bluuebunny/crossref_metadata_2025_split huggingface dataset:
P0938 Corticosteroid and opiate use in Inflammatory Bowel Disease, 25 years after the Crohn’s Therapy, Resource, Evaluation, and Assessment Tool (TREAT) registry was established
Authors: Pinnuck B , Su W K , Wilson W , Pipicella J , Wark G , Archdiacono M , Walker G , Forbes A , Su H , Schultz M , Lawrance I , Dutt S , Brett L , Lynch K , Connor S J , Andrews J M 
Published: January 2025

Abstract

Background
Despite data from the TREAT registry, corticosteroids and opiates are still commonly used in inflammatory bowel disease (IBD). During an IBD flare, corticosteroids are a common first line option and opiates are often prescribed for associated abdominal pain. Longer term use of both agents increases the risk of complications, adverse IBD outcomes and can impair quality of life. We sought to understand the size of the “problem” by examining the current real-world prescribing practices for people with IBD across Australia and New Zealand.

Methods
Crohn’s Colitis Care (CCCare) is a cloud-based electronic medical record used in Australasia. Data feed into a deidentified clinical quality registry (CQR), which was interrogated in September 2024. People with IBD under active care (encounter within 14 months) were included.

Results
Of 7506 eligible people, 73.1% resided in Australia (n=5487) and 26.9% (n=2019) in New Zealand. There was an even gender distribution with 49.0% (n=3679) male, 48.0% (n=3606) female, and 2.9% (n=221) with gender not documented. The median age was 42 years (IQR 31 – 56) and median disease duration was 10.7 years (IQR 5.1 – 19.2). In the preceding year, 8.6% (n=645) of the cohort were prescribed a course of oral steroids, of whom 61.1% (n=394) were also prescribed an advanced therapy (biologic or novel small molecule). The most common reasons for discontinuing steroids were “course completed” (26.4%, n=112), “inadequate efficacy” (20.75%, n=88), and “rationalisation and/or deep remission” (12.0%, n=51). There was no difference in the rate of steroid use between IBD subtypes (7.9% in Crohn’s disease (CD) vs 9.4% in Ulcerative Colitis (UC) vs 10.4% in IBD-Unclassified (IBDU), p = 0.06). Opiates were prescribed in 7.6% (n=567) of the cohort. However, opiates were only for an IBD indication in 184 people (2.5% of the cohort), with others receiving opiates for non-IBD indications. People with CD were more likely to have been prescribed an opiate than those with IBDU and UC (p &lt; 0.001).

Conclusion
These are the first data on corticosteroid and opiate use in IBD across Australia and New Zealand. Steroid use in ambulatory care is low and most use appears to be as a bridge to maintaining disease control with other therapy. Globally, reported rates of corticosteroid use have ranged from 13-57%, however much of the data has been explored over longer time periods in comparison to our study. Opiate use within our Australian and New Zealand cohort is comparable to international IBD cohorts. While steroids are predominately used for IBD, opiate use appears to be related to other co-morbidities. These comorbidities are of interest to examine to identify further opportunities to optimise care.
P0943 Estimated benefits and willingness of remote monitoring in IBD patients under maintenance therapy – ATTENDANT study
Authors: Brams S , Beeckmans D , Delen S , Fierens L , Vanhaverbeke M , Sabino J , Verstockt B , Vermeire S , Ferrante M 
Published: January 2025

Abstract

Background
Following STRIDE II guidelines, patients with inflammatory bowel diseases (IBD) are tightly monitored evaluating effectiveness of IBD-therapies and predicting flares. In many centres, patients on stable conventional therapy typically have annual outpatient visits with their IBD physician, while patients on advanced therapies are seen every six months. However, the growing number of IBD patients in active follow-up is straining outpatient clinic capacity and increasing time pressures on healthcare professionals. Furthermore, many patients do not require specialised interventions during these visits, and those in long-term remission often prefer less frequent follow-up to reduce absenteeism from work or school.
We aimed to evaluate the potential optimization of resources of remote monitoring for IBD patients in a large-volume referral centre.

Methods
An anonymous survey was conducted in 300 adult IBD patients, either untreated or on stable subcutaneous or oral maintenance therapy for at least two years, to assess their interest in a remote monitoring program and gather insights into their preferences for its implementation.

