bluuebunny/crossref_metadata_2025 huggingface dataset:
P0925 Risk of postoperative Crohn’s disease recurrence in patients smoking e-cigarettes and heat-not-burn tobacco products: a multicenter retrospective study
Authors: Parigi MD T L , Nardone O M , Lisa M , Gabbiadini R , innocenti T , Bertani L , Allocca M , D’Amico F , Furfaro F , Zilli A , Castiglione F , Dragoni G , Fiorino G , Armuzzi A , Danese S
Published: January 2025

Background

Tobacco is a known risk factor for Crohn’s disease (CD) recurrence after surgery. However, the impact of electronic cigarettes (or vape) and heat-no-burn tobacco products on post-operative recurrence is unknown.

Methods

We conducted a retrospective study across five centers in Italy. We included consecutive patients with CD who underwent ileocolic resections and endoscopic reassessment within 3 to 12 months after surgery, for whom smoking habit after surgery and before reassessment was known. Endoscopic recurrence was defined as a modified Rutgeerts score of i2b or higher. Recurrence rates were compared with Fisher’s exact test.

Results

In total 332 patients were retrieved, 65% male and 35% female, with an average age of 44, 55 (16.6%) with a history of other prior intestinal resections. (Table 1)

Of these, 64 (19.3%) patients were excluded for uncertain endoscopic outcomes or missing Rutgeerts score. Additionally, because we focused the analysis on the consumption of e-cigarettes, heat-not-burn tobacco products (ie. IQOS), and traditional tobacco cigarettes, 4 patients were excluded due to mixed smoking habits (e-cigarettes and conventional cigarettes), and 1 for smoking cannabis.

In the overall population, post-operative endoscopic recurrence was observed in 76% (13/17) of heat-not-burn tobacco smokers, 72% (51/71) of conventional cigarette smokers, 56% (9/16) of e-cigarette smokers, and 52% (82/159) of non-smokers. Figure A

To avoid the potential confounding effect of therapy, we restricted the analysis to patients who received immunomodulators, biologics, or advanced small molecules after surgery for prevention of post-op recurrence. In the 208 patients who received prophylaxis, recurrence rates were broadly similar, 80% (12/15), 73% (43/59), 58% (7/12), and 51% (62/122) for the respective groups. Figure B

Irrespective of post-operative treatment, recurrence rates were similar for heat-not-burn tobacco and traditional tobacco cigarettes (76% vs 72%, p=0.9; and 80% vs 73% p=0.7) and similar between e-cigarettes and non-smokers (56% vs 52% p=0.8; and 58% vs 51% p=0.7). Instead, as expected, tobacco increased the risk of recurrence compared to non-smoking (both p=0.005). Although not significant, a trend of progressively greater recurrence was observed from non-smoke, vape, tobacco, and heat-not-burning tobacco products.

Conclusion

In the first study on the impact of novel smoking habits on CD postoperative recurrence, vaping was not associated with higher recurrence rates compared to non-smoking, instead heat-not-burn tobacco products had recurrence rates similar to traditional cigarettes. A larger study is underway to confirm these results.
P0927 Surgery as a Treatment Option for CD: A Nationwide Cohort Study
Authors: Faye A , Axelrad J , Sun J , Halfvarson J , Soderling J , Olen O , Ludvigsson J
Published: January 2025

Background

Although surgery is often reserved for individuals with refractory Crohn’s disease (CD), recent data suggest that intestinal resection in select individuals may obviate the need for future CD-related treatment, particularly among older adults. Despite this, limited data characterizing these patients exist.

Methods

We performed a nationwide cohort study using the Swedish National Patient Register and the ESPRESSO (Epidemiology Strengthened by histoPathology Reports in Sweden) cohort to identify all individuals who underwent a first CD-related intestinal resection between 2007-2018 (allows for five years of follow-up among all individuals). Intestinal resection for dysplasia and/or malignancy were excluded in order to identify those with ongoing CD-related disease activity. Our primary outcome was the need for an IBD-related treatment (medical therapy, surgery, and/or IBD-related hospitalization) within the five years following intestinal resection; subgroup analysis was performed among older adults. Univariable and multivariable logistic regression were used to calculate odds ratios (ORs).

