Adult Ulcerative Colitis Patients Research Articles

National Trends in the Creation of Diverting Ileostomy at the Time of Ileal Pouch-Anal Anastomosis in Adults With Ulcerative Colitis.

The impact of diverting ileostomy in adults with ulcerative colitis (UC) undergoing ileal pouch-anal anastomosis (IPAA) is unclear. This study uses a novel approach with population-level data to identify patients with diverting ileostomy at the time of IPAA and determine the impact of diverting ileostomy on postoperative outcomes. Using the International Business Machines (IBM) MarketScan® database, adults (18-64years old) with a diagnosis of UC who underwent IPAA between 2000 and 2019 were examined. Patients were assigned to the diverting ileostomy (DI) cohort or no-DI cohort based on the presence of an ostomy closure code in the 1-year following their IPAA. Rates of ileostomy formation and readmissions were quantified and outcomes between cohorts compared. There were 540 patients in the no-DI and 2494 in the DI cohort. There were regional differences in the rate of ostomy creation, but the overall rate of ostomy creation remained stable across years. Patients with no-DI vs DI had a longer index length of stay (LOS) (7 vs 6days, P = .001). Adverse postoperative outcomes did not differ between cohorts. Diversion did not independently affect the likelihood of a 30-day readmission, and since 2000, readmission rates have declined for all IPAA patients. This is the first study to capture population-level data on the effect of diversion at the time of IPAA for adult UC patients. This study demonstrates that the rate of fecal diversion at the time of IPAA has remained stable over time, but readmission rates have declined.

Factors Associated With Abdominal Pain in Patients With Active and Quiescent Ulcerative Colitis: A Multicohort Study.

Abdominal pain can be an overlooked symptom in patients with ulcerative colitis (UC). The aim of this study was to investigate the prevalence and factors associated with abdominal pain in active and quiescent UC. Three study cohorts of adult UC patients were used. Cross-sectional cohorts I and II included 130 (46 active) and 288 (156 active) patients. Longitudinal cohort III included 83 patients with active disease at diagnosis that reached deep remission during follow-up. The Gastrointestinal Symptom Rating Scale was used to assess abdominal pain and other validated questionnaires to assess psychological distress, fatigue and quality of life (QoL). In the two cross-sectional cohorts, 63% and 58% of the active vs. 54% and 33% of the quiescent UC patients reported abdominal pain (both p ≤ 0.02). In the longitudinal cohort, 71% had abdominal pain at diagnosis vs. 46% when in remission (p < 0.001). In multivariable models, symptoms of anxiety were associated with higher abdominal pain levels in both cross-sectional cohorts (OR 1.75 [IQR 1.11-2.76] and OR 1.99 [1.45-2.73]), whereas in cohort II, active disease (OR 2.68 [1.61-4.45]) and female sex (OR 2.03 [1.21-3.41]) were also associated with pain. QoL was negatively correlated with higher levels of abdominal pain, both in active and quiescent disease. Abdominal pain in UC is prevalent and associated with lower QoL in both active and quiescent disease. Associated factors are active disease, female sex and psychological symptoms, especially anxiety. We suggest considering a holistic approach when treating UC patients with abdominal pain.

Similar Efficacy of Mesalazine in Adult and Older Adult Ulcerative Colitis Patients: Post Hoc Analysis of a Randomized Noninferiority Trial of 1600mg vs 400mg Tablets.

