive CPI-c pts from 2 U.K centres. Pts with diarrhoea and histological ± endoscopic colonic inflammation were included. Factors associated with macroscopic inflammation were analysed using Chi squared tests and multivariable logistic regression.

Results
Of 161 pts (55% male, median age 64), cancers included melanoma (50%), renal (18%), lung (16%) and others (16%). CPI therapies included anti-PD-1/L1 monotherapy (41%), dual anti-CTLA-4/PD-1 (47%) and chemoimmunotherapy (6%). Toxicity onset was earlier with dual anti-PD-(L)1/CTLA-4 therapy vs. anti PD-(L)1 monotherapy (47 vs.150 days, p &lt; 0.001). The average bowel frequency was 8x/day (range 2-20); 115 (71%) had nocturnal symptoms; 28 (17%) had bloody stool and 63% required hospitalisation.
89 pts (54%) were corticosteroid (cs) refractory, requiring biologics (infliximab (IFX), 73; vedolizumab, 13). 41/73 (56%) responded to IFX, and 5/13 (38%) to vedolizumab. Three underwent colectomy for refractory colitis.
Macroscopic inflammation occurred in 78%, while 22% had microscopic inflammation. Time to endoscopy did not differ between groups. Among macroscopic cases, 91 (70%) had mild (Mayo 1), while 30% had moderate or severe inflammation (Mayo 2-3). CTCAE grade did not correlate with endoscopic severity.
In the regression analysis, male sex (OR 3.25 p&lt;0.01) and dual anti-CTLA-4/PD-1 (OR 2.63 p&lt;0.01) predicted macroscopic inflammation. Age, cancer, CTCAE grade, duration of diarrhoea, concurrent CMV colitis, number of cs tapers, duration of cs therapy, hospitalisation and recurrence of colitis were not predictive.
Macroscopic inflammation correlated with higher faecal calprotectin (FC) levels (889 vs 414, p=0.02) and biologic escalation (52.7% vs 30.6%, p&lt;0.05).
30% received CPI re-challenge, with colitis relapse in 13/45 (29%). No relapses exceeded initial CTCAE or endoscopic severity.

Conclusion
This study represents one of the largest real-world cohorts of robustly defined CPI-c pts. Pts with macroscopic inflammation have a more aggressive clinical course, marked by higher FC levels and greater need for biologic escalation, emphasising the need for heightened monitoring in this group. Reassuringly, CPI re-challenge did not lead to more severe colitis relapses than the initial episode.
P0413 Clinical features of pediatric ulcerative colitis with atypical endoscopic findings
Authors: Miyazaki H , Agawa M , Nakamura H , Ito Y , Okamoto N , Ku Y , Watanabe D , Hoshi N , Ueda C , Kondo A , Horinouchi T , Ooi M , Kodama Y 
Published: January 2025

Abstract

Background
Atypical endoscopic features are not uncommon in newly diagnosed pediatric ulcerative colitis (UC) compared to adults. However, the clinical meaning of these atypical endoscopic features at diagnosis are obscure. We aimed to clarify the clinical characteristics of pediatric patients with UC who do not exhibit typical endoscopic findings.

Methods
This is a retrospective study of the newly diagnosed pediatric patients with UC. The inclusion criteria are as follows: (1) aged 15 years or younger at the time of diagnosis, (2) diagnosis of UC according to the criteria set by the Japanese Ministry of Health, Labour and Welfare, and (3) attendance at Kobe University Hospital (Kobe, Japan) between April 2018 to January 2024. Endoscopic activity was assessed using the Mayo Endoscopic Subscore. Patients were categorized into two groups based on the endoscopic findings at diagnosis. The “typical group” was defined as patients who showed endoscopic inflammatory activity starting in the rectum and expanding proximally in a continuous manner. All other patients were classified as the “atypical group”. We compared the background characteristics and the clinical course between the two groups.

