bluuebunny/crossref_metadata_2025_split huggingface dataset:
P1000 A quasi-experimental study evaluating effectiveness of partial enteral nutrition combined with exclusion diet in patients with mild to moderately severe ulcerative colitis
Authors: Vuyyuru S , Madan D , Kante B , Goswami S , Kumar P , Kumar Ranjan M , Mundhra S , Golla R , Singh N , Ranjan Dash N , Sharma R , Das P , Makharia G , Shankar Ghosh T , Kedia S , Ahuja V 
Published: January 2025

Abstract

Background
We designed this trial to evaluate efficacy of partial enteral nutrition (PEN) combined with exclusion diet (ED) in patients with mild to moderately active ulcerative colitis (UC).

Methods
In this quasi-experimental study, patients with mild-to-moderate UC (SCCAI=3-11) were allowed to choose either PEN+ED along with standard of care (SOC) or SOC alone. Disease activity was measured using simple clinical colitis activity index (SCCAI). Primary outcome was clinical remission (SCCAI≤2) 4 weeks. In addition, fecal microbiota analysis was performed at baseline and after week 4 in ten responders and four non-responders in PEN+ED arm.

Results
Sixty UC patients were included (PEN+ED=30; SOC=30). In the intervention group, 23 patients completed 4 weeks of PEN, 3 took a lower than prescribed dose, and 4 stopped after one week but continued ED. At week 4, 66.7% (20/30) patients in the PEN+ED arm achieved clinical remission at week 4 compared to 83.3% (25/30) receiving SOC. The proportion of patients with stool frequency score≤1 was similar between the two arms (90% vs 93.3%, p&gt;0.99), however proportion of patients with rectal bleeding score ‘0’ was lower in patients receiving PEN+ED (56.7% vs 86.7%, p=0.01) at week 4. A numerically higher number of patients required steroids in SOC arm compared to PEN+ED arm, but it was not significant (23.3% vs 16.7%, p=0.748). At the microbiome level, PEN+ED was associated with a significant enrichment of ‘healthy-gut’ associated taxa (Figure 1) at week 4 compared to baseline and a concomitant-significant reduction in median Kendall distance to reference healthy Indian controls (p-value ≤1e-5), indicating the treatment shifts the microbiomes of patients towards controls.

Conclusion
Although PEN+ED does not appear to have additional clinical benefit to SOC at week 4, it was associated with significant improvement in gut microbiota. Long-term benefits of this therapy should be explored in future trials.
Table 1: Baseline characteristics of included patients

Figure 1: Figure showing change in the composition of the top 20 taxa across baseline and week4 with parenteral nutrition and exclusion diet in ulcerative colitis patients
P1005 Comparative short-term effectiveness of tofacitinib and upadacitinib in refractory, moderate-to-severe ulcerative colitis – An international, multicenter cohort study
Authors: Farkas B , Resál T , Lakatos P L , Limdi J K , Armuzzi A , Bezzio C , Savarino E V , Saibeni S , Michalopoulos G , Attauabi M , Seidelin J B , Fousekis F S , Katsanos K , Bacsur P , Ivány E , Bálint A , Szepes Z , Farkas K , Molnár T 
Published: January 2025

Abstract

Background
Limited comparative data is available on the real-world effectiveness and safety of tofacitinib (TOFA) and upadacitinib (UPA) in ulcerative colitis (UC).

Methods
We conducted an international, multicenter, real-life retrospective cohort study to assess and compare the short-term effectiveness of TOFA and UPA in bio-experienced, moderate-to-severe UC. The primary outcome was week 12 corticosteroid-free remission (CSFR) defined as clinical remission (CR; partial Mayo score [pMayo]&lt;2 with a rectal bleeding subscore of 0) and C-reactive protein (CRP) ≤5 mg/L, as well as not receiving local and systemic steroids ≥30 days. The secondary outcomes were CR and biochemical remission (defined as CRP ≤5 mg/L and fecal calprotectin [Fcal] ≤ 250 mg/g) assessed at week 8 and week 12. Data was handled by intention to treat analysis. We performed multivariable logistic regression models with backward stepwise elimination to control potential confounders and to reduce bias. The most reliable models were selected based on ROC analyzes with highest area under the curve (AUC). Statistical power was calculated on the primary outcome with the number of subjects involved, resulting in 1-β=0.97.

