bluuebunny/crossref_metadata_2025 huggingface dataset:
P523 The performance indicator of colonic intubation (PICI) in an Irish Inflammatory Bowel Disease (IBD) cohort
Authors: Jones F , Lavelle A , McCarthy F , Patchett S , Morcos A , Moloney M , Cullen G , Slattery E , Leyden J , O' Morain C , Egan L , Doherty G A
Published: January 2024

Background

Comprehensive assessment of endoscopic disease activity and mucosal healing is central to therapeutic decision making in IBD. Data suggests that IBD patients may have a poorer experience of endoscopy with a higher burden associated with bowel preparation, higher GI specific anxiety and increased procedure related pain. Existing KPIs may be inadequate in capturing appropriate patient outcomes in IBD patients. PICI is a novel composite endpoint incorporating patient safety and comfort to ensure targets are met without compromising patient safety.

Methods

The aims of this study were to assess the safety, tolerability, and feasibility of colonoscopy in patients with IBD compared to non-IBD patients in Ireland using PICI, defined as successful caecal intubation with nurse assisted comfort score ≤3 and midazolam dose ≤2. We reviewed de-identified national endoscopy procedure data on all colonoscopies performed over a 6 year period in 24 hospitals nationally using the EndoRAAD reporting system. Procedures were categorised into IBD and non-IBD procedures on the basis or procedure indication (IBD surveillance or assessment) or a new diagnosis of IBD.

Results

Procedure data from 261,889 colonoscopies from 2014-2020 were analyzed (IBD: n=18,675; non-IBD: n=243,214 procedures). The Odds Ratio (OR) of achieving PICI was significantly lower in IBD patients compared to non-IBD patients, particularly in patients with Crohn’s Disease (0.74, 0.68-0.81, p<0.001). Male gender was associated with a significantly higher OR of achieving PICI (1.32 (1.29-1.35, p<0.001). Poor bowel prep was associated with reduced PICI (OR 0.78, p<0.001). Additionally, procedures performed by supervised trainees had significantly reduced PICI (OR 0.69, p=0.032). The extent of colonic inflammation had no significant impact on PICI in IBD patients (OR moderate and severe inflammation 1.08 (p=0.66); and 1.06 (p=0.79) respectively). Mean procedure time was slightly longer for IBD patients (28.7 min versus 26.7 min, p<0.001), with 91.1% of IBD patients having mucosal biopsies compared to only 26.3% of non-IBD patients (p < 0.001).

Conclusion

This large retrospective cohort study utilises the novel composite measure of PICI to assess the safety, tolerability, and feasibility of colonoscopy in IBD patients compared to non-IBD patients. We have identified significantly poorer comfort scores and higher sedation rates required to achieve caecal intubation at colonoscopy in IBD patients, particularly in patients with Crohn’s Disease. Further exploration is required to identify factors to improve the safety and quality of endoscopy in IBD patients.
P528 Re-induction of intravenous ustekinumab to maintain drug persistence. A UK experience
Authors: Muir J , Hazir Y , Butterworth J
Published: January 2024

Background

In this study we seek to add to the body of knowledge on the practical use of ustekinumab in patients with Crohns and Colitis. Patients commencing ustekinumab will mostly have failed, or are intolerant to, conventional biologic agents and therefore have a limited number of medical options available to manage their disease. Results from the IM-UNITI long-term extension study have shown that a proportion of patients will lose response to maintenance dose therapy, and a small number of studies have suggested that repeated induction doses of this therapy can prolong its effective use and allow patients a greater period of disease free remission.

Shrewsbury and Telford hospital NHS trust is a multi-site UK hospital serving a large population in the west-midlands region which has established the routine use of usetkinumab therapy over 5 years ago and by reviewing data on our patient cohort we aimed to identify characteristics amongst patients who have required reinduction doses and how effective they have been in maintaining remission.

Methods

In this retrospective, interventional study two researchers gathered data including baseline characteristics, disease type and distribution, previous surgical and medical therapies and time from diagnosis on all patients who had received ustekinumab therapy over the past five years. We used biochemical and endoscopic data, as well as clinical records, to determine the efficacy of ustekinumab on the disease course. We identified the subgroup of patients requiring reinduction doses and noted whether this was a successful intervention and sought to describe similarities which could help identify patients at risk of failing maintenance therapy in future.

Results

Data from 213 patients was gathered (Crohns: 150, UC: 61, IBDU: 2) and of which 87 (Crohns: 63, UC: 24) received reinduction doses. Average time to reinduction from therapy commencement was 19.5 months (Crohns) and 16.3 months (UC) respectively. Of the reinduction group 63% showed improvement in their disease control and a variety of characteristics were noted amongst the successful patients for discussion including disease location, presence of perianal disease and time from diagnosis.

Conclusion

Ustekinumab reinduction is an important area for further research as it allows patients to prolong their successful therapy and delay the need for surgical intervention for difficult to manage disease. This study suggests characteristics which could inform further trials and establish protocols to aid clinicians when making decisions about switching biologic therapies.
P530 Early Intestinal Ultrasound changes to predict treatment response to anti-TNF therapy in paediatric Inflammatory Bowel Disease; a pilot study
Authors: Vos H , Gecse K , D'Haens G , Benninga M , Koot B ,   RAINBOW group
Published: January 2024

Background

In paediatric Inflammatory Bowel Disease (IBD) selecting the right treatment in the early stages of disease is key to prevent disease progression and to prevent unnecessary exposure to ineffective treatment. Intestinal ultrasound (IUS) is increasingly used to monitor disease activity in response to therapy. However, little is known about the early transmural changes during anti-tumour necrosis factor (anti-TNF) therapy in paediatric IBD. The aim of this study is to assess the early changes in IUS parameters and to evaluate the very early predictive value of IUS for therapy response in paediatric IBD treated with anti-TNF-α therapy.