Results

Overall, there were a total of 1,760 individuals included. The average age at surgery was 41.4 years, and the median duration of disease prior to resection was 0.5 years (IQR: 0.0-2.1 years). At 5-years, 341 (19.4%) of individuals did not require an IBD-related treatment; of those who required treatment, 2.3% had another intestinal resection, 15.8% had an IBD-related hospitalization, and the majority required corticosteroids, an immunomodulator, and/or an advanced therapy. On multivariable analysis, longer disease duration (aOR 1.07, 95%CI 1.01-1.15), the absence of COPD (suggesting no smoking: aOR 4.35, 95%CI 1.32-14.3), and being bio-naïve (aOR 2.97, 95%CI 1.11-8.00) prior to surgery increased the odds of remaining IBD-treatment/hospitalization free for 5-years post intestinal resection (Table 1). On subgroup analysis among adults ≥ 50 years-old (given data suggest this group may derive the most benefit from elective surgery), longer disease duration (aOR 1.10, 95%CI 1.00-1.22), as well as the absence of COPD (aOR 4.76, 95%CI 1.43-16.70) were associated with a higher odds of remaining IBD-treatment/hospitalization free.

Conclusion

Individuals with CD who have a longer disease duration, do not smoke, and are bio-naive, may be more likely to remain treatment free in the five years following intestinal resection; similar results were observed among older adults with CD. These data can help identify individuals in which surgery may obviate the need for future CD-therapy, though future studies should assess whether earlier surgery among these individuals can improve long-term clinical outcomes.
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

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 < 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

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

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

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

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<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<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<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

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 < 18 years of age at time of extraction.

Results

A total of 7506 people with IBD were included in the study. In the <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<0.001), whereas current immunomodulator use was less common in adults compared to children (32.2% vs 61.0% respectively, P<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<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<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

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 <-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

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 <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 < 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 < 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.
P0967 The role of bound anti-drug antibodies to infliximab in predicting future immunogenic failure when de-escalating from combination therapy with an immunomodulator to anti-TNF monotherapy (RAPID-IM Study)
Authors: Cameron K , Sam M , Theena N , Gu B , Arzivian A , Skinner T , Shelton E , Connor S J , Toong C , Gibson P R , Gibson D J , Sparrow M P , Ward M G
Published: January 2025

Background

Withdrawing immunomodulators (IM) from combination therapy with infliximab (IFX) can lead to immunogenic failure due to development of antibodies to IFX (ATI). Conventional drug sensitive ELISAs detect ATI only when IFX drug levels are undetectable. We investigated whether bound ATIs detected using a novel drug tolerant ELISA taken at time of de-escalation to IFX monotherapy, predicted subsequent loss of response and unfavourable IFX pharmacokinetics in IBD patients on combination therapy.

Methods

Multicentre case-control retrospective study of IBD patients treated with combination IV IFX and IM. Patients had > 6 months steroid-free clinical (Harvey Bradshaw Index ≤ 4 / Partial Mayo Score ≤ 2) and biochemical remission (C-reactive protein (CRP) <5 mg/L or faecal calprotectin (FCP) <150 µg/g). Cases (withdrew IM and continued IFX monotherapy) were compared to controls (continued combination therapy). The primary endpoint was relapse (clinically active disease with elevated FCP or CRP) over 24 months follow-up; secondary endpoints included changes in therapy and IFX drug levels. Therapeutic drug monitoring with a drug-tolerant ELISA was collected within 3 months of IM withdrawal.