The efficacy data on treatment in older adults are scarce, while the greatest increase in ulcerative colitis (UC) prevalence is observed in age groups of individuals 40 to 65 years of age and ≥65 years of age. We assessed the difference in rates of clinical and endoscopic response and remission in UC adults (≤60 years) and older adults (>60 years) treated with mesalazine. We performed a post hoc analysis of data from a phase 3 noninferiority trial of 817 UC patients treated with mesalazine for 8 and additional 26 weeks in a double-blind and open-label study, respectively. We used Wilcoxon rank sum or chi-square test to analyze differences between groups and multivariable logistic regression to determine the associations between endoscopic remission as outcome (Mayo endoscopic subscore [MES] = 0 or ≤1) and independent variables including disease duration, baseline MES, age, sex, comedications, and comorbidities. Older adults had a longer disease duration, a higher number of comorbidities, concomitant medications, and higher baseline MES (2.38 ± 0.486 in older adults vs 2.26 ± 0.439 in adults; P = .008) compared with adults. We observed no difference in rates of combined clinical and endoscopic remission, clinical remission and response, and endoscopic remission and response at week 8 and 38 post-treatment. In addition to other well-known predictors of worse outcome, patients with ≥3 comedications were less likely to achieve an MES = 0 at week 8 and 38 and an MES ≤1 at week 38. We observed similar efficacy of mesalazine in adult and older adult UC patients. The increased comedication number rather than age may decrease effectiveness of UC medications, highlighting the importance of healthy aging.

A Comparison of Clinical Outcomes of Colectomies for Pediatric and Adult Patients With Inflammatory Bowel Disease.

Background: Crohn's disease (CD) and ulcerative colitis (UC) are prevalent in adult and pediatric populations, but their differences are not well studied using national data. We compared the clinical outcomes of these patients using the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) databases.Methods: Colectomy cases for CD and UC, the 2 major forms of inflammatory bowel disease (IBD), were compared between adult and pediatric patients using the 2017-2019 ACS NSQIP databases. Various clinical factors were analyzed, with postoperative complications being the primary outcome of interest.Results: We identified 542 pediatric and 5174 adult CD patients and 360 pediatric and 1292 adult UC patients. Adults with CD or UC were more likely to be on steroids preoperatively (CD: 60.15% vs 24.54%; UC: 65.63% vs 51.39%). Children with IBD were more likely to have preoperative transfusions (CD: 1.48% vs .33%; UC: 8.33% vs .62%), systemic inflammatory response syndrome (CD: 3.51% vs .93%; UC: 12.78% vs 3.10%), or sepsis (CD: 1.85% vs .66%; UC: 1.39% vs .31%). Unplanned reoperations were more common among pediatric patients in both disease states compared to adults (CD: 6.27% vs 4.10%; UC: 11.11% vs 4.26%), with P-values for all factors described as ≤.02. Multivariate logistic regression found pediatric age to be associated with higher odds of needing a reoperation among UC patients but not CD patients.Conclusion: Pediatric patients were sicker at the time of surgery, and those with either disease were more likely to require a reoperation within 30days.

Diagnostic Performance of a Fecal Calprotectin Assay as a Biomarker for Mayo Endoscopic Subscore in Ulcerative Colitis: Result From a Tertiary Referral Center.

Fecal calprotectin (FC) is a promising biomarker for assessing ulcerative colitis (UC) endoscopic activity. However, the optimal FC cutoff to identify each Mayo endoscopic subscore (MES) remains inconclusive. The electronic medical records of 177 adult UC patients evaluated at Mayo Clinic Rochester from January 2017 to March 2023 were retrospectively reviewed, obtaining clinical data and US-based Werfen Diagnostics FC levels collected within 30 days before colonoscopy or flexible sigmoidoscopy. Three independent inflammatory bowel disease specialist endoscopists blindly reviewed the most severe endoscopic images for grading MES. The median interval between FC collection and endoscopy was 2 days. Fecal calprotectin showed strong positive correlations with MES (Spearman's r = 0.709; P < .01) and other clinical parameters. Fecal calprotectin cutoff of 60 mcg/g effectively distinguished MES 0 from MES 1-3 (sensitivity, 0.78; specificity, 0.97; area under the receiver operating characteristic curve [AUC], 0.901) and predicted clinical remission (Total Mayo Score ≤2 and no subscore >1; sensitivity, 0.83; specificity, 0.98; AUC, 0.921). Fecal calprotectin cutoff of 110 mcg/g effectively differentiated MES 0-1 from MES 2-3 (sensitivity, 0.86; specificity, 0.87; AUC, 0.915), while a cutoff of 310 mcg/g distinguished MES 0-2 from MES 3 (sensitivity, 0.80; specificity, 0.76; AUC, 0.820). This study supports the reliability and applicability of FC as a valuable marker of endoscopic inflammation, particularly in distinguishing MES 0 from MES 1-3 using the FC cutoff of 60 mcg/g. Sensitivity analysis demonstrated robust results.