Methods

In this pilot study children (aged 3-18 years) starting with anti-TNF therapy (infliximab or adalimumab) were enrolled prospectively if ultrasound at baseline showed bowel wall thickness (BWT) ≥ 2,5mm. IUS was performed at baseline and the most affected bowel segment was identified. Subsequently IUS was repeated in this segment at week 2 and week 13. Response to therapy was determined at week 13.

Response and remission was defined as follows.

- Therapy response: a ≥50% decrease in faecal calprotectin (FCP) in combination with a decrease in PUCAI (≥20 points or normalisation) /PCDAI (≥12.5 points or normalisation), or normalisation of FCP (<250mg/kg))

- IUS response: decrease in BWT by 25% OR decrease in BWT by >2.0 mm of the most severely affected segment compared to baseline

- IUS remission/Transmural healing: BWT<2.0 mm and no Doppler signal(Limberg score) and no mesenteric fat proliferation

Results

Eleven IBD patients (aged 7 to 12 years; 64% female) were enrolled. IUS response was observed in 5/11 patients at week 2 (decrease in BWT -25% in all). Doppler signal decreased in 3/11(one point in Limberg score in all). After 13 weeks 4/11 patients showed therapy response and 3/11 showed IUS remission.

Conclusion

Transmural changes were detected by IUS as early as 2 weeks after initiating anti-TNF therapy. This pilot study observed mainly reactivity in BWT, in contrast with previous studies that initially noted changes in Doppler signal.

IUS has the potential to predict therapy response at an early stage. A larger sample size is needed to accurately assess its predictive value at week 2 for treatment response.
P534 The preference for controlled-release mesalazine formulation of 2 g-granule sachet in patients already experienced 1 g-tablet
Authors: Moon W , Park S J , Kim J H
Published: January 2024

Background

The important factor is a good adherence in the treatment of inflammatory bowel disease (IBD) and the major guidelines recommend that the choice of formulation of mesalazine should consider patient preference and likely adherence. This study was to evaluate the preference for controlled-release (CR) mesalazine 2 g-granule sachet in patients who have been already experienced CR mesalazine 1 g-tablet and its related clinical factors.

Methods

First was treatment with 4 g CR mesalazine a day as two 2 g-granule sachets for 2 weeks in patients with IBD in remission who have already taken 4 g CR mesalazine a day as four 1 g-tablets for more than 3 months in Kosin University Gospel Hospital, Korea. The patients were consecutively enrolled. Second were the patients’ survey with 10 questionnaires about preferences (Table 1) after the 2 week-treatment and medical review of clinical information of patients.

Results

A total of 80 patients (46 in ulcerative colitis and 34 in Crohn’s disease, and 54 of male) were enrolled. Previous use of CR mesalazine four 1 g-tablets a day more than 1 year was in 88.6% of patients. In preference of formulation by ease to swallow, 70.0% of patients answered 2 g-granule sachet was better but just 20.0% of patients answered 1 g-tablet was better. In preference of formulation by next prescription, that is about overall preference, 63.8% of patients answered granule was better but 30.0% for tablet. In the number of 1 g-tablet or 2 g-granule sachet able to be swallowed at once, 46.9% of patients could swallow one or less tablet (1 g or less) and 96.1% of patients could swallow one or two sachets (2 g or more) (Fig. 1). When the patients who chose ‘granule was much better or better in overall preference' are classified as granule preference group and the remaining as others group. Number of tablet able to be swallowed at once in the medication before the granule trial was significantly less in granule preference group compared to others group (1.6 tablet vs. 2.0 tablet) (Fig. 2). However, the other factors including age, sex, body weight, height, body mass index, type of disease, concomitant oral medications, previous duration of 1 g-tablet use, were not associated with the overall preference.

Conclusion

In patients already experienced CR mesalazine 1 g-tablet for a long time, two-thirds of the patients more preferred to be prescribed 2 g-granule sachet and the preference was associated with the ability to swallow 1 g-tablets at once. Not only CR mesalazine 1 g-tablet but also 2 g-granule sachet can be an excellent choice for improving adherence of mesalazine treatment in IBD, especially when it comes to patients who can't take two or more 1 g-tablets at once.
P540 Non-serious adverse events in patients with ulcerative colitis receiving etrasimod: An analysis of the phase 2 OASIS and phase 3 ELEVATE UC 52 and ELEVATE UC 12 clinical trials
Authors: Lees C , Torres J , Leung Y , Vermeire S , Fellmann M , Modesto I , McDonnell A , Lazin K , Keating M , Goetsch M , Wu J , Loftus Jr E V
Published: January 2024

Background

Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate (S1P)1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). Adverse events (AEs) pertaining to tolerability, laboratory and serious AEs are described elsewhere1,2; we present a post hoc analysis of the incidence, onset and duration of the most commonly occurring non-serious AEs in the etrasimod UC clinical programme.

Methods

Data from the pooled Placebo-controlled UC cohort, derived from the phase 2 OASIS (NCT02447302) and phase 3 ELEVATE UC 52 (NCT03945188) and ELEVATE UC 12 (NCT03996369) double-blind clinical trials, were included. Cohorts comprised OASIS and ELEVATE UC 12 12-week induction periods alongside the ELEVATE UC 52 12-week induction and 40-week maintenance periods utilising a "treat-through" design. Patients (pts) with moderately to severely active UC were eligible for the etrasimod UC clinical programme. Pts were randomised to etrasimod 1 mg once daily (QD; OASIS only), etrasimod 2 mg QD or placebo. Proportions and incidence rates (IRs) of non-serious AEs (MedDRA v24.1 Preferred Terms of headache, pyrexia, nausea, fatigue and dizziness) were analysed in the Placebo-controlled UC cohort.