Results

Bound-ATI were detected in 7/45 (15.6%) cases and 5/37 (13.5%) of controls, none of which tested positive for ATI using drug sensitive ELISA. The groups were well matched, although median duration of combination therapy was longer in cases than controls (41 vs. 20 months, p=0.045) (Table 1). Median duration of follow-up was 17 months. No patients with bound ATI at baseline met the primary endpoint of disease relapse. Higher rates of biochemical disease activity and treatment escalation in the withdrawal group were noted, however ATI status was not associated with these outcomes. When considering changes in IFX levels over subsequent 12 months, there was no significant difference between cases and controls (-0.99 and -0.84 mg/L respectively, p = 0.20). However, in all IM withdrawal patients with ATI, IFX levels reduced from baseline, with greater decreases in IFX drug levels observed in this cohort.

Conclusion

Drug tolerant ELISA can detect bound-ATI that were previously not measureable using drug sensitive ELISA. However, presence of bound-ATI did not predict subsequent disease relapse suggesting conventional assays are suitable in this setting. In IM withdrawal, ATI positivity is associated with greater risk of reduction in IFX levels, and ultimately, potential immunogenic failure. Higher rates of disease activity were observed in IM withdrawal, suggesting that IM might be important in maintaining disease control.
P0971 Effectiveness of Vedolizumab in Bio-Naïve Chinese Patients with Crohn’s Disease: A Subgroup Analysis of Second Interim Analysis of the VALUE Study
Authors: Guo H , Shen H , Jiang Q , Xu X , Qian X , Zhou F , Chen M
Published: January 2025

Background

Vedolizumab (VDZ) is a humanized monoclonal antibody, that selectively targets α4β7 integrin and is approved for Crohn’s disease (CD) and Ulcerative colitis (UC). Previous studies demonstrated better efficacy of VDZ in bio-naïve pts with CD, however, there is lack of sufficient data in Chinese pts. VALUE study (NCT04872491) is a prospective, multicenter, single-armed observational study evaluating the safety and effectiveness of VDZ in UC and CD patients (pts).

Methods

This subgroup of bio-naïve pts with CD in second interim analysis of VALUE trial was assessed for clinical effectiveness (clinical response: ≥3 point-reduction in Harvey-Bradshaw index (HBI) score; clinical remission: HBI score ≤4; endoscopic remission: absence of any ulcers excluding aphthous ulcers.) on treatment of Vedolizumab, at week 14, 30, and 54. (Data cutoff: 21 Oct 23).

Results

Of the 91 pts with CD, 57 pts (62.64%) were bio-naïve, with a mean HBI score of 6.0±3.51 with the median duration of CD of 2.693 (4.1384) years. The majority of disease locations were Ileocolonic (49.12%) with 2 (3.51%) pts had history of Fistulas (Table 1).

After treatment with VDZ, 44.44% (16/36), 52% (13/25) and 53.85% (7/13) achieved clinical response at week 14, 30 and 54, respectively. Overall, 83.33% (30/36), 96.15% (25/26) and 92.31% (12/13) pts achieved clinical remission at week 14, 30 and 54, respectively. Additionally, 100% of pts (13/13) achieved clinical response or remission, by 54 weeks (Figure 1). Further, 66.67% (4/6), 33.33% (2/6) and 0/1 pts achieved endoscopic remission at week 14 ,30 and 54, respectively.

Conclusion

This study demonstrated good effectiveness of VDZ in bio-naïve patients with CD in China.
P0976 Guselkumab efficacy and safety in East Asian participants with moderate to severely active Crohn’s disease: Subgroup analysis of the GALAXI 2 & 3 Phase 3 studies
Authors: Nakase H , Chen B , Cao Q , Matsuoka K , Hisamatsu T , Park D I , Wahking B , Yiu W C , Zhuo J , Chen M
Published: January 2025

Background

Guselkumab (GUS), a dual-acting interleukin-23p19 subunit inhibitor, demonstrated efficacy and safety in participants (pts) with moderately to severely active Crohn’s disease (CD) in the global Phase 3 GALAXI 2 & 3 (G2 & G3) studies.1 We report a subgroup analysis of GUS efficacy and safety in East Asian pts from G2 & G3.