Results
Of the 300 patients, 48% were male, 68% had Crohn’s disease, 31% ulcerative colitis and 1% IBD type unclassified. Forty-one percent had a disease duration of more than 20 years. Additionally, 17% were without any IBD-related therapy, 9% were on conventional therapy only, and 74% were receiving subcutaneous or oral advanced therapy. Most patients (68%) were actively employed, 70% of whom worked full-time. Notably, 77% (n=230) expressed interest in significantly reducing their outpatient visits in favour of remote monitoring. The study also identified cost and time savings for patients, as an outpatient visit takes approximately 3 hours (range 2-4 hours). Also, 24% incur public transport cost of 25 to 56 euros to attend the clinic (N = 41).
Among the patients interested in remote monitoring, 94% were willing to complete three-monthly questionnaires taking about 10 minutes, and 94% agreed to annual blood analyses. Regarding faecal calprotectin, 66% were open to conducting home-based stool analyses every three months, while 72% would agree to bring a stool sample to their general practitioner or local hospital. Also, 79% were willing to attend biennial outpatient visits (Fig1). Patients also emphasized the importance of personal contact in establishing a trustworthy and safe remote monitoring system.

Conclusion
Remote monitoring is a promising program for IBD patients in stable remission, offering potential financial and time savings for employers, patients, and society. However, further research is required to evaluate the safety and feasibility of this approach.
P0944 Fluorescently labelled adalimumab to visualise drug targeting in Inflammatory Bowel Disease: a safety, feasibility and dose-finding study
Authors: Van Dijken R , Volkmer P , Huizinga H , Aledlbi N , Gabriels R , Robinson D , Gorpas D , Visschedijk M , Lub-de Hooge M , Nagengast W 
Published: January 2025

Abstract

Background
Treatment of inflammatory bowel disease (IBD) with biologicals, such as adalimumab, is hampered by high non-response rates and lack of reliable response prediction tools. Therefore, patients are potentially exposed to ineffective treatment and side effects, while clinical deterioration continues. Moreover, it is unclear whether the drug reaches its target site in adequate concentrations to achieve treatment response. We aim to visualise adalimumab distribution and detect adalimumab target cells using quantified fluorescence molecular endoscopy (qFME).

Methods
Adalimumab was labelled with IRDye 680LT under cGMP conditions, resulting in a fluorescent tracer suitable for human use. This tracer is used in an ongoing, non-randomized, non-blinded, prospective feasibility study. A total of 21 IBD patients scheduled for an endoscopy will be included. Up until now, eight patients received adalimumab-680LT (4.5 mg: n=3, 15 mg: n=3, 25 mg: n=2), and three patients were included as a control. Two to four days after tracer administration, qFME was performed to gather in vivo fluorescence data of inflamed and non-inflamed tissue. Fluorescent signals were quantified by multi-diameter single fibre reflectance/single fibre fluorescence (MDSFR/SFF) spectroscopy. Furthermore, biopsies were taken from inflamed and non-inflamed mucosa for ex vivo analysis.

Results
To date, 11 patients were included. Tracer administration was well tolerated and no adverse events occurred in any dose group. Real-time in vivo macroscopic imaging showed clear uptake of adalimumab-680LT in inflamed tissue compared to non-inflamed tissue (figure 1A). Spectroscopy revealed a dose-dependent increase in fluorescent signal for adalimumab-680LT in inflamed tissue, with a significant difference between 4.5 and 15 mg (0.016 [0.011-0.021] vs 0.033 [0.021-0.043] (p=0.036)) (figure 1B). The difference between inflamed and non-inflamed tissue is most noticeable in the 25 mg group. Ex vivo Mean Fluorescent Intensity (MFI) quantification of all biopsies showed a significant increase of fluorescent signal in the 15 and 25 mg dose groups compared to control in inflamed tissue (65.0 [54.0-75.7] vs 32.4 [27.1-38.2] (p=0.0040), and 62.1 [44.1-82.8] vs 32.4 [27.1-38.2] (p=0.0286), respectively) (figure 1C).

Conclusion
Preliminary results show adalimumab-680LT is safe for visualising adalimumab distribution. Doses of at least 15 mg are sufficient for visualisation and quantification of fluorescent signal in vivo. Furthermore, higher MFI’s and spectroscopy results were measured in inflamed tissue compared to healthy tissue, indicating targeting of the tracer to inflamed tissue. Future ex vivo experiments are ongoing to visualise adalimumab target cells.
P0946 Switching from intravenous to subcutaneous Infliximab in patients with immune mediated diseases in clinical remission
Authors: Viazis N , Karamanakos A , Mousourakis K , Christidou A , Fousekis F , Mpakogiannis K , Koukoudis A , Katsanos K , Christodoulou D , Cheila M , Tzouvala M , Zacharopoulou E , Palatianou M , Giouleme O , Katsoula A , Liatsos C , Kyriakos N , Zampeli E , Papathanasiou E , Theodoropoulou A , Karmiris K , Psaroudakis I , Tribonias G , Gazi S , Mole E , Dimitroulas T , Koutsianas C , Vasilopoulos D , Fragoulis G , Michalakeas N , Papagoras C , Panagakis P , Papoutsaki M , Chasapi V , Stratigos A , Katsikas G 
Published: January 2025

Abstract

Background
We aimed to report on the efficacy and safety of elective switching from intravenously (IV) to subcutaneously (SC) administered Infliximab (IFX) in patients with immune mediated diseases.

