bluuebunny/crossref_metadata_2025_split huggingface dataset:
P1038 Establishing a Tertiary-Level Inflammatory Bowel Disease Service in the UAE: A Response to Rising Incidence and Service Gaps
Authors: Omar N M , Alahmed M A , Ahmed E F , Kumar K K C , Quraishi M N 
Published: January 2025

Abstract

Background
Inflammatory bowel disease (IBD) is a growing public health concern in the Middle East, with the UAE experiencing a rapid rise in its incidence. Due to the predominance of private healthcare facilities, dedicated IBD services are exceedingly rare, and care is often fragmented. We outline the key initiatives undertaken to establish one of the few structured and comprehensive IBD services in the region.

Methods
Post-2023, our hospital initiated targeted changes to establish a tertiary care IBD service in the UAE. Through an analysis of service modifications and organizational strategies, we detail efforts to improve care delivery towards providing excellence in IBD care.

Results
The introduction of a structured care model has significantly improved IBD outcomes through a dedicated team of IBD-trained physicians, IBD clinical nurse specialist (CNS), and an administrator. Multidisciplinary meetings have standardized care, enabling early diagnosis, initiation and optimisation of advanced therapies (AT). The service has notably reduced corticosteroid use, indicating effective disease control. A growing comprehensive IBD registry now prospectively tracks over 320 patients on AT, providing valuable data for clinical and research needs. High-risk patient lists and virtual flare clinics have decreased hospital admissions by nearly 90%, facilitating proactive management. The service has early adoption of novel ATs and is supported by an active clinical trials program. Early initiation of AT, particularly for moderate to severe Crohn’s disease, has reduced the median time to treatment from diagnosis to 1.54 months (IQR 2.23) in 2024. Holistic IBD clinics, with access to a specialist dietitian and psychologist, have improved patient satisfaction and outcomes. CNS-led initiatives, including educational sessions on medication use, disease management, preconception and pregnancy care have significantly boosted patient engagement and health outcomes. Patient support and advocacy groups have been established, providing a platform for education and shared experiences. Additionally, Arabic versions of disease and AT patient information leaflets have been developed to enhance accessibility and understanding. Advanced IBD endoscopy, including chromoendoscopy, is now offered as standard care.

Conclusion
The establishment of a structured, multidisciplinary IBD service has transformed care delivery, addressing critical gaps in the regional healthcare landscape. Key initiatives have led to improved clinical outcomes, reduced hospital admissions, and enhanced patient satisfaction. This model serves as a benchmark for comprehensive IBD care in the region, demonstrating the impact of specialized, patient-centred services.
P1039 An Evaluation of Anti-IL23 Therapy in Primary Sclerosing Cholangitis Associated Inflammatory Bowel Disease
Authors: Al-Shakhshir S , Morris S , Kaur S , Culver E , Elzubeir A , Rushbrook S , Nayagam J S , Joshi D , Hernandez-Evole H , Schregel I , Schramm C , Rodriguez S , Leibovitzh H , Shibolet O , Cristoferi L , Vigano C , Carbone M , Invernizzi P , Trivedi P 
Published: January 2025

Abstract

Background
The majority of patients with primary sclerosing cholangitis (PSC) have inflammatory bowel disease (IBD). This association has fostered several pathogenic hypotheses linking mucosal immunity to hepatobiliary inflammation. A putative therapeutic target along this axis centres on gut-derived IL-17 secretor cell subtypes, which are activated by interleukin (IL)23. Notably, emergent forms of IBD treatment host several anti-IL23 agents, however safety and efficacy data in PSC patients is limited.

Methods
We conducted a multi-centre study, evaluating treatment experiences with Ustekinumab (a dual anti-IL12/23 agent), Risankizumab, and Mirikizumab (anti-IL23 alone). Data was analysed to determine treatment impact on liver biochemistry; IBD response defined by serial Mayo colitis scores or faecal calprotectin (FCP) values; and treatment-emergent adverse events.

