bluuebunny/crossref_metadata_2025 huggingface dataset:
P484 Intestinal Ultrasound Can Detect Active Inflammation In Inflammatory Bowel Disease Patients Despite Combined Clinical And Biomarker Remission
Authors: Saleh A , Abraham B
Published: January 2024

Background

Intestinal ultrasound (IUS) has only recently been implemented in the USA for inflammatory bowel disease (IBD) monitoring. Colonoscopy is considered the gold standard for evaluation of inflammation but may not be feasible for every assessment due to cost, time, and accessibility. Clinical activity scores and biomarkers are used instead as adjunct measures of disease. Since IUS incurs low cost and time with easy accessibility, our study aimed to demonstrate the utility of incorporating IUS into IBD practice by evaluating the sensitivity and specificity of these adjunct measures of inflammation and the impact of decisions made based on IUS.

Methods

This retrospective cohort analysis evaluated patients with IBD at our institution who underwent IUS from July 2020 to May 2021. The patients were reviewed for repeat IUS visits until July 2022. Patients received IUS regardless of clinical or biomarker remission, and/or if they were able to receive a colonoscopy. Clinical remission was defined as UCAI ≤ 5 and partial Mayo ≤ 2 or HBI ≤ 5. Biomarker remission was defined as ESR ≤ 40 mm/hour; CRP ≤ 8 mg/L; FCP ≤ 125 mg/mg; and fecal lactoferrin ≤ 30 mcg/mL. Combined remission was defined as both clinical and biomarker remission. The sensitivity and specificity of these groups was evaluated based on IUS. Treatment plans were decided based on IUS findings. Patients with normal IUS maintained therapy while those with positive findings required a change/escalation of therapy. These patients had repeat IUS to ensure the changes resulted in reduction of inflammation.

Results

In 148 total patients receiving IUS, 62% (N=92) had active disease. Clinical remission (figure 1) was 41% sensitive and 75% specific while biomarker remission was 49% sensitive and 58% specific to IUS findings. When combined (clinical + biomarker remission), sensitivity increased to 62% and specificity decreased to 52% (figure 2). There was a total of 39 repeat ultrasounds. Inflammation was improved at repeat IUS, measured by a decrease in overall bowel wall thickness in 77% (30/39) patients for a mean of 0.121 cm. Vascular flow improved in 79% (15/19) of patients with abnormal Doppler at initial IUS by a mean of 0.65, and mural stratification improved in 80% (20/25) of patients with mural disruption at initial IUS.

Conclusion

Our study showed that even when combining biomarker results and clinical scores, the sensitivity for detecting inflammation was 62%. Additionally, as demonstrated by the improvement in inflammation at IUS follow up, clinical decisions based on IUS results effectively reduced inflammation in IBD patients. As such, IUS is necessary in the management of IBD to effectively identify and treat patients with masked inflammation.
P490 Prevalence and clinical features of chronic nonbacterial osteomyelitis in a nationwide cohort of children with inflammatory bowel diseases
Authors: Scarallo L , Knafeltz D , Marrani E , Alvisi P , Arrigo S , Bramuzzo M , Felici E , Romano C , Simonini G , Lionetti P
Published: January 2024

Background

Among musculoskeletal extraintestinal manifestations (EIM), the association between IBD and a rare autoinflammatory condition, chronic nonbacterial osteomyelitis (CNO), has been reported. The primary objective of our study was to report the clinical characteristics and the disease course of a cohort of patient with concurrent diagnosis of CNO and IBD. The secondary outcome was to define the prevalence of CNO in a nationwide cohort of patients with IBD.

Methods

This is a retrospective, multicenter study based on the Italian Society of Gastroenterology, Hepatology, and Pediatric Nutrition (SIGENP) IBD National Registry. The diagnosis of CNO was defined as the presence of uni- or multifocal bone inflammatory lesions with suggestive radiological or histopathological characteristics, having excluded infectious, oncological, or other inflammatory conditions. All patients under 18 years of age with a combined diagnosis of IBD and CNO identified in the registry were included.

