Ulcerative Colitis Activity Research Articles

Evaluation of Risk for Thromboembolic Events in Pediatric Inflammatory Bowel Disease.

The occurrence of thrombotic events in adult patients with inflammatory bowel disease (IBD) is linked to multiple interactions between hereditary and acquired risk factors. There are few published data concerning children with iBD. The aim of this study was to investigate the presence of thromboembolic risk factors also in children with iBD. We enrolled three groups of children: one with Crohn disease (cD), one with ulcerative colitis (Uc), and a control group of healthy subjects. For all the participants the potential thromboembolic risk was evaluated clinically and with laboratory tests. We studied: 30 children (25.6%) with CD, 28 (23.9%) with UC, and 59 (50.4%) healthy control subjects. Regarding Pediatric Crohn Disease Activity Index, no significant differences between thromboembolic risk factors and disease activity were detected. Instead, in the patients with UC, stratified with the Pediatric Ulcerative Colitis Activity Index, there was a statistically significant difference in serum fibrinogen levels between patients with mild and moderate/severe disease [3.8 (3.2-4.5) g/L vs 5.7 (4.8-6.2) g/L, P < 0.0032]. serum homocysteine levels were lower in healthy controls than in CD (P = 0.176) and UC (P = 0.026). An increased level ofhomocysteine in UC with a homozygous mutation in the methylene tetrahydrofolate reductase C677T gene was also observed. Our study showed that children with IBD have clinical features, acquired and congenital factors that can increase thrombotic risk, similarly to adults.

Serum Immune-Inflammation Index Assessment in the Patients with Ulcerative Colitis.

Radiologic and endoscopic diagnostic methods are used to determine disease activity in ulcerative colitis (UC). In order for endoscopic procedures to be invasive and to prevent radiation exposure, especially in young people, studies have been carried out frequently to determine a simple, fast, and reliable activity marker with laboratory methods. Our aim in this study is to determine the usefulness of serum immune-inflammatory index as a noninvasive marker of activation in patients with ulcerative colitis. A total of 82 consecutive patients treated with a diagnosis of ulcerative colitis were included in the study. The disease activation was assessed using the Mayo endoscopic subscore. The site of involvement was grouped into two as left colitis and extensive colitis. Patients were divided into two groups as those who had active disease based on clinical and endoscopic findings and those who were in remission. C-reactive protein (CRP) levels, platelets, neutrophils, and lymphocytes were recorded in all participants. The systemic immune-inflammation index (SII) and CRP values were compared between UC patients with active disease or remission. The correlations between CRP, SII, and Mayo endoscopic subscores were analyzed. In addition, ROC curve analysis for SII was performed to determine the cut-off value, sensitivity, and specificity in determining ulcerative colitis activity. The value of SII was significantly higher in the active group than the remission group (respectively, 1497 ± 1300 and 495 ± 224, p < 0.001). In the correlation analysis, a significant correlation was found between SII and Mayo subscore. In ROC curve analysis, SII was found to be significantly effective in determining activity in ulcerative colitis patients. For 0.860 area under the curve, the sensitivity was 68.1% and the specificity was 91.2% at a cut-off value of 781.5. SII is significantly higher in patients with active ulcerative colitis than those in remission. It shows promise for use as a noninvasive marker of active ulcerative colitis.

Effect of disease duration on the association between C-reactive protein-albumin ratio and endoscopic activity in ulcerative colitis

BackgroundA simple serum biomarker for clinical outcome in patients with ulcerative colitis (UC) remains an unmet need. Some studies have shown an association between C-reactive protein (CRP)-albumin ratio (CAR) and prognosis in patients with inflammatory bowel disease (IBD), but evidence regarding the association between CAR and UC remains limited. We evaluated the association between CAR and clinical outcome in Japanese patients with UC.MethodsSubjects were 273 Japanese patients with UC. Clinical remission was defined as absence of both abnormally high stool frequency (< 3 per day) and rectal bleeding. Mucosal healing (MH) was defined as Mayo endoscopic subscore (MES) 0. Moderate to severe endoscopic activity was defined as MES 2–3. Subjects were divided according to CAR into tertiles (low, moderate, and high).ResultsThe proportions of patients with clinical remission, MH, and moderate to severe endoscopic activity were 57.9%, 26.0%, and 37.0%, respectively. High CAR was significantly positively associated with moderate to severe endoscopic activity but not MH or clinical remission after adjustment (adjusted odds ratio [OR] 2.18 [95% confidence interval (CI) (1.11–4.35)], p for trend 0.023), but only in patients with long disease duration (> 7 years) (adjusted OR 2.95 [95% CI (1.06–8.79)], p for trend 0.023). CAR was not associated with clinical remission or MH.ConclusionsCAR may be significantly positively associated with moderate to severe endoscopic activity but not clinical remission or MH in Japanese patients with UC. In patients with long UC duration, CAR might be a useful serum marker for disease activity.

