bluuebunny/crossref_metadata_2025 huggingface dataset:
P0739 Treatment persistence, clinical, and biological outcomes following an elective switch from intravenous to subcutaneous infliximab and vedolizumab
Authors: Outtier A , Hoffert Y , De Dycker E , Geens P , Lambrechts T , Loddewijkx E , Paps A , Verstockt B , Sabino J , Vermeire S , Ferrante M ,   TARGID
Published: January 2025

Background

Subcutaneous (SC) formulations of infliximab (IFX) and vedolizumab (VDZ) are approved for treating ulcerative colitis (UC) and Crohn’s disease (CD). This study reports on treatment persistence, as well as clinical, biological and pharmacological outcomes following an elective switch from maintenance intravenous (IV) to SC IFX and VDZ.

Methods

We conducted a single–centre, prospective, observational study from November 2021 through June 2024, enrolling stable inflammatory bowel disease (IBD) patients (based on physician global assessment) willing to switch from maintenance IV IFX or VDZ to SC treatment, and with a minimum follow-up of 34 weeks. Data were collected on patient characteristics, prior and current medications, clinical and biological activity, and pharmacokinetics. Assessments were made at time of last IV infusion, baseline (first SC injection, 4 weeks after last IV), week 8, week 34, and last follow-up. The primary objective was SC treatment persistence. Secondary objectives included change in the two-component patient reported outcome (PRO2), C-reactive protein (CRP), faecal calprotectin and serum levels (SL).

Results

In this study, 140 IBD patients (median age 44.2 years, 78 female, 64 UC, 76 CD) switched from IV IFX (n=59) or VDZ (n=81) to SC treatment. One hundred and fifteen patients were on standard IV dosing versus 25 patients on optimized IV dosing (19 IFX, 6 VDZ). No patient received concomitant immunosuppressants. Over a median follow-up of 20.2 (IQR 13.6-26.4) months, 83.6% of patients remained on the SC formulation, with more patients continuing on SC IFX compared to VDZ (odds ratio 2.56 [95% CI 1.12-5.88], p=0.025, Figure 1). No other baseline factors were linked to treatment persistence. The main reasons for discontinuation were disease flare and side effects (Figure 1). Seventeen patients returned to IV treatment, while six patients switched to another biologic. Median (IQR) PRO2 (for UC: 0 [0-0] at baseline, 0 [0-1] at week 8, and 0 [0-0] at week 34; for CD: 2 [0-7] at baseline, 2 [0-7] at week 8, and 0 [0-6] at week 34), CRP (1.6 [0.7-3.8] mg/L at baseline, 1.4 [0.6-3.7] mg/L at week 8, and 1.9 [0.7-5.1] mg/L at week 34), and faecal calprotectin (30 [30-112] µg/g at baseline, 37 [30-139] µg/g at week 8, and 54 [30-86] µg/g at week 34) remained stable over time. However, median (IQR) IFX and VDZ SL increased significantly over time compared to time of last IV infusion (all p<0.0001) (Table 1).

Conclusion

Switching from maintenance IV to SC IFX or VDZ is a viable option for stable IBD patients, though 16% experienced flare-ups or side effects after switch. Treatment discontinuation was more common with SC VDZ than IFX.
P0740 Effectiveness and safety of ustekinumab in elderly Crohn's Disease patients
Authors: Ruiz Núñez I , Morera Sauca L , Madrigal Domínguez R E , Barrio Andrés J , De Prado Santos Á , Mata Román L , Marinero Muñoz M Á , García Alonso J
Published: January 2025

Background

The incidence of inflammatory bowel disease is increasing among elderly patients. Ustekinumab (UST) has demonstrated an excellent safety profile in various clinical trials, being a promising alternative for this group of patients.

Methods

We present a retrospective 2-centre case series. Patients over 50 years old with a Charlson comorbidity index >=3 with Crohn’s disease (CD) started on Ustekinumab between January 2017 and December 2023 were included. Clinical remission was defined as a Harvey Bradshaw index <5 and biochemical remission as a fecal calprotectin <250 mg/kg and a C reactive protein <10 mg/L. Target variables were analysed at 12, 24,48 and 96 weeks of treatment. Serious infections (those requiring a hospital admission) and de novo neoplasms were collected during the entire follow-up. Missing data were imputed using the last observation carried forward method.

Results

Among the 286 patients receiving UST during the study period, 82 subjects were eligible. Baseline characteristics are shown in table 1. Most frequent comorbidities were previous malignancy in 26 (31%), diabetes in 17 (21%) and rheumatic diseases in 12 (15%). At 12, 24, 48 and 96 weeks, clinical remission was observed in 84%, 82%, 88% and 78% of patients, while corticosteroid-free clinical remission was achieved in 78%, 82%, 87% and 76%, respectively. Clinical remission rates were higher in bio-naïve patients (figure 1).

Biochemical remission was achieved in 41%, 45%, 41% and 42% at 12, 24, 48 and 96 weeks, respectively. Again, relevant differences were observed depending on previous treatments. Bio-naïve patients reached 52.2% and 55% at weeks 48 and 96, while bio-experienced patients presented poorer results (34.2% and 32.1%)

Adverse events were evaluated considering the whole follow-up available (median: 649.5 days (IQR 378-1280)). Serious infections were detected in 4 (4.9%) patients, with an estimated risk of 3 cases per 100 patients-year. Malignant neoplasms were diagnosed in 4 (4.9%) patients. Most (75, 91.5%) patients were still under treatment at the end of the study period, with a 2-year treatment persistence of 93.6% (95% CI: 83.7-97.5%).