Methods
This was a multicenter retrospective study in which we analyzed data collected from consecutive patients with immune mediated diseases treated in a hospital setting. Each hospital department was considered a study center and overall, 8 gastroenterology departments, 6 rheumatology departments and 1 dermatology department from 13 Greek hospitals, that are all referral centers, recruited patients for the study. Patients with Crohn’s disease (CD), Ulcerative Colitis (UC), Spondyloarthritis (SpA), Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and chronic plaque Psoriasis (PsO) who were receiving IFX-IV for maintenance of remission and were switched to IFX-SC based on their physician’s choice were included. All patients with gastrointestinal and skin diseases were in clinical remission, while those with musculoskeletal disease had inactive disease or low disease activity. The primary endpoint was disease deterioration during the follow up period, according to disease specific composite measures.

Results
Between April 2023 and April 2024, a total of 344 patients (CD=136, UC=62, SpA=52, PsA=38, RA=7, PsO=44, co-existence of more than one disease=5) were switched from IFX-IV to IFX-SC. The mean duration of treatment with IFX before switching was a mean (SD) 53.7 (36.2) months. Eleven patients (3.2%) were receiving combination treatment with an immunomodulator and 2 patients (0.6%) were using oral or iv steroids at the time of switch. After a mean (SD) follow up period of 8 (4) months, 12 patients (3.5%) discontinued treatment with IFX-SC. Five of them (1.5%) because of disease worsening and the remaining 7 (2.0%) because of the occurrence of side effects. All other 332 patients (96.5%) showed favorable response, none of them requested an unscheduled visit, or developed an adverse event (clinical or laboratory) or needed escalation of treatment.

Conclusion
Elective switching from IFX-IV to IFX-SC seems to be an effective and safe approach in real-world every day clinical practice to maintain long-term clinical remission, inactive disease or low disease activity in patients with immune-mediated diseases.
P0948 Comparative outcomes of Adalimumab and Infliximab dose escalation in Inflammatory Bowel Disease patients failing first-line biologic treatment
Authors: Atay A , Cagir Y , Ergul M , Ozturk O , Durak M B , Yuksel I 
Published: January 2025

Abstract

Background
Dose escalation has been commonly used as a strategy to achieve and maintain response; however, there was no research studied in patients who dose escalated with ulcerative colitis (UC) and Crohn’s disease (CD) who failed first-line anti-TNF-α therapy. We aimed to compare the outcomes of adalimumab (ADA) or infliximab (IFX) dose escalation in inflammatory bowel disease (IBD) patients.

Methods
All patients were evaluated between 2019 and 2024. Treatment persistence (TP) and the predictor factors for discontinuation were evaluated in patients treated with ADA or IFX dose escalation.

Results
A total of 749 patients received either ADA 409 (54.6%) or IFX 340 (45.4%) as their first-line biologic agent. Among them, dose escalation was identified in 142 (34.7%) patients of ADA group (UC: 34, 23.9% and CD: 108, 76.1%) and in 126 (37.0%) patients of IFX group (UC: 30, 23.8% and CD: 96, 76.2%). Concomitant immunomodulator use was lower in ADA group; however, erythema nodosum, budesonide use, and BMI were higher in ADA group. Other baseline characteristics were similar between the groups.
The treatment persistence rate was significantly lower in ADA group (50, 35.2%) than IFX group (67, 53.2%) (p=0.003). The survival analysis showed that drug durability was lower in ADA group than IFX group (mean time: 74.3 vs 99.5 months, p&lt;0.001, respectively). TP rates were no significantly differences between UC and CD in both ADA (mean time UC: 64.7 months vs CD: 76.2 months, p=0.403) and IFX (Mean time UC: 80.3 months and CD: 102.6 months, p=0.151).
Remission-free treatment discontinuation rates were significantly higher in the ADA group (89, 62.7%) than IFX group (50, 39.7%) (p&lt;0.001). Both primary lack of response and secondary loss of response (sLOR) rates were higher in ADA group (11, 7.7% and 73, 51.4%, respectively) than IFX group (2, 1.6% and 36, 28.6%, respectively). In the subgroup analysis of the sLOR, steroid needed was significantly higher in ADA group (15, 10.6%) than IFX group (4, 3.2%) (p=0.019) and switch to another biotherapy was higher in ADA group (72, 50.7%) than IFX group (35, 27.8%) (p&lt;0.001). However, serious adverse events were lower in ADA group (3, 2.1 %) than IFX group (10, 7.9%) (p=0.027).