Results

Among 943 pts (any dose of etrasimod, N=629 [288.1 pt years (PY)]; placebo, N=314 [115.1 PY]), there were 77, 36, 30, 15 and 23 headache, pyrexia, nausea, fatigue and dizziness AEs, respectively. All were non-serious and did not lead to treatment discontinuation, apart from one case of pyrexia in which early termination visits were incomplete. Proportions and IRs (per 100 PY) for headache and dizziness AEs were higher with etrasimod (any dose) vs placebo (IRs: 13.45 vs 8.63 and 6.52 vs 1.69, respectively); IRs for other non-serious AEs were similar in etrasimod (any dose) and placebo groups (Table). Onset of AEs varied over time and most AEs were short in duration (Figure shows onset and duration for headache and dizziness AEs). Most AEs were deemed not related to study treatment by the site investigator. Pts with dizziness on Days 1–3 had similar changes in heart rate vs those with dizziness after Day 3. No consistent trend in heart rate was observed in pts receiving etrasimod with early dizziness.

Conclusion

Among pts in the etrasimod UC clinical programme, all headache, pyrexia, nausea, fatigue and dizziness events were non-serious. IRs were similar for most non-serious AEs across treatment groups, excluding headache and dizziness. Most non-serious AEs were short in duration and judged as not related to study treatment, suggesting they may not impact on the overall tolerability of etrasimod.

References

1. Sandborn WJ et al. Gastroenterology 2020; 158: 550–61.

2. Sandborn WJ et al. Lancet 2023; 401: 1159–71.
P555 Switching from intravenous vedolizumab to subcutaneous maintains clinical remission even in intensified patients with Inflammatory Bowel Disease. One year follow-up
Authors: Andres Pascual L , Arias García L , Saiz Chumillas R M , Chivato Martín-Falquina I , Sicilia Aladren B
Published: January 2024

Background

Vedolizumab is a humanized monoclonal antibody. It is indicated for moderate to severe flare of Inflammatory Bowel Disease (IBD). Subcutaneous (SC) vedolizumab, is a major advantage for patients for home administration. This study aimed to analyze the percentage of clinical and biochemical remission at 52 weeks in all IBD patients on treatment with intravenous (IV) vedolizumab after switching to the SC one.

Methods

Single-center, descriptive, observational, and retrospective study. The study included all the IBD patients (19 patients) who were at the moment of inclusion with IV vedolizumab treatment in a tertiary hospital, who underwent a switch from IV vedolizumab to SC vedolizumab. In addition, the relationship between treatment with intensified IV vedolizumab and subsequent drug levels versus patients without intensification for 52 weeks.

Results

Ten patients (22.6%) were diagnosed with Ulcerative Colitis (UC) and 9 patients (47.3%) with Crohn´s disease (CD). The baseline characteristics of the 19 patients are described in Table 1. Reasons for starting IV vedolizumab: there was loss of response to a first anti-TNF in 10 patients (52.6%) and loss of response to two previous anti-TNFs was observed in 3 patients (15.7%). In 4 patients (21%) IV vedolizumab was started as the first line of treatment due to the increased risk of infections and a previous history of neoplasia. Finally, in 2 patients with CD (10.5%) it was started as prevention of recurrence. Up to a total of 8 patients (42.1%) were on an intensified IV vedolizumab before switching to SC vedolizumab. All 19 patients (100%) were in clinical remission and 15 patients (78.9 %) remained in biochemical remission prior to switching to SC vedolizumab. At the end of the follow-up (52 weeks) all of them achieved clinical remission and 17 patients (89.4%) achieved biochemical remission (Figure 1). Therefore, biochemical remission was achieved in 10% more patients after the switch. It was noted that biochemical remission was achieved in 87% of patients on the intensified regimen with IV vedolizumab versus 100% of patients on the non-intensified regimen. No statistically significant differences were obtained between patients who had been on intensified IV vedolizumab and those who had not. At one year of follow-up, SC vedolizumab was suspended in one patient due to muscle pain, and IV vedolizumab was restarted again.

Conclusion

Following the standard dose switch of SC vedolizumab, clinical remission is maintained, achieving biochemical remission in 89.4 % of patients one year with SC vedolizumab with maintained vedolizumab levels, even in previously intensified IV vedolizumab patients.
P576 Fecal calprotectin could predict clinical and endoscopic response to ustekinumab therapy
Authors: Bertani L , Tricò D , Barberio B , Vernero M , Bretto E , Ceccarelli L , Pardi V , Calabrese F , Pasta A , Bertin L , Fabiana Z , Semprucci G , Bodini G , Ribaldone D G , Savarino E V , Costa F
Published: January 2024

Background

Ustekinumab (UST) is one of the most used biologic drugs for the treatment of Crohn’s Disease (CD) and Ulcerative Colitis (UC). However, not all patients achieve clinical remission and even less mucosal healing. There is currently scarce knowledge about the early markers of therapeutic response in this setting, with particular regard to mucosal healing. The aim of this multicenter study was to evaluate the role of fecal calprotectin (FC) as early predictor of mucosal healing.

Methods

We enrolled consecutive patients with CD or UC treated with UST for at least 48 weeks at four referral centers in the last 5 years. Therapeutic response was evaluated in terms of clinical remission (defined as a Partial Mayo Score <2 for patients with UC and as Harvey Bradshaw Index <5 for patients with CD, without concomitant corticosteroid therapy) and mucosal healing (defined as a Mayo Endoscopic Score <2 for UC and as the disappearance of ulcers for CD). We collected clinical and demographic data, as well as fecal calprotectin (FC) and C-Reactive Protein (CRP) levels at baseline and at week 24.

Results

Among 196 patients enrolled (73 [37.2%] women), 167 were affected by CD, whereas 29 by UC. Globally, 128 (65.3%) patients achieved clinical remission and 83 (42.3%) endoscopic remission at 48 weeks of treatment. There were no group differences in age, sex, BMI, baseline clinical and endoscopic indexes, or baseline CRP levels between patients achieving or not either clinical or endoscopic remission. Baseline calprotectin levels were lower in patients who achieved endoscopic remission (median [interquartile range] 391 [103, 1050] versus 825 [317, 1800] µg/mL,p=0.002). At week 24, lower calprotectin levels were observed in both the groups who achieved clinical (160 [50, 426] versus 439 [146, 1000] µg/mL,p<0.0001) and endoscopic remission (114 [43, 265] versus 392 [139, 912] µg/mL,p<0.0001) compared with non-responders. The effects of week-24 calprotectin levels on clinical remission (β= -0.003,p<0.0001) and endoscopic remission (β= -0.004,p<0.0001) remained significant in multivariable models adjusted for age, sex, and BMI. A cut-point of 268 µg/mL was identified as the optimal threshold of week-24 calprotectin for predicting clinical remission (sensitivity 65%, specificity 67%, ROC AUC 0.689), while a cut-point of 309 µg/mL was identified to predict endoscopic remission (sensitivity 79%, specificity 59%, ROC AUC 0.712).

Conclusion

Our data suggest that FC assessment after 24 weeks of treatment with UST could represent a promising early marker of response, even in terms of mucosal healing, in both CD and UC.
P599 An Antioxidant diet in comparison to a Mediterranean diet for children and adults with Inflammatory Bowel Disease: clinical outcomes and nutritional data from OXIBDiet trial
Authors: Quattrini S , Galeazzi T , Greco A , Fioroni M C , Mattioli S , Monachesi C , Cianfruglia L , Romaldi B , Catassi G , Quatraccioni C , Di Sario A , Armeni T , Catassi C , Gatti S
Published: January 2024

Background

The multicentre OXIBDiet trial (NCT04513015) has already demonstrated a redox imbalance in IBD children compared to adults and controls. The second part of the study aimed to evaluate the impact of an Antioxidant Diet (AoD) in comparison to a Mediterranean Diet (MD) in IBD patients. Clinical outcomes and nutritional data are reported.

Methods

IBD children and adults with mild symptoms/remission were randomly assigned to AoD (polyphenols intake >650 mg/die) or MD for 12 weeks. In the paediatric sample a Free Diet (FD) group was enrolled. At baseline and at 12 weeks inflammatory, oxidative stress (OS), clinical and anthropometric parameters were recorded. Dietary habits were registered by a validated Food Frequency Questionnaire and nutritional intakes were estimated with Winfood software.

Results

Twenty-five children (10 OD, 10 MD, 5 FD) and 17 adults (9 OD, 8 MD) completed the study. The total antioxidant capacity (Ferric reducing antioxidant power, FRAP) of the total IBD cohort significantly increased only in AoD (p=0.024) group and the Protein Oxidation (AOPP) showed a trend of decrease in AoD group (p=0.065). Stratifying for age, the same results of FRAP emerged only in the paediatric sample, following the AoD (Figure 1).

Weight z-score (p=0.04) and BMI z-score (p=0.054) increased significantly in children following the AoD. The AoD groups both in children and in adults showed respectively a significant improved in health status (p=0.016) and in Food Related QoL. Faecal calprotectin (FC) showed a trend toward reduction both in AoD and MD groups and an increase in the FD group. At week 0 dietetic habits and nutrients intakes were similar in children in the AoD and MD groups. Changes in nutrients intakes at week 12 for both groups are reported in Table 1. In AoD group of IBD children a significant positive correlation between FRAP and intake of polyphenols emerged (p=0.015).

Conclusion

Preliminary results showed a significant improvement in OS imbalance and anthropometric parameters in IBD subject following an AoD. Antioxidant micronutrients intakes increased in IBD children especially on AoD, with a positive effect on the total antioxidant capacity. Also, QoL and Faecal calprotectin showed a favourable trend in AoD group, both in children and in adults. Final results of the study will allow to clarify the role of oxidative stress and antioxidants in IBD pathogenesis and treatment.
P604 Exploring the role of chest X-ray in latent tuberculosis screening in Inflammatory Bowel Disease
Authors: Farrugia Y , Chatlani D , Camilleri C , Sciberras M , Ellul P
Published: January 2024

Background

Patients being treated with biologics or JAK inhibitors have an increased reactivation risk of latent tuberculosis infection (LTBI), and this is associated with a more severe infective course. Current ECCO guidance recommends the screening for LTBI by a combination of patient clinical data and epidemiological factors, chest X-ray (CXR), and tuberculin skin test or interferon-gamma release assay (IGRA) prior to starting immunosuppressive treatment. The evidence supporting CXR is categorized at evidence level 5, and information on its use in screening for LTBI originates from two decades ago. Apart from radiation exposure, a single posterior-anterior view has limited diagnostic capabilities.

This study aims to determine the relation between CXR findings and IGRA test results in patients undergoing LTBI screening before commencing immunosuppressive therapy for Inflammatory bowel disease (IBD) patients in a low-risk population.

Methods

This is a retrospective analysis whereby IBD patients (≥16 years) on biologics or JAK inhibitors were identified from our local database. The clinical data, epidemiological, CXR and IGRA result were then analysed from the electronic case records. The IGRA test used was the QuantiFERON-TB Gold.

Results

A total of 356 patients were included in the study, with 58.7% (n=209) being male. Among these patients, the majority had Crohn's disease (66.6%, n=236), 30.1% (n=109) had ulcerative colitis, and the remaining 2.8% were classified as having IBD-unclassified. Most patients (97.1%) had been exposed to anti-TNF alpha medications and 13.2% were exposed to multiple biologicals.

The mean age of IBD diagnosis was 30.3 years (SD+/-15.7). None of the patients had any clinical suggestion nor any evidence for exposure to TB.

None of the CXRs performed revealed any radiological signs of prior TB infection. 93.8% (n=334) of the IGRA results were negative and 4.2% (n=15) were categorized as indeterminate. Among those with indeterminate results, 66.7% (n=10) were undergoing corticosteroid treatment for active disease. The remaining 2.0% (n=7) had a positive IGRA test and were treated for LTBI.None of these patients had TB reactivation when then treated with biologicals.

Conclusion

This research highlights that performing routinely a CXR in individuals with a negative IGRA offers little to no benefit, and subjects patients to unnecessary radiation. It also demonstrates the importance of conducting the IGRA test early, before initiating any immunosuppressive treatment.

Furthermore, in patients with a negative IGRA, if chest imaging is required for screening purposes, opting for an ultra-low dose CT might be more prudent than a CXR, as it visualises the lungs better and the radiation exposure is not substantially different.
P606 A Retrospective Observational Study of Patterns of Biologic Drug Change in Inflammatory Bowel Disease
Authors: Mosli M H A
Published: January 2024

Background

The treatment of inflammatory bowel disease (IBD) has evolved over the past two decades. Due to the recent introduction of multiple new biologics, it is crucial to understand the temporal patterns of drug change. This study aimed to examine the patterns of biological drug change over time and identify predictors of change in a cohort of patients with IBD.

Methods

We performed a retrospective study of patients diagnosed with IBD who were initiated on biologics and followed up at King Abdulaziz University (KAU) hospital, Jeddah, Saudi Arabia between June 2017, and October 2022. The KAUH inflammatory bowel disease information system (IBDIS) database was used to identify eligible patients. The study's primary objective was to describe biologics drug change patterns. Secondary outcomes included identifying predictors of drug change and time to discontinue biologics. Uni- and multi-variable odds ratios (ORs) were used to determine the predictors of drug change.

Results

A total of 910 patients who were registered in the IBDIS database were screened; 475 patients fulfilled the study criteria. 67% had CD, and 53.3% were males. The mean age at diagnosis was 22.6 (11.0) years. The most selected first and second choice of biologic was adalimumab (58.2% and 39.1%, p<0.001) and infliximab (37.6% and 48.9%, p=0.004) for both CD and UC, respectively. Ustekinumab was the primary third choice for CD (65.4%), while vedolizumab was the third choice for UC (83.3%). The proportions of patients who switched from first- and second-line adalimumab, infliximab, and vedolizumab were 52.3% and 20.9%, 37.6% and 39.9%, and 10.1% and 18.3%, respectively. On multiple regression analysis, a history of venous thromboembolism (VTE) (OR=3.60, 95% CI=1.20-11.71, p=0.025) and active smoking (OR=0.34, 95% CI=0.12-0.82, p=0.026) were associated with drug change for all patients. When stratified by disease subtype, drug change was associated with a diagnosis made between age 17 and 40 years (OR=0.46, 95% CI=0.23-0.90, p=0.024) and EIMs (OR=2.07, 95% CI=1.16-3.76, p=0.015) in CD while selecting vedolizumab as first biologic (OR=0.30, 95% CI=0.09-0.92, p=0.041), male gender (OR=2.40, 95% CI=1.04-5.73, p=0.043), and history of VTE (OR=7.32, 95% CI=0.23-49.97, p=0.031) were associated with drug change in UC.

Conclusion

Despite introducing several new biologics, anti-TNF therapies remain the preferred first and second choice of biologics for patients with IBD. The use of adalimumab is associated with the highest risk of switch. Multiple predictors of drug change over time exist for both diseases. The selection of vedolizumab as the first biologic for UC is associated with a lower risk of drug change.
P609 Artificial intelligence in the image recognition of pouchoscopies in patients who have undergone restorative proctocolectomy with ileal pouch anal-anastomosis (IPAA)
Authors: Saifi M , Schmitz D , Ringwald F , Eisenmann U , Rudi J , Kienle P
Published: January 2024

Background

Restorative proctocolectomy with ileal pouch anastomosis (IPAA) has become the gold standard in the surgical treatment of ulcerative colitis, with pouchitis being the most common late complication of IPAA. Pouchoscopy is the diagnostic tool of choice to examine the pouch in cases of pouchitis. Artificial intelligence (AI)-based image recognition programmes can assist the examiner in making a diagnosis, support in the education of physicians in training and potentially improve patient outcomes. The use of artificial intelligence has not yet been demonstrated in patients with IBD. The aim of this study is the development of an image recognition algorithm based on Convolutional Neural Networks (CNN) that reliably detects the endoscopic findings of pouchitis analogue to the PDAI score in endoscopic images.

Methods

The dataset consisted of 10 pouchoscopy videos, which were split into individual frames and assessed using a specially developed labelling tool. In the training process, the labelled images were divided into training, validation and test datasets (ratio 60:20:20). Pre-trained networks and hyperparameters were selected by cross-validation. The defined networks were then fine-tuned through tenfold cross-validation and evaluated for accuracy, specificity, precision F1 score and AUC.

Results

Our dataset consisted of 7130 images, with 1961 images in the „Inflammation“ group, 2326 images in the „Not assessable“ group and 2843 images in the „Healthy“ group. The final model has been cross-validated 10 times and has been shown to be able to correctly assess the endoscopic features of pouchitis to a certain extent. However, its performance is not yet sufficient for clinical use.

Conclusion

The work has shown that it is possible to develop an image recognition programme using artificial intelligence that is capable of detecting endoscopic features of pouchitis to a certain extent. Our model is not yet able to make a reliable classification, so it is not yet ready for practical use. However, it should be noted that this project was a feasibility study with a small number of cases and a limited patient population. Further research and more data are needed to sufficiently train the model. Once this is done, the model could be further developed to make reliable classifications and be used in clinical practice.
P611 Relation between AntiTNF levels during the induction and clinical and radiological outcomes in perianal Crohn´s disease
Authors: Amiama Roig C , Suarez Ferrer C , Martin Arranz E , Rueda Garcia J L , Sánchez Azofra M , Poza Cordón J , Gonzalez Diaz I , Amor Costa C , Martín-Arranz M D
Published: January 2024

Background

Perianal Crohn's disease(PCD) significantly impacts quality of life with poor long-term prognosis. Anti-tumor necrosis factor(anti-TNF) therapy improves fistula closure rates. However, achieving permanent closure remains challenging. Our aim is to evaluate the relation between antiTNF(infliximab (IFX) and adalimumab(ADA) serum concentrations at induction(w2 and 6), and clinical and radiological outcomes at w24 and w52

Methods

We conducted a single tertiary center, retrospective, cohort study including patients with an established diagnosis of PCD treated with antiTNF because of perianal activity. Variables related to their PCD(phenotype, location, fistulas type) were collected. Regarding treatment, we collected serum levels at week 2,6,24 and 52, concomitant treatment and setons presence. We defined clinical response as the absence of drainage on physical examination and clinical remission as the absence of external fistula openings. Radiological response was defined as the absence of T2 hypersignal, gadolinium enhancement, abscess and proctitis in pelvic MRI

Results

65 patients were included, baseline characteristics are in Table1. None of the demographic characteristics collected were statistically significant related to clinical or radiological response although non smokers(p=0.01), ileal(p=0.02) and non-stricturing disease(p=0.01) had statistically significant higher drug levels. Taking into account the clinical response at w52, IFX mean levels at w2 were 25.8µg/mL(SD 4.1) in non responders and 30.9µg/mL(SD 14) in responders(p=0.39). At w6 they were 17.2µg/mL(SD 12.2) and 19.4µg/mL(SD 13.8) respectively(p=0.7). ADA mean levels at w2 were 13.3µg/mL(SD 7.7) in non responders and 14µg/mL(SD 6.3) in responders(p=0.87). At w6 they were 10.1µg/mL(SD 3.3) and 12µg/mL(SD 6.1) respectively(p= 0.59). For radiological response at w52 IFX mean levels at w2 were 27µg/mL(SD 15.3) in non responders and 32.7µg/mL(SD 14.5) in responders(p=0.45). At w6 the mean levels were 15.9µg/mL(SD 6.7) and 23.7µg/mL(SD 14.8) respectively(p=0.27). In ADA group the mean levels at w2 were 14.8µg/mL(SD 7.6) in responders and only one patient did not respond. At w6 ADA mean levels were 12.3µg/mL(SD 5.9) in non responders and 12.7µg/mL(SD 6.2) in responders(p=0.94). Early response at w24 was related with a long-term response at w52, 89.9% of the patients who responded at w52, had already responded at w24.

Conclusion

In our study we observed that almost 90% of the patients who had an early response also responded at w52, so trying to achieve an early response should be an aim in clinical practice. Despite the limited number of patients, our study shows a trend in the relationship between higher antiTNF levels and clinical and radiological response rates
P646 Clinical decision support in the prevention of adverse effects associated with immunosuppressive drugs in patients with Inflammatory Bowel Disease
Authors: Lobato Matilla M E , Marin Jimenez I , Menchén Viso L A , Miranda Bautista J , Chamorro de Vega E , Romero Jiménez R , Ferris Villanueva M , Herranz Alonso A , Sanjurjo Sáez M
Published: January 2024

Background

With the goal of effective and early prevention and detection of medication-related adverse effects, an explosion of technological advances is taking place. However, none of these systems are currently intelligent enough to ensure safe prescribing of treatments on their own.

Purpose

To design and integrate clinical decision rules (CDR) to increase the safety of immunosuppressive treatments in patients with inflammatory bowel disease (IBD) into an electronic prescribing assistance software (HIGEA).

Methods

This is a descriptive study conducted in a tertiary university hospital in Madrid (Spain).

1. We reviewed the technical product information sheet of the immunomodulatory drugs used in the treatment of patients with IBD and the current recommendations and clinical practice guidelines on the management of IBD.

2. The CDR were developed within a multidisciplinary team of physicians and pharmacists by integrating data from pharmacogenetics, microbiology, biochemistry, immunology and haematology laboratories, the electronic medical record and the electronic prescribing programme.

3. Integration was performed using a standard language (HL7).

Results

The technical product information sheet of 33 immunomodulatory drugs (19 biological therapies, 6 small molecules and 8 traditional disease-modifying drugs) and the clinical practice guidelines for the treatment of IBD of the European Crohn's and Colitis organisation (ECCO) and the Spanish working group on Crohn's disease and ulcerative colitis (GETECCU) were reviewed.

A total of 169 CDR were developed: 2 related to pharmacogenetics laboratory values, 26 to microbiology, 38 to biochemistry, 24 to immunology, 42 to haematology, 28 to clinical history and 9 related to concomitant use of other drugs.

Of the 169 CDR, 50 (29.58 %) were related to screening prior to initiation of immunosuppressive treatment, 10 (5.92%) to drug interactions and 109 (64.5%) related to clinical conditions requiring adjustment or discontinuation of immunosuppressive treatment.

Conclusion

The incorporation of personalised clinical rules into the medical prescription and pharmaceutical validation process will allow the selection of patients in whom there could be a safety problem with immunosuppressive treatment, increasing the percentage of early detected and avoided adverse events.

Future steps will be to evaluate the impact of the implementation of the CDR tool on increasing safety, reducing healthcare costs and improving patient health outcomes.
P665 Statins use and the risk of colorectal cancer in patients with inflammatory bowel disease: A Systematic review and meta-analysis
Authors: Jung B W , Lee W M , Choi S , Lee H S , Park Assistant professor J J
Published: January 2024

Background

Statin use has been linked to a reduced risk of advanced colorectal adenomas; however, its association with colitis-associated dysplasia and cancer is not well-defined. We aimed to perform a systematic review and meta-analysis to assess the pooled association of statin exposure with dysplasia and colorectal cancer in patients with inflammatory bowel disease (IBD).

Methods

We searched MEDLINE, EMBASE, and the COCHRANE library to identify full text articles analyzing the risk of CRC or dysplasia development based on statin use in patients with IBD. A meta-analysis was performed using a random-effects model to pool estimates and report hazard ratios [HRs] or odds ratios [ORs], following the data format specified in the individual studies.

Results

A total of 4 studies were identified as eligible for the meta-analysis. In the analysis of studies presented with time-to-event outcomes, statin use was associated with a statistically significant reduction in risk of colorectal cancer (HR 0.76, 95% confidence interval [CI] 0.61-0.95, P=0.016). Meanwhile, in the analysis of non-time-to-event study results, statin use was associated with a trend towards lower colorectal cancer risk (OR 0.28, 95% CI 0.07-1.10, P=0.068).

Conclusion

Statin use appears to be associated with a reduced risk of colorectal cancer in patients with inflammatory bowel disease. Statins may serve as potential chemopreventive agents for long-standing IBD patients, and further large-scale prospective studies will be needed to confirm its potential benefit.
P710 Prevalence, Characteristics and Management of Patients with Difficult-To-Treat Inflammatory Bowel Disease: A Cross-Sectional Study From a Tertiary Referral Center
Authors: Parigi T L , Massimino L , Carini A , Allocca M , D'Amico F , Furfaro F , Zilli A , Peyrin-Biroulet L , Ungaro F , Danese S
Published: January 2024

Background

Difficult-to-treat (D2T) inflammatory bowel disease (IBD) is defined by lack or loss of response to advanced treatments with 2 or more mechanisms of action (MoA), Crohn’s (CD) recurrence after 2 resections, chronic antibiotic refractory pouchitis, complex perianal CD or by the presence of psychiatric comorbidities impairing IBD management.1 We aimed to assess the prevalence, characteristics, management, and outcomes of D2T-IBD.

Methods

We retrospectively searched the electronic medical records of patients with IBD followed at San Raffaele Hospital (Milan, Italy) as of October 1st, 2023. Patients enrolled in clinical trials altering disease management were excluded.

Results

In total 679 patients with moderate-to-severe IBD were included (350 CD, 326 UC, 3 IBD-U). 163 patients (24%) met at least one criterion of D2T (25% CD, 23% UC). Of these, 75% did not respond or lost response to 2 or more biologics/small molecules with different MoA, 18% had complex perianal CD, 17% had CD recurrence after 2 or more resections for active CD, the remaining had antibiotic refractory pouchitis or psychiatric comorbidities impairing IBD management. Multiple criteria can coexist. Figure 1.

Drug-wise, 54% of patients with D2T-IBD failed 2 MoA, 26% 3 MoA, and 3% 4 MoA, the remaining had other causes of D2T-IBD.

Prevalence of D2T varied across phenotypes of CD. The presence of perianal disease doubled the probability of D2T-CD (48 vs 24%); stricturing (B2), fistulizing (B3), and upper gastrointestinal involvement (L4) also increased risk. In UC, 22% of left-sided colitis (E2) and 27% of pancolitis (E3) were D2T, no proctitis was D2T.

Patients with D2T-CD had a longer mean disease duration (14 vs 8.7 years; p<0.05) and time on advanced treatments (78 vs 63 months; p<0.05). The same two analyses showed no significant difference for UC (11.6 vs 11.2 years; and 41 vs 50 months; both p>0.05).

Differently from bio-naive patients (Figure 2A), patients with D2T-IBD were mostly on ustekinumab, followed by infliximab and adalimumab in CD, and by upadacitinib, infliximab and tofacitinib in UC. Notably, 11 patients with D2T-CD received a combination of advanced therapies. Figure 2B

Overall, 61% of patients with D2T-IBD were in clinical remission, 43% in biochemical remission (calprotectin <150 μg/g), and 13% in endoscopic remission (Mayo≤1; or SES-CD≤3 or Rutgeerts i0-i1).

Conclusion

D2T-IBD is heterogeneous but most commonly due to multidrug failure and associated with certain phenotypes of IBD. Ustekinumab was the most common treatment choice for D2T-IBD. The majority of patients with D2T-IBD achieved clinical remission but failed to achieve biochemical or endoscopic remission.

1. Parigi et al. Lancet Gastroenterol. & Hep. 2023
P712 Effectiveness of switching from intravenous to subcutaneous infliximab in Inflammatory Bowel Disease patients: A combined analysis of real-world evidence
Authors: Cummings F , Buisson A , Smith P J , Rahmany S , Subramanian S , Kwon B , Park S , Lee Y N , Fumery M
Published: January 2024

Background

Since approval, numerous inflammatory bowel disease (IBD) patients have been treated with subcutaneous (SC) infliximab (IFX), but real-life data based on a large multi-national population of patients switching from intravenous (IV) to SC IFX is lacking.