Conclusion

Among frail patients, UST reached over 75% clinical remission rates with biochemical remission rates approaching 45%. Despite this biochemical remission rates, treatment persistence at 2 years was over 90%, suggesting current management of frail patients prioritise clinical outcomes.
P0741 Adherence to mesalazine suppositories maintenance treatment in patients with ulcerative proctitis: MESUPO multicenter prospective observational study from GETECCU
Authors: Ferreiro Iglesias R , Nieto García L , de Castro M L , Pérez Galindo P , Hernández Camba A , García M J , Calvo Íñiguez M , Rodríguez-Lago I , Martí E , Iriarte A , Pallarés H , Dueñas Sadornil C , Zabalza San Martín L , Ramirez de la Piscina P , Rodríguez L , Bastón Rey I , Martínez Cadilla J , Álvarez Cancelo A , Porto Silva S , Zabana Y , Barreiro-de Acosta M ,   Young Group of GETECCU
Published: January 2025

Background

Mesalazine suppositories are recommended in guidelines for the induction and maintenance of remission in patients with ulcerative proctitis (UP). Nevertheless, nonadherence can be frequent and the recommended dose of mesalazine suppositories in maintenance treatment remains unknown. The aim of this study was to determine the frequency of non-adherence to mesalazine suppositories, evaluate potential factors for nonadherence and the impact on quality of life and number of relapses in patients with UP.

Methods

A multicenter, prospective observational study was designed in patients ≥18 years old with UP under maintenance treatment with mesalazine suppositories (Claversal© 500 mg, Pentasa© 1g or Salofalk©1g). We evaluated adherence, sociodemographic data and complications associated with poor adherence at 6 and 12 months. Adherence was assessed by tracking pharmacy refills (medication possession ratio, MPR). We defined good adherence as MPR ≥80% over 12 months. Health-Related Quality of Life (HRQoL) was evaluated using the disease-specific shortened Spanish version of the IBDQ (SIBDQ-9). Relapse was defined as partial Mayo ≥2. Quantitative data were analyzed using Rstudio software (version 2023.12.1 + 402)

Results

A total of 188 patients with mean age 51 were consecutively included across 14 Spanish hospitals (Table 1). Of these, mean MPR was 76% and 56% presented MPR ≥80%. Mean age was higher among patients with MPR ≥80% (p=0.045). A total of 31 patients (16%) had a relapse and 3 (1.6%) patients were hospitalized during the follow-up. Unemployment(OR=5.08, p=0.025), concomitant anal pathology (OR=5.08, p =0.025) and use of corticosteroids during the follow-up (OR=4.25, p=0.041) were associated with better adherence. There were no differences between the different brands and doses of suppositories analyzed. Low adherence was not related with increased number of flares (p=0.927), hospitalizations (p=0.225) or decreased quality of life (p = 0.353) over the 12 months of follow-up.

Conclusion

Almost half of patients with UP on maintenance treatment with mesalazine suppositories have low adherence. Older age, unemployment, use of corticosteroids during the follow-up or the presence of concomitant anal pathology may increase adherence, but poor adherence to mesalazine suppositories was not related with risk of relapse, hospitalizations or worst quality of life.
P0747 The real-world practice patterns and clinical outcomes of 5-aminosalicylic acid treatment in Korean patients with ulcerative colitis: a population-based retrospective study
Authors: Park S J , Park S W , Kim T I , Cheon J H
Published: January 2025

Background

This retrospective study analysed the real-world use patterns and clinical outcomes of 5-aminosalicylic acid (5-ASA) treatment in Korean patients with ulcerative colitis (UC) based on the records from national health insurance claims database (NHICD).

Methods

The records of individuals aged ≥15 years, first diagnosed as having UC between January 2009 and September 2018, were considered eligible for the study if 5-ASA was prescribed for ≥30 days within six months after the diagnosis. The data were extracted until the events of interest, patient’s death, or March 2019, whichever occurred earlier. The events of interest were defined as UC-related hospitalisation, UC-related surgery, and 5-ASA non-response, the latter corresponding to the prescription of steroids, immunosuppressants, and/or biological medications during the follow-up period. The yearly proportions of patients in each average daily dose (ADD) group, i.e., rectal monotherapy (RM), oral low dose (<2 g/day) monotherapy (OML), oral standard-to-high dose (2 g/day to ≥3 g/day) monotherapy, oral low dose combination therapy (OCL), and oral standard-to-high dose combination therapy (OCSH) group, were presented. Odds ratio for prescribing 5-ASA dose was calculated from a logistic regression model. The incidence of the events of interest was expressed per 1000 person-years (PY). Hazard ratios for 5-ASA non-response and UC-related hospitalisation in each ADD group were obtained from a Cox proportional hazard model, with OML as a reference group. Treatment adherence was expressed as a proportion of days covered (PDC) within the first 12 months from the prescription index date.

Results

The analysis included the data of 11,338 patients (mean age 42.15 years, 59.53% of males). During a median observation period of 1,720 days, a tendency to a decrease in RM proportion was observed, along with an increase in the proportions of oral + rectal combination therapies. The odds of prescribing high-dose 5-ASA increased significantly since 2013. The proportion of OCSH increased from 18.1% in 2009 to 39.5% in 2018, whereas OML and OCL proportions decreased from 17.5% to 6.6% and from 11.6% to 6.6%, respectively. The incidence rates for non-responses and UC-related hospitalisations (per 1000 PY) were 51.16 and 13.40, respectively. Both incidence rates were significantly lower in the RM group than in the OML group, with no significant differences between the latter and other ADD groups. Mean PDC in overall population was 0.70, ranging from 0.65 to 0.76 across the ADD groups.