Results
With the participation of 13 tertiary IBD centres, a total of 350 UC patients (Table 1.; mean age: 38.6 ± 13.8 years; 58.6% male) were enrolled in the study. Patients receiving UPA were more likely (OR=4.01 [95%CI: 1.49-10.82]) to achieve CSFR by week 12 compared to the patients on TOFA (47.1% vs. 22.4%). Additionally, higher baseline pMayo (OR=0.76 [95%CI: 0.59-0.98]) and baseline concomitant steroid use (OR=0.17 [95%CI: 0.08-0.40]) decreased the probability of reaching the primary outcome (AUC=0.80). Furthermore, UPA-treated UC patients were more likely to achieve CR at week 8 (54.8% vs. 26.4%; OR=4.06 [95%CI: 1.66-9.93; AUC=0.76]), and at week 12 (69.2% vs. 45.1%; OR=2.3 [95%CI: 1.04-5.13]; AUC=0.80), as well as biochemical remission at week 12 (43.3% vs. 27.3%; OR=6.96 [95%CI: 2.59-18.7]) than patients receiving TOFA. IBD-related hospitalisation was needed in 6.1% (15/246) of the patients on TOFA, as compared to 1.9% (2/104) of patients receiving UPA. Near-significant difference was observed in colectomy rates between the two patient groups (UPA vs. TOFA: 0% vs. 3.7%; p=0.066). Herpes zoster infection was reported in 1.6% (4/246) of the TOFA-treated patients, and in 1.0% (1/104) of the UPA-treated patients. No venous thromboembolism was observed.

Conclusion
Based on our real-life data, UPA might be associated with better short-term clinical outcomes compared with TOFA in refractory, moderate-to-severe UC.
P1012 Systemic biologic therapies are associated with comparable safety outcomes to vedolizumab for the management of Inflammatory Bowel Disease following liver transplantation
Authors: Chin S , Con D , Hilley P , Corte C , Testro A , De Cruz P , Choy M , Srinivasan A 
Published: January 2025

Abstract

Background
Although the ‘gut-specific’ safety profile of vedolizumab may be considered advantageous in inflammatory bowel disease (IBD) patients on concomitant immunosuppression following liver transplant, the safety of vedolizumab has not been compared with ‘systemic’ biologic therapies in this context. This study aimed to compare the safety of ‘gut-specific’ and ‘systemic’ biologic therapies to manage IBD following liver transplantation (LTx).

Methods
A retrospective observational study of IBD patients exposed to biologic therapy following LTx was undertaken across two Australian LTx centers. The primary outcome was the incidence rate of safety events per patient-year of biologic exposure, while the secondary outcome was the impact of non-biologic immunosuppression on safety events. Safety events were defined as any documented infection whilst on biologic therapy, and were stratified accordingly to ‘gut-specific’ (vedolizumab) or ‘systemic’ (anti-TNF, ustekinumab) biologic exposure. A severe safety event was defined as one that required hospitalisation.

Results
Thirty-six patients were exposed to 59 (median 12 (IQR 6-27) months) biologic episodes for IBD following LTx. Most patients had co-existing primary sclerosing cholangitis (88.9%) and ulcerative colitis (72.2%) (Table 1). The cohort were collectively exposed to 44.5 and 44.4 patient-years of ‘gut-specific’ (n=27) and ‘systemic’ (anti-TNF, n=22; ustekinumab, n=10) biologic therapy, respectively. Twenty-seven (45%) biologic episodes were associated with 41 safety events a median of 8 months (IQR 4.5-13.5) following biologic initiation (Table 2A). The incidence rate of safety events were comparable between ‘gut-specific’ and ‘systemic’ biologic exposures (0.43 vs 0.50 per patient-year, p=0.79). Corticosteroid exposure at biologic initiation was the only non-biologic immunosuppressive exposure associated with more frequent severe safety events (incidence ratio 5.40 [95% CI 1.66-17.63, P&lt;0.01]; Table 2B).