National trends and outcomes of total proctocolectomy and completion proctectomy ileal pouch-anal anastomosis procedures for ulcerative colitis.

The purpose of this study is to assess US operative trends and outcomes of ulcerative colitis (UC) patients undergoing total proctocolectomy with ileal pouch-anal anastomosis (TPC-IPAA) or completion proctectomy with IPAA (CP-IPAA). Adult UC patients who underwent TPC-IPAA or CP-IPAA were analysed retrospectively using the 2016-2020 American College of Surgeons National Surgical Quality Improvement Program database. Factors associated with 30-day overall and serious morbidity were identified using multivariable logistic regression. A total of 1696 patients were identified, with 958 patients (56.5%) undergoing TPC-IPAA and 738 (43.5%) undergoing CP-IPAA. A greater proportion of TPC-IPAAs were performed each year (except in 2019) compared to CP-IPAAs over the study period (P trend <0.001). Unadjusted analysis showed comparable rates of overall (20.8% vs. 24.4%, P = 0.076) and serious morbidity (14.3% vs. 12.7%, P = 0.352) between TPC-IPAA and CP-IPAA patients. Robotic TPC-IPAA had no differences in complications compared to laparoscopic and open approaches. Robotic CP-IPAA had higher anastomotic leak rates and longer hospital length of stay compared to laparoscopic and open approaches. Obesity was associated with increased odds of overall and serious morbidity for patients who underwent TPC-IPAA. Steroid/immunosuppressive therapy was associated with increased odds of overall and serious morbidity for patients who underwent CP-IPAA. Obese patients should be informed of their increased morbidity risk and offered counselling on weight loss prior to surgery when feasible. Patients on steroid/immunosuppressive therapy within 30 days preoperatively should not undergo CP-IPAA or should delay surgery until they can be safely off those medications.

Modified 2-stage IPAA has similar postoperative complication rates and functional outcomes compared to 3-stage IPAA

IntroductionReconstructive ileal-pouch anal anastomosis (IPAA) for ulcerative colitis (UC) is often created in 3-stages: colectomy ​+ ​ileostomy, proctectomy ​+ ​pouch creation with diverting loop ileostomy, then subsequent ileostomy closure. Modified 2-stage IPAA is without pouch diversion, thus avoiding a third operation. This study compares perioperative complications, quality of life (QOL) and functional outcomes of 3- versus modified 2-stage IPAA. MethodsCharts were reviewed for adult UC patients undergoing IPAA between 2010 and 2020. QOL and function were assessed with EQ-5D-3L Quality of Life and Pouch Functional Score questionnaires. Results152 patients were identified. 43 modified 2-stage and 109 3-stage IPAA were similar for anastomotic leak (9.3% vs. 1.8%, p ​= ​0.06), SSI (34.9% vs. 29.7%, p ​= ​0.51) and ileus (32.6% vs. 33%, p ​= ​0.96). Modified 2-stage had less bowel obstruction than 3-stage IPAA (7.0% vs. 30.1%, p ​= ​0.006). 92 patients returned questionnaires with similar QOL and pouch function. ConclusionsPerioperative complications, QOL and function are similar for 3-stage IPAA and modified 2-stage IPAA. Modified 2-stage IPAA in select patients is safe and has less postoperative bowel obstruction than 3-stage IPAA.