Methods

G2 & G3 (NCT03466411) are identical 48-week, randomised, double-blind, double-dummy, placebo (PBO)- and active comparator- (ustekinumab; UST) controlled treat-through trials assessing the efficacy and safety of GUS in pts with CD (Figure 1).1 Pts with moderately to severely active CD (Crohn’s Disease Activity Index [CDAI] 220–450 and either mean daily stool frequency [SF]>3 or abdominal pain [AP]>1), Simple Endoscopic Score for Crohn’s Disease (SES-CD) ≥6 (≥4 for isolated ileal disease), and inadequate response or intolerance to conventional or biologic therapy were randomised 2:2:2:1 to the following induction→maintenance regimens: GUS 200 mg intravenous (IV) every 4 weeks (q4w) (x3)→100 mg subcutaneous (SC) every 8 weeks (q8w), GUS 200 mg IV q4w (x3)→200 mg SC q4w, UST ~6 mg/kg IV→90 mg SC q8w, or PBO. PBO pts not in clinical response at Week (W)12 switched to UST. Composite co-primary endpoints for both studies were (1) clinical response at W12 + clinical remission at W48 and (2) clinical response at W12 + endoscopic response at W48, comparing each GUS regimen to PBO. This subgroup analysis included G2 and G3 pts from study sites located in East Asia (China, Japan, Korea, and Taiwan).

Results

The East Asian subgroups included 98 G2 and 94 G3 pts. Greater proportions of G2 & G3 pts in both GUS SC maintenance dose cohorts achieved the composite co-primary efficacy endpoints relative to PBO (Figure 2).

In pooled analysis of G2 & G3 in 192 pts, proportions of pts with ≥1 treatment-emergent adverse event (TEAE)/serious TEAE through W48 were 87.3%/11.1% in the GUS 200 mg IV→100 mg SC q8w cohort, 90.2%/7.8% in the GUS 200 mg IV→200 mg SC q4w cohort, 71.9%/15.6% for PBO pts, and 89.1%/13.0% among UST pts. Corresponding rates of infections/serious infections were 57.1%/0 in the GUS 100 mg SC q8w cohort, 54.9%/0 in the GUS 200 mg SC q4w cohort, 25.0%/6.3% for PBO, and 52.2%/4.3% for UST.

Conclusion

Efficacy of GUS in the subgroup of East Asian pts from G2 & G3 was consistent with that observed in the global study population. The safety profile of GUS was also favourable and consistent with previous reports.

This study was supported by Janssen Scientific Affairs, LLC.

References

1.Panaccione R, Danese S, Feagan B, et al. Gastroenterology. 2024;166(5 Suppl):1057b.
P0978 Effectiveness of risankizumab in moderate-to-severe Crohn’s Disease: A Canadian multicentric real-world study
Authors: Zoughlami A , Abbas A , Almushir S , Zeghal M , Khan N S , Milgrom R , Daher S , McCurdy J D , Narula N , Rosenfeld G , Silverberg M S , Lakatos P L , Bessissow T
Published: January 2025

Background

Risankizumab is an interleukin-23 (IL-23) targeting monoclonal antibody, and has recently been approved for the treatment of moderate-to-severe Crohn’s Disease (CD). To this date, there is limited effectiveness and safety real-world data.

Methods

We performed a retrospective chart review at 5 inflammatory bowel disease centers in Canada between January 2023 and November 2023 to evaluate the safety and effectiveness of risankizumab in moderate-to-severe Crohn’s Disease. Adult patients with confirmed CD diagnosis on risankizumab for active clinical or endoscopic disease were included. Patients with indeterminate colitis, and patients treated for post-operative recurrence prophylaxis were excluded. Clinical, biochemical and endoscopic data was collected at 3, 6, and 12 months.We evaluated the rates of clinical remission (defined as Harvey-Bradshaw Index (HBI) <5) and response (decrease in HBI of >50%), biochemical remission (CRP<5mg/L and/or fecal calprotectin (FCAL) < 250ug/g), as well as endoscopic remission (SES-CD <4) and response (SES-CD decrease >50%) at each time point. If HBI or SES-CD scores were not available, treating physicians’ assessments of response and remission were used. Requirement for steroids, drug discontinuation, and drug-associated adverse events were also collected.

