bluuebunny/crossref_metadata_2025_split huggingface dataset:
P766 Practical application of evidence-based dietary therapy into inflammatory bowel disease care shows high patient satisfaction, compliance, and efficacy. The Delectable Program
Authors: Russell E , Trakman G , Hamilton A L , Wilson-O’Brien A , Hendricks N , Simmance N , Thompson E , Niewiadomski O , Kamm M 
Published: January 2023

Abstract

Background
Diet is an accepted therapy for Inflammatory Bowel Disease (IBD). Controlled trials have demonstrated that exclusive enteral nutrition (EEN) and the Crohn’s Disease Exclusion Diet (CDED) induce remission in Crohn’s disease. Low sulphur and plant-based diets are being investigated in ulcerative colitis (UC). Reducing ultra-processed, additive-containing food intake is emerging as important, given its role in initiating and perpetuating disease. IBD patients believe in the value of the diet, but there is no evidence for diet tolerability and benefit outside of clinical trials. The DELECTABLE program, a dietitian-led telehealth service, aims to evaluate structured, evidence-based dietary therapy as part of routine clinical care. Here we present satisfaction, compliance and efficacy results.

Methods
In this open-label, prospective, observational program, Crohn’s disease and pouchitis patients were offered the CDED or a wholefood additive-free diet, UC patients were offered a low-sulphur plant-based diet or wholefood diet, and patients with microscopic colitis were offered the wholefood diet. The primary outcome was diet satisfaction (modified DSAT-28; possible range: 28 to 140). Dietitian-rated compliance, patient-rated compliance, disease activity score (CDAI, partial Mayo score), CRP, and faecal calprotectin were secondary outcomes. Baseline to week 12 differences were assessed using the Mann-Whitney-U-test or Wilcoxon-sign-test for continuous variables and McNemar’s test for categorical variables.

Results
Of 165 patients referred, 79 enrolled in the program. Fifty-seven (72%) enrolled patients have completed 12 weeks of diet therapy. Across all diet arms combined, diet satisfaction score increased from week 1 (89.3) to week 12 (93.7; P&lt;0.001). Dietitian and patient-rated compliance were 4/6 and 3/5, respectively, at week 1 and did not change at week 12. CDAI was reduced on all diet arms combined (60.0 to 41.5, P=0.003) and on the CDED (128.9 to 46.6, P=0.004), with a trend for reduced CDAI on the wholefood diet. There was a trend towards reduced CRP across all diet arms and on the wholefood diet (49.5 to 25.3, P=0.363). The proportion of patients in remission, based on CDAI, increased when all diet arms were combined and on the CDED and wholefood diet (P&lt;0.001). Faecal calprotectin was numerically reduced on the CDED (95.0 ug/g to 53.5 ug/g) and UC diet (184.0 ug/g to 159.0 ug/g), but these results did not reach statistical significance.

Conclusion
Half of the referred patients are interested in pursuing a supervised, long-term diet program. Implementation of well-balanced, effective diet therapies is feasible and well-accepted by patients, with a promising impact on disease activity.
P768 The prevalence and risk factors for malignancies in patients with inflammatory bowel disease in Crete : a case control study
Authors: Foteinogiannopoulou K , Nicolaou P , Mala A , Theodoraki E , Orfanoudaki E , Theodoropoulou A , Karmiris K , Koutroubakis I 
Published: January 2023

Abstract

Background
There is evidence that about 30% of the patients with inflammatory bowel disease (IBD) develop malignancies whichconstitute the second cause of death, after cardiovascular diseases, such as in general population.

Methods
The aim of this study was to investigate the prevalence and risk factors for malignancies in IBD patients followed in two tertiary centers. It was a retrospective analysis of prospectively recorded data in an established IBD registry for seven years (06/2015 to 06/2022). IBD patients with malignancies were compared with controls-IBD patients without malignancies [matching 1:3 according to sex, IBD diagnosis (Ulcerative Colitis; UC, Crohn’s Disease; CD) and age (±5 years)] so as to elucidate possible risk factors for cancer (CA) development in these individuals.