Conclusion
In this study of LTx recipients with IBD, incidence of safety events between those exposed to ‘gut specific’ and ‘systemic’ biologic therapies were comparable. These data suggest that choice of IBD biologic therapy should not be primarily influenced by concurrent transplant immunosuppression. However, corticosteroid co-therapy at biologic initiation may be associated with a higher incidence of severe safety events, highlighting the need to rationalise corticosteroid therapy following biologic initiation. These observations warrant validation in separate cohorts.
P1015 Upadacitinib as a Rescue Therapy in Patients with Steroid- and Infliximab-Refractory Acute Severe Ulcerative Colitis: Real-Life Multicentre Results
Authors: Ünal Gülsen N , Bakkaloglu O K , Kav T , Kani H T , Akpinar A , Akincioglu P , Eskazan T , Balamir M , Dagci G , Sendur I , Buyuktorun I , Barutcu S , Bengi G , Cavus B , Oruc N , Alabdah Y , Atug O , Dincer D , Hatemi I , Erzin Y Z , Tezel A , Toruner M , Akyuz F , Celik A F 
Published: January 2025

Abstract

Background
Ulcerative colitis (UC) is a chronic inflammatory bowel disease with remissions and flares. Approximately 20% of UC Patients develop acute severe ulcerative colitis (ASUC), a serious condition that is refractory to standard therapies and leads to morbidity and mortality. Rescue therapy (salvage therapy) with steroids, cyclosporine, and/or infliximab is recommended by guidelines.1 The colectomy rate in ASUC remains at around 36% even in the biological millennium.2 Upadacitinib (UPA) is a JAK1 selective inhibitor used effectively to treat UC. The role of UPA as a rescue therapy in ASUC is not clear. This study aims to evaluate the outcomes of UPA as a rescue therapy in ASUC patients.

Methods
A total of 31 steroid- and infliximab-refractory ASUC patients from 10 IBD centers from all over Türkiye were included between April 2023 and October 2024 in our study. Demographics of the patients and disease characteristics were recorded. Stool frequency (per day), rectal bleeding scores, and C reactive protein (CRP) were assessed from the electronic database at baseline (week 0), week 1, 4, 8, and 16 retrospectively. Complete clinical response was defined as stool frequency ≤3 per day and rectal bleeding score 0-1.

Results
Mean age was 36±13years; 16(51.6%) were female, mean disease duration was 6.9±5.4 years, 30(96.8%) had immunomodulator experience (Table1). A total of 10 patients had ≥ 3 biologics failures. Complete clinical response at weeks, 4, 8, and 16 were in 13 (42%), 16 (64%), 12 (67%), and 10 (77%) patients respectively.
Rescue therapy responses were not statistically significant between ≥3 and &lt;3 biologics failure groups (p=0.580) at week1. CRP normalization (&lt;3 mg/L) at week 4 was found in 9(36%) patients. By the end of the week, 6 (33%) patients had undergone colectomy. Clinical responses and surgery rates of UPA at week1,4,8, and 16 were detailed in Figure 1.

Conclusion
UPA provided a complete clinical response as a rescue therapy within the first week in 42% of cases in anti-TNF and steroid non-responders even with multiple biologics experience. Over half of the patients showed clinical remission by weeks 4 and 8.

References
1.Raine T, Bonovas S, Burisch J, et al. ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment. J Crohns Colitis. 2022;16(1):2-17. doi:10.1093/ecco-jcc/jjab1782.
2.Moore AC, Bressler B. Acute Severe Ulcerative Colitis: The Oxford Criteria No Longer Predict In-Hospital Colectomy Rates. Dig Dis Sci. Feb 2020;65(2):576-80.
P1017 Real-world effectiveness and safety of filgotinib with and without concomitant therapies in patients with Ulcerative Colitis: an interim analysis of the prospective, observational GALOCEAN study
Authors: Høivik MD- PhD M , Vermeire S , Reinisch W , Seenan J P , Löwenberg M , Schreiber S , Armuzzi A , Ricart E , Doherty G , Saldaña R , Sawyer W , Rudolph C , Jus A , Gilletta de Saint Joseph C 
Published: January 2025

Abstract

Background
Filgotinib (FIL), a once-daily, oral Janus kinase 1 preferential inhibitor, was approved for the treatment of Ulcerative Colitis (UC) following the phase 2b/3, randomized SELECTION clinical trial.1 Real-world data on the effectiveness and safety of FIL are needed to complement the results of clinical trials for applicability in daily clinical practice.

Methods
GALOCEAN (NCT05817942) is a European, multicenter, prospective, observational study that will recruit ~600 adults with UC receiving FIL in clinical care. In this interim analysis, we report data for up to 24 weeks. Effectiveness outcomes were the Mayo Clinic Score (MCS), the partial MCS (pMCS) and the two-item patient-reported outcome (PRO2) score, as well as Short Inflammatory Bowel Disease Questionnaire (SIBDQ), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) and Urgency Numerical Rating Scale (NRS) scores. Safety assessments included treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs). Data were analyzed for the overall patient group, and for those receiving FIL without baseline concomitant therapies (FIL−ct) or FIL with baseline concomitant therapies (FIL+ct; including conventional therapies, biologics and synthetic targeted small molecules).