Results

18 patients with a combined diagnosis of CNO and IBD out of 4229 patients with IBD were identified, with an overall prevalence of 0.4%. 15 (83.3%) patients were male. Median age at IBD diagnosis was 10.1 years (IQR: 6.16 years), whereas median age at CNO diagnosis was 11.7 years (IQR: 6.31 years). The most frequently reported IBD phenotype was CD (13 patients, 72.2%), followed by IBD-U (3 patients, 16.7%) and UC (2 patients, 11.1%). The diagnosis of concurrent CNO was more common in patients affected by CD than in those affected by either UC or IBD-U (13/1843, 0.7% vs 5/2886, 0.2%, p=0.01). Similarly, the occurrence of CNO was more frequent in male gender when compared to female one (15/2312, 0.6% vs 3/1917, 0.1%, p=0.01). All the patients had multifocal bone involvement; 2 (11.1%) developed subsequently dermatological manifestations consistent with SAPHO syndrome. In 8 patients (44.4%) IBD onset preceded CNO diagnosis, in 6 (33.3%) IBD onset followed CNO diagnosis, whereas in the remaining 4 patients (22.2%) the diagnosis of IBD and CNO was concomitant. Table 1. summarizes therapeutic approach to both conditions in each of the patient identified in our case series. At the end of follow-up, 14 (77.8%) patients had achieved IBD clinical and biochemical remission. Ten (55.6%) patients achieved clinical and radiological remission of bone lesions, 6 (32.3%) had achieved clinical remission but showed persistence of bone lesions at magnetic resonance imaging (MRI), 2 (11.1%) had persistence of both clinical and radiological activity.

Conclusion

Our findings support the hypothesis that CNO disease spectrum can be considered a rare extraintestinal manifestation of IBD, with a low but still non-negligible prevalence.
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

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

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

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 < 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

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

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<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

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

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<0.001), lower health status on the QoH scale (median 7(IQR: 5-8) vs 8 (IQR :7-9); p<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<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

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<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<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.
P549 Liver stiffness assessed with TE-CAP tends to increase with longer duration of disease in Crohn’s disease: A prospective cohort study for the evaluation of hepatic abnormalities in inflammatory bowel disease
Authors: Moon W , Seo K I , Park H J , Lee J W , Yun B C , Park S J , Kim J H , Park M I , Kim S E , Jung K
Published: January 2024

Background

Intestinal mucosal injury is supposed to cause liver disease and abnormal liver profiles are frequently observed in inflammatory bowel disease (IBD) patients. Therefore, we investigated the hepatic manifestations of IBD in Korea.

Methods

A prospective cohort for the evaluation of hepatic abnormalities in IBD was established at Kosin University Gospel Hospital, Busan, Korea in 2018. From December 2018 to June 2023, patients who diagnosed with IBD were consecutively enrolled and conducted both abdominal sonography and transient elastography-controlled attenuation parameter (TE-CAP) with liver function tests, viral tests, lipid profiles, and fecal calprotectin.

Results

Three hundred twelve (138 Crohn's disease, CD, 174 ulcerative colitis, UC, and 200 men) patients were enrolled. Mean ages (years old) were 46.4 in UC and 37.5 in CD. Mean body mass indexes, BMIs were 23.1 in UC and 21.9 in CD. Mean CAP (dB/m) score was 222.439 (±55.375) [UC 232.408 (±53.476), CD 209.869 (±55.358)]. Mean E (kPa) value was 4.481 (±1.801) [UC 4.496 (±2.028), CD 4.461 (±1.474)]. Mean fecal calprotectins were 982 in UC and 1160 in CD. The mean durations of disease (months) were 36.8 in UC and 44.0 in CD. In abdominal sonography, abnormal findings in gallbladder were found 38/169 (22.4%) in UC and 38/137 (27.7%) in CD (P=0.834). (Table 1) HBs Ag positivity was 7/173 (4.0%) in UC, 5/138 (3.6%) in CD (P=0.847). Anti-HBs was positive in 115/173 (66.4%) in UC and 68/138 (49.2%) in CD (P=0.002). Anti-HBc IgG was positive in 46/112 (29.1%) in UC and 17/130 (13.0%) in CD (P=0.001). Anti-HCV was positive in 0/173 (0.0%) in UC and 3/138 (2.1%) in CD (P=0.051). In UC patients, CAP value was associated with BMI (r=0.498, P<0.0001), triglyceride (TG) (r=0.264, P<0.0001), and low-density lipoprotein (LDL) (r=0.162, P=0.033). E value was related to BMI (r=0.267, P<0.0001). In CD patients, CAP value was associated with BMI (r=0.661, P<0.0001), total cholesterol (r=0.290, P=0.001), TG (r=0.286, P=0.001), LDL (r=0.217, P=0.011) and fecal calprotectin (r=-0.343, P<0.0001). E value was associated with total bilirubin (r=0.369, P<0.0001), ALP (r=0.236, P=0.005), r-GTP (r=0.318, P<0.0001), AST (r=0.384, P<0.0001), ALT (r=0.277, P<0.001) and disease duration (r=0.239, P=0.005). In CD patients with a disease duration of more than 1 year, the E value was confirmed to increase gradually as the disease period lengthened (r=0.346, P=0.004). (Figure 1)

