bluuebunny/crossref_metadata_2025_split huggingface dataset:
P1262 Factors associated with bowel urgency in patients with inflammatory bowel disease – interims analysis of the Health Outcome Observatory (H2O) project
Authors: Schreiner P O , Fierens L , Ferrante M , Primas C , Dabsch S , Schilling V , Frick A , Reinisch W , Dejaco C , Schweiger K , Ritschl V , Mosor E , Long P , Winkler E , Mooslechner T , Wisniowski K , Kazemi-Shirazi L , Bäuerle M , Novacek G , Stamm T 
Published: January 2025

Abstract

Background
Bowel urgency is one of the most bothersome symptoms in patients with Ulcerative colitis (UC) and Crohn´s disease (CD). However, only recently attention has been focused on this symptom and data on associated factors, especially in patients with CD, is scarce. The Health Outcome Observatory (H2O) project aims to standardize and facilitate the collection of patients reported outcomes (PROs) and clinical outcomes by developing multi-stakeholder agreed Core Outcome Sets (COS) including one for patients with inflammatory bowel disease (IBD). The present study describes preliminary data on bowel urgency.

Methods
We analyzed prospectively collected data from the Health Outcome Observatory (H2O) project at the Medical University of Vienna, Austria. Bowel urgency was one of the collected variables and was defined by the validated Urgency Numeric Rating Scale (NRS) ≥ 3 (on a 0-10 scale). We used linear regression with bowel urgency as the outcome and age, gender, diagnosis (CD/IBDU/UC) and quality of life (PROMIS_Global_10_02; scale from 1-5) as predictors.

Results
Out of a total of 480 included patients who took part in the H2O project, we analyzed 388 patients who answered the question regarding bowel urgency. The mean urgency NRS in CD patients was 2.71 (SD +/- 2.92) and 2.24 in UC (SD +/- 2.68). Numerically more patients with CD (40.9%) than with UC (33.8%) complained about bowel urgency. Quality of life (coef 1.30, coef (95% CI) 1.01-1.59, p&lt;0.01) was associated with bowel urgency. Age, gender, diagnosis (CD vs UC vs IBDU) was not associated with bowel urgency (see Table 1).

Conclusion
Bowel urgency is a common symptom in patients with inflammatory bowel disease and is associated with a lower quality of life. Caregivers should acknowledge the importance of this debilitating symptom.

References
Fierens L, Carney N, Novacek G, van der Woude CJ, Siegmund B, CasellasF, Borruel N, Huberts AS, Sonnenberg E, Gerold N, Primas C, Hedin CRH,Stamm T, Julsgaard M, Fiorino G, Radice S, Zini MLL, Gross E, Sander C,Arijs I, Vakouftsi VR, Koltai T, Health Outcomes Observatory H O PatientAdvisory Board For Inflammatory Bowel Diseases, Health OutcomesObservatory H2O Steering Committee, Charlafti I, Ferrante M. A CoreOutcome Set for Inflammatory Bowel Diseases: Development andRecommendations for Implementation in Clinical Practice Through anInternational Multi-stakeholder Consensus Process. J Crohns Colitis.2024 Oct 15;18(10):1583-1595. doi: 10.1093/ecco-jcc/jjad195. PMID:38019894.
P1263 Real-World Evidence Needs for Treatment Sequence Disease Modelling in Refractory Inflammatory Bowel Disease
Authors: Kodjamanova P , Sanon M , Dimova M , Wu E , Atanasov P 
Published: January 2025

Abstract

Background
Sequential use of biologics in Inflammatory Bowel Disease (IBD) is often required in clinical practice to restore or maintain long-term remission. Health technology agencies are requiring treatment sequencing models which are more reflective of clinical practice. The accurate modelling of treatment sequences would help better understand expected patient benefit and make more informed decisions. The aim of our targeted literature review (TLR) was to identify real-world evidence (RWE) on the effectiveness of second-line or later treatments for Crohn’s disease (CD) or ulcerative colitis (UC) refractory to initial therapy and assess its suitability for treatment sequence modelling.