Results

A total of 335 patients were included in the study. Baseline data is presented in Table 1. Median age was 39, and 172 (51.3) of patients were female. Most patients (304, 90.7%) had previous biologic exposure, and 112 (33.4%) patients had been exposed to three or more biologics.

Overall, 131/235 (55.7%) patients clinically responded at 3 months, and 121/233 (51.9%) were in clinical remission. At 12 months, rates of clinical response and remission were similar (73/129, 56.6% and 74/132, 56.1% respectively). Endoscopic remission was noted in 6/17 (35.3%), 13/41 (31.7%), and 29/72 (40.3%) at 3, 6 and 12 months respectively. Normalization of biochemical parameters at 12 months was found in 73/99 (73.7%) of patients for CRP, and 21/49 (42.9%) for FCAL. Patients were less likely to require steroids over time, with respectively 49 (14.6%), 25 (7.5%) and 15 (4.5%) of them with active steroid use at 3, 6 and 12 months. Forty-seven (16.1%) patients had discontinued risankizumab prior to 12 months of use. By 12 months, 28 (8.4%) had to undergo surgery for active disease, and 41 (12.2%) required hospitalization.

Conclusion

In this real-world, multicentric, Canadian study, risankizumab was an effective therapy in the management of Crohn’s Disease in a population with significant number of patients with refractory disease.
P0981 Comparative efficacy of standard vs enhanced dose treatment with infliximab in the management of acute severe ulcerative colitis: a single centre retrospective cohort study
Authors: Saeed M H , Ismail A , Thiruselvan K , Umar N , Slater J , King D , De Silva S
Published: January 2025

Background

Acute severe ulcerative colitis (ASUC) often requires rescue therapy with infliximab, typically administered at an initial dose of 5mg/kg or 10mg/kg. There is some uncertainty regarding the optimal dose of infliximab for rescue therapy and current guidance leaves this to the discretion of the treating clinician. A previous multicentre randomised controlled trial (PREDICT-UC) did not find a significant difference in clinical response or colectomy rates between 5mg/kg and 10mg/kg of infliximab in steroid-refractory ASUC 1. This study aimed to compare the clinical outcomes of patients receiving either 5mg/kg or 10mg/kg infliximab in the management of ASUC.

Methods

This retrospective cohort study examined patients with ASUC who were treated with rescue infliximab between 2019 and 2022. Patients were categorised into two groups based on the dose received; 5mg/kg and 10mg/kg. Demographic and clinical variables, including age, sex, disease extent (Montreal classification), and prior treatments (no prior treatment, 5-ASA, biologics), were recorded. The outcomes measured included remission (defined as sustained remission at 1 year), the need for surgery, the requirement for additional doses of infliximab, or change in biological agent. Outcomes at 1 month, 6 months, and 1 year were also recorded. Chi-square tests were used to analyse differences between the two treatment groups.

Results

Of the 50 UC patients, 60% received 5 mg/kg, and 40% received 10 mg/kg. No significant differences were found between the 5 mg/kg and 10 mg/kg infliximab treatment groups for outcomes including surgery (p = 1.00), remission (p = 0.22), and biologic switch (p = 0.22). Additionally, no significant differences were observed when categorising patients by pre-existing treatment (p = 0.06) or disease severity subgroups (E1, E2, E3). When assessing the effect of severe disease markers on treatment outcomes, no significant difference in colectomy rates was found between the two groups for CRP > 50 mg/L (p = 0.34) and albumin < 25 g/L (p = 0.13).

Conclusion

This study showed no significant difference in the clinical outcomes between patients receiving 5mg/kg and 10mg/kg infliximab for the management of ASUC. These findings suggest that escalating the dose to 10mg/kg does not provide a clear clinical advantage in reducing the need for surgery or achieving sustained remission. Larger, multicentre studies with more diverse patient populations are needed to further investigate the potential benefits of higher infliximab dosing in this clinical context.

References

1.Intensified versus standard dose infliximab induction therapy for steroid-refractory acute severe ulcerative colitis (PREDICT-UC): an open-label, multicentre, randomised controlled trial. Choy, Matthew C et al. The Lancet Gastroenterology & Hepatology, Volume 9, Issue 11, 981 - 996
P0983 Addition of fibre to exclusive enteral nutrition (EEN) improves colonic effects and symptoms without compromising the benefits on small bowel paracellular permeability in healthy humans
Authors: Melton S , Gibson P , Taylor K , Halmos E
Published: January 2025

Background

How EEN works in Crohn’s disease is uncertain, but a unique compositional feature compared with whole-food diet is the absence of fibre. We aimed to determine the effects of EEN with and without fibre in healthy adults (to minimise confounders) on 1) intestinal barrier function, in the basal/fasting state and in response to acute stress; 2) inflammatory markers; 3) regional gut transit and fermentation; and 4) symptoms.

Methods

In a single-centre pilot study, 20 participants (age 33 [range 21-49] y, 10 female) were evaluated on their habitual diet and after 3 weeks of either ‘no-fibre EEN’ (n=10) or ‘fibre-EEN’ (22 g/d, 6 fibres) (n=10). Measures were: 1) small bowel permeability via 2-h lactulose:rhamnose ratio (LRR) in basal state and after 100 mg IV corticotrophin-releasing hormone (CRH) to simulate acute stress, and serum markers of lipopolysaccharide translocation; 2) intestinal and systemic inflammation via faecal calprotectin and serum C-reactive protein (CRP); 3) regional gut transit times and colonic H2 concentrations (carbohydrate fermentation) via a gas-sensing capsule; and 4) reported symptoms.

Results

There were no fibre-associated differences in barrier markers. EEN did not change basal barrier function overall, but normalised LRR when elevated (>0.05) on habitual diet (n=7; Fig 1). CRH-induced changes in LRR during the habitual diet were minimised by no-fibre EEN with a similar trend for fibre-EEN (Fig 2). CRP did not change. Calprotectin increased from median 11 (range: 0.5-44) to 41 (2-247) μg/g (p=0.006) with no-fibre-EEN and 13 (4-99) to 27 (4-167) μg/g (p=0.037) with fibre. Gastric emptying and small intestinal transit times on EEN ±fibre were not different to those on habitual diet, but colonic transit time was prolonged (36 [5-69] h) on no-fibre EEN compared with habitual diet (16 [6-24] h; p=0.04), but not on fibre-EEN (24 [16-44] vs 25 [0.4-89] h; p=0.32). Median colonic H2 concentrations were 11.2 [0.4-20.9]% with fibre vs (0.2 [0-7]%;) without fibre (p<0.001) The decreasing proximal-distal gradient in normalised H2 concentrations (1.7 [0-2.5] to 0 [0-1.3]%.h) with no-fibre were not seen for fibre-EEN (6.5 [0.7-12.6] to 10.6 [0.6-20.6]%.h) or habitual diet (3.2 [0-10.1] to 7.1 [0-13]%.h). Headaches in 6/10 within first week of no-fibre EEN and nausea in 9/10 were not reported with fibre-EEN, which induced abdominal pain in 2.

Conclusion

EEN ±fibre normalises basal small intestinal permeability and minimises stress-induced changes. The addition of fibre prevented marked prolongation of colonic transit, reduced carbohydrate fermentation and common symptoms with no-fibre EEN. Addition of fibre improves outcomes without compromising small intestinal action of EEN.