Conclusion

In CD patients, liver stiffness tends to increase with longer duration of disease or active liver inflammation. Both UC and CD patients, fatty liver may occur attributed to abnormal metabolic profiles. In addition, there is a need to encourage HBV vaccination in IBD patients in HBV endemic area, especially in UC patients.
P565 Capillary blood based self-collection device for infliximab therapeutic drug monitoring
Authors: Law C , Djalal A , Hopkins M , Trick D , Kang D , Brady K , Tucker D , Everts-van der Wind A , Dervieux T , Colombel J F
Published: January 2024

Background

Patient friendly new devices may improve therapeutic drug monitoring (TDM) in inflammatory bowel disease (IBD). Our objective was to evaluate an infliximab (IFX) precision guided dosing tool from capillary blood collected using an upper-arm self-collection device amongst IBD patients and compare its performances to gold standard venous blood collected using venipuncture.

Methods

Patients under maintenance therapy with IFX were recruited from a single IBD center and enrolled in the BEST (Bayesian Estimates Sustaining Trough) study. BEST is a prospective real world evidence clinical utility study to establish the value of an IFX Bayesian forecasting tool in the optimal management of IBD. Blood specimens were collected prospectively, at midcycle or at trough. Capillary blood specimens were collected using an upper arm self-collection device (Tasso Inc., Seattle, WA) connected to a serum separator tube. Paired venous blood was collected using venipuncture. IFX concentrations and antibodies to IFX (ATI) status were measured using drug tolerant homogenous mobility shift assay, albumin levels were measured using nephelometry. IFX Clearance was calculated using nonlinear mixed effect model with Bayesian priors. Statistical analysis consisted of Deming regression.

Results

Overall, 27 patients (n=9 with UC, mean age=37 years, weight=79 Kg) were enrolled. Median IFX dosing was 10 mg/Kg, and median dosing frequency every 6 weeks. A total of n=58 serum pairs isolated from capillary and venous blood were tested. PK profiles measured from venous blood were optimal during maintenance with no immune response detected (ATI < 3.1 U/mL) and most patients had IFX concentration at trough above 5 µg/mL (98%, median 15.4 µg/mL IQR: 10.9-28.0 µg/mL) and low Clearance (< 0.294 L/day: 89%; median 0.200 L/day IQR: 0.170-0.248 L/day). IFX concentrations and Clearance levels were comparable between venous and capillary blood with high correlation (R2= 0.975; slope =0.928; and R2=0.978; slope =1.035, respectively) (figure). In capillary blood specimens collected at midcycle (median 14 days before the next infusion, n=12 pairs), median IFX concentration was 38.3 µg/mL (IQR: 31.2-64.7 µg/mL) and declined to 21.9 µg/mL (IQR: 14.1-44.5 µg/mL) at trough. There was a high correlation between forecasted and measured trough concentrations in capillary blood (R2=0.925; Deming’s slope=1.093). Similar results were observed with venous blood pairs (R2=0.983; Deming’s slope=1.024).

Conclusion

IFX therapeutic drug monitoring using patient self-collection of capillary blood performed as well as standard venous blood measurement. This collection method may facilitate the implementation of point of care TDM in clinical practice.
P573 Simplified MARIA score does not predict long-term outcomes in Crohn’s disease patients undergoing modified side-to-side strictureplasty for extensive ileitis
Authors: De Greef I , Bislenghi G , Lenfant M , Verstockt S , Terrasson I , Verstockt B , Sabino J , Ferrante M , Vanbeckevoort D , D'Hoore A , Vermeire S
Published: January 2024

Background

Strictureplasty techniques were developed to limit the risk of short bowel syndrome in Crohn’s disease (CD) patients with affected small intestine. In the setting of extensive small bowel disease, long strictures might be treated with modified side-to-side isoperistaltic strictureplasty (SSIS). We studied long-term outcomes in patients who underwent SSIS and evaluated if radiological features on MR enterography (MRE) predict them.

Methods

This retrospective study included CD patients who underwent SSIS, for whom preoperative and six-month postoperative MRE were routinely performed. Simplified MARIA (MARIAs) score, considering wall thickness, edema, fat stranding and ulcers (score >1 active CD; maximum 5) was used. Improvement in maximal wall thickness was defined as decrease of at least 30% from baseline. Deep remission was defined as absence of symptoms and endoscopic remission (mRutgeerts score ≤i1), and clinical recurrence as occurrence of new symptoms confirmed by endoscopy (mRutgeerts score ≥i2b) or radiology (new strictures/inflammation) requiring treatment. Clinical data were collected from medical records. The correlation between recurrence and features within the MARIAs score was assessed.