DIFFERENTIAL MORTALITY OUTCOMES AMONG DIFFERENT CLASSES OF DRUGS IN ELDERLY PATIENTS WITH ULCERATIVE COLITIS USING A MULTI-CENTER RESEARCH NETWORK

Abstract BACKGROUND Several medical therapies exist for ulcerative colitis (UC) including 5-aminosalicylates (5-ASAs), immunomodulators (IMM), biologics and Janus Kinase (JAK) inhibitors that aim to induce and sustain both clinical and endoscopic remission of UC. Selection of treatment is dictated by disease severity and patient characteristics and preference. Long-term differences in mortality risk among these therapies is unknown. The aim of this study is to compare 10-year mortality among older adult UC patients exposed to different treatment regimens. METHODS Using TriNetX, a multicenter research database, elderly patients with UC who are 65 years or older were identified using ICD-10 code for ulcerative colitis(K51) on the Research Network, accessed on September 26th, 2023. Cohorts were subdivided according to exclusive different lines of therapy as shown in table 1: 5-ASAs, IMM, Biologics, and JAK inhibitors. Advanced therapy included the latter three classes of drugs whereas simple therapy included 5-ASA agents. Comparison of 10-year mortality profiles was done for advanced therapy and each different therapeutic class in reference to simple therapy (5-ASAs). Analyses were performed on a built-in statistical software on TriNetX. RESULTS When comparing advanced therapy to simple amino-salicylate-based therapies, elderly patients demonstrated higher 10-year mortality with advanced therapy (13.5% vs 12.4%, OR=1.10, 95 % CI [1.13,1.29], p=0.017) as shown in table 2. When breaking down the classes of advanced therapies, immunomodulators had the highest risk of mortality as compared to simple therapy ( 19.1% vs 12.4%, 1.67 95%CI [1.52, 1.84], p&amp;lt;0.0001). However, biologic therapies had a lower mortality risk when compared to simple therapy (9.3% vs 12.4%, OR=0.73, 95% CI [0.64, 0.83], p&amp;lt;0.0001). Further data are needed to assess the mortality risk of JAK inhibitors as they were recently approved for ulcerative colitis and 10-year mortality risk could not be examined. CONCLUSION Among the different drug classes, immunomodulators were significantly associated with higher 10-year mortality risk compared to simple therapy whereas biologic therapies had the lowest mortality risk. Table 1 Lines of Therapy Table 2 Characteristics and Mortality Outcome of Patients on Different Lines of Therapy

P412 Faecal Calprotectin as a predictor of endoscopic and histologic remission in patients with Ulcerative Colitis

Abstract Background Faecal calprotectin (FCP) is a reliable surrogate marker for disease activity in ulcerative colitis (UC). However, there are no consensus cut-off values for histoendoscopic remission. The aim of the study is to correlate FCP with Mayo Endoscopic Score (MES) and histological disease activity (Geboes score) of UC patients in clinical remission. Methods We performed a prospective study including adult UC patients at the McGill IBD Center between 2013 and 2017. Patients in clinical remission (partial Mayo score ≤2) or disease relapse, undergoing endoscopy for disease activity or dysplasia surveillance, were enrolled. Before bowel preparation, FCP was collected. MES was documented during colonoscopy. Biopsies were taken throughout the colon and histological activity was assessed using Geboes score (GS) by a blinded expert gastrointestinal pathologist. Results The study included 253 patients, of which 117 (46%) were male with a mean age of 38.2 years (standard deviation [SD] ± 24.8). 46% of the patients had pancolitis at the time of colonoscopy. 5-aminosalicylate were used by 68.4% of patients while 20.9% were on immunomodulators, 19% on biologics and 0.4% on small molecules as treatment. Regarding endoscopic correlation, it showed that an FCP ≥ 200 μg/g predicts MES &amp;gt; 1 despite clinical remission, yielding sensitivity of 59% and specificity of 74%. A FCP ≥ 123 predicts MES &amp;gt; 0 despite clinical remission (58% sensitivity and 70% specificity), also aiding to differentiate MES 0 from MES 1 (61% sensitivity and 70% specificity). As to histologic correlation, a FCP ≥ 80 μg/g identified histological disease activity using Geboes criteria (GS score &amp;gt; 3.1) in patients with clinical remission, yielding 64.7% sensitivity, 58.7% specificity and 77% positive predictive value (Figure 1). When using a GS score threshold of &amp;gt; 2, a cut-off value of FCP ≥ 50 μg/g, appears to be the most clinically relevant to identify patients in clinical remission who continue to have active histologic inflammation, with an 49.6% sensitivity, 41.6% specificity and 40% positive predict value. Results are summarized in Table 1. Conclusion FCP correlates very well with endoscopic and histologic disease activity and can be used as a surrogate marker for disease activity. Our study prospectively demonstrated the optimal cut-off values helping to discriminate endoscopic healing and histologic remission.

