bluuebunny/crossref_metadata_2025_split huggingface dataset:
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

Abstract

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&lt;0.0001), triglyceride (TG) (r=0.264, P&lt;0.0001), and low-density lipoprotein (LDL) (r=0.162, P=0.033). E value was related to BMI (r=0.267, P&lt;0.0001). In CD patients, CAP value was associated with BMI (r=0.661, P&lt;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&lt;0.0001). E value was associated with total bilirubin (r=0.369, P&lt;0.0001), ALP (r=0.236, P=0.005), r-GTP (r=0.318, P&lt;0.0001), AST (r=0.384, P&lt;0.0001), ALT (r=0.277, P&lt;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

Abstract

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 &lt; 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 (&lt; 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

Abstract

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 &gt;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 &gt;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

Abstract

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

Abstract

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

Abstract

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:
P602 Risankizumab levels but not IL22 are significantly correlated and predictive of clinical and biochemical remission in Crohn's disease
Authors: Roblin X , barrau M , Duru G , Nancey S , Paul S 
Published: January 2024

Abstract

Background
Risankizumab (RZB) is an anti-IL23 monoclonal antibody blocking the p19 subunit, whose recent Phase 3 trial demonstrated its efficacy in CD. Compassionate use has been possible since December 2019. The aim of this study was to investigate whether RZB and IL22 levels correlated with deep remission.

Methods
Any CD patient receiving RZB (compassionate use) was eligible for the study. All patients were treated with a regimen of RZB (600mg W0, W4 and W8) followed by 360 mg/sc every 8 weeks from W12. Patients with other dosing regimens were excluded. Before each infusion or SC injection, fecal calprotectin, CRP, RZB levels (ELISA ; Theradiag) and IL-22 levels (ELLA automated system; Biotechne). Clinical and biochemical remission was defined by a clinical score (CDAI) &lt; 150 with fecal calprotectin &lt; 250 µg/ml and CRP &lt; 5 mg/l.

Results
28 patients on failure to anti TNF, vedolizumab and ustekinumab (mean age: 44 years, sex ratio M/F: 1.3) with 95 RZB maintenance samples (360mg/sc every 8 weeks) were eligible. For 44 RZB samples (46%), patients were in clinical and biochemical remission . Patients with clinical and biochemical remission had higher mean RZB levels than patients without clinical and biochemical remission (21.6 +/-13.3 versus 7.4+/-6.4 µg/ml; p=0.001). Biochemical and clinical remission rates were significantly higher in the highest RZB quartiles (p=0.01) (Figure 1). Area under the curve analysis (AUC: 0.93; p&lt;0.001) isolated a RZB threshold significantly associated with clinical and biochemical remission: 11.5 µg/mL (sensitivity: 81.8%, specificity: 80.3%, PPV: 78.2%, NPV: 83.6%, accuracy: 81%.) . The progression-free survival curves towards loss of clinical and biochemical remission were significantly more favorable in the group of patients with RZB levels &gt; 11.5µg/mL (p=0.03) . In univariate and multivariate analysis, only RZB level was isolated as a factor associated with clinical and biochemical remission: HR: 1.36 (CI95: 1.05-1.35), p=0.001). Conversely, albumin, CRP, albumin and other patient variables were not significantly associated with deep remission. The IL22 levels are not statistically significantly different between clinical and biochemical remission or not (respectively, 10.4 pg/mL (4.2-17.2) vs 8.6 pg/mL (4.3-16.2); p = 0.73)

Conclusion
RZB levels are significantly higher in clinical and biochemical remission CD. A threshold of 11.5µg/mL predicts clinical and biochemical remission in CD and is associated with significantly better progression-free survival. Conversely, IL22 levels are not associated with clinical and biochemical remission. However, these results are in a limited patient population of those receiving compassionate use therapy.
P614 Endoscopic Electroincision Therapy for Children
Authors: Picoraro J , Shen B 
Published: January 2024

Abstract

Background
Anastomotic strictures can be successfully treated by endoscopic balloon dilation (EBD); however, the emerging modality of stricturotomy with electroincision therapy (EIT) and strictureplasty(stricturotomy followed by endoscopic clipping) may achieve superior outcomes. Endoscopic stricturotomy has been shown to have greater efficacy than EBD in adult patients with IBD. While the rate of perforation is lower in EIT as compared to EBD in IBD, stricturotomy has a 4-10% rate of delayed bleeding, with a smaller proportion requiring blood transfusion. EIT can delay the need for surgical intervention and in many circumstances obviate the need indefinitely. This study is to describe the use of EIT for luminal strictures in children.

Methods
Retrospective cohort study of 10 pediatric patients (including 18 procedures) with anastomotic and primary luminal stricture who underwent endoscopic EIT with stricturotomy or strictureplasty. Outcomes and complications were documented.

Results
Among 18 performed, 14 stricturotomy and 4 strictureplasty, 2 patients did not require further intervention and had no stricture recurrence at time of follow-up. 3 patients required repeat stricture therapy but the time duration between interventions, previously EBD, extended. There were 2 procedural complications, tension pneumoperitoneum managed by needle decompression and microperforation, neither of which required surgical repair or resection. There were no episodes of GI bleeding.

Conclusion
EIT for luminal stricture in children may offer an alternative to EBD or surgical resection and re-anastomosis. The relative risk in children remains to be delineated.