Methods

The ASSEMBLE project is an initiative to combine multi-national real-world cohort datasets and analyse the effectiveness and safety of SC IFX therapy. In the ASSEMBLE-1 analysis, three studies from France and the United Kingdom1-3 were integrated to assess the clinical outcomes up to 6 months (6M) after switching from IV to SC IFX. Clinical remission was defined as Harvey-Bradshaw Index (HBI) or modified HBI (mHBI) <5 for Crohn’s disease (CD) and Simple Clinical Colitis Activity Index (SCCAI) or partial Mayo score (PMS) <3 for ulcerative colitis (UC). Treatment persistence was assessed by Kaplan-Meier survival analysis.

Results

The data of 428 patients were pooled from the three datasets (70.6% CD, 29.4% UC). 85.4% of patients were in clinical remission before switching with median HBI or mHBI of 1 (IQR 0,2) for CD and median SCCAI of 2 (IQR 1,3) or PMS of 0 (IQR 0,0) for UC. 59.6% of patients were treated with the standard dose of IV IFX (5 mg/kg Q8W) before switching and 54.0% of patients were on concomitant immunomodulator therapy. Patients were switched to SC IFX 120 mg Q2W (94.4%) or 120 mg QW (5.6%) regimen. After switching, the overall clinical remission rates were 83.4% and 84.7% at 3M and 6M, respectively. CD patients were associated with higher remission rate (89.8%) than UC patients (71.9%) at 6M (p<0.001). The disease activity scores and the levels of fecal calprotectin and C-reactive protein of the overall population were maintained stable after switching (Table 1). High persistence was observed in both CD (97.3% at 3M, 94.8% at 6M) and UC patients (96% at 3M, 94.1% at 6M), with no significant difference between indications (p=0.47 at 3M and p=0.78 at 6M). Perianal CD patients (n=89) did not have a significantly worse treatment persistence rate than non-perianal CD patients (p=0.30). The most common reasons leading to drug discontinuation were lost to follow-up, consent withdrawal, worsening of disease activity, and worsening of perianal disease (3 cases for each). Two patients discontinued due to injection-site pain.

Conclusion

This pooled analysis of ASSEMBLE-1 confirms that switching from IV to SC IFX is effective and safe for CD and UC patients in clinical practice and that the clinical remission is well maintained up to 6M after switching, with no new concerns in safety profiles. [1] Smith et al. J Crohns Colitis 2022 [2] Buisson et al. Clin Gastroenterol Hepatol 2023 [3] Rahmany et al. Gastroenterology 2023.
P722 The steep ramp test is a valid practical test to assess cardiorespiratory fitness in patients with inflammatory bowel disease
Authors: Demers K , Bongers B C , Jonkers D M A E , Pierik M J , Stassen L P S
Published: January 2024

Background

Comprehensive disease management of inflammatory bowel disease (IBD) requires a holistic approach that extends beyond achieving endoscopic healing. Monitoring health-related physical fitness (HRPF) parameters (i.e. body composition, cardiorespiratory fitness, muscular strength, muscular endurance, and flexibility) may lead to a more proactive approach to managing IBD, as IBD may affect HRPF due to e.g. chronic inflammation, malnutrition, corticosteroid use, and reduced physical activity. Yet, knowledge regarding HRPF in patients with IBD is limited. Assessment of cardiorespiratory fitness (CRF), a key component of HRPF in other chronic diseases, could offer valuable insights into physical capacity and overall health. However, the gold standard, measuring oxygen uptake at peak exercise (VO2peak) achieved during cardiopulmonary exercise testing (CPET) is impractical for widespread implementation in clinical practice. The steep ramp test (SRT), a short-term maximal exercise test on a cycle ergometer, might serve as a less demanding assessment method to facilitate routine assessment of CRF in clinical practice and deliver more practical endpoints for intervention studies. This study aimed to examine the criterion validity of the SRT as compared with CPET in evaluating CRF in patients with IBD.

Methods

From August 2022 to October 2023, adult patients with IBD in remission or with mild-to-moderate clinical disease activity were consecutively enrolled. Each participant performed a SRT and a CPET within 14 days to examine CRF. The main outcome measures were the achieved work rate at peak exercise (WRpeak) for the SRT (SRT-WRpeak) and VO2peak as well as WRpeak for CPET (CPET-VO2peak and CPET-WRpeak). Validity of the SRT was evaluated with Pearson’s correlation coefficients between SRT-WRpeak and CPET-VO2peak and SRT-WRpeak and CPET-WRpeak.

Results

A total of 50 participants, with a mean age of 42.9 years and 56% diagnosed with CD, were included (Table 1). One participant was excluded from the analysis due to the inability to achieve a maximal effort during CPET. Mean (±SD) WRpeak attained at the SRT was 4.32 (±1.06) W·kg-1, and mean (±SD) VO2peak and WRpeak achieved during CPET were 33.47 (±9.85) mL·kg-1·min-1 and 2.90 (±0.95) W·kg-1, respectively. Figure 1 illustrates robust linear relationships with very strong correlations between SRT-WRpeak and CPET- VO2peak (r=0.945, p<0.001) and SRT-WRpeak and CPET-WRpeak (r=0.960, p<0.001).

Conclusion

Results of this study suggest that the SRT is a valid alternative test for examining CRF in patients with IBD, indicating its potential application in both clinical practice and intervention studies. Further research should explore the criterion validity of practical tests for other components of HRPF.