Results
As of June 2024, 277 patients had been enrolled in GALOCEAN. Of these, 223 had available baseline data; 139 and 83 completed 10 and 24 weeks of treatment, respectively. At baseline, 53% of patients (118/223) received FIL−ct and 47% (105/223) received FIL+ct, of whom 92.4% (97/105) received aminosalicylates. Baseline characteristics are shown in Table 1. MCS, pMCS, PRO2, SIBDQ, FACIT-Fatigue and Urgency NRS data are shown in Table 2. At week 24, remission was achieved by 30% of patients (FIL−ct, 29%; FIL+ct, 31%) for the MCS, 47% (FIL−ct, 47%; FIL+ct, 47%) for the pMCS and 50% (FIL−ct, 44%; FIL+ct, 55%) for the PRO2 score. At week 24, minimal clinically important differences (MCIDs) were achieved by 66% of patients (FIL−ct, 75%; FIL+ct, 58%) for the SIBDQ score, 64% (FIL−ct, 72%; FIL+ct, 57%) for the FACIT-Fatigue score and 43% (FIL−ct, 50%; FIL+ct, 36%) for the Urgency NRS score. Overall, 30% of patients (FIL−ct, 25%; FIL+ct, 36%) had ≥1 TEAE and 6% (6% in each subgroup) had ≥1 AESI.

Conclusion
This study highlights the overall effectiveness and safety profile of filgotinib up to 24 weeks in a real-world cohort, both when used alone or with concomitant therapy. The safety profiles were consistent with previous data. The GALOCEAN study is ongoing.

References
1.Feagan BG et al. Lancet 2021;397:2372–84.
P1020 Trends in Opioid Use among Patients with Inflammatory Bowel Disease and Changes Following Advanced Therapy Initiation: A Korean nationwide population-based study
Authors: Jun Y K , Ji E , Choi Y , Shin C M , Park Y S , Kim N , Lee D H , Yoon H 
Published: January 2025

Abstract

Background
Opioid use patterns among Asian patients with inflammatory bowel disease (IBD), and the impact of advanced therapy (AT) on opioid use, are not well understood. This study aimed to investigate trends in chronic opioid use and assess the impact of AT initiation on opioid use among Korean patients with IBD.

Methods
Data were extracted from the Korean Health Insurance Review and Assessment Service database for adult patients with IBD from 2010 to 2022. Chronic opioid use was defined as ≥90 days or ≥3 opioid prescriptions within a calendar year. Chronic opioid users were matched with non-chronic opioid users at a 1:3 ratio based on sex, age, and type of IBD. Analyses included Poisson regression, the McNemar test, and generalized estimating equation (GEE).

Results
Between 2010 and 2020, Chronic opioid use was more prevalent in patients with Crohn’s disease (CD) compared to those with ulcerative colitis (UC). The number and proportion of chronic opioid users among Korean patients with CD and UC increased significantly (p-values &lt;0.0001 for both trends). In 2010, only 123 patients with CD (1.57%) and 113 patients with UC (0.54%) were classified as chronic opioid users. However, by 2020, these numbers rose sharply to 1,286 patients with CD (5.44%) and 1,087 patients with UC (1.97%). In the McNemar test, the number of opioid users significantly decreased following AT initiation (p-value &lt;0.0001 for both CD and UC): a large number of patients discontinued opioids after initiating AT (1,639 patients with CD and 1,600 patients with UC), while only a small number of patients began opioids after initiating AT (681 patients with CD and 642 patients with UC). GEE analysis further demonstrated that AT was significantly effective in reducing the number of opioid users among patients with CD (odds ratio [OR] = 0.479, 95% confidence interval [95% CI] = 0.440–0.521, p-value &lt;0.0001) and UC (OR = 0.844, 95% CI = 0.775–0.919, p-value = 0.0001).

Conclusion
Although opioid use among Korean patients with IBD has been on the rise, AT is effective in reducing the number of opioid users among patients with both CD and UC.
P1025 A mental health intervention can support increased capacity and revenue in the IBD outpatient setting
Authors: Avery P , Cervantes M L , Moulton C , Hart A 
Published: January 2025

Abstract

Background
A national reference centre for inflammatory bowel disease (IBD) in the UK supports around 10000 people with inflammatory bowel disease. A mental health service development in our centre has provided access to medical treatments for IBD that have traditionally been used to treat mental health conditions. Fatigue, affecting an estimated 40% of patients with IBD, predicts increased use of outpatient services. In a psychiatrist-led clinic, modafinil, a medication used to treat narcolepsy, produced a mean 58% improvement in fatigue in a case series of 10 patients. This snapshot of patients treated in this clinic looks at the potential for cost and efficiency improvements to reduce the waiting list for consultant-led care.

Methods
The electronic health records of 10 individuals treated with modafinil (dose 50-400mg/day based on clinical response) were analysed. Contacts were compared for 12 months before and 12 months after the intervention. The mean average of any saved appointments was calculated. All patients had severe fatigue, defined as an IBD Fatigue Assessment Score &gt;10/20, for six months or more. Anonymous demographic data were collected, and potential savings in appointments between follow-ups charged at £87.00 and new appointments charged at £150.00; the possible increase in capacity was calculated.

Results
Of the 10 patients analysed, the mean age was 33.8; 40% were male and 60% female. Twenty per cent had comorbid irritable bowel syndrome, 10% had comorbid Ehlers-Danlos syndrome, 60% were prescribed advanced therapy (AT) and 30% had been on one or more previous ATs. IBD outpatient appointments for the combined cohort were reduced from 70 to 27 for the 12 months before modafinil commencement to the 12 months of treatment, a reduction of 43(61%) appointments and a mean average of 4.3 If clinic templates were altered to new from follow-up, for these appointments’ revenue would be increased from £3,741.00 to £6,450.00, representing an increase in revenue of £2,709.00. If just 10% of the 4000 patients estimated to have fatigue at our centre benefit from this treatment, 1,720 appointments in 12 months would be saved, representing a cost saving of £149,640.00. These appointments could also be made available for new patients with a revenue increase of £108,360.00. With 1,720 appointments made available, this also offers increased access to specialist opinions for patients with IBD who need it

Conclusion
In addition to improving patient quality of life, modafinil shows potential health-economic benefits in IBD, including reduced burden on outpatient services and potential for increased revenue for specialist services. Replication of these findings in larger cohorts and randomised trials is needed.
P1027 Assessment of body fat composition in patients with inflammatory bowel diseases by bioelectrical impendance analysis: a single-centre study
Authors: Vukovic J , Sundov Z , Sustic I , Ivana J , Ana K ,   J Vukovic Sustic I Jukic I Krizman A
Published: January 2025

Abstract

Background
Body fat percentage (BF%) serves as a valuable indicator of nutritional status and associated health risks, particularly in patients with chronic inflammatory conditions such as inflammatory bowel disease (IBD). This study aimed to evaluate and compare BF% between healthy controls and individuals diagnosed with IBD to determine potential disparities in body composition linked to the disease.

Methods
A cross-sectional study design was employed, involving 76 IBD patients (34 with UC and 42 with CD disease) who are in clinical remission treated with biological therapy and 64 healthy controls. BF% was assessed using bioelectrical impedance analysis, providing a comparative analysis between these two groups. Statistical significance was evaluated using a two-sample t-test with a significance threshold of p &lt; 0.05.

Results
The mean BF% was 22.54 for the IBD patient group and 23.59 for the healthy cohort. The observed difference was not statistically significant (p = 0.3765), suggesting that BF% in IBD patients may not differ substantially from that of healthy individuals within this sample.

Conclusion
Our findings indicate no significant deviation in BF% between IBD patients and healthy controls, suggesting that body fat levels might remain stable and indicate the quality for treatment of IBD. BIA related indices are effective tool for assessment of nutritional status, and indicate the quality for treatment of IBD. This study underscores the complexity of body composition in chronic inflammatory conditions and highlights the need for further research to assess the role of treatment on body composition in IBD populations.

References
1.Jabłońska B, Mrowiec S. Nutritional Status and Its Detection in Patients with Inflammatory Bowel Diseases. Nutrients. 2023;15(8).
2.Bischoff SC, Escher J, et al. ESPEN practical guideline: Clinical Nutrition in inflammatory bowel disease. Clinical nutrition (Edinburgh, Scotland). 2020;39(3):632-53.