Results
Data was accrued across eight centres from 66 pts (Ustekinumab, 62; Risankizumab, 4 [n=1 escalated from Ustekinumab] and Mirikizumab, 1) with median treatment time of 9 months (IQR 5-24). The majority of patients were men (63%; n=42) with a median age at PSC diagnosis of 24y (IQR 17-36). The predominant PSC phenotype was large duct (73%; n=49), with two patients having cirrhosis, 13% (n=7) being transplant recipients, and 66% (n=44) having an IBD phenotype consistent with ulcerative colitis. At baseline, the median FCP and Mayo colitis scores were 810ug/L (IQR 369-1727; n=33/66) and 5 (IQR3-8; n=31/66), respectively. 60 patients were commenced on these agents as 2nd-4th line, after failure of prior biologic therapy. In all, IBD response was observed in 15% (n=8/52) at 6 months, 20% (n=7/35) at 12 months and 21% (n=4/19) at 24 months. Remission was achieved in 3 pts (4.5%) at 18 months. Among non-transplant patients, the median change in ALP from baseline to 6 months was not significant (ALP x upper limit of normal [ULN] 1.4 vs. 1.2; p=0.67), nor from baseline to 12 (ULN 1.1 vs. 1.1; p=0.161) or 24 months (ULN 1.6 vs. 1.0; p=0.074) (Figure 1). No significant differences in serum ALT or bilirubin were observed from baseline to 6, 12 or 24 months. Treatment was discontinued in 37% (n=25/67) due to lack of efficacy and in one patient due to an adverse event.

Conclusion
Anti-IL23 agents are safe and well-tolerated in PSC-IBD. However, IBD response and remission rates appear to dwarf those seen in IBD alone, with no significant effects on liver biochemistry.
P1041 Efficacy and Safety of Adalimumab Biosimilar Dose Escalation Treatment in biologic naïve Patients With fistulas Crohn’s Disease: A Prospective, Single-Arm Clinical Practice
Authors: Cheng Y , Wang H , Yu Q , Zhu L 
Published: January 2025

Abstract

Background
The introduction of tumor necrosis factor (TNF) inhibitors, including adalimumab, has dramatically changed the treatment landscape for moderate-to-severe Crohn’s disease (CD). The availability of biosimilars has minimized the economic burden on patients and reduced global health inequalities while ensuring efficacy. However, the efficacy of adalimumab biosimilars for fistula CD is unclear.

Methods
Sixty patients with fistulas CD from July 2021 to July 2023 were included, and all of them were treated with adalimumab biosimilar treatment for 12 weeks (subcutaneous injection of 160 mg in the 0th week, 80 mg in the 2nd week, and 40 mg from the 4th to the 12th week), and the decision of whether to receive adalimumab conventional therapy (40 mg q2w) or incremental therapy (80 mg q2w) was made based on the patients’ traumatic response at the end of the 12-week period. The decision to follow up with regular (40 mg q2w) or incremental (80 mg q2w) treatment of adalimumab was made based on wound response after 12 weeks, and the dosage was again adjusted according to efficacy after 24 weeks, and the patients were followed up to 52 weeks. The primary outcome of this study was the fistula healing rate at 52 week. Secondary outcomes were fistula response rate, endoscopic response rate and endoscopic remission rate.

Results
A total of 60 patients with active fistula-type Crohn’s disease were enrolled in the study. Most of the enrolled patients were in the middle-aged and young age group, with a mean age of (26.8±9.5) years, 75.5% males, CDAI score (180.9±97.62), SES-CD score (15.69±7.79), and PDAI score (4.58±2.12). In the conventional treatment group, the fistula response rate was 57.89%, 65.22% and 73.91% at 12, 24 and 52 weeks, respectively; the fistula healing rate was 55.26%, 69.57% and 65.22%, respectively; the endoscopic response rate was 60.53%, 82.61% and 100%, respectively; and the endoscopic relief rate was 36.84%, 73.91% and 86.96%, respectively. In the incremental treatment group, the fistula response rate was 12.5%, 66.67% and 66.67% at 12, 24 and 52 weeks, respectively; the fistula healing rate was 12.5%, 66.67% and 0, respectively; the endoscopic response rate was 50%, 66.67% and 66.67%, respectively; and the endoscopic remission rate was 0, 0 and 16.67%, respectively. All patients had no adverse drug reactions or serious infections during treatment.

Conclusion
In the real world, adalimumab biosimilar dose escalation treatment may somewhat improve fistula response rates and endoscopic response rates in fistulous CD patients initially treated with biologics, but has a limited effect on fistula healing rates and endoscopic remission rates.
P1042 Effectiveness and safety of vedolizumab in real-world studies in Chinese patients with inflammatory bowel disease: a systematic review and meta-analysis
Authors: Gu Y , Zhang X , Gu L , Zou D 
Published: January 2025

Abstract

Background
Inflammatory bowel diseases (IBD), consisting of Crohn’s disease (CD) and ulcerative colitis (UC), are chronic gastrointestinal conditions with increasing prevalence in China. Vedolizumab (VDZ), a humanized monoclonal antibody that targets α4β7 integrin, has been approved for use in China since 2020. This systematic review and meta-analysis aimed to evaluate the real-world effectiveness and safety of VDZ in Chinese patients with IBD.