Regional features of the course of ulcerative colitis: clinical observations (on the example of Rostov-on-Don)

The aim of the study was to identify the clinical, epidemiological and therapeutic features of ulcerative colitis in children in Rostov-on-Don. Under the observation were 34 children aged 1 to 14 years with a diagnosis of ulcerative colitis, which was based on anamnesis, clinical picture, laboratory results, and colonoscopy. The activity of ulcerative colitis was assessed taking into account the PUCAI index. To determine the reliability of the compared indicators (%), the χ2 criterion was used. Clinical and epidemiological studies have shown an increase in the incidence of ulcerative colitis in children in Rostov-on-Don over the past 10 years. In the clinic of ulcerative colitis, mild, erased forms of the course of the disease dominated, which determined the later diagnosis at the prehospital stage. There was a «rejuvenation» of the disease: ulcerative colitis was more often detected in the preschool group of children. The incidence of ulcerative colitis in boys was higher than in girls. In the treatment of mild and moderate forms of ulcerative colitis, the use of basic drugs is very effective, taking into account the principle of «step up».

Impact of iron deficiency anemia on quality of life in patients with ulcerative colitis

AbstractAdvances in the last two decades have resulted in better long‐term remissions in patients with ulcerative colitis (UC), which is defined as an idiopathic, chronic inflammatory disorder of the colonic mucosa. This better remission has not transformed into a better quality of life. Almost one‐third of these patients have mild to moderate anemia, which is one of the main factors leading to decreased quality of life; hence we aimed to determine the prevalence of iron deficiency anemia (IDA) in UC during remission and its impact on the quality of life in this subpopulation. In this prospective study, all consecutive patients of UC in remission for the last 3 months were evaluated for disease activity by Simple Clinical Colitis Activity Index (SCCAI), IDA by blood parameters and quality of life by Short Inflammatory Bowel Disease Questionnaire (SIBDQ). All patients with proven IDA were given oral iron supplements (Ferrous Ascorbate elemental iron 100 mg) for 3 months. Blood parameters, SCCAI, and SIBDQ scores were evaluated at the end of therapy to compare them before iron supplementation. Out of 125 patients of UC seen during the study period, 69 were in remission. IDA was seen in 34 patients (49.27%). Median pre‐intervention and postintervention quality of life scores—SIBDQ (4.9 [4.2‐5.8] vs 5.4 [5.0‐6.1]) and blood parameters [hemoglobin 10.7 (9.8‐11.4) g% vs 13.2 (12.8‐13.7) g%]—showed significant improvement after iron supplementation. Prevalence of IDA in UC during remission is common (49.27%). Oral iron supplementation improves the quality of life and anemia significantly without increasing disease activity in UC under remission.

TOWARDS A COMMON VALIDATED METHODOLOGY FOR HISTOLOGIC MEASUREMENT OF MUCOSAL HEALING IN ULCERATIVE COLITIS: INTRODUCING A NEW PROJECT OF THE BIOMARKERS CONSORTIUM OF THE FOUNDATION FOR THE NIH

Abstract Ulcerative colitis is a chronic, debilitating disease characterized by damage to the mucous membrane (mucosa) lining the lower gastrointestinal tract. Endoscopic and histological evidence of healing of the damaged mucosa, referred to as mucosal healing, is increasingly accepted as an important endpoint in clinical practice and in clinical trials due to its association with improved clinical outcomes. In fact, in a draft guidance to industry, the Food and Drug Administration encouraged incorporating histologic evaluation in ulcerative colitis clinical trials. However, there is no community consensus regarding how to define mucosal healing and the field lacks standardized protocols for measuring this treatment target endpoint. Standardized assessment of histologic disease activity in clinical trials is challenging for many reasons, including variability in collection of mucosal biopsies (e.g., number and location), lack of fully validated histology scoring systems, and absence of standard definitions of histologic improvement and remission. The lack of standardized measurement of mucosal healing constitutes a major challenge for drug development and negatively impacts optimization of clinical management for patients. Therefore, the Biomarkers Consortium of the Foundation for the National Institutes of Health recently launched a consortium project, with governmental, nonprofit and industry partners, to address this gap by establishing a common methodology for a histologic measurement of mucosal healing in ulcerative colitis. The project will: 1) Establish the optimum number and locations of biopsies required to determine histological inflammation in ulcerative colitis; 2) Establish a standardized histopathologic measurement of mucosal healing that correlates with clinical outcomes; and 3) Develop an automated machine learning-based methodology for histopathological scoring of mucosal healing. The final results of this project will contribute to a consensus methodology with the goal of establishing a regulatory standard for future industry-sponsored clinical trials, with the potential to contribute to improved tools for clinical monitoring of disease activity in ulcerative colitis.

CORRELATION OF PUCAI BETWEEN MAYO ENDOSCOPIC AND GEBOES PATHOLOGY SCORES IN ASSESSING DISEASE ACTIVITY OF PEDIATRIC PATIENTS WITH UC AMONG HISPANICS AND NON-HISPANICS

Abstract BACKGROUND Disease activity in ulcerative colitis (UC) has traditionally been assessed by clinical scoring systems, including the pediatric ulcerative colitis activity index (PUCAI), a non-invasive, reliable way to monitor disease severity and the therapeutic efficacy of interventions in pediatric UC. Practice guidelines have recommended the use of PUCAI in routine clinical pediatric care. Therefore, we aim to investigate the correlation of PUCAI with the endoscopic assessment of disease activity (Mayo endoscopic score) and histologic features of mucosal inflammation (Geboes pathology grading score) in a Hispanic pediatric UC population compared to a non-Hispanic pediatric population. METHODS We conducted a retrospective study in pediatric patients aged 7 - 21 with UC enrolled at Children’s Hospital of Los Angeles. We first assess the distribution of the PUCAI, the Mayo, and the Geboes grading scales of disease activity (0=remission, 1=mild, 2=moderate, 3=severe) of the Physician Global Assessment (PGA). Reviewed data was collected directly from the physician report or calculated retrospectively using clinic notes. Although different pathologists graded the samples, the Geboes score is used as a department-wide standard for grading UC. Spearman correlation coefficient was assessed to measure the degree of linear association between two order-valued variables. Bootstrap simulations were used to calculate 95% confidence intervals, and approximate permutation tests were applied to compare these correlations between Hispanics and Non-Hispanics. RESULTS In total, 172 patients fit our inclusion criteria. Overall, a modest correlation between PUCAI with the Mayo endoscopic and Geboes pathology grading scores was observed (0.72 and 0.68). The PUCAI-Endoscopic correlations were 0.65 and 0.79 for Hispanics and non-Hispanics, respectively (p-value of difference = 0.084). The correlations between Geboes pathology and PUCAI grading scores were weaker but still larger for non-Hispanics (0.73) than Hispanics (0.64). A linear relationship between PUCAI scores and the two gradings scores, Mayo endoscopy and Geboes pathology, is shown in Figure 1 (p for trend &amp;lt; 0.001). CONCLUSION Endoscopic/pathology disease severity generally correlates with clinical disease activity measured by PUCAI score. The PUCAI correlated well with the endoscopy/pathology scores in severe clinical disease, and an agreement was less robust in assessing UC patients’ mild to moderate disease activity. However, the strength of the association varies by ethnic background. Hence, caution should be exercised when using the PUCAI score to assess UC disease activity in Hispanic pediatric patients.

DOP58 An artificial intelligence–driven scoring system to measure histological disease activity in Ulcerative Colitis

Abstract Background Histological remission is increasingly regarded as an important and deep therapeutic target for ulcerative colitis (UC). Assessment and scoring of histological images is a tedious procedure, that can be imprecise and prone to inter- and intra-observer variability. Therefore, a need exists for an automated method that is accurate, reproducible and reliable. This study aimed to investigate whether an artificial intelligence (AI) system developed using image processing and machine learning algorithms could measure histological disease activity based on the Nancy index. Methods A total of 200 histological images of patients with UC from a database at University Hospital, Vandoeuvre-lès-Nancy, France were used for this study. The novel AI system was used to fully characterise histological images and automatically measure Nancy index. The in-house AI algorithm was developed using state-of-the-art image processing and machine learning algorithms based on deep learning and feature extraction. The cell regions of each image, followed by Nancy index, were manually annotated and measured independently by 3 histopathologists. Manual and AI-automated measurements of Nancy index score were done and assessed using the intraclass correlation coefficient (ICC). Results The 200-image dataset was divided into 2 groups (80% was used for training and 20% for testing). ICC statistical analyses were performed to evaluate AI tool and used as a reference to calculate the accuracy (Table 1). The average ICC amongst the histopathologists was 89.33 and average ICC between histopathologists and AI tool was 87.20. Despite the small number of image data, the AI tool was found to be highly correlated with histopathologists. Conclusion The high correlation of performance of the AI method suggested promising potential for IBD clinical applications. A standardised and validated histological AI-driven scoring system can potentially be used in daily IBD practice to eliminate the subjectivity of the pathologists and assess the disease severity for treatment decision.

P071 Intestinal CD8+ T cell exhaustion is linked to disease activity in ulcerative colitis

Abstract Background The immune pathogenesis of ulcerative colitis (UC) has been linked to imbalanced CD4+ T-cell responses while the contribution of CD8+ T cells is less well characterized. Chronically activated CD8+ T cells may become dysfunctional and acquire an exhausted phenotype during chronic viral infection or cancer. Recently, exhausted T cell (Tex) signatures have been proposed as a potential prognostic marker in autoimmune diseases. We therefore set out to characterize features of CD8+ T cell exhaustion in UC patients in more detail. Methods Lymphocytes were isolated from peripheral blood and sigmoid biopsies of UC patients in remission (n = 9) and active disease (n = 20). Cytokine production and expression of exhaustion-associated markers were analyzed ex vivo by flow cytometry. Results were correlated with disease activity (Mayo Score) and mucosal inflammation (assessed endoscopically and histologically [Nancy Score]). To further analyze the role of CD8+ T cells within the intestinal tissue microenvironment, Imaging Mass Cytometry (IMC) was applied on sigma biopsies (n= 21). Results Analysis of CD8+ Tex marker expression and functionality did not reveal major differences between peripheral blood lymphocytes isolated from UC patients with either active disease or remission as well as healthy controls. In contrast, in the sigmoid colon of patients with active UC, CD8+ T cell numbers were strongly increased. Moreover, expression of exhaustion markers was significantly increased in intestinal CD8+ T cells during active disease compared to remission. These cells also displayed dysfunctional cytokine profile patterns, as assessed by an established functional exhaustion score. This phenotype also closely correlated with clinical, endoscopic and histological markers of UC disease activity. The findings were confirmed by IMC, which revealed the presence of several clusters of CD8+ T cells with an exhaustion signature in inflamed colonic tissues. Conclusion Our findings indicate that inflammation in the intestines of UC patients is associated with the induction of CD8+ T-cell responses that phenotypically and functionally resemble Tex. The functional relevance, prognostic value and therapeutic relevance of these exhausted CD8+ T cell signatures in UC need to be analyzed in future studies.