Results

Thirty CD patients underwent SSIS and had pre- and six-month postoperative MRE (table). Immediately after surgery, 13 (43.3%) patients were continued or initiated on advanced therapy. Over a median [IQR] follow-up of 7.4 [3.3-9.3] years, 17 (56.7%) patients showed clinical recurrence of whom 6 (20.0%) needed surgical reintervention (figure). Deep remission was observed in 8 (26.7%) patients. Preoperatively, all patients had a maximum MARIAs score of 5. After surgery, the median [IQR] change in MARIAs score was 0.0 [0.0-0.8]. Cox regression analysis showed no association between decrease in overall MARIAs score, nor separate components of this score, with clinical or surgical recurrence free survival. Wall thickness decrease of >30%, observed in 15 (50%) patients, showed a trend for clinical recurrence free survival (p=0.098). Three patients showed normalization of MARIAs score and showed no recurrence thereafter. None of the clinical variables collected showed significant association with recurrence, except for immediate postoperative advanced therapy which had a 70% protection from clinical recurrence [p=0.036 / HR 0.3 (0.097-0.92)].

Conclusion

Long-term follow-up of CD patients undergoing SSIS showed that 57% of patients had clinical recurrence and 20% needed surgical reintervention. The MARIAs score was not predictive of long-term postoperative clinical or surgical recurrence as most features of the score remained unaltered. These shortcomings of the MARIAs score should be addressed when designing improved scoring tools.
P586 Influence of HLA-DQA1∗05 on the loss of response to anti-TNF treatment in inflammatory bowel disease. Spanish cohort of real clinical practice
Authors: Pérez Pérez J , Escobar Ortiz J , Franco Moreno A I , Plaza Santos M D R , Castillo Pradillo M , Ponferrada Díaz Á
Published: January 2024

Background

The presence of the HLA-DQA1*05 allele has been related to a loss of early secondary response, which could have clinical implications when choosing the first-line biological drug. Although its usefulness as a response predictor variant is not yet clearly established, the determination of polymorphism is common in clinical practice.

Methods

The objective of this study is to determine if there is an association between the presence of HLA-DQA1*05 and the loss of response in the short-medium term in the clinical practice of a real cohort. A retrospective cohort study has been carried out including adult patients with Crohn's Disease (CD), ulcerative colitis (UC) and indeterminate colitis (IC) who have received anti-TNF treatment with Infliximab (IFX) and Adalimumab (ADA) with a period of follow-up from 6 to 48 months.

Results

A total of 102 patients were included (73.52% CD- 75; 25.5% UC- 26; 0.98% IC- 1), of which 54.9% were men (56) and 45.1% were women (46), with a median age of 45 years (IQR 18-83).

No statistically significant differences were observed between the HLA carrier and non-HLA carrier groups in age, sex, tobacco consumption, or type of inflammatory bowel disease. No differences were also observed between the location or severity of the disease.

From the group of patients treated with Infliximab:

• IFX at 6 months: a total of 52 patients were analyzed. Treatment was suspended in 6 patients (11.54%).

• IFX at 18 months: a total of 35 patients were analyzed.Treatment was suspended in 4 patients (11.43%).

• IFX at 48 months: a total of 26 patients were analyzed. Treatment was suspended in 7 patients (26.92%).

From the group of patients treated with Adalimumab:

• ADA at 6 months: a total of 50 patients were analyzed. Treatment was suspended in 6 patients (12%).

• ADA at 18 months: a total of 31 patients were analyzed. Treatment was suspended in 1 patient (3.22%).

• ADA at 48 months: a total of 22 patients were analyzed. Treatment was suspended in 3 patients (13.64%).

Therefore, no statistically significant differences were observed in the loss of anti-TNF response between the HLA-DQA1*05 carrier and non-carrier groups for IFX and ADA at 6, 18 or 48 months. Nor were any differences found in the loss of response depending on the type of inflammatory bowel disease that the patients suffered from (CD or UC).

Conclusion

In this Spanish cohort from real clinical practice, the presence of the HLA-DQA1*05 allele in patients with inflammatory bowel disease does not influence the loss of response to anti-TNF treatment in the first 48 months of follow-up. However, more studies with larger samples are necessary to determine the usefulness of the polymorphism in clinical practice and establish its possible predictive implication.
P590 Use of upadacitinib in Refractory Paediatric Inflammatory Bowel Diseasein: A Single-Center Cohort Study
Authors: Potapov A , Vinokurova A , Pushkareva A , Prokhorenkova M , Anushenko A , Fisenko A
Published: January 2024

Background

Upadacitinib (UPA) is a novel selective JAK-1 inhibitor that has demonstrated efficacy in the treatment of ulcerative colitis (UC) and Crohn's disease (CD) and has received regulatory approval in adults only. Current data on the efficacy of this drug in children are limited. We report our experience in the treatment of pediatric patients with UC and CD with failure of immunosuppressive and biologic therapies. The aim of this study was to evaluate short-term effectiveness and safety UPA therapy in children with IBD.