Methods
A systematic literature search was conducted on 20th Dec 2023 to identify real-world studies evaluating intravenous VDZ in Chinese patients with IBD. Meta-analyses were performed separately for CD and UC patients using a random-effects model in R software to pool clinical remission and response rates, and endoscopic remission rates across induction (6-14 weeks), medium term (22-30 weeks), and long term (over 48 or 52 weeks). Subgroup analysis was conducted based on the history of biologics. Incidence of adverse events (AE), serious AE (SAE), and serious infection was assessed for safety.

Results
A total of 20 studies (12 CD, and 15 UC), involving 1472 patients (610 CD, and 862 UC), were included in the analysis (Figure 1). During the induction phase, a clinical response and clinical remission were achieved by 71.31% and 75.58% of CD patients, and 67.89% and 46.46% of UC patients, respectively. In the medium term, 64.32% of CD patients and 65.72% of UC patients achieved a clinical response, while 60.72% of CD patients and 60.95% of UC patients achieved clinical remission. In the long term, clinical response rates were 57.14% in CD patients and 73.50% in UC patients, while clinical remission rates were 51.28% and 60.84% for CD and UC patients, respectively.
For the endoscopic remission, there were 11.11%, 18.41%, and 36.42% of that in CD patients, and 44.58%, 53.32%, and 62.40% of that in UC patients were achieved in the induction, medium term, and long term. Subgroup analyses indicated that both bio-naïve and bio-exposed patients, in both UC and CD groups, showed relatively favourable outcomes across the available time points (Table 1).
Adverse events (AEs) were reported in 6.67% to 61.54% of CD patients, and 29.69% to 75.38% of UC patients. Serious adverse events (SAEs) and serious infection rates ranged from 0.00% to 1.56%, and 0.00% to 2.70%, respectively, in UC patients, while neither SAE nor serious infections were reported in the CD studies.

Conclusion
VDZ demonstrated favourable effectiveness in Chinese patients with IBD across induction, medium- and long-term treatment periods, with a good safety profile.
P1045 Treat-smart study: Leveraging individual inflammatory markers for personalized therapy in patients with IBD
Authors: Medhat M , Ramadan Y N , Hashem M , Doaa A , Nariman Z , Hetta H F ,   “Assiut Tropical IBD Study Group” (ATISG)
Published: January 2025

Abstract

Background
Diverse patient responses to treatment challenge the management of inflammatory bowel disease (IBD). This study aims to evaluate if there are differences in the inflammatory mediators among IBD patients and the treatment outcome concerning these variations.

Methods
This study was conducted in the IBD clinic at AL-Rajhi Hospital, Assiut University. The concentrations of TNF-α and IL-12/23 (p40) were measured in IBD patients and healthy controls using enzyme-linked immunosorbent assay (ELISA) technique. In IBD patients, marker levels were assessed before and after induction of biological therapy to evaluate changes in their levels. Biological therapies were prescribed according to the treatment protocols of the funding entities (such as health insurance). The investigators did not know the levels of inflammatory markers at the time of treatment prescription.

Results
From May 23, 2023, to July 16, 2024,18 IBD patients were enrolled in this study. Half of the study population were males with a median age of 27 years. The cohort included 16 patients with Ulcerative Colitis and 2 with Crohn’s disease, as shown in table 1. Before enrollment, 9 patients had failed to achieve remission on conventional therapy, and 9 had also failed on both conventional and first-line biological therapies. The analysis of the inflammatory markers at baseline showed significant variation among patients. Third of the patients (6 out of 18) showed only elevation in the TNF- α, one patient had only elevated IL 12/23, and the rest had combined elevation of both markers. Among patients with TNF-α as the predominant pathway, remission was achieved in all patients given anti-TNF-α therapy (5 out of 6 patients). In contrast, one patient with IL12/23–dominant group failed to achieve remission after receiving Ustekinumab. In the same context, another patient with elevated IL-12/23 alone failed to respond after receiving anti-TNF-α treatment. Patients with elevated levels of both TNF-α and IL 12/23 (11 patients) exhibited mixed responses. Among those treated with anti-TNF-α, only 1 achieved remission, while 7 experienced treatment failure. Using Ustekinumab in this subgroup led to remission in only 1 out of 3 cases, as shown in figure 1.

Conclusion
These results showed that treatment response is significantly influenced by the predominant inflammatory pathway expressed in patients with IBD. Specifically, patients with TNF-α dominant pathway showed a high remission rate with anti-TNF-α therapy. Conversely, non-specific treatments were less effective, emphasizing the importance of targeted therapy. Patients with dual-marker elevation may have better responses by combo therapy or JAK inhibitors. These results may pave the way for tailored treatment for IBD patients.
P1051 Establishment and Validation of Prediction Models for Short-term and Long-term Effectiveness of Ustekinumab in Patients with Crohn’s Disease
Authors: Su T , Wu H , Zhi M , Yao J 
Published: January 2025

Abstract

Background
Ustekinumab (UST), a novel biological agent for Crohn’s disease (CD), has shown efficacy in CD patients. Our objective was to establish clinical prediction models to accurately forecast the short- and long-term effectiveness of UST in individuals diagnosed with CD.

Methods
We established a derivation cohort comprising patients diagnosed with CD and treated with UST at the Sixth Affiliated Hospital of Sun Yat-sen University from May 2020 to July 2023. The patients were assigned in a 7:3 ratio at random to the training cohort and the validation cohort. Predictors were compressed through the Least Absolute Shrinkage and Selection Operator (LASSO) regression analysis. Logistic regression analysis was used to create the final prediction models.

Results
A total of 464 patients with CD were included in the statistical analysis, 171 of whom had complete endoscopic data. Four models were constructed: two to predict the probability of clinical or endoscopic remission at week 16 or 20 based on baseline data, and two to predict the probability of clinical or endoscopic remission at week 52 based on data obtained at week 16 or 20. The C-index was 0.714, 0.866, 0.814 and 0.841, respectively. Because of poor calibration, we constructed another model to predict the probability of endoscopic remission at week 52 based on baseline data (C-index:0.748). In the internal validation, the above models showed good performance.

Conclusion
We have constructed several models to predict the short- and long-term effectiveness of UST in patients with CD, promising to be a simple and practical clinical tool.
P1053 Clostridioides difficile Infection in Admitted patients with Ulcerative Colitis: Analysis of 23 Years through Propensity Score Matching
Authors: Alañón P , Carrillo B , Benítez J M , Soto P , Marín Pedrosa S , Iglesias-Flores E , Gros B 
Published: January 2025

Abstract

Background
Clostridioides difficile infection (CDI) represents the leading cause of nosocomial diarrhea in the Western world. Patients with ulcerative colitis (UC) have a higher risk of developing this infection, which has been associated with an increased risk of flare-ups, need for surgery, and mortality. The aim of the present study was to evaluate the impact of this infection in patients hospitalized for a UC flare-up.

Methods
Retrospective case-control study including all patients hospitalized for a UC flare-up at Reina Sofía Hospital in Córdoba between January 2000 and January 2023. To avoid potential selection biases, Propensity Matching Score (PMS) adjusted for age, gender, duration, and extent of the disease, with a 1:2 ratio was used. Primary objective was to assess the need for treatment intensification (initiation or dose escalation of biologics/small molecules or immunosuppressant). Secondary endpoints included readmission rate, colectomy, mortality, and CDI risk factors identification.

Results
During the study period, 419 patients were hospitalized for a UC flare-up, of whom 251 (59.9%) were men, with a median age of 41 (IQR 28-55) years and disease duration of 0.89 (0-5.8) years. Baseline characteristics of patients at admission are shown in Table 1. Of all admissions, 46 (11%) had CDI. After PMS, CDI was associated with increased therapeutic intensification between 3-12 months after discharge (27.5% vs. 11.7%, p = 0.004) and a higher risk of readmission at 12 months (37.5% vs. 13.7%, p = 0.009) but not to risk of colectomy or mortality (Table 2). Infection recurrence was detected in 8 (16.7%) patients.
Classical risk factors for CDI were not found to increase the risk of CDI among UC patients, however antiTNF therapy was associated to CDI in both models: full cohort (OR 3.52, 95%CI 1.46-8.49) and PMS (OR 4.63, 95%CI 1.32-16.31).

Conclusion
CDI in UC was associated with a greater need for therapeutic intensification and a higher readmission rate at one year. There was no evidence of an increased risk of colectomy or mortality in these patients. Classical risk factors for CDI were not identified but patients on antiTNF were at higher risk of CDI.
P1054 Filgotinib effectiveness and safety as second or third-line therapy in patients with ulcerative colitis: data from a real-world study
Authors: Mocci MD FRCP G , Costa F , Ceccarelli L , Savarino E , Mucherino C , Marzo M , Scaldaferri F , Napolitano D , Pugliese D , Gravina A G , Pellegrino R , Spagnuolo R , Cuomo A , Maconi G , Bertani L , Bodini G , Orrù G , Piergallini S , Scarcelli A , Capone P , Cortellini F , Rodinò S , Vespere G , Gaiani F , Pagnini C , Graziani G , Allegretta L , Ferronato A , Ribaldone D G , Aragona G , Forti G , Di Fonzo M , Iacopini F , Pica R , Onidi M F , Usai Satta P , Elisei W , Picchio M , Papa A , Tursi A ,   De Barba Caterina D’Antonio Elvira Montesano Laura Luzza Francesco Donnarumma Laura Cataletti Giovanni Pasta Andrea Serio Mariaelena Sebkova Ladislava Sedda Silvia D’Onofrio Vittorio De Luca Leonardo Kayali Stefano Di Paolo Maria Carla Cazato Alessia Immacolata Scorza Stefano Perazzo Patrizia Cassieri Claudio
Published: January 2025

Abstract

Background
Filgotinib (FILGO), a selective anti-JAK1, has obtained refundability from the Italian National Health System in February 2023 for its use in patients with Ulcerative Colitis (UC) refractory to other therapies, including anti-TNF-α, anti-integrins and ustekinumab. At present, no Italian data are available yet about its effectiveness and safety in Real World.

Methods
A retrospective assessment of clinical and endoscopic activity was performed according to the Mayo score. The primary endpoints were to evaluate the effectiveness and safety of FILGO.

Results
We enrolled 102 patients with a median follow-up of 24 weeks (M/F 54/48, median age 47). The clinical remission and clinical response rates at 8 weeks were 12% (13/102) and 29% (30/102), respectively, and 51% (20/39, p&lt;0.01) and 82% (32/39, p&lt;0.01) at 24-week follow-ups, respectively. Adverse events occurred in 6 (5.8%) patients and severe in 2 (1.9%).

Conclusion
Our realworld data confirm that FILGO is effective and safe in UC patients. It performs remarkably better when used as the first/second line of treatment.
P1068 Preventable hospitalisations for patients with IBD are relatively uncommon in a modern multidisciplinary IBD service, and due to non-adherence or non-engagement in a significant proportion
Authors: Massouridis B , Lucas S , Lewis D , Garg M 
Published: January 2025

Abstract

Background
Despite tighter treatment targets and an expanding array of therapeutics, hospitalisations for patients with inflammatory bowel disease (IBD) continue to occur, resulting in significant healthcare expense. This study aimed to identify factors associated with hospitalisation.

Methods
Patients seen at specialist IBD clinics at a tertiary health service and those hospitalised over a 13-month period from September 2022 to September 2023 were identified, and medical records interrogated for demographic and disease characteristics. Data including indication for admission, length of stay and cost was recorded.

Results
1082 patients with IBD (median age 48 [IQR 34-63] years, 495 [48.2%] female) were seen in specialist IBD outpatients clinics during the study time frame. Of these, 468 (43.3%) had Crohn’s disease (CD), 464 (42.9%) ulcerative colitis (UC), 13 (1.2%) IBD-unclassified, and 143 (13.2%) had other/uncertain diagnoses.
During the same period, 115 patients (48 [41.7%] female, median age 35 [IQR 27-51] years), with either new or pre-existing diagnosis of IBD, were admitted to hospital for a total of 138 admissions. 18 patients had multiple admissions (twice, n=14; thrice, n=3; four times, n=1). 64 (55.7%) had CD, and 48 (41.7%) UC. The main reasons for presentation for UC-related admissions included active disease (55.2%, n=32) and acute severe ulcerative colitis (36.2%, n=21). For Crohn’s-related admissions, main reasons for presentation were active disease without obstructive symptoms (53.9%, n=42) and small bowel obstruction (19.2%, n=15).
31 (27%) were unknown to the health service prior to their admission, and a further 23 (20%) patients (12 with CD and 11 UC) were newly diagnosed with IBD as the index hospitalisation. Of the remaining 61 patients who were known to the IBD service (5.6% of total), non-adherence and/or non-engagement was a contributing factor in 20 (32.8%) patients. Progressive, treatment refractory disease or loss of response to medications was noted in 43 (70.5%), with Clostridium difficile infection in 5 (8.2%) patients.
Across all admissions, median length of stay was 3 (IQR 2-6) days. 5 patients were readmitted within 30 days (UC, n=3; Crohn’s, n=2) and 13 patients were readmitted within 90 days (UC, n=6; Crohn’s, n=7). Cost of hospitalisation as per DRG codes was available from September 2022 to June 2023, with median cost being $13,308 AUD (IQR $9,464-$21,058 AUD).

Conclusion
The proportion of patients requiring hospitalisation in a 12-month period seen at a modern IBD service is small, and accounted for by non-adherence and/or non-engagement in a third. Measures to reduce non-adherence and non-engagement may result in further reduction in hospitalisation.