P185 The role of neutrophil-lymphocyte ratio, neutrophil-monocyte ratio, and lymphocyte-monocyte ratio in estimating disease activity in patients with ulcerative colitis

Abstract Background Determining disease activity in ulcerative colitis (UC) patients is important in order to reduce surgery rate and mortality. Colonoscopy has the disadvantage of being invasive, time consuming and expensive. Several laboratory markers have been proposed in order to evaluate UC disease activity. Methods The aim is to investigate the utility of neutrophil-lymphocyte ratio (NLR), neutrophil-monocyte ratio (NMR), and lymphocyte-monocyte ratio (LMR) in differentiating active UC from UC in remission. This is a prospective study carried out at a hospital center in Albania, from 2019–2020. Demographic and endoscopic data along with complete blood counts were collected for each UC patient. Based on Mayo score system, patients were classified as active UC (total Mayo score &amp;gt;2 points) and UC in remission (total Mayo score ≤ 2 points). Pearson correlation coefficient was used to analyze associations between parameters. The sensitivity, specificity, and cut-off values were assessed using a receiver operating characteristic curve analysis. Results 65 UC patients, with a mean age of 45.05 ± 15.5 (16–85) years, of whom 52.3% were females and 47.7% males, were enrolled in this study. 21.4% were in remission and 63.4% were classified as active UC disease. We found a positive correlation between NLR, NMR and disease activity [(r=0.295, p=0.002); (r=0.241, p=0.011) respectively]. NLR and NMR were also significantly higher in active disease group compared to UC in remission (p=0.016 and p=0.03 respectively). ROC analyses revealed that NLR (AUC=0.664, 95% CI, 0.557–0.772) and NMR (AUC=0.644, 95% CI, 0.531–0.756) are satisfactory in differentiating active UC from UC remission patients. A NLR cutoff value of 2.1 had a sensitivity of 60% and specificity of 61% for active UC, while a NMR cutoff value of 12.2 had a sensitivity of 63% and a specificity of 61% for active UC. We didn’t found any correlation between LMR and disease activity Conclusion This study shows that NLR and NMR are significantly associated with active UC disease. Given the fact that complete blood count is widely available and inexpensive, NLR and NMR may play a role in differentiating active UC from UC in remission.

P571 The Nordic diet as a tool to improve the activity of disease and psycho-emotional wellbeing in patients with mild and moderate Ulcerative Colitis – the pilot study

Abstract Background The Nordic diet (ND) has been associated with reduced inflammatory markers and improved anxiety and stress symptoms. Our aim was to evaluate the effect of the ND on the activity of ulcerative colitis (UC), symptoms of anxiety, depression, and fatigue. Methods Patients (N=12) with mild and moderate UC were included (excluding severe UC, UC proctitis, infections). The activity of UC was evaluated with partial Mayo score (pMS) and fecal calprotectin (FC), psycho-emotional wellbeing – using hospital anxiety and depression scale (HADS) and inflammatory bowel disease – fatigue (IBD-F) questionnaire. The patients were evaluated at 3 consecutive visits at week 0, 6 and 10. During the first visit, the patients were consulted by a nutritionist to adjust their diets, received written recommendations and were able to contact the nutritionist later. At every visit HADS, IBD-F scores, and BMI, pMS and FC were registered. The ND score was calculated as described by Bjørnarå et al., 2015. Patients were considered compliant if the ND score increased by at least 2 points and unhealthy snacks were absent or almost excluded. Related samples Wilcoxon signed rank test and independent samples Kruskal-Wallis test were used to assess statistical significance. The ND score was described as low (0–3), medium (4–5) or high (6–10). Results The characteristics of all patients are summarised in Table 1. One patient had mild exacerbation of UC during the study managed with increased dose of mesalamine. Changes of the ND score (Fig.1) differed significantly in visit 2 (p=0.01). After exclusion of non-compliant patients, the data of 8 patients was analysed. The pMS, FC, HADS, IBD-F (level and impact) did not show significant changes at visit 2. BMI was significantly reduced at visit 2 (p=0.018), median at visit 1 was 28.55 (IQR: 24.16 – 32), visit 2 - 27.65 (23.2 – 30.16) kg/m2. We also found lower FC levels in patients with high ND score, but the difference was not statistically significant (Fig. 2). No significant differences were found regarding the psycho-emotional wellbeing but the impact of fatigue on everyday life was higher in low ND score group (Fig. 3). Conclusion We were not able to show improved FC nor psycho-emotional symptoms after 6 weeks of the ND. The adherence decreased after visit 2, therefore another consultation with the nutritionist could be beneficial to improve the understanding and motivation of the patients. Compliance with the ND reduced BMI and high adherence might be associated with lower FC levels. Further studies with larger patient groups would improve reliability of the results. This pilot study is part of the project financed by BIOCODEX MICROBIOTA FOUNDATION 2020.

DOP12 Non-invasive assessment of intestinal inflammatory activity in Ulcerative Colitis by Multispectral Optoacoustic Tomography (MSOT)

Abstract Background In order to guide therapy in Ulcerative Colitis (UC), repeated determination of intestinal inflammatory activity is essential. Endoscopy is the standard procedure to assess inflammation in UC. However innovative methods for non-invasive, uncomplicated and risk free estimation of inflammatory activity are needed as bowel preparation, patients discomfort and risk of procedural complications limit the (frequent) use of colonoscopy. Multispectral optoacoustic tomography (MSOT) is a promising new method to measure inflammation in UC. Using short and harmless impulses of NIR-lasers, it allows for determination of a specific hemoglobin-signal in the bowel-wall and therefore inflammatory activity in affected bowel segments. However, its informative value in UC has not been evaluated so far. Methods In 34 patients with confirmed UC, clinical activity parameters (e.g. clinical Mayo-Subscore, B-mode-sonography, C-reactive protein, white blood count) were collected and MSOT of the sigmoid was performed within 2 weeks before/after endoscopy. For MSOT, a commercially available clinical MSOT-system (Acuity Echo, iThera Medical, Munich) was used with sequential analysis of collected data on an external desktop PC. Finally, clinical data, ultrasound findings (Limberg) and MSOT-parameters (single wavelenghts 760 nm, 800 nm, 900 nm; multispectral signals hb, hbO2, hbT) were correlated with endoscopic findings (Mayo endoscopic Subscore, MES). Results We found strong and significant correlation between MES and MSOT parameters 800 nm (Spearman r = 0,6599; p &amp;lt; 0,0001) and HbO2 (Spearman r = 0,6695; p &amp;lt; 0,0001), superior to sonographic evaluation of the inflammatory activity in affected bowel segments (Spearman r = 0,4914; p = 0,0023). Simultaneously these MSOT parameters demonstrated excellent sensitivity and specifity in distinguishing moderately to highly active (MES 2,3) from inactive and mild disease (MES 0,1) (800nm: AUROC 0,9063 (p &amp;lt; 0,0001); sensitivity = 93,75 %, specificity = 88,89 %; HbO2: AUROC 0,9063 (p &amp;lt; 0,0001); sensitivity = 100 %, specificity = 88,89 %). Conclusion MSOT is a promising approach to non-invasively assess intestinal inflammation in UC and therefore monitor anti-inflammatory therapy in these patients. Further studies are required to validate these findings.

P392 To study the prevalence of depression and anxiety in patients of Inflammatory Bowel Disease (IBD) and the efficacy of psychopharmacotherapy in these patients: A pilot study

Abstract Background There is high prevalence of psychiatric disorders amongst IBD patients which independently affect quality of life. Studies have shown psychological stress leads to IBD flare. Non pharmacological psychotherapy has been studied in treatment of IBD, but not psychopharmacotherapy. We feel treatment for mental disorders in IBD patients may improve outcomes. Methods This is a prospective, observational single centre pilot study. After ethics committee approval, 200 patients were accrued between November, 2019 &amp; June, 2021, with, 1 year follow up for patients with anxiety or depression. All patients &amp;gt;18 years with Ulcerative Colitis (UC)/Crohn’s disease (CD) were enrolled. We excluded patients with IBD-Unclassified, post ileostomy/colostomy, on biologicals, malignancy. For assessing disease activity in UC we used UCEIS &amp; pMAYO scores; CDEIS &amp; Harvey-Bradshaw scores for CD. HADS-A &amp; HADS-D scores were used to determine anxiety and depression, respectively. Patient with HADS-A or HADS-D &amp;gt;, 7 were considered to have significant anxiety/depression, were given psychopharmacotherapy as per psychiatrist. All patients received IBD therapy as per standard of care. These patients were followed up at, 3, 6, 9 and, 12 months to assess the clinical parameters and HADS scores at each visit. Colonoscopy was repeated after a year to assess endoscopic activity. Results In our pilot study of, 200 patients CD was seen in, 84 (42.0%) &amp; UC in, 116 (58.0%). Prevalence of Anxiety was, 15%, Depression, 7% &amp; pooled prevalence, 22%., 86 patients (43.0%) received only IBD therapy., 66 (33.0%) received, 1 antipsychotic drug, 33 received, 2 (16.5%), 15 (7.5%) were prescribed, 3. Patients receiving psychopharmacotherapy, showed significant improvement in HADS-A or HADS-D scores at, 3, 6,9 and, 12 months. Amongst patients with UC, there was a significant improvement in UCEIS score (4.73 to, 2.36) in patients who received psychopharmacotherapy in addition to IBD standard of care after, 1 year (p&amp;lt;0.05). Similarly, the mean p-MAYO score dropped from, 4.91 to, 2.17 in patients receiving psychopharmacotherapy (p&amp;lt;0.05). The same pattern was observed in patients with Crohn’s disease receiving psychopharmacotherapy, in whom the mean CDEIS score dropped from, 5.43 to, 2.16 after, 1 year. Also, the mean Harvey-Bradshaw score dropped from, 5.57 to, 2.86. Both in UC &amp; CD; clinical, endoscopic scores significantly improved in patients who were given psychopharmacotherapy in addition to SOC. Conclusion Our study confirmed the high prevalence of anxiety and depression amongst Indian IBD patients. IBD patients with significant anxiety or depression benefit from Psychopharmacotherapy in addition to standard of care treatment, showed improvement in clinical as well as endoscopic disease activity.

DOP59 Development of a novel Ulcerative Colitis (UC) endoscopic activity prediction model using machine learning (ML)

Abstract Background Previous studies have described machine learning (ML) models to predict how human readers would score disease activity in UC using the endoscopic Mayo Score (eMS). So far, none employed deep human annotation that considers all the endoscopic features making up the eMS. Here we report the results of an ML model that is trained on eMS features using centrally read endoscopies. Methods 793 full-length videos were obtained from 249 patients with UC who participated in NCT02589665, a phase 2 trial with mirikizumab in patients with UC and associated with centrally read (single reader) eMS (CReMS) as the primary dataset. After cleaning for usable frames, the data were split into training, validation and testing subsets. The ML workflow consisted of annotation, segmentation, and classification (e.g., erosions, ulcers, erythema, vascular pattern, and bleeding). Human image classification and segmentation with bounding boxes and was subjected to quality control adjudicated by one of three IBD specialists, generating more than 60,000 eMS-relevant annotation labels. The model was evaluated on a test set of 147 videos using the CReMS, and a consensus set of 94 test videos, where CReMS and annotator reported eMS (AReMS) were in agreement without adjudication. The primary objective of the model was a categorical prediction of endoscopically inactive disease (eMS 0 &amp; 1) compared with active disease (eMS 2 &amp; 3). The secondary objectives of the model were to predict endoscopic healing (eMS 0) and to predict severe disease (eMS 3). Results The model performances are in Table 1. On the full test set of 147 videos, the model predicted inactive disease compared with active disease with an accuracy of 84%, positive predictive value (PPV) of 80%, and negative predictive value (NPV) of 85%. In the subset of 94 videos with CreMS and AReMS consensus, the model predicted inactive disease compared with active disease with an accuracy of 89%, PPV 87%, and NPV of 90%. In this same subset, the model predicted endoscopic healing and severe disease with an accuracy of 95% and 85%, PPVs of 86% and 82% and NPVs of 95% and 87%, respectively. For the secondary objectives in the full set of 147 videos, the model predicted endoscopic healing and severe disease with an accuracy of 90% and 80%, PPVs of 44% and 86%, and NPVs of 95% and 86%, respectively. Conclusion We have developed a ML predictive model of the eMS in UC using centrally read videos and demonstrate excellent distinction between active and inactive disease, and clear discrimination between other levels of endoscopic activity. We propose that this unique ML approach to endoscopic assessment be considered as a substitute to human central reading in future clinical trials.

P408 Faecal infliximab and disease activity in Acute Severe Ulcerative Colitis

Abstract Background Infliximab (IFX) is increasingly used in the management of moderate to severe ulcerative colitis (UC) and as a ‘rescue’ treatment for acute severe UC (ASUC) but primary non response (PNR) and colectomy rates remain significant. Reasons for IFX treatment failure in ASUC are multifactorial but immunogenicity and faecal loss of drug are thought to be important factors. Emerging evidence suggests accelerated ‘rescue’ IFX dosing may be more effective. The aim of this work was to establish if a relationship exists between faecal IFX levels, disease activity, and clinical outcomes early in IFX treatment. Methods Patients with UC were prospectively recruited following initiation of IFX and designated as ASUC or non-ASUC based on Truelove and Witt’s criteria. Stool and serum were collected on days, 0, 7, 14, 28 and, 42 after initiation of IFX. Additional samples on days, 1–5 after IFX were obtained from inpatients. Albumin and CRP results were extracted from electronic patient records. Faecal calprotectin (FC) was measured using ELISA (CALPROLAB). Faecal IFX within the first, 2 weeks of treatment was analysed using a Promonitor-IFX-1DV ELISA assay, performed on the Triturus ELISA instrument. R studio was used to calculate areas under the curves of the time series. Spearman’s rank correlation test was used for correlation analysis. Results 20 patients were recruited, 12 with ASUC. Faecal IFX correlated strongly with FC (ρ=0.793;p&amp;lt;0.001) (Fig., 1), and moderately with CRP (ρ=0.51;p=0.02), and serum albumin (ρ=-0.51;p=0.02). The correlation was strongest between faecal IFX and FC within in the first week (ρ=0.93;p&amp;lt;0.001), and less strong for crp (ρ=0.481;p=0.037) and albumin (ρ=-0.474;p=0.04). Higher faecal IFX was associated with increased colectomy and PNR rates but this did not reach statistical significance (p=0.098). A rapid decline in median FC was seen after initiation of IFX with a rebound rise in FC observed at day, 3 of IFX treatment (Fig. 2). Conclusion In this small cohort, faecal loss of IFX was associated with increased markers of systemic and luminal inflammation. Its role as a biomarker for disease severity, treatment response and clinical outcomes warrants further investigation. The rapid fall but early rebound rise in FC may support the need for earlier accelerated dosing in ASUC. However, larger studies are needed to establish the optimal early IFX regime to improve clinical outcomes. References Papamichael et al. Aliment Pharmacol Ther, 2018;47:478–484. Hindryckx et al. Aliment Pharmacol Ther., 2017 March;45(5):, 617–630 Brandse et al. Gastroenterology., 2015 Aug;149(2):350–5

P218 Accuracy of Ultrasonography in Assessing Disease Activity in Pediatric Ulcerative Colitis: Preliminary Results of a two-center study