Conclusion

A tendency to a more frequent prescription of high-dose 5-ASA as combination therapy was observed in 2009-2018, along with a decrease in RM prescription frequency, which is consistent with the current guidelines.
P0749 Infection adverse events with tulisokibart over 50 weeks of treatment in the phase 2 Crohn’s disease APOLLO-CD trial
Authors: Guedelha Sabino J , Sands B E , Peyrin-Biroulet L , Yen M , Zhou W , Dong B , Feagan B G
Published: January 2025

Background

Biologic medications for inflammatory bowel disease are associated with increased risk of infections1. This analysis evaluates infection adverse events (AEs) with tulisokibart, an anti-tumor necrosis factor–like cytokine 1A (TL1A) monoclonal antibody, in APOLLO-CD, a Phase 2a trial in participants with Crohn’s disease (CD) in which tulisokibart was well tolerated and led to achievement of endoscopic response and other endpoints during a 12-week induction period and 36-week open-label extension (OLE) period2

Methods

Participants (≥18 years of age, moderately to severely active CD and inadequate response to conventional therapy or approved biologic therapies) received open label intravenous (IV) induction tulisokibart treatment (1000 mg at baseline then 500 mg at Weeks 2, 6, and 10). Tulisokibart induction responders were able to enter the OLE study and randomized at week 14 to receive IV tulisokibart 100 mg or 250 mg every 4 weeks. Adverse events (AEs) related to infections during the 12-week induction and up to Week 50 in the OLE are reported.

Results

A total of 55 participants were treated in the induction period, of which 37 responders continued in the OLE (19 received tulisokibart 100 mg and 18 received tulisokibart 250 mg). During the induction period, 25 (46%) participants reported infection AEs; all were considered mild to moderate in severity, and the most common were COVID-19 and Urinary Tract Infection (Table). Two infections were serious (anal abscess and COVID-19 pneumonia), requiring hospitalization; both were deemed not drug related and resolved without treatment discontinuation. In the OLE at Week 50, 12 (63%) participants on 100 mg and 11 (61%) on 250 mg reported infection AEs, with none considered serious. The most common infection AEs were Urinary Tract Infection and COVID-19. There were two severe infection AEs (bronchitis and Clostridioides difficile) in the 250 mg dose group. No participants discontinued study treatment due to an infection AE during the entire 50 weeks of treatment (Table). No dose-dependent safety signal was observed.

Conclusion

Tulisokibart treatment over the 12-week induction demonstrated low incidence of serious infection AEs and no apparent increased risk of infection AEs when compared with biologic treatments for CD in prior clinical trials3,4. No new infection safety signals appeared in the OLE. All infection AEs resolved, most were considered non-serious and mild to moderate in severity, and no participant discontinued treatment due to an infection AE.

References

1. Singh et al. Clin Gastroenterol Hepatol 2020;18(1):69-81).

2. Siegel et al. United European Gastroenterol J 2024; 12 (S8): OP078

3. Feagan BG, et al. Lancet 2017; 29;389:1699-709

4. Vermeire S, Lancet 2017; 21;389:266-75
P0750 Association between intestinal fibrosis and clinical and surgical recurrence after intestinal resection in stenotic Crohn's disease patients
Authors: Che T , Wang X , Zhang S , Zhang Y , Gu Y , Sun J , He Z , Li Y , Zou D
Published: January 2025

Background

Despite recent advances in the medical care of Crohn's disease (CD), most patients, particularly those with stenosis, still require intestinal resection during their disease course. However, more than half of the patients experience postoperative recurrence. Intestinal fibrosis is an important pathological feature of stenotic Crohn's disease. We aim to investigate the association between fibrosis at the site of intestinal stenosis and normal area and risk of clinical and surgical recurrence after first intestinal resection in patients with stenotic Crohn's disease.

Methods

A retrospective, multi-center study was conducted on stenotic Crohn's disease patients who received first intestinal resection between January 2010 and July 2023. The most representative pathological slides from the resected stenotic intestinal tissues and normal slides from the normal tissues were selected. We used Masson's trichrome staining to visualize collagen fibers and calculated the proportion of collagen fiber area in the slides using the Image-Pro-Plus software to assess the degree of intestinal fibrosis. Baseline information and postoperative clinical recurrence were collected through electronic medical record systems and telephone follow-up. Survival analysis and univariate and multivariate Cox regression models were used to assess the impact of intestinal fibrosis on clinical and surgical recurrence.

Results

257 patients were included in this study. 94 (36.5%) and 25 (9.7%) of the patients experienced clinical and surgical recurrence during the follow-up period, respectively. In the univariate cox analysis, high degree transmural intestinal fibrosis at stenotic area was significantly associated with clinical recurrence (HR 4.94, 95%CI 2.72-8.96, P<0.001) and surgical recurrence (HR 4.45, 95%CI 1.45-13.72, P=0.009). This association remained significant when considering fibrosis only in the mucosa, submucosa, muscular layers of stenotic area, or in the normal area. In the multivariate cox analysis, transmural fibrosis was still related to clinical recurrence.

Conclusion

The degree of transmural fibrosis at the site of intestinal stenosis and normal area was significantly associated with clinical recurrence after first intestinal resection in patients with stenotic Crohn's disease. Intestinal fibrosis should be considered in postoperative treatment and follow-up decision-making.
P0751 The effects of high and low emulsifier diets in active Crohn’s disease: A pilot double-blinded randomised feeding trial
Authors: Fitzpatrick J A , Gibson P R , Taylor K M , Anderson E J , Friedman A B , Ardalan Z S , Smith R L , Halmos E P
Published: January 2025

Background

Preclinical studies implicate dietary emulsifiers as detrimental to patients with Crohn’s disease. We aimed to examine the effect of high- and low-emulsifiers diets on intestinal inflammation in adults with ileal Crohn’s disease.