Methods
We identified observational studies from Europe, the United States (US), and Canada via EMBASE, MEDLINE, and MEDLINE-In-Process (searched from 01/01/2018 to 11/12/2023). Study selection was conducted by a senior researcher and quality was checked by a second one. Evidence was analysed to assess the availability of clinical remission and response, and steroid-free remission data by line of therapy and across various time points. We then conducted a gap analysis against the evidence needs of a treatment sequence model

Results
After screening a total of 145 publications were included for data extraction in the review: 61 in ulcerative colitis (UC), 50 in Crohn’s disease (CD), and 34 in combined IBD. Studies were predominantly conducted in Europe (n=95), followed by the US (n=26), and Canada (n=3). A total of 12 studies reported clinical remission for first line, four for second line, and two each for third and fourth lines of treatments of refractory patients with UC. Additionally, eight studies reported data for first line, seven for second line, eight for third line, three for fourth line, and two for fifth line treatments of refractory patients with CD. The remaining studies combined results for multiple lines of treatment. Clinical remission during maintenance for patients with CD ranged between 47% - 79%, 38% - 87%, 28% - 68%, and 16% - 63%, for first, second, third, and fourth line, respectively and 40%-67%, 35% - 77%, 41% - 47%, and 16% - 21% for patients with UC. Studies lacked granularity in the assessment of clinical remission and response specific to individual treatments, stratified by specific treatment failure history

Conclusion
Studies identified in our evidence review did not report sufficiently granular data on clinical response or remission to reliably inform a treatment sequence model. Addressing these data gaps is essential for enabling more reliable decision-making in clinical practice, supporting better resource allocation, and ultimately improving long-term outcomes for refractory patients with IBD.
P1264 Metabolic dysfunction-associated steatotic liver disease (MASLD) in patients with Inflammatory Bowel Disease (IBD). A prospective single-center study
Authors: Pastras P , Papantoniou K , Tsounis E , Kanaloupitis S , Aggeletopoulou I , Geramoutsos G , Sotiropoulos C , Zisimopoulos K , Thomopoulos K , Theocharis G , Triantos C 
Published: January 2025

Abstract

Background
Inflammatory bowel disease (IBD) has been linked to an increased risk of metabolic dysfunction-associated steatotic liver disease (MASLD). This study assesses MASLD prevalence in IBD patients and its associations with demographic, clinical, and laboratory features.

Methods
This prospective study included 113 adult IBD outpatients [Crohn’s disease (CD): 63, ulcerative colitis (UC): 49, unclassified colitis: 1; male/female: 68/45; mean age: 47.8 years (SD: 15.06); mean age at IBD diagnosis: 35.84 years (SD: 15.57)] derived from the Gastroenterology Division, University Hospital of Patras, Greece. Of these, 95 patients underwent ultrasound, clinical evaluation, and laboratory testing to diagnose MASLD.

Results
Among the 95 patients evaluated, 22 (23.2%) were diagnosed with MASLD, 8 (9.4%) with alcoholic liver disease (ALD), and 65 (68.4%) had no steatotic liver disease (No-SLD). MASLD patients were predominantly male (n = 11), with a CD to UC ratio of 16:6, a mean age of 46.4 years (SD:10.80), and a mean IBD diagnosis age 34.82 years (SD:14.20). Patients with MASLD had significantly increased rates of central obesity (p = 0.001, OR = 5.90, CI: 2.10-16.58), overall obesity (p = 0.001, OR = 4.2, CI:1.15-15.22), higher body mass index (BMI) (p = 0.001, OR-1.25, CI:1.10-1.42), elevated SGOT (p=0.019, OR=1.06, CI=1.01-1.117), SGPT (p=0,027, OR=1.03, CI=1.003-1.059), and greater waist circumference (p=0.04, OR=1.05, CI:1.01-1.09) compared to non-MASLD patients. No significant differences were observed between groups regarding age (p = 0.787), age at IBD diagnosis (p = 0.723), sex distribution (p = 0.277), disease type (p = 0.312), smoking status (p = 0.335), γ-GT (p = 0.896) and ALP (p = 0.440). Lastly, no significant differences were found regarding IBD clinical activity markers (CDAI, p = 0.698; Trulove-Witts, p = 0.764), CRP (p=0.798), IBD-related surgery(p=0.734), or extraintestinal manifestations(p=0.059).