Abstract Background Ulcerative colitis (UC) is an inflammatory bowel disease involving rectum and colon. Transabdominal bowel ultrasound (TBUS) is a non-invasive technique evaluating inflamed colonic segments. Previous studies showed optimal concordance between TBUS and endoscopy in the colon, but suboptimal in the rectum. Transperineal ultrasound (TPUS) of the rectum achieved high agreement with endoscopy in adult UC patients. Aim of this study was to assess the accuracy of ultrasound in evaluating disease activity in pediatric UC patients by means of TBUS and TPUS Methods Pediatric UC patients were enrolled in two IBD centers from March to November 2021. Disease activity was determined using PUCAI score and Mayo Endoscopic Subscore (MES). TBUS and TPUS were performed within a week from endoscopy. MES ≤ 1, bowel wall thickness ≤ 3mm in the colon and ≤ 4mm in the rectum were defined as remission. A concordance analysis comparing endoscopy and US was performed. Results Eighteen patients were enrolled with a mean age of 9.1 ± 4.0 years and a mean disease duration of 2 ± 2.9 years.10 patiens had pancolitis, 2 distal colitis, 4 proctitis. Fifteen patients had endoscopic active disease (2 mild, 12 moderate and 1 severe), and 3 were in remission. Good correlation at the Cohen κ-value between endoscopy and TPUS was observed (K= 0.68). In the evaluation of colon with TBUS the same concordance was found in right (K= 0.64), the transverse (K= 0.75) and in the left colon (K= 0.77), while moderate in the sigma (K= 0.55). Conclusion If these results will be confirmed in a larger study, the combination of TBUS and TPUS could represent a non-invasive technique to assess disease activity in UC children.

P639 Incidence and disease presentation of inflammatory bowel disease in Denmark: initial findings from a Copenhagen IBD Inception Cohort Study

Abstract Background Denmark has one of the highest occurrences of inflammatory bowel disease (IBD) in the world, with reported incidence rates of 7.2 and 6.2 in paediatric ulcerative colitis (pUC) and 10 and 9.4 per 105 for girls and boys in Crohn’s disease (pCD). Incidence rates in adult patients have been reported to be 9.1 and 18.6 per 105 for ulcerative colitis (UC) and Crohn’s disease (CD), respectively. We aimed to evaluate the incidence and initial disease presentation of newly diagnosed paediatric and adult IBD patients in the Hvidovre and Herlev Hospital uptake areas, covering approximately 1.050.000 inhabitants, corresponding to ~20% of the Danish population. Methods During a 2-year inclusion period, all incident paediatric (≤18 years of age, pIBD) and adult IBD patients residing in the uptake area at the time of diagnosis are included in a prospective, multicentre, population-based inception cohort (IBD Prognosis Study). The study was initiated on May 1st, 2021. Patients are prospectively followed with regular intestinal biopsies, stool-, serum-, and whole blood samples to analyze biomarkers, microbiome and genetic profiles at predefined time points. Demographics and disease-related characteristics were collected at diagnosis. Incidence was defined as the number of new IBD cases during May 1st – October 31st divided by the total inhabitants covered in included sites during the same period. Results A total of 125 IBD patients were included during the initial six months (table 1). For paediatric patients, the incidence rates were 8.2 and 16.4 per 105 for pUC and pCD. Adult incidence rates were 19.4, 17.0, and 2.4 per 105 for UC, CD and IBD-unclassified (IBD-U), respectively. At diagnosis, extraintestinal manifestations were present in 15% of paediatric and 36% of adult patients. In paediatric patients, 20% and 0% of pUC and pCD had moderate to severe disease activity at diagnosis, based on PUCAI- and PCDAI scores. In adults, 33%, 50% and 50% of UC, CD and IBD-U patients had moderate to severe disease activity at disease onset based on SCCAI- and HBI scores. More extensive disease and increased faecal calprotectin were associated with more severe disease activity in adult UC. CRP correlated positively, while haemoglobin and albumin correlated negatively with UC disease extension. Conclusion The IBD incidence rates in paediatric and adult patients continuously increase in Denmark, thus constituting a substantial burden for the Danish health care system. A large proportion of patients presented with significant symptoms and future findings of this cohort will potentially bring us a better understanding of the heterogeneous course of IBD, including the differential need for, and response to, treatment.

P414 Stoma in patiens with IBD: friend or foe? -\tEffect of stoma on course of disease, psychological well-being and working capacity