Results
Thirty-three patients were included in this study. Sixteen patients (48.5%) were male, and the median age at diagnosis was 13 years. The median Pediatric Ulcerative Colitis Activity Index (PUCAI) score was 40, while the median serum level of albumin, hemoglobin, and CRP were 3.8 g/dL, 11.9 g/dL, and 1.0 mg/L, respectively. At the time of diagnosis, 2 patients had proctitis, 3 had left-sided colitis, 27 had pancolitis, and 1 had right-sided colitis. Endoscopic activity was mild in 4 patients (12.1%), and moderate in 29 (87.9%).
Of the 33 patients, 21 (63.6%) were classified into the typical group and 12 (36.4%) into the atypical group based on colonoscopy at diagnosis. There was no difference between the two groups in terms of baseline characteristics such as sex, age at diagnosis, duration of symptoms before diagnosis, endoscopic activity, and the extent of the disease. The median albumin level was lower in the typical group than in the atypical group (p=0.006).
Kaplan-Meier analysis showed that patients in the atypical group were more likely to maintain a biologic-free condition than those in the typical group (p=0.028). Patients in the atypical group were also likely to remain in a steroid-free condition compared with those in the typical group, although not statistically significant.

Conclusion
Pediatric patients with UC who have typical endoscopic findings of a continuous lesion extending from the rectum at diagnosis may have a poor prognosis and require advanced therapy compared to those with atypical endoscopic findings.
P0418 The implementation of IBD-dedicated multidisciplinary healthcare pathway improves patients’ satisfaction and reduces disability in patients with IBD
Authors: Buisson A , Banana Hamadidi A , Dumas V , Dodel M , Coban D , Bazoge M , Rivière C , Heux J , Pereira B 
Published: January 2025

Abstract

Background
The management of patients with Inflammatory Bowel Diseases (IBD) has recently evolved highlighting the need for holistic approach.
We evaluated patients’ satisfaction after the implementation of an IBD-dedicated multidisciplinary healthcare pathway (IBD-MHP) compared to the previous organization and assessed its impact on medical follow-up and disability in patients with IBD.

Methods
In this prospective study, we enrolled consecutively all adult IBD patients seen in the IBD-MHP during 8 weeks. A questionnaire was specifically developed for this study. Patients’ satisfaction was assessed using a numerical scale from 0 to 10 (10 = perfect satisfaction).
The previous organization followed a traditional model of medical consultations and additional examinations. The IBD-MHP was organized with dedicated reception by a secretary, completion of IBD-Disk to assess functional disability, a consultation with one of two IBD nurses (including blood tests, pre-analytical faecal calprotectin testing, and therapeutic education program), optional consultation with a psychologist, followed by a medical consultation. Additional examinations (e.g., sigmoidoscopy, ultrasound, MRI) were performed the same day just before the care pathway within or near the IBD unit.

Results
Among 388 patients, 276 patients (57.6% female, mean age 43.8 ± 15.0 years, 58.3% with Crohn’s disease) completed the questionnaires.
Overall satisfaction was significantly higher with the new organization (IBD-MHP) compared to the previous (8.7 ± 1.5 vs. 7.6 ± 1.8, p &lt;0.0001; effect size (ES) = 0.69). Patients’ satisfaction were improved regarding the attention paid by the team to the indirect consequences of the disease (8.8 ± 1.6 vs. 7.2 ± 2.1, p &lt;0.0001; ES = 0.87), time spent at the IBD unit during each visit (7.6 ± 2.0 vs. 6.7 ± 2.2, p &lt;0.0001; ES = 0.50), punctuality of healthcare professionals (7.7 ± 1.8 vs. 6.8 ± 2.0, p &lt;0.0001; ES = 0.45), coordination of examinations (8.4 ± 1.8 vs. 7.4 ± 2.1, p &lt;0.0001; ES = 0.60), knowledge about their disease (8.5 ± 1.7 vs. 8.1 ± 1.8, p &lt;0.0001; ES = 0.23), and interaction with medical staff (8.5 ± 1.8 vs. 7.0 ± 2.2, p &lt;0.0001; ES = 0.81).
IBD-MHP led to a slight increase of treatment adherence (71.3% vs. 75.2%, p &lt; 0.05), a modest decrease in active smoking (18.8% vs. 17.0%, p &lt;0.001 and an overall improvement in disability (IBD-Disk) (32.60 ± 21.59 vs. 30.50 ± 23.92; p &lt;0.001).

Conclusion
The implementation of IBD-MHP, replacing the traditional consultation model, led to improved patients’ satisfaction and reduced patients’ disability, meeting the objectives of holistic approach. This type of organization should be promoted in IBD unit.