Conclusion
MASLD is prevalent among IBD patients and is significantly associated with central and overall obesity, increased BMI, liver enzymes, and waist circumference. These findings suggest MASLD could be an early indicator of metabolic syndrome in IBD patients, preceding other cardiometabolic disorders. Further research is needed to clarify the relationship between MASLD and IBD and guide early intervention strategies.
P1266 Gender Influence on Cutaneous Manifestations in IBD: A Focus on Contraceptive Use
Authors: Darkaoui D , benmoussa M , Koulali H , Zazour A , Ouiam E , Ismaili Z , Kharrasse G 
Published: January 2025

Abstract

Background
Inflammatory bowel disease (IBD) encompasses disorders characterized by chronic relapsing intestinal inflammation, often accompanied by extraintestinal manifestations, including skin involvement. The relationship between gender and cutaneous manifestations in IBD remains debated. This study aims to analyze the association between gender, contraceptive use, and the occurrence of cutaneous manifestations in IBD patients.

Methods
This retrospective study, conducted over eight years from January 2016 to December 2023, included IBD patients. Dermatological lesions (excluding anoperineal lesions) were diagnosed by dermatologists through clinical examinations, cultures, and biopsies as needed. Data were extracted from medical records and analyzed using SPSS version 21.0.

Results
A total of 273 IBD patients with a median age of 41 years (range 15–72, SD ±13). Females accounted for 51.6% (n = 141). Cutaneous manifestations were observed in 89 patients (32.6%), with a median age of 39 years (range 15–70, SD ±13) and a female-to-male ratio of 1.02.
Among these 89 patients, 45 (31.9%) were female, with no significant gender association (P = 0.8). Of the 141 female patients, 18 (24.7%) were using contraception and exhibited cutaneous manifestations, showing a significant association (P = 0.05). Regarding disease type, 62 patients (35.4%) had Crohn's disease, while 27 (27%) had ulcerative colitis, with no significant difference in cutaneous manifestations between the groups (P = 0.18).
Different subtypes of cutaneous manifestations included:
•Reactive lesions: 32 patients (11.7%), with 19 (13.5%) female (P = 0.6).
•IBD-associated lesions: 36 patients (13.2%), with 20 (14.2%) female (P = 0.61).
•Treatment-related mucocutaneous lesions: 48 patients (17.6%), with 26 (18.4%) female.
•Nutritional malabsorption-related lesions: 28 patients (10.3%), with no significant gender association (P = 0.32).
Notably, erythema nodosum was found exclusively in females (n = 5, 1.8%), showing a significant gender association (P = 0.02). Psoriasis occurred in 12 patients (4.4%), with 4 (3%) female, which was not significant (P = 0.19). Aphthous stomatitis affected 23 patients (8.4%), with 14 (9.9%) female (P = 0.35). Pyoderma gangrenosum and vitiligo were rare, with no notable gender disparities.

Conclusion
This study highlights the complex relationship between gender and skin manifestations in IBD, showing a significant association between erythema nodosum and females, as well as a link between contraceptive use and skin issues. These findings suggest the need for further research into the hormonal and immunological factors involved. Adopting gender-specific strategies in managing IBD-related skin manifestations could improve patient outcomes and inform clinical practice.
P1270 Drugs associated with Microscopic Colitis: a comprehensive pharmacovigilance analysis
Authors: Cohen Y , Ben-Horin S , Goldman A 
Published: January 2025

Abstract

Background
Microscopic colitis (MC), a chronic inflammatory disease of the colon, has a strong association with drug exposure. The evolving landscape of drug prescriptions highlights the need for ongoing monitoring of medications that may contribute to MC development. This study aimed to comprehensively analyze contemporary global pharmacovigilance data to identify drugs associated with increased reporting of MC in real-world settings.

Methods
We conducted a disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) from September 2014 to June 2024. The reporting odds ratio (ROR) was used to identify drugs associated with increased reporting of MC, adjusted for age, sex, and concomitant medications already linked to MC through a multivariable logistic regression model.

Results
Of 12,510,699 individual case safety reports in the entire database, 2,661 cases of MC were identified, with 103 drugs reported in at least five cases. The mean age in MC reports was 64.4 (±15.3), with a female predominance (73%). While several known drug-MC associations were corroborated (PPI: ROR= 13.20 [95% CI: 11.70-14.95], SSRI: ROR= 15.40 [13.36-17.63]), angiotensin 2 receptor blockers (ARBs), Angiotensin-Converting Enzyme inhibitors (ACEis) and statins also emerged as major contributors to MC reporting (ROR = 9.23 [7.8–10.84], ROR = 2.02 [1.28-3], ROR= 2.72 [2.11–3.44], respectively). Additionally, a strong association was identified with tocilizumab (ROR = 6.10 [4.63–7.87]), anti-interleukin 17 antibodies (ROR = 2.85 [2.01 - 3.91]), and immune checkpoint inhibitors (ROR = 2.09 [1.61–2.67]). Concomitant treatment of one or more drugs that increase MC risk was reported in 50% of the cases and was significantly associated with MC reporting in the multivariable model, suggesting cumulative drug exposure as a potential MC risk factor.

Conclusion
In this global contemporary pharmacovigilance study, MC was associated with increased reporting of ARBs, statins, tocilizumab, anti-interleukin 17 antibodies, and immune checkpoint inhibitors. The link between ARBs and MC, along with their known association with autoimmune-like enteropathy, suggests shared underlying etiological pathways. Prescribing physicians should be aware of this potential toxicity when gastrointestinal symptoms develop, particularly in patients with relevant concomitant medications.
Table 1 highlights significant differences between individuals with and without MC in age, gender, time to onset, concomitant medications, and hospitalization rates.

Figure 1 presents reporting odds ratios (ROR) with 95% confidence intervals, highlighting drug associations with microscopic colitis (MC) across age- and sex-adjusted and fully adjusted models.
P1271 The Astur-Frailty-IBD Study: Prevalence and factors associated with Frailty in elderly patients with Inflammatory Bowel Disease.
Authors: Carballo-Folgoso L , Duque Alcorta J M , Varela P , De Francisco García R , Armesto González E , Mancebo Mata A , Pérez-Martínez I , Rodríguez López P , De Jorge Turrión M Á , Castaño-García A , García-Pérez C , Martínez Martín G , Fernández-González E , Chiminazzo V , Díaz-Simal A , Suarez A , Riestra S 
Published: January 2025

Abstract

Background
Frailty is a dynamic concept that provide a more comprehensive assessment of biological reserve and functional status rather than chronological age alone. The aim of this study is to evaluate the prevalence of frailty and to analyse the factors associated with this condition in elderly inflammatory bowel disease (IBD) patients.

Methods
As part of the Astur-Frailty-IBD study (a multicentre prospective study of elderly IBD patients attended at three hospitals in Asturias, Spain), we present the baseline data of the cohort. We recruited all consecutive IBD patients ≥ 60 years during outpatient visits between March 1 and June 30, 2024. Demographic data and clinical characteristics of IBD were collected from the medical records and disease activity was assessed using clinical scores and biomarkers. All the patients were surveyed by face-to-face questionaries. Frailty was assessed using the Fried Frailty Phenotype which defines non-frail (0 criteria), prefrail (1-2), and frail phenotype (≥ 3 criteria). Comorbidity was assessed using Charlson Comorbidity Index (CCI) and Cumulative Illness Rating Scale-Geriatric (CIRS-G). Univariable and multivariable ordinal logistic regression model was performed.

Results
A total of 612 IBD patients (median age 68.8 years, 50.2% females, 56.4% Crohn’s disease, median duration of the disease 15 years) were included in our study. One hundred and three (16.8%) patients were considered frail, 302 (49.3%) prefrail and 207 (33.8%) non-frail. Association of demographic, social and clinical factors according to different frailty levels are shown in Table 1. Univariate analysis showed the factors that are independently associated with increased risk of frailty were higher age, female gender, higher BMI, osteoarticular disease, polypharmacy, clinical activity, faecal calprotectin ≥ 250 μg/g, currently use of steroids, immunomodulator, or biologics, CCI ≥4, and CIRS-G ≥ 3. In contrast, ulcerative colitis, IBD-Unclassified and having good family support were associated with a lower risk of frailty (p=0.02). On multivariate analysis, higher age, female gender, family support, osteoarticular disease, both axial and peripheral, polypharmacy, clinical activity, currently use of steroids, and CIRS-G ≥ 3 were independent predictors of increased risk of frailty. The strongest predictor of risk of frailty was the clinical activity. These results are presented in table 2.

Conclusion
In our cohort, higher age, female gender, poor family support, osteoarticular disease, polypharmacy, clinical activity, current use of steroids, and CIRS-G ≥ 3 are independent predictors of increased risk of frailty.
P1272 Spatio-temporal distribution of IBD incidence at a territorial level in northern France using the EPIMAD registry (2000-2017): analysis of environmental determinants suggests influence of agricultural practices.
Authors: Paumelle M , Occelli F , Sarter H , Fumery M , Savoye G , Ley D , Lanier C , Wakim L M , Deram A , Genin M 
Published: January 2025

Abstract

Background
Crohn’s disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBDs) with complex and multifactorial etiologies. Genetic factors have been identified but cannot fully account for disease incidence. Spatial heterogeneity in IBD incidence has been reported across various countries and scales, suggesting a significant influence of environmental factors. Leveraging the population-based EPIMAD registry in northern France (6 million inhabitants), this study aimed to analyze the spatial distribution of CD and UC incidence and identify potential environmental risk factors at a territorial level.

Methods
This ecological study was conducted at the municipal level across 3,041 municipalities within the EPIMAD registry's area for the period 2000-2017. Incident cases included 9,019 CD and 5,789 UC patients. Spatio-temporal age- and sex-standardized incidence ratios were modeled using Bayesian hierarchical models. An inventory of open-access environmental data sources identified 128 datasets, 19 of which were selected to generate 112 indicators at the municipal level. These indicators included contamination levels (air, water, soil), proximity to emission sources (e.g., industrial sites), land use, agricultural practices, natural features, and climate. Ecological regressions were used to explore associations between environmental indicators and incidence.

Results
Significant spatial disparities in CD and UC incidence were observed, remaining stable over time (Figure 1). For both CD and UC, associations were found with certain types of crops (e.g., sugar beets, barley, wheat, flax, and potatoes) and several metals in soil (e.g., molybdenum, nickel). Associations were more pronounced for CD, including strong links with pesticide use indicators (growth regulators, herbicides, fungicides) and soil contamination by other metals such as arsenic, cadmium, and thallium. For UC, a unique association was observed with soil contamination by polycyclic aromatic hydrocarbons (PAHs), while no significant association with pesticide use was found.

Conclusion
These findings highlight a relationship between IBD incidence and agricultural practices, providing new insights to the existing literature. Multivariate approaches should be employed to better describe environmental exposure profiles. Additionally, individual-level epidemiological studies are needed to confirm and expand upon these results.
P1273 High Crohn's Disease incidence associated with multiple heavy metal contamination in agricultural soils: findings from the CROPS project in Northern France
Authors: Wakim L M , Occelli F , Sarter H , Fumery M , Savoye G , Lanier C , Ley D , Paumelle M , Genin M , Deram A 
Published: January 2025

Abstract

Background
Crohn's Disease (CD) is a chronic intestinal disease with an unclear etiology and suspected environmental risk factors. The CROPS (CROhn’s disease and Pollution of Soils) project was initiated in Northern France to investigate links between the high incidence of CD and environmental pollutants. In this context, we combined data of a population-based registry of Inflammatory Bowel Disease (IBD) with environmental sampling data to identify the environmental profile of multi-contamination associated with high incidence.

Methods
This ecological study was conducted at the municipal level within the coverage area of the registry in Northern France. All patients diagnosed between 2000 and 2017 were included (n=9,019). Spatial clusters of significantly high (n=4) and low (n=4) CD incidence, adjusted for age and sex, were identified based on patients' residence addresses at diagnosis. Within these clusters, environmental sampling was performed across 240 sites using a hexagonal grid to ensure 30 samples per cluster. A total of 490 parameters were analyzed: 306 in soil (including emerging pollutants such as hormones and antibiotics, polycyclic aromatic hydrocarbons [PAHs], heavy metals, and pesticides), 152 in tap water (examining heavy metals and PAHs), and 30 in lichens (assessing heavy metals as indicators of air quality). Multi-contamination indices, such as the Mean Impregnation Ratio (MIR) and Pollution Index, were applied. Data analysis included Principal Component Analysis (PCA), Hierarchical Cluster Analysis (HCA), and Analysis of Variance (ANOVA) tests.

Results
High-incidence clusters, predominantly agricultural, had elevated heavy metal concentrations in soil (notably chromium, arsenic, zinc, and nickel), sulfadiazine in soils, high nitrate levels in water, and heavy metals in lichens. Low-incidence clusters, with greater urbanization, showed elevated PAHs in soil, heavy metals in water, and BPA in soils. Pollution profiles aligned with different land covers, with significant findings for agricultural lands (p&lt;0.0001). A positive correlation between the relative risk and soil’s MIR for heavy metals in agricultural zones was noted (r=0.557, p=0.005).

Conclusion
These findings suggest a possible link between high CD incidence and heavy metal exposure in agricultural lands. Profiles of pollution were created for each cluster. Future studies should expand on pesticide and agricultural pollutant analysis to strengthen this hypothesis, and consider individual-level epidemiological approaches to further elucidate these potential environmental risk factors.