Abstract Background Knowledge on the impact of stoma formation surgery on course of disease, psychological well-being, quality of life (QoL) and working capacity in patients with IBD is scarce. Methods To investigate this, we analysed prospectively followed-up patients from the Swiss inflammatory bowel disease cohort study (SIBDCS), comparing ulcerative colitis (UC) and Crohn’s disease (CD) with vs without stoma surgery, for both temporary and permanent stoma formation. Results From a total of, 3825 SIBDCS patients, 352 patients were included in our analysis -, 176 with stoma surgery (52.8% and, 47.2% with CD and UC, respectively) - amongst these, 111 with permanent and, 65 with temporary stoma - matched with, 176 patients without stoma. Mean and maximal disease activity was lower in patients with vs. without stoma overall in CD but not in UC (Fig., 1, A/B). However, in UC, disease activity was lower in permanent vs. temporary stoma patients (Fig., 1, C/D). Figure, 1 A-D: Average disease activity with mean Crohn’s disease activity index (CDAI; A) in CD and Modified Truelove &amp; Witts activity index (MTWAI; B) and UC for patients with vs. without stoma as well as (within the stoma group) permanents vs. closed ostomy (C,D). Furthermore, active EIM as well as need for steroids, immuno-modulators and biologics were lower in stoma vs. control patients. Amongst stoma patients, quality of life and psychological wellbeing was similar in permanent vs. closed stoma (Inflammatory Bowel Disease Quality of Life questionnaire Total score (IBDQ); Hospital Anxiety and Depression Scale Total Score (HADS); Posttraumatic Diagnostic Scale Total Score (PDS); and effort-reward ratio – all mean values obtained during prospective SIBDCS follow-up). However, we found a significantly lower (i.e. more favourable) PDS avoidance score in permanent vs. closed ostomy (Fig., 2A). Working capacity was lower in permanent vs. closed stoma patients (Fig. 2B). Figure, 2 A,B: IBDQ, HADS total, PDS total and Effort-Reward ratio (A), Working status, absentism from work and need for disability insurance (B) in permanent vs. closed IBD patients with stoma. Conclusion In CD patients with stoma surgery disease activity was significantly reduced after ostomy. Moreover, in UC we observed a benefit of patients with permanent compared to their counter-parts with temporary stoma to control disease activity. We found no differences in psychological functioning and QoL between temporary and closed stoma, with the exception of higher avoidance indicative of posttraumatic stress in the latter. In contrast, working capacity revealed to be higher closed vs. permanent ostomy.

P497 Early improvement in bowel wall thickness on transperineal ultrasonography predicts treatment success in active ulcerative colitis

Abstract Background Bowel ultrasonography is a non-invasive imaging tool that can repeatedly monitor the activity of ulcerative colitis (UC). This study aimed to determine whether early changes in bowel ultrasonographic findings could predict subsequent clinical response to induction treatment in patients with ulcerative colitis. Methods This single-center prospective study compared ultrasonographic findings with fecal calprotectin, and C-reactive protein (measured at baseline, week 1, and week 8) in predicting remission (patient-reported outcome-2 ≤ 1 with no rectal bleeding subscore) at week 8 in active UC patients who initiated the remission-induction treatments. Predictive factors were assessed using multivariate regression models and a receiver operating curve analysis. Results A total of 100 patients were analysed, of which 54 achieved remission at week 8. Baseline values of biomarkers, and ultrasonographic parameters were not predictive of remission. Bowel wall thickness and bowel wall flow at baseline and week 1 were also not sufficiently predictive. By contrast, changes from baseline to week 1 in bowel wall thickness in the rectum measured by transperineal ultrasonography was an independent predictor of remission by week 8 (adjusted odds ratio associated with 1 mm decrease: 1.90 (95% confidence interval 1.22–2.95)). Predictive value of changes in rectal bowel wall thickness remained high for clinical improvement even among patients who did not achieve remission in 1 week. Conclusion Improvement in rectal bowel wall thickness measured by transperineal ultrasonography at week 1 predicts treatment success and thus would help decision making during the early course of induction treatment in UC.

DOP22 Clinical, biochemical and endoscopic disease activity of Inflammatory Bowel Diseases are not associated with the severity or long-term outcomes of COVID-19 – A Danish prospective population-based cohort study

BackgroundWhether the disease activity of ulcerative colitis (UC) and Crohn’s disease (CD) is correlated with the severity of coronavirus disease 2019 (COVID-19) remains poorly investigated with only few selected cohort studies having addressed this in the past.MethodsWe conducted a population-based study investigating the outcomes of COVID-19 among patients with UC and CD in Denmark. The Danish COVID-19 IBD Database is an extensive population-based database which prospectively monitors the disease course of laboratory-confirmed COVID-19 among patients with UC and CD. Severe COVID-19 was defined as COVID-19 necessitating intensive care unit admission, ventilator use, or death, while adverse COVID-19 was defined as requirement of COVID-19 related hospitalization. Clinical disease activity was measured by simple clinical colitis index and Harvey-Bradshaw Index in UC and CD, respectively. The biochemical activity was defined as C-reactive protein higher than 5 mg/L or fecal calprotectin higher than 250 μg/g. The endoscopic activity was defined as Mayo Endoscopic Subscore of at least 2 in UC, or Simple Endoscopic Score Crohn’s Disease of at least 3 for CD. Sequelae following COVID-19 were defined as symptoms that (i) developed during or after an infection consistent with COVID-19, (ii) and were present for more than 12 weeks, (iii) and were not attributable to alternative diagnoses.ResultsDuring the inclusion period between January 28th, 2020, to April 1st, 2021, the study included 319 patients with UC and 197 patients with CD who developed laboratory confirmed COVID-19. Of these, data on clinical, biochemical, and endoscopic activity were available among 265/319 (83.1%), 319/319 (100.0%), and 66/319 (20.7%) of patients with UC, respectively, and 140/197 (71.1%), 131/197 (66.5%), and 42/197 (21.3%) of patients with CD. Figures 1–2 outlines the outcomes of COVID-19 according to the degree of clinical, biochemical and endoscopic disease activity. In both UC and CD, clinical, biochemical, and endoscopic activity were not associated with adverse or severe COVID-19, nor long-term outcomes, in unadjusted nor adjusted analysis (Table 1). ConclusionIn this population-based study, we found no association between disease activity of UC or CD and severity of COVID-19. These findings have implications for the risk stratification of patients with IBD acquiring COVID-19.