bluuebunny/crossref_metadata_2025_split huggingface dataset:
P0734 Real-World Experience of Curcumin+Qing Dai Reduces Biochemical and Intestinal Ultrasound Disease Markers in Patients with Inflammatory Bowel Disease
Authors: Krugliak Cleveland N , Duty C , Bhondwe K , Rubin D T 
Published: January 2025

Abstract

Background
Curcumin + Qing Dai (CurQD) is an herbal supplement previously demonstrated in a placebo controlled trial to induce response and remission in patients (pts) with active Ulcerative colitis (UC).1 We report the real-world experience from a tertiary Inflammatory Bowel Disease center of this nutraceutical in pts with UC or Crohn’s disease (CD).

Methods
This is a retrospective study at the University of Chicago. We included adult pts with IBD who were recommended and then received CurQD. CurQD is administered as a daily dose ranging from 540-1300 mg of Qing Dai and 320-1200 mg of curcumin. We reviewed pt demographics, medication history, Simple Clinical Colitis Index (SCCAI), Harvey-Bradshaw Index (HBI), faecal calprotectin (FCP) levels, and International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) or Milan ultrasound criteria (MUC), and evaluated for remission at follow-up (f/u) 8 weeks ± 4 weeks. Remission was defined as SCCAI≤2, HBI&lt;5, FCP&lt;150 μg/g, IBUS-SAS&lt;37.5 or MUC≤6.2.

Results
18 UC and 9 CD pts were included. Concomitant IBD therapy was continued at CurQD initiation. (Table 1). 14 (78%) UC pts and 7 (78%) CD pts were on advanced therapy. At baseline, median FCP and IBUS-SAS/MUC were elevated in both CD and UC cohorts. Median SCCAI was elevated in the UC group, but median HBI for the CD group was not. Median time to f/u was 54 days and 50 days for UC and CD cohorts, respectively. In the UC cohort, median SCCAI lowered from 3 to 1, FCP from 507 to 157, and MUC from 7.6 to 6.09. In the CD cohort, 6 pts had a decrease in HBI from a mean of 2 to 0.67, and 3 pts worsened from 1.3 to 9.67, one who changed therapies in f/u, one who underwent total colectomy 4 months after CurQD initiation, one who discontinued CurQD at f/u. FCP decreased from 254 to 54.6, and IBUS-SAS decreased from 54.6 to 26.2. At f/u, 13/20 (65%) pts (10/14 UC, 3/6 CD) were in clinical remission by SCCAI/HBI, 7/14 (50%) (4/9 UC, 3/5 CD) in biochemical remission by FCP, and 6/8 (75%) (4/5 UC, 2/3 CD) in sonographic remission by MUC/IBUS-SAS. Of the 6 UC pts on steroids at CurQD initiation, 4 (66.7%) were in steroid-free remission at f/u. No pts with CD required steroids. One patient with UC reported a headache, and two pts with UC discontinued CurQD due to non-specific intolerance. No AEs were reported among CD pts and no major or serious AEs were reported in either UC or CD pts.

Conclusion
This real world experience with CurQD as add-on therapy for adult pts with IBD in the U.S. demonstrated overall improvement in clinical, biochemical and sonographic disease markers within 8±4 weeks, as well as favorable safety and tolerability.

References
1.Ben-Horin S, Salomon N, Karampekos G, et al. Curcumin-QingDai Combination for Patients With Active Ulcerative Colitis: A Randomized, Double-Blinded, Placebo-Controlled Trial. Clin Gastroenterol Hepatol. 2024;22(2):347-356.e6. doi:10.1016/j.cgh.2023.05.023
P0735 Early dietetic assessment predicts clinical efficacy of Exclusive Enteral Nutrition in adults with Crohn’s disease
Authors: Chu M , Day A S , Bogatic D , Hatzi M , Chu S K , Costello S P , Bryant R V 
Published: January 2025

Abstract

Background
Exclusive Enteral Nutrition (EEN) is an effective but underutilised therapy in adults with Crohn’s disease (CD). Key factors influencing patient adherence and clinical outcomes for EEN in adults remain poorly understood. This study aims to identify the determinants of adherence, therapy completion, and clinical outcomes in adults with CD.

Methods
This retrospective, multicentre study evaluated consecutive adult patients (≥18 years) prescribed EEN from February 1, 2019, to February 28, 2022, at two tertiary hospitals in Adelaide, South Australia, prior to EEN protocol implementation. Adherence was defined as complete exclusion of table food and fluids and meeting the minimum prescribed daily volume of EEN. Therapy completion was defined as completing the prescribed duration. The primary outcome was clinical remission (Harvey Bradshaw Index (HBI)≤4) or response (HBI change ≥3). The dietetic review frequency and adverse effects were recorded. Early review was defined as dietetic assessment during weeks 1–3 for courses ≥6 weeks. Statistical tests included Chi-squared, Fisher’s exact, and Mann-Whitney U tests, with significance at p&lt;0.05. Multivariable logistic regression included significant covariates with age and sex as controls.

Results
Among 108 patients (50.0% female, mean age 41.8±16.1 years), most had ileocolonic (51/108, 47.2%) disease and stricturing phenotype (44/108, 40.7%). Baseline HBI was 8 (IQR 6-11) with 60.2% (65/108) on advanced therapies (Table 1). Full adherence to EEN was achieved by 68.2% (73/107). Of 94 patients (87.0%) prescribed EEN with a defined duration (median 6 weeks, range 2-8), completion rate was 71.8% (67/94). Among 67 patients treated for remission induction, remission and response rate was 59.7% (40/67) and 58.2% (39/67), respectively. Patients attended a median of 4 (IQR 3–6) dietetic visits. Constipation (19.2%, 20/104) was a common adverse effect. On multivariable analysis, active smoking reduced odds of remission (OR 0.028, 95% CI 0.001-0.709, p=0.030); while therapy completion (OR 23.0, 95% CI 1.8-683.5, p=0.019), early response (OR 35.2, 95% CI 1.8-683.5,p=0.019) and early remission (OR 20.4, 95% CI 1.5-273.3,p=0.019) improved odds. Number of dietetic visits predicted therapy completion (OR 2.43, 95% CI 1.53-3.85,p&lt;0.001) and use of broth was linked to poorer adherence (OR 0.369, 95% CI 0.152-0.898,p=0.028).

Conclusion
EEN induced clinical response and remission in adults with CD. Clinical efficacy is enhanced by adherence and completion of therapy, which can be facilitated by increased dietetic support and avoiding non-nutritive items. Optimised EEN protocols to standardise and guide application of this effective nutrition therapy are required to determine if efficacy can be further improved.
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

Abstract

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&lt;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

Abstract

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 &gt;=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 &lt;5 and biochemical remission as a fecal calprotectin &lt;250 mg/kg and a C reactive protein &lt;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

Abstract

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

Abstract

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 (&lt;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

Abstract

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

Abstract

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&lt;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.