Methods

In a pilot double-blinded, randomized, controlled feeding study, patients with symptomatic and sonographically active Crohn’s disease with ileal involvement on stable medical therapy were randomized to received four weeks of an isocaloric high (HED) or low (LED) emulsifier diet modelled on Australian healthy eating guidelines. Evaluation of objective markers (faecal calprotectin, C-reactive protein, sonographic indices), clinical disease activity (Harvey Bradshaw Index), body composition (waist circumference, visceral adipose tissue via bioimpedance and quantitative muscle ultrasound) and quality of life were measured at baseline and at study completion.

Results

Of 116 patients screened, 24, mean age 37 (95% CI 32, 41) years, 12 male, were randomized. Five participants (2 HED, 3 LED) withdrew due to increased gastrointestinal symptoms. Dietary adherence was excellent. On ultrasound, IBUS-SAS fell from 51 (35, 68) to 33 (15, 51) on HED (p=0.014) and from 57 (38, 76) to 44 (29, 59) on LED (p=0.010) with no difference between diets (p=0.28). C-reactive protein and faecal calprotectin did not change overall. 9/12 on HED and 7/12 on LED entered clinical remission (Harvey Bradshaw Index ≤4). Quality of life improved on both diets (both p<0.003) as did fatigue (both p≤0.050). The HED and LED reduced weight by 2.2 [1.3,3.2] kg (p=0.009), waist circumference by 4% (p<0.001) and visceral adipose tissue by 16% (p<0.001) without a change of quantitative muscle ultrasound (p=0.78).There was no difference in any outcomes between the diets.

Conclusion

Emulsifiers in the food supply have no effect on intestinal inflammation in patients with active ileal Crohn’s disease, but a diet that follows healthy eating principles was associated with reduction of intestinal inflammation, clinical remission, improved quality of life and fatigue scores with reduction of visceral adipose tissue whilst maintaining lean muscle mass. Australian New Zealand Clinical Trials Registry (ACTRN12619000980134).
P0762 Early ustekinumab use improves clinical outcomes in biologic-naive Crohn’s Disease patients: A retrospective multicenter cohort study in Taiwan
Authors: Chang Y C , Chuang C H , Huang T Y , Chung C S , Kuo C J , Pan Y B , Sheng W J , Lin S H , Le P H
Published: January 2025

Background

Crohn’s disease (CD) is a progressive condition, and early treatment with infliximab combined with an immunosuppressant within six months has been shown to improve clinical outcomes. However, the impact of early ustekinumab (UST) use in biologic-naïve CD patients remains unclear. This study aims to address this gap by evaluating the clinical outcomes of early UST intervention in such patients.

Methods

In this retrospective cohort study, we included biologic-naïve CD patients treated with UST, with a clinical follow-up period of at least six months, from October 2020 to January 2024 across four medical centers in Taiwan. Patients who received UST within six months of CD diagnosis were categorized into the early-UST group, while the rest formed the control group. The primary endpoint was the improvement of clinical outcomes at six months.

Results

A total of 60 biologic-naïve CD patients were enrolled. Baseline characteristics were comparable between the two groups. At six months, the early-UST group (n=24) demonstrated significantly lower Crohn’s Disease Activity Index (CDAI) scores (73.03 vs. 112.42, p=0.038), lower Harvey-Bradshaw Index (HBI) scores (1.46±1.69 vs. 2.72±2.17, p=0.020), higher rates of clinical remission (91.7% vs. 63.9%, p=0.017), and higher rates of steroid-free clinical remission (79.2% vs. 50.0%, p=0.031) compared to the control group (n=36). Extending the evaluation to one year, the early-UST group continued to show lower CDAI scores (39.94 vs. 91.48, p=0.005). Adverse event rates were similar between the two groups.

Conclusion

Initiating ustekinumab within six months of CD diagnosis is associated with improved clinical outcomes and enhanced quality of life in biologic-naïve Crohn’s disease patients.
P0769 Impact of Nurse-Led Day Case Management of Acute Inflammatory Bowel Disease Flares on Admissions to Hospital
Authors: Lloyd-Ford G , Bowler N , Lewis A , Gordon M , Haviland S , Hill J
Published: January 2025

Background

To assess the impact on admissions to hospital when patients are treated on a nurse led day case unit for inflammatory bowel disease flares over a 1-year period.

Methods

During the COVID 19 pandemic, patients were reluctant to be admitted to hospital and where possible wanted care as day case patients. This has continued due to the pressures of the acute gastroenterology hospital ward and demand for bed spaces. The Gastroenterology and Medical Ambulatory Care Unit allowed for rapid assessment, diagnosis, and treatment with appropriate safety netting for this group of patients. 63 patients where identified. Those who needed admission were advised to do so based on presenting symptoms and response to treatment.

Data Collection and Results

63 patients presented to the Unit with a pre-existing diagnosis of IBD, 88% (n=55) where Ulcerative Colitis and 12% (n=8) Crohns Disease and had failed to suppress the flare with oral steroid and topical therapies. Symptoms varied from loose stools, urgency, bleeding, pain, lethargic and dehydration, common signs of an IBD flare, (Sturm and White 2019). Patients were offered admission, however all wanted to be treated as a day case on the proviso that if needed admission would be arranged. The aim was to give the same initial flare treatment as would be received on the ward. Hydrocortisone 200mg IV am followed by 500mls of IV fluids and a further Hydrocortisone 200mg IV in the pm. Patients were also supported by the team on the Unit during their flare allowing perspective to be placed on their disease and management as a whole. Open dialogue was held with the Unit and IBD nursing teams further enhancing patient care. Bloods and faecal calprotectin were checked as a baseline for our interventions.

Results

Of the 63 only 9.5% (n=6) did not respond and needed admission.

Conclusion: Outcome and Recommendations

Overall patients were happy with and responded to treatment in the day case unit. This saved at least 171 bed days in hospital based on a minimum of 3 days per patient treated. Being able to access support as well as treatment worked well. Day case assessment treatment and care has a clear future for this group of patients providing patients are selected appropriately.

References

Sturm A and White L (2019) Inflammatory Bowel Disease Nursing Manual. Springer
P0770 Assessing the level of anxiety among patients attending an IBD surveillance
Authors: White L , Sundramoorthi R , Mohan S , Johnston E
Published: January 2025

Background

The aim of the project was to assess the level of anxiety among patients attending an IBD surveillance colonoscopy as well as their views on the bowel preparation, their understanding of the purpose of the procedure and their perceived risk of colorectal cancer. We hypothesised that there is a link between the anxious state and the perceived risk of colon cancer.

Methods

Questionnaires were conducted immediately pre-endoscopy. Anxiety was assessed quantitatively using the State Trait Anxiety Inventory (STAI)(1) as well as through qualitative feedback. Tolerance of bowel preparation was also assessed through a combination of qualitative and quantitative assessment, including a visual analogue scale (VAS 0=worst to 100=best). Perceived risk of colorectal cancer in the next ten years was assessed using a visual analogue scale (VAS 0 to 100% risk).

Results

A total of 42 patients participated. 38% of respondents reported feeling anxious about their colonoscopy however the mean STAI score for the cohort was relatively low (STAI score 34 SD=11.6) being comparable to normal working adults (mean STAI=35)(1). 45% reported anxiety regarding bowel preparation and 33% felt they tolerated it poorly (VAS ≤50). 100% of respondents reported that the purpose of surveillance had been explained to them, however only 10% of respondents mentioned the word "cancer" when asked to clarify their understanding of this. The range of cancer risk perception over the next ten years was 0% to 70% risk, and the median was 0.9% (SD=24). There was no correlation between STAI scores and perceived cancer risk (Pearson correlation coefficient (r) = 0.43).

Conclusion

IBD patients attending surveillance colonoscopy have low levels of anxiety and lower than those attending colorectal cancer screening (mean STAI=45)(2). There is a wide range of perceived colorectal cancer risk and our results suggest there is an opportunity for patient education on the purpose of surveillance and estimates of their risk of colorectal cancer. There is no correlation between anxiety and perceived cancer risk in our cohort. Bowel preparation is a common cause of anxiety and a third of patients tolerate it poorly. Approaches to address this would have a significant benefit on patient experience in IBD surveillance endoscopy.

References

(1)Spielberger, C. D., Gorsuch, R. L., Lushene, R., Vagg, P. R., & Jacobs, G. A. (1983). Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press

(2)Shaikh AA, Hussain SM, Rahn S, Desilets DJ. Effect of an educational pamphlet on colon cancer screening: a randomized, prospective trial. Eur J Gastroenterol Hepatol. 2010 Apr;22(4):444-9. doi: 10.1097/MEG.0b013e328333fca6. PMID: 19940781.
P0773 Real-World Application of Intestinal Ultrasound for Monitoring Ulcerative Colitis in South Korea
Authors: Kim K W , Jeong J , Noh H D , Lee H J , Koh S J , Kang H W , Im J P , Kim B G , Kim J S , Lee K L , Kim J W
Published: January 2025

Background

Intestinal ultrasound (IUS) has emerged as a valuable tool for monitoring ulcerative colitis (UC).1 However, a few studies have explored the practical application of IUS in UC within Asian countries, particularly South Korea.

Methods

We conducted a cross-sectional study at two academic medical center involving patients with UC who received IUS and simultaneous clinical exams including endoscopy. The primary endpoint was to assess the predictive accuracy of IUS for disease activity, defined by the Mayo score with endoscopic disease activity by Mayo endoscopic subscore (MES). IUS parameters were evaluated with Milan ultrasound criteria (MUC) and bowel wall thickening (BWT).

Results

A total of 81 patients were enrolled in this study. The numbers of low- and high-MUC groups were 35 and 46, respectively. The median ages were 40 and 43.5 years old, respectively. The proportion of males in each group was 60% and 76%. There were no significant differences between the two groups in terms of body mass index, smoking status, age at disease onset, disease duration, or current medication such as 5-aminosalicylic acid, steroid, immunomodulator, and advanced therapies.

Compared with the low- and high-MUC groups, biochemical parameters with C-reactive protein and fecal calprotectin were significantly different {median with interquartile range: 0.05 (0.02-0.13) vs. 0.10 (0.07-0.65), p = 0.043; 99.00 (98.50-372.25) vs. 496.00 (90.00-1870.50), p < 0.001, respectively}. Disease activities as Mayo score, partial Mayo subscore, and endoscopic Mayo subscore also showed significantly differences between the two groups {2 (1-5) vs. 5 (4-8), p < 0.001; 2 (0-3) vs. 3 (2-6), p < 0.001; 1 (0-2) vs. 2 (1-2), p < 0.001, respectively}.

Analyzing the predictive accuracy of IUS parameters and biochemical markers for disease activity measured by the Mayo score and MES, revealed that BWT and MUC were comparable to biochemical markers. The cut-off values determined using Youden’s index for predicting clinical and endoscopic remission in MUC were 5.7 and 7.1, respectively, while those for BWT were 4.0 and 5.0.

Conclusion

IUS parameters in the patients with UC demonstrated trends similar to classic markers and provided comparable predictions of clinical and endoscopic disease activity. Although the cut-off values of IUS parameters related to disease activity appeared to differ slightly from those reported in Western studies, further prospective research exploring the relationship between IUS findings and various clinical courses of UC is needed to establish robust evidence in Asia, particularly South Korea.