Conclusion
IFX dose escalation was more effective than ADA dose escalation in both UC and CD patients. Regarding the side effect profile, ADA dose escalation was found to be safer compared to IFX.
P0950 Comparing Real-World use of Dietary and Medical Therapies in Children and Adults with IBD
Authors: Barnett M , Su W K , Pipicella J , Kaur H , Wilson W , Connor S J , Andrews J M 
Published: January 2025

Abstract

Background
Approximately 10% of people with inflammatory bowel disease (IBD) are diagnosed before 18 years of age. We explored the real-world use of dietary and medical therapies across the age spectrum in people with IBD under routine ambulatory care in Australia and New Zealand (ANZ).

Methods
Crohn’s Colitis Care (CCCare) is an IBD-specific electronic medical record (EMR) used across ANZ. De-identified data from CCCare’s linked clinical quality registry were analysed in September 2024. All people with IBD under active care (clinical encounter within the prior 14 months) were included. Children were defined as being &lt; 18 years of age at time of extraction.

Results
A total of 7506 people with IBD were included in the study. In the &lt;18 years age group (n=315), 58.7% were male with a median age of 16 (IQR 14-18). The majority resided in Australia (83.8%, n=264), and most had Crohn’s disease (65.1%, n=205). In the ≥18 years age group (n=7191), 45.6% (n=3494) were male with a median age of 43 years (IQR 32 - 57). The majority (72.6%, n=5223) resided in Australia, and over half had Crohn’s disease (55.4%, n=3982). Interestingly, 5-aminosalicylate use was more prevalent in adults than children (37.2% vs 27.4% respectively, P&lt;0.001), whereas current immunomodulator use was less common in adults compared to children (32.2% vs 61.0% respectively, P&lt;0.001). Steroid use within the past year was close to 10% in both cohorts (11.1% for the paediatrics cohort and 8.5% for adults, P=0.11). Over half of the paediatric and adult cohorts were on an advanced therapy (biologic or novel small molecule) (57.8% and 51.4% respectively, p&lt;0.05). Advanced therapy use by age group is shown below.
Anti-TNF therapies (infliximab and adalimumab) predominated in the paediatric cohort. Across the cohort, infliximab use decreased with age, whereas vedolizumab use increased with age. Dietary therapies were infrequently used/documented, with only 13/315 (4.1%) receiving dietary therapy in the paediatric cohort and 53/7191 (0.7%) in the adult cohort (p&lt;0.001).

Conclusion
This study highlights CCCare’s ability to facilitate clinical research involving individuals of all ages with IBD, as well as to monitor therapy choices within a large, real-world cohort in real time. The findings provide intriguing insights into the variation in the use of dietary and advanced therapies. While certain differences in advanced therapy usage may be attributed to licensing and funding arrangements, others may be linked to concerns over drug safety in older populations. Future efforts aimed at correlating these therapeutic choices with outcomes, complications, and associated costs will soon enable a comparative evaluation of treatment strategies.
P0955 Calcium supplementation, but not the Mediterranean diet, significantly reduced bone resorption metabolite in patients with inflammatory bowel disease (IBD): A randomized controlled trial
Authors: Pfeffer-Gik T , Godny L , Cohen S , Shakhman S , Avni Biron I , Yanai H , Banai Eran H , Broitman Y , Snir Y , Ollech J , Barkan R , Elial Fatal S , Yackobovich Gavan M , Shimon I , Tzvetov G , Dotan I 
Published: January 2025

Abstract

Background
Reduced bone mineral density (BMD), osteoporosis and osteopenia, are prevalent comorbidities in IBD. Reduced BMD first line treatment is calcium and vitamin D supplementation. Mediterranean diet (MED) pattern has been associated with lower risk of reduced BMD in the general population. We aimed to assess the effectiveness of MED and vitamin D supplementation versus the standard of care on bone turn-over metabolites in patients with quiescent IBD diagnosed with reduced BMD.