Results
From a total of 2.382 IBD patients of the IBD registry in University Hospital and Venizeleio General Hospital of Heraklion in Crete, 107 (4.5 %) were diagnosed with CAs during their follow-up whereas 22 (0.92 %) had a history of CA before IBD diagnosis. Demographic, clinical and therapeutic data for the total of 428 patients (107 with CA and 321 without CA) are presented in Table 1. Among patients with CA, 49 (45.8%) were females, 54 (50.5%) had CD, the median age of CA diagnosis was 61 years (51.3-69.8) and the median IBD duration was 10 years (3-20). Thirty-two (29.9 %) of the CA-IBD patients had known familial history of CA and 28 (26.1 %) were active smokers whereas 46 (42.9 %) were ex-smokers. Twenty-nine patients (27.1 %) were exposed to immunomodulators, 32 (29.9 %) to anti-TNFs, 20 (18.7 %) to other biologics and 16 (14.9 %) to combination treatment. The majority of CA cases were extra-intestinal, only 12 (11.2 %) had colorectal cancer (CRC) and 11 (10.3 %) had a CA recurrence whereas 19 (17.8 %) died from the CA. In the univariate analysis the median IBD duration (OR 0.96, CI 95%0.94- 0.99), inflammatory phenotype in CD (OR 0.46, CI 95% 0.23-0.93) and treatment with other biologics (other than ant-TNFs) (OR 0.50, CI 95%0.29- 0.86) were protective factors, whereas colonic location in CD (OR 3.24, CI 95% 1,49-7,04) found to be a risk factor for CA development(Table 1). No association with disease characteristics, smoking habits, family history of CA and extra intestinal manifestations was found. In the multivariate analysis only CD inflammatory phenotype (OR 0.28, CI 95%0.09-0.58) was a protective factor whereas colonic location (OR 4.8, CI 95% 1.81-12.79) remained a risk factor for malignancies (Table 2).

Conclusion
The prevalence of malignancy in IBD patients in Crete is 4.5%. It seems that in CD disease phenotype is associated with the development of malignancies. Non association with the used medications was found.
P769 Randomised feasibility study of preoperative medical nutrition therapy in adults undergoing surgery for Crohn’s disease
Authors: Wall C , Glyn T , Rowbotham D , Haines M , Bissett I , Eglinton T , Gearry R 
Published: January 2023

Abstract

Background
Preoperatively patients with Crohn’s disease are at high risk of malnutrition. Patients requiring surgery to manage stricturing disease are often advised to follow a low residue/low fibre diet to reduce risk of bowel obstruction. This diet is usually nutritionally inadequate and may negatively affect nutritional status. Research suggests that preoperative exclusive enteral nutrition (EEN) improves nutritional status, reduces intestinal inflammation and consequently improves surgical outcomes. Recently the Crohn’s disease exclusion diet has been shown to reduce intestinal inflammation in adults but its use preoperatively has not been reported. This research aimed to determine whether it is feasible to recruit and retain patients with Crohn’s disease in a single-blinded, multicentre, randomised controlled trial of three preoperative nutritional therapies.

Methods
Patients undergoing elective surgery to manage Crohn’s disease at three New Zealand tertiary care hospitals (Christchurch, Auckland and Waikato hospitals), aged &gt;18 years old, with body mass index (BMI) &gt; 18.5 kg/m2 and without recent significant weight loss were eligible to participate. Patients were randomised to six weeks of preoperative EEN, partial enteral nutrition with Phase-1 Crohn’s Disease Exclusion Diet (CDED) or standard care. Nutritional and radiological assessment at baseline and preoperatively was completed and surgical outcomes recorded. Descriptive statistical analysis was undertaken. Health and Disability Ethics Committee approval was given (20/NTB/134).

Results
Over 18 months (September 2020 to March 2022), 48 patients were screened and 17 were randomised. Patient characteristics were: median age 37.9 (range, 28-68) years, 9 (53%) female, 10 (59%) on biologic medication, median BMI 25.7 (range, 19.7-38.6) kg/m2 and 2 (12%) had low fat-free mass index. Medical nutrition therapy was completed by 13/17 (76%) patients (EEN n=4, CDED n=4 and standard care n=5) and four withdrew. BMI and simplified magnetic resonance index of activity (MaRIA) score changed by a median of -0.3 (range, -1.8 to 2.1) kg/m2 and 0.5 (range, -3 to 2) points respectively. At day 30, 10 patients had no surgical complications. Three patients had Clavien Dindo Grade 2 complications; one (standard care group) experienced fever treated with antibiotics, one (standard care group) had postoperative ileus requiring total parenteral nutrition and one (CDED group) required a blood transfusion postoperatively and antibiotics for a wound infection.

Conclusion
Patients who need elective Crohn’s disease surgery tolerate preoperative EEN or CDED. Use of preoperative nutrition therapies are feasible and the impact on surgical outcomes should be assessed in a larger study.
P775 Disease activity and treatment patterns of newly diagnosed adult patients with Crohn's disease in Japan: Interim analysis of inception cohort registry study of patients with Crohn's disease (iCREST-CD)
Authors: Shinzaki S , Matsuoka K , Fujii T , Okamoto R , Yamada A , Kunisaki R , Matsuura M , Watanabe K , Shiga H , Takatsu N , Bamba S , Mikami Y , Yamamoto T , Shimoyama T , Motoya S , Torisu T , Kobayashi T , Ohmiya N , Saruta M , Matsuda K , Matsumoto T , Nakase H , Maemoto A , Murata Y , Yoshigoe S , Tsuchiya H , Hisamatsu T 
Published: January 2023

Abstract

Background
Biologics are commonly used for the treatment of Crohn’s disase (CD); however, the proportion of biologics used and their initiation time from diagnosis differs widely between different regions. There is limited information about the patient characteristics and the treatment persistence of each initial biologics, and the treatment persistence of top-down and step-up therapy. iCREST-CD is a prospective, non-interventional, longitudinal, observational registry study conducted at 19 tertiary centres to understand the characteristics of CD treatments in actual clinical settings in Japan. We conducted an interim analysis (cutoff date: 30 June 2022) of iCREST-CD to mainly evaluate the indication and outcomes of initial biologic therapy.

Methods
Patients newly diagnosed with CD after June 2016 based on the diagnostic criteria of the Japanese Guidelines, aged ≥16 years at the time of informed consent with no prior exposure to biologics were enrolled. Patient demographics, clinical data, disease activity and medical treatment were recorded. Biologic use without prior steroid use was defined as top-down and biologic use with prior steroid use was defined as step-up.

Results
A total of 672 eligible patients (68.2% male) with mean age (±SD) of 29.4 (13.1) years were analysed. Cumulative proportion of patients prescribed 5-aminosalicylic acid, steroids, immunomodulators, and biologics at 6- and 12-months from diagnosis were 71.3%, 40.6%, 31.4%, and 47.5%; and 75.0%, 43.6%, 36.0%, and 59.7%, respectively (Figure 1).

A total of 498 patients received biological therapy—infliximab (IFX; 121 [24.3%]), adalimumab (ADA; 244 [49.0%]), ustekinumab (UST; 107 [21.5%]), and vedolizumab (VDZ; 26 [5.2%]). The mean age (±SD) at the initiation of biologic treatment was IFX: 28.2 (11.3), ADA: 26.6 (10.8), UST: 30.4 (14.1), and VDZ: 36.2 (17.4), and the mean (±SD) levels of C-reactive protein (CRP) (mg/L) was IFX: 25.9 (26.8), ADA: 18.9 (26.0), UST: 13.5 (17.9), and VDZ: 9.5 (19.0) (Table.1). The initial biologic treatment persistence rates of IFX, ADA, UST and VDZ at 36-months were 77.5%, 75.8%, 79.8%, and 49.0%, respectively (Figure 2).

Patients receiving top-down and step-up therapy were 284 (57.0%) and 214 (43.0%), respectively. The treatment persistence rate of initial biologics by top-down and step-up therapy at 36-months from diagnosis was 81.6% and 66.9%, respectively (P=0.001) (Figure 3).

Conclusion
This registry study that demonstrated the treatment persistence rate of initial biologic therapy was significantly higher in the top-down than the step-up approach.
P776 Polymeric exclusive enteral nutrition induces biochemical remission in adults with active Crohn’s Disease irrespective of disease location or concomitant steroid use
Authors: Kuo H , Tognolini K , Willmann L , Haig A , Subhaharan D , Mutsekwa R , Shukla D , Moattar H , Dorrington A , Ishaq N , Bhullar M , Edwards J , Mohsen W , Kakkadasam Ramaswamy P ,   Gold Coast Inflammatory Bowel Diseases Research Group
Published: January 2023

Abstract

Background
Data on the effectiveness of polymeric Exclusive Enteral nutrition (EEN) in inducing biochemical remission in adult patients with active Crohn’s disease (CD) is scarce. Our aim was to assess the effectiveness of polymeric EEN in inducing biochemical remission in adults with active CD.

Methods
Single tertiary centre retrospective study of patients with active CD who received induction therapy with EEN from January 2018 to September 2022. Active CD was defined as CRP ≥ 10mg/L or faeces calprotectin (FC) ≥ 250mcg/g. Primary endpoint (PE) was biochemical remission at 8 weeks. Biochemical remission was defined as CRP &lt; 6 mg/L in patients with CRP ≥ 10mg/L at baseline OR FC &lt;150 mcg/g in patients with an FC ≥ 250mcg/g at baseline.

Results
Sixty-one patients were included, 32 (52.4%) females, median age 53 years (IQR: 28-62). Median disease duration was 6 years (IQR: 1-20), median duration of EEN was 7 weeks (IQR: 5.5-8 weeks). 34 (55.7%) patients received steroids concurrently. PE was achieved in 35 (57.4%) patients overall; 20 (58.8%) with concurrent steroid and 15 (55.6%) without steroid use at baseline achieved PE, p=1. 43.7% (7/16) of patients with ileal, 50% (4/8) with colonic and 64.9% (24/37) with ileo-colonic (p=0.33) disease phenotype achieved PE. Significantly fewer patients with baseline concurrent biologic achieved PE [12/29 (41.38%) vs 23/32 (71.9%), p=0.021]. On univariable analysis, absence of biologic therapy at baseline was a predictor for achieving PE [OR 3.6 (1.23-10.6), p=0.019]. Age, disease location, age at diagnosis, behaviour, sex, disease duration, smoking status, concurrent steroid use or concurrent immunomodulator use did not predict achieving PE. 40 patients had CRP ≥ 10mg/L at baseline, of whom 25 (62.5%) achieved CRP &lt; 6 mg/L. 49 patients with ≥ 250mcg/g at baseline, of whom 22 (45%) achieved FC &lt;150 mcg/g.

Conclusion
Polymeric EEN is effective in inducing biochemical remission in adults with active CD irrespective of disease location or concurrent steroid use. Significantly fewer patients on concurrent biologics at baseline achieved biochemical remission.
P790 Examining mental health disease burden among Crohn’s Disease (CD) patients in Europe
Authors: Thoo M , Baynton E 
Published: January 2023

Abstract

Background
Mental health is an overlooked aspect of inflammatory bowel disease (IBD) patient care and the most common psychological conditions in patients with IBD are anxiety and depression1. The objective of this study was to examine the possible factors that will impact mental health burden of CD patients in Europe.

Methods
A multi-centre online medical chart review study of patients with CD was conducted between Jul – Sep 2022 among UK, FR, DE, IT & ES gastroenterologists practicing across hospital and private practices. Physicians were screened for practice duration and patient volume. Charts of patients prescribed with advanced therapy were included in the analysis.

Results
206 sampled physicians collectively reported 1178 CD patients. From the reported CD patients, 190 suffered mental health burden (depression or anxiety) and 988 CD patients did not suffered any mental health burden. Among CD patients suffered mental health burden, a higher proportion of CD patients are female vs those who did not suffered any (55% vs 46%). ‘Family history of IBD’ was the co-morbidity more likely to experience in reported CD patients suffered mental health burden vs those who did not (11% vs 7%).

When looking at employment status between these two patient groups, reported CD patients suffer mental health burden was less likely to be in full-time employment vs those not suffered mental health burden. A higher proportion of reported CD patients suffered mental health burden were in part-time employment or housewife/househusband.
CD patients with mental health burden had greater CRP level than patients without mental health burden (CRP mean: 16 vs 12). This aligns with reported CD patients with mental health burden had frequent surgery times vs without mental health burden (Mean surgery times: 2 vs 1) and had greater steroid usage (% reported patients currently on steroids – 18% vs 13%).

Conclusion
Comparisons in this study cohort highlight there are other factors could impact CD patients’ mental health burden other than IBD itself. This coincided with low full-time employment rate that attributed to financial stress may increase CD patients’ mental health burden. Also, higher rate of surgery and steroid usage in CD patients experienced mental health burden might suggest they had more severe or complications with their disease that will impact overall mental health. Further investigation using comparator cohort is warranted.
P803 Plasma N-glycan biomarkers predict patient Response to Vedolizumab treatment for Crohn’s Disease
Authors: Elgood Hunt G , Adams A , Senard T , Gardner R , Jonge W , Li Yim A , Noble A , Satsangi J , Joustra V , D’Haens G , Spencer D 
Published: January 2023

Abstract

Background
Vedolizumab (VDZ) is a monoclonal antibody directed against α4β7 integrin used to treat Crohn’s disease, which has proven to be efficacious in phase 3 clinical trials¹ and in real-world studies². However, there is a need for reliable biomarkers to predict whether an individual patient will respond to VDZ treatment. Glycosylation changes have been associated with CD, but have never been studied as potential predictors of remission to biological therapy³. A comparison of plasma N-glycan profiles between responders and non-responders to VDZ was used to detect potential biomarkers to response.

Methods
Plasma samples before (t1) and after (t2) initiation of vedolizumab treatment (mean follow up time at t2 215 ± 61 days) were taken from 58 patients with Crohn’s disease. They were analysed by high-performance liquid chromatography with mass spectrometry. Response to VDZ was assessed by a combination of clinical and endoscopic outcomes and was observed in 34 of 58 patients. 89 direct glycan traits met the criteria for quantification and were extracted from the data via LacyTools. Consequently, 21 derived glycan traits were calculated by combining direct traits with shared structural similarities. Correcting for age and sex, the direct and derived traits were tested across responses using logistic regression and cross-validation to determine which traits at t1 are predictive of response (p-value &lt; 0.05) and traits at t2 are markers of response (p-value &lt; 0.05).

Results
Two glycans, MAN6 (0.65 AUC) and FA2G2S2 (0.7 AUC) were higher in responders prior to treatment and moderate predictors of response, with no improvement in a combined model (figure 1A). Congruent to previous studies, galactosylation levels increased in responders after treatment. Overall, 17 direct traits and 4 derived traits were markers of response after treatment and collectively proved to be good predictors of response (0.80 AUC) (figure 1B).

Conclusion
This study has demonstrated multiple N-glycans are indicators of future response to VDZ treatment, with the potential to guide clinicians in determining the most appropriate form of treatment for individuals. These data require to be validated in the future; and to be assessed alongside other emerging biomarkers.
References:
1 Sands BE, et al .2014 Sep;147(3):618-627.e3
2 Bressler B,et al.2021 Mar 30;15(10):1694–706.
3 Šimurina M, et al. 2018 Apr;154(5):1320-1333.e10
P814 Clinical trial design in Crohn’s disease: interpreting future endpoints based on post hoc analyses of the vedolizumab phase 3 trials GEMINI 2 and VISIBLE 2
Authors: Khan R M Q , Schwartz D A , Sands B E , Hanauer S , Uddin S , Mukherjee R , Lichtenstein G 
Published: January 2023

Abstract

Background
Crohn’s disease (CD) is a chronic, relapsing–remitting disease characterized by inflammation of the gastrointestinal tract. Historically, the Crohn’s Disease Activity Index (CDAI) has been used to assess outcomes in clinical trials involving patients with CD. However, in contrast to the alignment of regulatory standards for trials in ulcerative colitis, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) differ regarding the most appropriate endpoint definitions for trials in CD. We examined how clinical remission endpoints in CD trials have evolved and conducted post hoc analyses of two vedolizumab trials, GEMINI 2 and VISIBLE 2, to understand how endpoint definitions influence clinical trial outcome measures of treatment efficacy.

Methods
Endpoint definitions of clinical remission in completed and ongoing phase 3 trials of advanced therapies in CD were extracted from published literature and ClinicalTrials.gov. Post hoc analyses of data from GEMINI 2 and VISIBLE 2 were conducted by measuring the difference (%Δ) between the proportions of patients achieving clinical remission with vedolizumab versus placebo at week 52 as assessed by six endpoint definitions (A: stool frequency score [SFS] ≤ 2.8 and not worse than baseline score; B: SFS ≤ 3 and not worse than baseline score; C: abdominal pain score (APS) ≤ 1 and not worse than baseline score; D: SFS ≤ 2.8 and APS ≤ 1; E: SFS ≤ 3 and APS ≤ 1; F: CDAI ≤ 150) (Figure 1).

Results
Most phase 3 trials of advanced therapies in CD included a clinical remission endpoint that was defined by CDAI score: typically, CDAI &lt; 150 or ≤ 150. However, several recent trials have also included a primary or secondary clinical remission endpoint defined using components of the CDAI score such as SFS and APS (Table 1). Post hoc analyses of GEMINI 2 and VISIBLE 2 revealed minimal change in %Δ for each of the new endpoint definitions tested compared with the primary analysis for each trial (Figure 1).

Conclusion
Objective measures, including patient-reported outcomes and components of the CDAI score such as SFS and APS, have been used to define clinical remission in recent CD trials. Despite differences in regulatory guidance for defining clinical remission, our post hoc analyses of GEMINI 2 and VISIBLE 2 reveal that the efficacy of vedolizumab, measured using a variety of endpoint definitions from recent CD trials, was similar to that previously reported using CDAI ≤ 150.