References

1.Allocca M, Dell'Avalle C, Furfaro F, et al. Early Intestinal Ultrasound Predicts Long-Term Endoscopic Response to Biologics in Ulcerative Colitis. J Crohns Colitis. 2023;17(10):1579-1586.
P0775 The IBD Specialist Pharmacist actively contributes to the IBD clinical team, providing significant benefits and enhancements to patient care
Authors: Garcia Fuertes F , Lee H , Sundar N , Shirazi-Nejad A , Bullas D , Hyde L , Gray R , Atkinson R
Published: January 2025

Background

The prevalence of IBD is rising globally, and in the UK has risen from 328/100,000 in the 90s to 970/100,000 in 2017 [1]. This, together with a rapidly expanding and more complicated range of therapeutic options has necessitated the need for proactive management, intervention and monitoring of patients. Through a combination of Physician, Nurse and Pharmacist clinics, we provide a comprehensive IBD outpatient service to meet these requirements in line with UK IBD standards [2]. Our pharmacist-led clinic prescribes initial treatments (JAK inhibitors, immunomodulators and ongoing prescribing of biologic therapy infliximab and vedolizumab) to ensure effective close monitoring, correct dose adjustments, therapeutic drug monitoring and early identification of possible side effects to the new treatments.

Methods

The study aims to identify all referrals and clinical outcomes to the pharmacist clinic during the period between January to August 2024. All patients are appointed from our weekly IBD Multidisciplinary team (MDT) meeting. The data is obtained from the IBD MDT log.

Results

During the period analysed of the pharmacist clinic activity, the drug distribution was as follows: JAK inhibitor 35.9% (14 patients), thiopurines monotherapy 25.6% (10 patients) and combination therapy anti-TNF + immunomodulators and allopurinol if shunting 38.5% (15 patients). The total number of patients reviewed during this period was 39, accumulating a total of 289 appointments which equates to an average 7.4 appointments per patient over this period. During the analysed period 234 cases were discussed at IBD MDT. 39 cases (16.7%) were referred to the pharmacist to conduct treatment initiation and drug monitoring. The pharmacist referred 21 cases (7.27%) to IBD MDT for new discussion resulting in 26 agreed-upon outcomes by the IBD team as detailed below. Some patient reviewed had more than one outcome.

Conclusion

Two specialist IBD pharmacists (Whole Time Equivalent (WTE) 0.6) are the essential part of the IBD multidisciplinary team, providing early identification of treatment failure or serious adverse effects, and closer monitoring of patients with monthly appointment on average. The 26 clinical outcomes demonstrated an effective model for more personalised medicine. Therefore, it integrates an additional pathway for patients' management. The model of care aligns with UK national recommendations and showcases the positive impact that specialist pharmacists as non-medical prescribers can assist in over-stretched conventional IBD services.

References

1.King D, et al., Changing patterns in the epidemiology and outcomes of inflammatory bowel disease in the United Kingdom: 2000–2018. Aliment Pharmacol Ther. 2020;51(10):922–34

2.IBD UK. IBD standards 2019. www.IBDUK.org (accessed August 2024).

Table 1. Outcomes of the referrals submitted by pharmacist at IBD MDT
P0777 Sonographic transmural induction outcomes across advanced therapies in Crohn’s Disease
Authors: Smyth M , Dolinger M , Dubinsky M
Published: January 2025

Background

Intestinal ultrasound (IUS) is increasingly being used to evaluate induction efficacy in both clinical practice and clinical trials. The differential healing rates across advanced therapies (AT) remains unknown. We aimed to quantify the rates of early post induction IUS transmural (TM) remission and response across AT in Crohn’s Disease (CD).

Methods

Single center retrospective review of patients with CD initiating AT who underwent IUS pre and post induction and had disease activity and biomarker data available. Patients with normal pre-AT IUS or post op were excluded. Primary outcome was post-induction TM response of the most affected segment (segmental response compared to baseline: >25% decrease in bowel wall thickness (BWT), absolute BWT decrease >2mm, or absolute decrease >1mm with ≥1-point improvement in Modified Limberg Score (MLS)). Secondary outcomes were segmental and complete (all bowel segments) TM remission (BWT ≤ 3.0mm and MLS 0). Descriptive statistics summarized data (median [IQR]), univariate and multivariate analysis tested associations.

Results

101 patients (53% female, age 17.4 [15.0-21.1] years); disease duration 0.80 years [0.17-3.96]; post induction IUS performed 78 days [56-102] on AT (44% anti-TNF, 53% AT naïve). Segmental TM induction response across all AT was 63%. Segmental and complete TM remission was 36% and 35%, respectively (figure). Complete TM remission was seen at a higher rate with upadacitinib (UPA) than ustekinumab (UST) (p=0.009) and risankizumab (RZB) (p=0.032) but not anti-TNF (NS). Patients with severe IUS inflammation (MLS 3) at baseline were less likely to achieve TM remission independent of AT (aOR 0.21 [0.059-0.76]). Complete TM remission was independently associated with infliximab (IFX) (aOR 11.7 [2.2-62.4]) and UPA (aOR 5.22 [1.0-27.2]). Rates of segmental TM response were greater for colonic than ileal disease in UST/RZB (88% vs 47%, p=0.038), but no different in TNF/UPA. Patients started on UST/RZB after >1 failed prior AT had a trend for lower rates of TM outcomes (NS), while number of prior therapies had no impact on UPA response or remission rates.

Conclusion

Post-induction TM outcomes are achievable across AT: 2/3 of patients achieve segmental TM response and 1/3 achieve complete TM remission. This data, combined with the high correlation between IUS and endoscopy, suggests that IUS response could be considered as a clinical trial endpoint.
P0779 Resting-state MRI data fusion reveals distinct disease-state dependent patterns for fatigue, depression and anxiety in Crohn’s Disease
Authors: Thomann A , Schmitgen M , Stephan J C , Knoedler L L , Thomann P A , Ebert M P , Szabo K , Reindl W , Wolf R C
Published: January 2025

Background

Many persons with Crohn’s Disease (CD) suffer from symptoms not directly linked to the gastrointestinal tract. Among these extraintestinal symptoms (EIS), fatigue, depression and anxiety are the most prevalent, especially during active disease. Growing evidence links disturbed brain-gut-interactions to EIS. We examined intrinsic brain activity in patients with active and remitted CD using a multivariate MRI data fusion approach, evaluated the relationship of functional joint components with EIS and inflammatory markers, and explored the components’ associated neurotransmitter systems.

Methods

Patients (n=71) with active (aCD, n=47) or remitted disease (rCD, n=24) and healthy controls (HC, n=35) underwent resting-state functional magnetic resonance imaging and completed questionnaires for symptoms of fatigue, depression and anxiety. Patients provided stool samples for faecal calprotectin (fC) analysis. A joint independent component analysis (jICA) of intrinsic brain function (ALFF and ReHo) was conducted to detect convergent neural activity patterns in functionally distinct neural networks (components) that differ between aCD, rCD, and HC. Functional connectivity strength (FCS) in networks with disease state-dependent changes were correlated with EIS and fC, and we performed cross-modal correlations between MRI components and specific PET/SPECT receptor probability maps.

Results

JICA identified two components that differed between aCD and rCD. One showed a pattern of predominantly orbitofrontal-cingulate cortex connectivity, with lower FCS in aCD vs rCD and HC (Fig. 1A top). This component related to serotonergic and dopaminergic transmission with significant associations between FCS and fatigue as well as fC (Fig. 1B). The other component revealed lower FCS in a sensorimotor network (Fig. 1A middle) with predominantly dopaminergic neurotransmission in rCD vs aCD and HC that was associated with anxiety and depression (Fig. 1B). A third component, predominantly involving cortical midline regions attributed to the so-called “default mode network” was found to differ between HC and CD irrespective of disease status (Fig. 1A bottom). Here, FCS was not associated with EIS (Fig 1B).

Conclusion

Functional connectivity of distinct resting-state networks differs between disease states and differentially relates to EIS. A sensorimotor network is associated with symptoms of depression and anxiety and dopaminergic neurotransmission, while an affective network correlates with fatigue and serotonergic/dopaminergic neurotransmission. The latter shows the relationship with fatigue only in rCD, suggesting a contribution of disturbed brain-gut-interactions especially in fatigue during remission.
P0780 Impact of Hyperbaric Oxygen Therapy on Perianal Fistulas in Crohn’s Disease: Clinical Outcomes and Remission Rates
Authors: Piotrowicz G , Rudnik A , Kot J , Babicki A , Banaszkiewicz P , Piotrowicz A , Rzeszutek M , Zientara P , Adamska-Mieruszewska J , Rydzewska G
Published: January 2025

Background

Crohn's disease (CD) is a chronic inflammatory bowel disorder with debilitating complications such as perianal fistulas, affecting 14-38% of patients (1). Conventional treatments often achieve limited success, necessitating adjunctive approaches (2,3). Hyperbaric Oxygen Therapy (HBOT), known for its wound-healing and anti-inflammatory properties, has emerged as a potential therapy for complex CD cases (4,5). This study evaluates the efficacy of HBOT in combination with standard treatments for reducing perianal fistula activity and achieving clinical remission in patients with CD.

Methods

A cohort of 11 patients with CD-associated perianal fistulas underwent surgical preparation followed by 30 sessions of HBOT (2.5 ATA, 90 minutes per session). Disease activity was assessed using the Crohn’s Disease Activity Index (CDAI), Simple Endoscopic Score for Crohn’s Disease (SES-CD), Perianal Disease Activity Index (PDAI), and laboratory markers (CRP, fecal calprotectin, hemoglobin, and serum iron). Outcomes were evaluated at baseline, post-treatment (6 weeks), and follow-up (9 months).

Results

Clinical Improvement: 81.8% of patients demonstrated a significant reduction in CDAI scores. Remission Rates: 54.5% achieved remission (SES-CD, PDAI). 72.8% exhibited normalized fecal calprotectin levels (≤250 µg/g). Improvements were maintained 9 months post-treatment. Minimal side effects, including transient hearing impairment and headaches, were reported.

Conclusion

HBOT as an adjunctive therapy significantly improves clinical outcomes in CD patients with perianal fistulas. It enhances remission rates, reduces inflammation, and sustains benefits over long-term follow-up. This study highlights the potential of HBOT as a therapeutic option for refractory CD cases. Further randomized controlled trials are warranted to validate these findings.

References

1.Feroz SH, Ahmed A, Muralidharan A, Thirunavukarasu P. Comparison of the efficacy of the various treatment modalities in the management of perianal Crohn’s fistula: a review. Cureus. 2020;12(12).

2.Cheifetz AS. Management of active Crohn disease. Jama. 2013;22;309(20):2150-8.

3.Cushing K, Higgins PD. Management of Crohn disease: a review. Jama. 2021;325(1):69-80.

4.Parra RS, Féres O, Lansdorp CA. Hyperbaric oxygen therapy: More hope than hype for future treatment of perianal fistulizing Crohn's disease?. United European Gastroenterology Journal. 2022;10(3):346.

5.Adamina M, Minozzi S, Warusavitarne J, Buskens CJ, Chaparro M, Verstockt B, Kopylov U, Yanai H, Vavricka SR, Sigall-Boneh R, Sica GS. ECCO guidelines on therapeutics in Crohn’s disease: surgical treatment. Journal of Crohn's and Colitis. 2024;18(10):1556-82.
P0782 Resetting the Clock: Does Redo IPAA Restore Quality of Life? Patient Reported Outcomes Before and After Redo Ileoanal Pouch Surgery
Authors: Holubar MD- MS S , Lavryk O , Lipman J , Kanters A , Cohen B , Falloon K , Rieder F , Qazi T , Gorgun E , Steele S , Liska D
Published: January 2025

Background

Patient-reported outcomes (PROs) after ileoanal pouch (IPAA) salvage with redo pouch procedures are known to be worse compared to after primary (index) pouch surgery. Although pouch failure is associated with decreased pouch function and quality of life (QoL), PROs prior to redo IPAA have not been reported. We aimed to report on PRO before and after redo IPAA. We hypothesized that redo IPAA is associated with improved quality of life.

Methods

Our pouch registry was queried for adults who underwent redo IPAA between 1984 and 2024, who had at least one pouch survey before and after redo pouch surgery. Pouch surveys were mailed to all patients annually and also collected in clinic (paper survey), and several items were administered electronically from to 2015-2019 (electronic survey). Our primary outcome was the Cleveland Global QoL index (CGQLI), a composite of QoL, quality of health (QoH), and quality of energy (QoE), each of which was scored from 0 (lowest) to 10 (highest). These three scores were then summed and divided by 30 to obtain an overall score ranging from 0 (lowest) to 1 (highest). Before and after survey responses were compared using univariate analysis with t-tests and Wilcoxon rank-sum tests, and matched paired analysis, using JMP v18.1.

Results

A total of 659 redo pouch procedures, including pouch excision with neo-IPAA in 387 (58%) and pouch repair with neo-IPAA in 272 (41%), were included, of which 472 (72%) had survey data available and were analyzed. Results from the paper survey (Table 1) revealed bowel frequency, urgency, incontinence, seepage, pad usage, fiber, and anti-diarrheal usage were not significantly different after, compared with before, redo IPAA. After redo IPAA, 87% would undergo redo surgery again and 89% would recommend IPAA. Happiness with surgery was higher after redo IPAA (from 8 to 9, p=0.02 overall; p=0.08, pairwise). Matched pair analysis of the electronic survey responses (Table 1) revealed after redo IPAA, dietary restrictions increased (from 51% to 54%, p=0.03), social restrictions decreased (from 44% to 34%, p=0.05), whereas work and sexual restrictions remained unchanged. After redo IPAA, QoL (from 7 to 8, p=0.0004), QoH (from 7 to 8, p=0.0003) and CGQLI (from 0.57 to 0.67, p=0.003) and were significantly higher after, compared with before, redo IPAA.

Conclusion

Redo IPAA, on matched pair analysis, was restorative for the decreased quality of life and social restrictions observed prior to redo pouch surgery, without sacrificing functional outcomes for most patients. This novel view of PROs after redo IPAA compared with before redo IPAA sheds new light on what may be reasonably be expected after redo IPAA for patients with failing pouches contemplating redo IPAA surgery.
P0783 High risk of adrenal insufficiency in patients with Inflammatory Bowel Disease treated with a conventional course of systemic corticosteroids: Results from a prospective study
Authors: Navarro Llavat M , García-Bosch O , Castro-Poceiro J , Bargalló García A , Blasco Pelicano A , Albareda Riera M , Domènech Morral E
Published: January 2025

Background

Corticosteroids (CS) remain the first-line treatment for inflammatory bowel disease (IBD) although they can cause adrenal insufficiency (AI) due to the alteration of the hypothalamic-pituitary-adrenal (HPA) axis. Assessing this risk is essential, as these patients are often in stressful situations, and AI can mimic IBD symptoms, leading to misdiagnosis. However, there is a lack of studies adequately assessing adrenal function in these patients. The objectives of this study were to determine the proportion of IBD patients who present HPA axis suppression following CS treatment, assess the time required for axis recovery, and identify risk factors for AI.

Methods

A prospective observational study was conducted including adult patients with active IBD who started systemic CS treatment and with no exposure to CS within the last 6 months. They all followed a pre-defined regimen of 1 mg/kg/day of prednisone (maximum 60mg) for 2 weeks, tapering by 10 mg weekly until reaching 20 mg, then tapering by 5 mg weekly. The HPA axis was assessed 24 hours after CS discontinuation by the measurement of baseline cortisol and ACTH, and cortisol 30 and 60 minutes after stimulation with 250 mcg of ACTH. HPA axis recovery was evaluated 3 and 6 months after CS discontinuation. The association between clinical and demographic variables and the occurrence of AI was analysed.

Results

Ninety-two patients were included (58% Crohn's disease, 39% ulcerative colitis, mean age 39.8±16 years, 50% women), who received a total CS dose of 2000.7±543.1 mg for 63.5±14.1 days. Forty patients (43.5%) were diagnosed with AI (32 partial, 8 complete). The recovery test was not performed in 10/40 patients (5 due to loss of follow-up, 5 due to need of a new course of CS). 23/30 patients recovered the adrenal function 3 months after stopping CS, and 27/30 patients after 6 months. In the univariate analysis, only fecal calprotectin at the end of CS treatment was associated with AI (P=0.026).

Conclusion

A high proportion of IBD patients treated with a conventional CS treatment schedule develop HPA axis suppression, although most of them recover adrenal function within six months. The development of AI was not associated with any of the studied variables, except for faecal calprotectin levels. Our results highlight the potential risks associated with prolonged CS use and underscore the importance of considering AI in this context, particularly when the patient faces physical stress.