Methods
Patients with IBD in clinical remission, age 20-50 years diagnosed with reduced BMD defined as DXA scan T score &lt;-1were randomized for a 12-week, dietitian-led intervention to either MED (including calcium rich foods) or Calcium supplementation. Vitamin D supplementation was mandatory in both groups. Bone turn-over metabolites including bone resorption metabolite (CTX) and bone formation metabolite (P1NP) were used to assess bone dynamics within 12 weeks of treatment and vitamin D levels at baselined and after 12 weeks. Adherence to MED pattern was assed via validated MED score.

Results
Out of 72 patients approached, 38 (52.8%) consented to perform screening DXA and 17 (44.8%) were diagnosed with reduced BMD. Finally, 15 patients were recruited to the RCT- 7(46.6%) male 8 (53.4%) female, median age: 34 (IQR 29-40) years, median years since IBD diagnosis: 8 (IQR 7-16) years. Patients were randomized to MED (8) or Ca (7) groups. MED score increased in the MED group: median of 2.5 (IQR 2-3.75) points, but not the Ca group 0 (IQR 0-1) points (p=0.002).
After 12 weeks of intervention Ca group demonstrated a reduction of 12.5% (IQR -126-12.2) in bone resorption metabolite, CTX. In the MED group an increase of bone resorption metabolite, CTX, by 18.2% (IQR -2.5-32) was observed. CTX dynamic significantly differed between groups (p=0.04) (fig 1). Bone formation metabolite, P1NP, decreased in both groups- in Ca group by 5.7 % (IQR -19.1- 9.5) and in MED group 10.2% (IQR -14-1.4). P1NP dynamic was comparable between groups.
Vitamin D levels increased after 12 weeks in both Ca group and MED group (23.9 % vs 14.8%) the increase was comparable (p=0.536)

Conclusion
In this short-term intervention, we found that Ca supplementation significantly improved bone resorption in patients with IBD and reduced BMD, while MED (including calcium rich foods) alone was insufficient. Patients with IBD and reduced BMD should be encouraged to adhere to Ca supplementation for the long run to prevent long term metabolic bone complications.
P0963 Nationwide analysis of targeted telemedicinal patient education in IBD – a randomized-controlled trial
Authors: Bacsur P , Ivány E , Farkas B , Bálint A , Fábián A , Bor R , Rutka M , Bősze Z , Szepes Z , Molnár T , Farkas K 
Published: January 2025

Abstract

Background
Data suggest that patients’ knowledge about their chronic disease is associated with treatment adherence, and education may help improve disease outcomes. The effectiveness of educational activities depends on the source of the information. Our study aimed to compare the effectiveness of targeted educational activities in written and podcast formats for patients with inflammatory bowel disease (IBD).

Methods
In this nationwide randomized controlled trial, IBD patients were enrolled between December 2023 and May 2024. At baseline, enrolled patients completed an online questionnaire assessing general knowledge of their disease (Inflammatory Bowel Disease Knowledge [IBD-KNOW]) and health-related quality of life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ] and Patient Health Questionnaire-9 [PHQ-9]). Patients were randomized (1:1) into a control and an intervention group and the latter received targeted telemedical educational material, either in podcast format or as a written version, covering topics on anatomy, medical and surgical therapy, quality of life, epidemiology, diet/lifestyle, reproduction, and vaccination. This content was developed by IBD experts. Two months after the educational material was distributed, intervention group was re-tested, and satisfaction was measured. Descriptive statistics, Welch’s test, and Fisher’s exact test were used, with p-values &lt;0.05 considered significant.

Results
A total of 221 patients were recruited, among whom 129 (58%) had Crohn’s disease (median age was 42 years [IQR 34-49], and median disease duration was 10 years [IQR 4-19], Table 1). Higher baseline IBD-KNOW scores were associated with longer disease duration (95% CI for B: 0.08-0.22, p &lt; 0.001) and lower PHQ-9 scores (95% CI for B: 0.23-0.001, p = 0.052). Of the 221 patients, 95 were randomized into the intervention group to receive educational content, with 46/95 receiving the written version and 49/95 the podcast. Baseline characteristics and overall IBD-KNOW scores did not differ significantly between groups, except for a clinically irrelevant age discrepancy. After the educational intervention, the intervention group had higher overall IBD-KNOW scores compared to the control group (26.7 vs. 23.7, p &lt; 0.001), while the format of the educational activity or quality of life had no significant impact on scores (Figure 1). Patient satisfaction was high (mean score of 8 ± 1.98) and was not influenced by the format of the educational content.

Conclusion
Telemedical education may enhance disease knowledge among IBD patients, with both forms of educational materials proving equally effective. Although no clear predictors of educational efficacy were identified, disease duration was associated with higher baseline knowledge.