Methods

Disease activity was monitored using clinical PUCAI/PCDAI scores, faecal calprotectin (FC), C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), platelet. Hemoglobin (Hb), leukocyte, total cholesterol, prothrombin time, INR - international normalized ratio, fibrinogen, activated partial thromboplastin time, thrombin time were evaluated to assess side effects. At baseline biochemical and previous therapies were recorded.

Results

We performed a prospective analysis of clinical outcomes from January to October 2023 during UPA therapy 11 children aged 12 to 16 years (4 boys, 7 girls) 3 with UС and 8 with CD. All 11 children had received immunosuppressive and biological therapies prior to UPA prescription without success. UPA induction was administered in UC for 8 weeks and CD for 12 weeks at a dose of 45 mg once a day, then 15 mg once a day as maintenance. At the beginning 2 (18%) of 11 children had high PUCAI/PCDAI disease activity and remain 9 (82%) had mild disease activity. Elevated white blood cells was determined in 3 (27%) out of 11 children, platelet increase in 9 (82%) children, and Hb less than 110 g/L in 6 (54%) children, elevation of ESR and CRP was observed in 7 (63%) subjects. FC was elevated in 5 (62.5%) out of 8 children. Total cholesterol was normal in all patients, coagulation tests showed increased fibrinogen in 3 out of 11 children. After induction 3 (27%) of 11 children achieved remission and 8 (73%) had clinical response according to the PUCAI/PCDAI score. Elevated white blood cells was detected in 2 (18%) and decrease Hb persisted in 3 (27%) out of 11 children, elevation of ESR persisted in 5 (45%) and CRP in 6 (54%) of 11 children. FC was elevated in 6 (75%) out 8 patients. Total cholesterol and the coagulation tests remained within normal range. Side effects were not observed and UPA maintenance treatment was continued in all children.

Conclusion

In this real-world experience in drug-resistant pediatric patients with UC and CD we verified the efficacy and safety of UPA, but longer follow-up is needed.
P598 Validating and Enhancing Real-time Disease Severity Classification in Ulcerative Colitis: Artificial Intelligence as a Second Opinion Trigger
Authors: Lo B Z S , Møller B , Igel C , Wildt S , Vind I , Bendtsen F , Burisch J , Bulat I
Published: January 2024

Background

Endoscopic ulcerative colitis (UC) severity classification shows high interobserver variance. Our prior study proved AI matches central reading scoring still images. To be clinically useful, assessing longer segments is vital. Our aim: a new model for real-time or video-based severity evaluation and demonstrate the supporting value it might offer.

Methods

Data was Mayo Endoscopic Subscore (MES)-scored using 2561 images and 53 videos from 645 patients to train a convolutional neural network. Through open-set-recognition, the model differentiated scoreable from unscoreable endoscopy sections. The validation included 140 videoclips from 44 UC patients. Six IBD-experts and 16 non-IBD experts independently rated these clips, with the majority IBD-expert score serving as ground truth. We assessed its value as a second opinion for non-IBD experts and conducted an alpha test with real-time endoscopic support on a real-world patient.

Results

The model achieved an overall accuracy of 0.82 and 0.84 for MES 0, 0.81 for MES 1, 0.72 for MES 2, and 0.96 for MES 3. No significant distinction between individual experts or ground truth vs. the AI model was observed (figure 1).

When employed as a trigger for second opinions, non-IBD experts' performance improved by 10% (table 1). On average, 26-32 % (range on an individual level: 17-39 %) of the time (depending on the evaluated seniority) the framework disagreed with the primary physician. In those cases, the model was correct in an average of 57-59 % (range on an individual level: 33-76%), and the second physician’s opinion was correct in an average of 64-70 % (range on an individual level: 60-77%) of the time according to the ground truth.

The alpha test successfully integrated the model into the endoscopic column for real-time classification. It accurately discerned MES 0 and MES 1 frames, aligning with the endoscopist's assessment.

Conclusion

Our innovative AI model exhibits significant potential for enhancing UC severity classification accuracy, rivalling IBD-experts and notably improving non-specialists' proficiency. It is designed for clinical implementation and has demonstrated clinical feasibility in an alpha test.

Figure 1:

Table 1: