bluuebunny/crossref_metadata_2025_split huggingface dataset:
P501 Communicating Needs and Features of IBD Experiences (CONFIDE) Survey: Prevalence and patients’ experience of moderate-to-severe Crohn's disease symptoms in Canada
Authors: Jairath V , Glass J , Braun M , Bessissow T , Gibble T , Atkinson C , Ellis H , Dewar T , Panaccione R 
Published: January 2024

Abstract

Background
Bowel urgency is known to negatively affect a patient’s quality of life1. The Communicating Needs and Features of IBD Experiences (CONFIDE) study explores patients’ experiences and the impact of moderate-to-severe Crohn's disease (CD) and ulcerative colitis symptoms on their lives in the United States, Europe, Japan, and Canada. The current analyses focus on Canadian patients with moderate-to-severe CD.

Methods
An online, quantitative, cross-sectional survey was conducted between February and April 2023 in patients with CD. Moderate-to-severe CD was self-reported and defined based on previous treatment, steroid use, and/or hospitalisation. Data on patients' experiences and the impact of CD were descriptively summarised.

Results
A total of 107 Canadian patients with CD completed the survey (71% male, mean age 45.1 (14.8) years, mean disease duration 10 (10.2) years), of which 79% were receiving advanced therapies at the time of the survey. The top three symptoms currently (in the past month) experienced by patients were diarrhoea (49%), bowel urgency (44%), and loud stomach gurgling/rumbling (40%). Of the patients who had ever experienced bowel urgency (67%), 61% reported experiencing it at least once a week in the past 3 months. Of the patients who had ever experienced bowel urgency-related accidents (48%), 33% reported doing so at least once a week in the past 3 months. Overall, 35% of patients reported wearing diaper/pad/protection at least once a week in the past 3 months due to fear of bowel urgency-related accidents (Table). Bowel urgency (32%), fear of faecal seepage/unnoticed leakage of stool, and increased stool frequency (27% each) were the leading causes for declined participation in work/school (Fig. 1 A). Over one-third of patients declined participation in social events due to bowel urgency (36%) and fear of BU-related accidents (32%; Fig. 1 B). Overall, 37% and 29% of patients declined participation in physical exercise due to bowel urgency and fear of passive incontinence, respectively (Fig. 1 C).

Conclusion
Bowel urgency was the second-most common symptom among patients with moderate-to-severe CD and the most reported symptom leading to patients declining participation in work/school, social events, and physical exercise. Despite receiving treatment for CD, including advanced therapies, many patients with moderate-to-severe CD continue to report bowel urgency, bowel urgency-related accidents, and the use of diaper/pad/protection. These results underscore the immediate need for a holistic approach to CD management in Canada, focusing on symptom control.
Reference:
1. Panaccione, R., et. al., (2023), American Journal of Gastroenterology. 118, S912-S912.
P503 Differentiation of patients with IBD at increased risk of CRC using UR-CARE: A Single Centre Experience
Authors: Valkov H , Lyutakov I , Peneva P , Vladimirov B , Penchev P 
Published: January 2024

Abstract

Background
The United Registries for Clinical Assessment and Research (UR-CARE) platform aims to facilitate and improve the daily clinical care of patients with Inflammatory Bowel Disease (IBD). The possibility of updating the medical data in UR-CARE at each patient visit allows for strict follow-up and enables the doctor to draw relevant recommendations. The study is aimed at identifying registered IBD patients at increased risk of colorectal cancer (CRC) via UR-CARE.

Methods
Outpatients and inpatients with a confirmed IBD diagnosis, who had signed informed consent, were entered with their clinical data in UR-CARE to the centre UMHAT “Tsaritsa Yoanna-ISUL”. Only the statistical and filter opportunities of the digital platform were used. The study was conducted with our own data from our centre database.

Results
274 IBD patients (120 with ulcerative colitis [UC], 144 with Crohn’s disease [CD] and 10 with IBD unclassified [IBD-U]) were entered in UR-CARE. Among all registered patients, colorectal dysplasia was entered for 19 (6.93%) persons (15 males; 14 with UC). The column for “Dysplasia” in the drop-down menu could be left empty. These 19 patients with colorectal dysplasia make up 7.98% of all 238 patients with filled in one of the three options for dysplasia. 7 (2.55%) IBD patients (5 males; 5 with UC) had primary sclerosing cholangitis, and for two of them with UC, colorectal dysplasia was entered. Among all registered IBD patients, four had undergone surgery for CRC, and one patient was operated on for familial adenomatous polyposis. UR-CARE filtered 73 patients with extensive and left-sided UC with a duration of UC ≥ 8 years who should undergo screening colonoscopy for dysplasia.

Conclusion
UR-CARE can quickly and effectively differentiate patients with IBD and at an increased risk of developing CRC. It enables the provision of graphic data and provides access to the files of patients at high risk of CRC, allowing for their individual follow-up.
P505 Accelerating Crohn's Disease clinical trials using generative artificial intelligence
Authors: Turner M , Millar S , Kusiak C , Fuller F D , Walsh J , Zhuang R 
Published: January 2024

Abstract

Background
At Unlearn.AI, we expedite decision making and address challenges of lengthy and costly Crohn’s Disease (CD) trial enrollment by introducing deep learning models that create digital twins of trial participants, which are comprehensive forecasts of health outcomes. These generative predictions are incorporated into standard linear and logistic regression analyses, in addition to more advanced methods, in clinical trials. Our TwinRCT technology, which aligns with regulatory guidance, augments standard RCTs for easy integration into clinical programs. We demonstrate the expected benefit of these solutions in a subset of IBD Plexus data that were not previously involved in the training of the generative model, showcasing its potential to transform future CD trials.

Methods
We developed a generative deep learning model using data from approximately 4,500 Inflammatory Bowel Disorder (IBD) participants in observational studies and randomized controlled trial (RCT) control arms from the IBD Plexus program of the Crohn’s & Colitis Foundation. The trained model was used to forecast, entirely from each participant’s baseline data, the control outcomes of participants in a held out set of 300 participants. The resultant forecasts, or digital twins, represent comprehensive longitudinal trajectories across a range of outcomes, laboratory measures, and vital signs. We evaluated the expected benefits of incorporating the digital twins in linear and logistic regression models, analyzing the change from baseline to follow-up (Weeks 12 through 52) on sCDAI total score, change in daily bowel movement count, change in abdominal pain score and proportion of patients achieving clinical remission (sCDAI &lt; 150; sCDAI is very closely related to CDAI).

Results
Digital twins provided substantial attainable benefit across outcomes and time points, enabling up to 21% overall sample size reduction or 34% reduction in the control arm only.

Conclusion
TwinRCTs offer a strategic enhancement to traditional RCTs by minimizing the required sample size needed to identify significant treatment effects. Aligning with existing FDA and EMA guidelines, TwinRCTs can be effectively utilized in Phase 2 and Phase 3 CD studies for faster decision making, as well as reduced timelines and costs, without increasing regulatory risk over standard approaches.
P510 Relapse rate following withdrawal of vedolizumab and ustekinumab in patients with inflammatory bowel disease. The VEDUST-EXIT study
Authors: Albshesh A , Kucha P , Mahajna H , Amiot A , Abitbol C M , Eder P , Imperatore N , Krznaric Z , Zaborowska M , Zagórowicz E , Carbonnel F , Zittan E , Ben-Horin S , Kopylov U 
Published: January 2024

Abstract

Background
Approximately half of patients with IBD in clinical remission (CR) flare within 12 months of withdrawing anti-TNF therapy. However, the outcomes of vedolizumab (VDZ) or ustekinumab (UST) cessation in terms of CR in routine practice are unknown. There is a need for more data to establish the relapse rates following treatment cessation.

Methods
This was a retrospective observational multicenter study. We included adult IBD patients who had withdrawn from either VDZ or UST after achieving CR and had available follow-up data for one year following treatment discontinuation or until relapse occurred. The control arm comprised patients discontinuing anti-TNFs after achieving CR. The primary objectives of this study are to assess the clinical relapse rates after discontinuing VDZ or UST and to identify potential predictors of sustained remission and relapse after therapy discontinuation.

Results
A total of 133 patients were included (48.1% Crohn’s disease and 51.9% ulcerative colitis). Sixty out of the 133 (45%) patients discontinued anti-TNF, 54 (40%) VDZ and 19 (15%) UST. All patients were in CR prior to drug discontinuation. The most common cause for drug discontinuations was patients’ preferences (80%) followed by cost and administrative issues. Duration of remission before drug discontinuation was 11 (IQR 7.5-10), 8.5 (6-12.2), and 12 (8-27) months, for anti-TNF, VDZ, and UST, respectively.
The median follow-up duration was 14 months (5.5-20), with an overall relapse rate of 78.9% (105/133). Relapse rates in each cohort were 71.6%, 83.3%, and 89.4%, respectively, p=0.5. The median time to relapse was 10 months (3-9), 9 (6-16.5), and 8 (5-16.5), respectively. There was no significant difference in the relapse rates between the different drugs (anti-TNF vs VDZ, anti-TNF vs UST, and VDZ vs UST, (hazard ratio, HR 1.2, confidence interval, CI 95% 0.2-1.8; P = 0.35), HR 1.2, CI 95% 0.9-1.6; p=0.13, HR 1.2, CI 95% 0.6-2.1; P=0.5, respectively). Predictors of relapse after drug withdrawal were a short treatment period (HR 0.98, CI 95% 0.96-0.99; P = 0.04), shorter remission period (HR 0.9, CI 95% 0.95-0.99, P =0.03), multiple prior biologics (HR 1.2, CI 95% 1.04-1.44, P= 0.013), perianal disease (HR 5.5, CI 95% 1.6-1.8, P=0,006) and lower hemoglobin level (HR 1.95, CI 95% 1.1-3.1, P= 0.008). The following factors were not associated with an increased risk of relapse: IBD type, disease phenotype, extraintestinal manifestations, active smoking status, prior IBD-related surgery, elevated CRP or calprotectin, and endoscopic or radiologic signs of active disease.

Conclusion
In IBD patients that discontinue biologics after achieving clinical remission, relapse rates following withdrawal of VDZ and UST are comparable with those of anti-TNF.
P518 Dietary and non-dietary predictors of treatment response to adalimumab in anti-TNFα-naïve adults with Crohn’s disease
Authors: Jatkowska A , White B , Campbell I , Brownson E , Short B , Clowe J , Seenan J P , Gaya D R , Din S , Ho G T , Robertson E , Mowat C , Milling S , MacDonald J , Gerasimidis K 
Published: January 2024

Abstract

Background
Biologics, such as anti-TNFα agents, are commonly used in the management of Crohn’s disease (CD). A significant proportion of patients do not respond to treatment, necessitating the exploration of pre-treatment predictors of treatment response.

Methods
Anti-TNFα-naïve adults with active CD (Crohn’s Disease Activity Index; CDAI≥150) participating in an RCT (NCT04859088) were randomised to receive adalimumab monotherapy or adalimumab combination therapy with 50% partial enteral nutrition (PEN). Treatment response (CDAI&lt;150) was assessed after 6 weeks, baseline diet was assessed with EPIC-Norfolk FFQ, alternative Mediterranean diet scores (aMED), and principal component analysis (PCA) with orthogonal (varimax) rotation was used to identify data-derived dietary patterns. Baseline predictors evaluated included PEN use, steroid use, immunomodulator use, age, disease duration, CDAI, C-Reactive protein (CRP), albumin, haemoglobin, Scottish Index of Multiple Deprivation (SIMD) score, adherence to dietary patterns identified, aMED score, smoking status, alcohol consumption, physical activity level, body mass index (BMI), fat mass (kg/m2), fat-free mass (kg/m2), and handgrip strength. Differential analysis between responders and non-responders was carried out with general linear model or chi-square test when appropriate. Random forest model with recursive feature elimination (RF-RFE) was used to identify the most predictive factors of treatment response.

Results
Of 42 participants recruited to the study, 62% (26) responded to treatment. PCA revealed four dietary patterns (Figure 1A). Responders to adalimumab were younger (mean (SD): 36.0 (17.1) vs 50.8 (10.0), P=0.004), had lower baseline CDAI (mean (SD): 228 (62) vs 286 (78), P=0.018), higher CRP (14.5 (19.2) vs 4.6 (5.8) mg/L, P=0.036), were less likely to smoke (31% (5 of 16) vs 8% (2 of 26), and less likely to adhere to a dietary pattern characterised by high consumption of animal products (PC2) (P=0.030). Adherence to PC2 also correlated positively with age (r=0.327, P=0.035). The RF-RFE algorithm highlighted young age, low baseline CDAI and low PC2 adherence as key factors (Sensitivity: 77%, Specificity: 63%, PPV: 77%, NPV: 63%, OOB: 29%, P=0.012) (Figure 1B). Interestingly, exclusion of dietary factors improved diagnostic performance of the model (Sensitivity: 77%, Specificity: 75%, PPV: 83%, NPV: 67%, OOB: 24%, P=0.003) (Figure 1C), indicating potential interactions by other factors like age.

Conclusion
Young age, non-smoking, low baseline CDAI and elevated CRP predict adalimumab response in anti-TNFα-naïve adults. While dietary factors may also play a role, their impact seems confounded by other non-dietary factors. Further research is warranted in this area.
P519 Assessment of anal sphincter complex in pregnant patients with non-active perianal Crohns disease
Authors: Bar-Gil Shitrit A , Mishael T , Reiss Mintz H , Goldenberg R , Freund M R , Yellinek S 
Published: January 2024

Abstract

Background
Pregnant IBD patients are more likely to undergo Cesarean delivery (CS).. Active perianal Crohn’s disease (PCD) is the only Crohns - related indication for CS. The rationale for CS in this group is that active PCD damages the sphincters and therefore a vaginal delivery may exacerbate the damage to the point of fecal incontinence. Pregnant PCD patients with non-active PCD are commonly not offered CS.
We suspect that lack of active PCD does not necessarily attest for the physiological function of the anal complex sphincter and that vaginal delivery may exacerbate their condition to the point of incontinence. Therefore, we conducted a prospective trial to examine, prior to delivery, the anatomy and physiology of the sphincter complex in our cohort and weather pregnant patients with non-active PCD suffer from sphincter damageMethods
All consecutive pregnant patients with Non-active PCD were enlisted. Patients underwent physical examination, anal manometry and Trans Rectal Ultra Sound (TRUS) before conception or during pregnancy before delivery.
Active PCD was defined as: Perianal abscess, fistulas with active drainage, severe fissures and stricture.
Non active PCD was defined as history of prior PCD, history of surgery for perianal fistula or old scars from previous abscess drainage.

Results
There were 13 patients who were enlisted to our study. Table 1 describes the TRUS, Manometry and pregnancy details. There were 9 patients (69%) with evidence of sphincter damage in our cohort including external and/or internal sphincter of at least 30 degrees of the muscle radius. Of them, 6 had posterior damage and 4 had anterior damage. In Manometry all patients had either normal or satisfying results. Three patients were strongly recommended to choose CS due to the sphincter damage.

Conclusion
patients with non-active PCD and future intent to deliver should be assessed routinely regarding their sphincter complex status. This should include TRUS, manometry and clinical evaluation. We discuss with each patient the advantages and disadvantages of vaginal delivery versus CS, weighing the risk of repeated CS (mainly placenta previa and accreta) against the risk of incontinence. Maternal age, Obstetrical history and estimated fetal weight at delivery are the main factors to consider. Although it is still unclear if detected muscle injury affect clinical incontinence, it is our practice to recommend CS for patients with significant muscle damage. We emphasize our recommendation specifically in patients with anterior damage because potentially delivery damage would be to the same area
P521 Impact of pouch leaks on quality of life and symptoms in patients after ileal pouch-anal anastomosis surgery
Authors: Alipouriani A , Schabl L , hull T , Lipman J , Gorgun E , Liska D , valente M , Steele S R , Holubar S 
Published: January 2024

Abstract

Background
Ileal pouch-anal anastomosis(IPAA)is the procedure of choice in patients requiring total proctocolectomy.The reported leak rates after IPAA surgery range from 1-12% with well described significant impact on postoperative morbidity and recovery.However, the long-term impact of salvaged pouch leaks on the broader quality of life outcome and pouch function remains poorly understood.The aim of this study was to compare between patients with and without postoperative leaks after IPAA surgery, hypothesizing that patients with salvaged pouch leaks would have worse long-term quality of life and pouch function compared to matched patients without leaks.

Methods
This retrospective cohort study included patients who underwent IPAA(n=4058) between 1995-2022.Leak was defined as abscess or fistula requiring intervention, who had definitive resolution of their pouch leaks, whether with conservative treatment or after salvage surgery or pouch excision with end ileostomy creation. The Leak group consisted of 194 patients with treated leaks.The No Leak group included 963 patients without leaks,matched 1:5 on sex, age(± 3 years),and surgery date.Questionnaire data were available for 85 of 194 patients with leaks and 614 of 963 without leaks. Quality of life(QoL) was assessed using SF-36, health status using EORTC QLQ-C30(QoH),and life enjoyment(QoE) using a standardized scale.Bowel movements,seepage,and pad usage were recorded.Outcomes were compared using Mann-Whitney U,t-tests, and chi-square tests.

Results
A total of 699 patients with IPAA were included, with 85(12%)in the leak group. The median age was 42 (IQR, 31-53) years, and 54% were male. Median time from surgery to the last QoL assessment was 6.58(IQR: 3.5-11.3) years in the Leak group and 6.05 (IQR: 2.5-11.2) days in the No Leak group. Patients with Leaks reported significantly lower QoL (median 7(IQR:5-9)vs8 (IQR:7-9);p&lt;0.001), lower health status on the QoH scale (median 7(IQR: 5-8) vs 8 (IQR :7-9); p&lt;0.001), and lower life enjoyment on the QoE scale (median 7(IQR: 5-8)vs7(IQR :6-9);p=0.003) compared to the No Leak group. A higher proportion of patients in the Leak group reported daytime (49%vs.20%,p&lt;0.001) and nocturnal seepage (66%vs.38%, p=0.001), along with greater daytime(40%vs.22%,p=0.01) and nighttime pad usage (53%vs.30%,p=0.001). There were no significant differences in the number of bowel movements per 24h (p=0.54), daytime bowel movements(p=0.7), or nighttime bowel movements (p=0.695) between the groups.

Conclusion
In matched cohorts,salvaged pouch leaks were associated with reduced quality of life,health status,and life enjoyment compared with matched patients without leaks.Patients with leaks also had increased rates of seepage and pad usage,indicating worse pouch function.
P533 Photo Biomodulation treatment in patients with Ulcerative Colitis
Authors: Weisshof R , Naftali T , Waterman M , Godneva A , Koifman E , Stein A , Segal E , Chowers Y 
Published: January 2024

Abstract

Background
Current UC treatment options still fall short in both effectiveness and safety. Rectal inflammation may be particularly difficult to treat. Photo-biomodulation (PBM) involves the irradiation of specific non-ionizing, non-thermal light exerting an anti-inflammatory effect. PBM has demonstrated efficacy in various dermatologic and mucosal inflammatory conditions. These observations combined with ex-vivo mucosal healing studies suggest a potential efficacy of this therapy in inflammatory bowel diseases. Therefore, we aimed to assess the safety and efficacy of PBM treatment in UC patients with significant rectal inflammation.

Methods
The PhotoPill-ProctCare system comprises a rectal tube that delivers therapeutic 850nm, illumination to the rectal mucosa, at ~1 J/cm2. UC patients with clinical and endoscopic evidence of rectal inflammation were enrolled to the study. The rectal device was inserted and activated for 4 minutes. The study included two parts. Part 1 involved 6 treatment sessions over 14 days. Part 2 included up to 6 additional treatments over 6 weeks. Primary endpoint was treatment safety. Secondary endpoints were clinical, biochemical, endoscopic, histologic, and microbiome composition parameters during and following the intervention.

Results
Five patients were recruited for the part 1 of the study and 6 to part 2. All patients tolerated the treatment well. Two patients reported adverse events related to intervention; these were mild in severity and spontaneously resolved (mild abdominal discomfort up to 2 hours post-treatment). Two unrelated events included COVID infection and URTI. In part 2, two patients dropped out after 6 sessions due to lack of efficacy.
Overall, 4/11 patients (36%) achieved clinical remission. Response was observed in 7/11 patients (63%). Mayo score decreased from 7.82±1.4 at baseline, to 4.91±1.93 post treatment (p&lt;0.01). Rectal bleeding sub-score decreased from 1.91±0.61 to 1.09±0.67 (p=0.03), and stool frequency sub-score decreased from 2.09±1 to 1±0.74 (p&lt;0.01) respectively. Mean Ulcerative Colitis Endoscopic Index of Severity decreased from 6.75±1.33 to 5.9±1.5 (p=0.02). The number of host (human genome) reads within microbiome samples (likely indicative of shedding of epithelial cells) decreased post-treatment significantly in 4 patients and did not increase significantly in any of the patients. Moreover, several gut bacteria species (e.g. Bacteroides species) and bacterial pathways that are known to be associated with IBD activity, decreased significantly post-treatment.

Conclusion
This pilot study demonstrated the safety and efficacy of rectal Photo-Biomodulation for induction of response and remission in UC patients. Further studies are needed to confirm these preliminary results.