Patient preferences in treatment options of ulcerative colitis: a discrete choice experiment

Introduction Since the number of medical treatment options for Ulcerative Colitis (UC) has expanded over the last decades, patients and physicians face challenges regarding decisions about the medication options. We aimed to identify patients’ preferences about their UC treatment options in the Netherlands. Furthermore, we assessed after how many failed treatment options, patients are willing to consider surgical treatment. Methods We conducted a web-based, multicenter, discrete choice experiment (DCE) among adult UC patients. Patients were repeatedly asked to choose between two hypothetical medicinal treatment options. The choice tasks were based on administration route, administration location, chance of symptom reduction (on short and long term) and chances on infection and other adverse events. Data were analyzed by using Hierarchical Bayes estimation. Results A total of 172 UC patients participated in the DCE. More than half were anti-TNF experienced (52.9%). The chance of symptom reduction after one year (relative importance (RI) 27.7 (95% CI 26.0–29.4)) was most important in choosing between medicinal treatments, followed by the chance of infection (RI 22.3 (21.4 − 23.3)) and chance of symptom reduction after eight weeks (RI 19.5 (18.3 − 20.6)). Considering surgical treatment, nineteen patients (14.3%) would not even consider surgery after failing eight treatment options without any new available therapies left. Nine patients would consider surgery before trying any treatment options. Conclusion We found that symptom reduction after one year was the most important attribute in choosing between treatments in UC patients. These outcomes can help understand the trade-offs and preferences of UC patients.

Utility of the Serum-Based Endoscopic Healing Index in Monitoring Therapeutic Response in Ulcerative Colitis.

Convenient and objective noninvasive tools to monitor therapy response in patients with ulcerative colitis (UC) are needed. This study aimed to evaluate the performance of the Endoscopic Healing Index [EHI], a serum test originally developed to monitor mucosal inflammation in Crohn's disease, in patients with UC. Serum samples paired with endoscopic data from consecutive adult patients with UC initiating advanced therapy for active disease (Mayo Endoscopic Subscore [MES] > 1) were analyzed. EHI values were compared between groups showing endoscopic improvement, remission, and nonresponse, defined, respectively, as MES of ≤1, 0 and >1. We also assessed the association of EHI with longitudinal changes of MES and compared its performance with that of fecal calprotectin (FC) and C-reactive protein. A total of 127 patients provided 303 samples. Median EHI increased significantly with increasing MES score ( P < 0.001). Median EHI was significantly lower in patients with endoscopic remission or improvement compared with patients with no response ( P < 0.001, P < 0.001, respectively). A 10-point decrease in EHI was associated with 89% higher odds of 1-point decrease in MES ( P < 0.001). EHI detected MES 0-1 with an area under the receiver operating curve of 77.8%, which was comparable with that of FC and C-reactive protein (85.0% [ P = 0.076] and 70.6% [ P = 0.055], respectively). EHI values are significantly responsive to changes in mucosal inflammation, also in patients with UC, and can confirm and/or rule out mucosal inflammation with an almost similar accuracy to that of FC.

P688 Patient preferences in medication to treat Ulcerative Colitis: a discrete choice experiment

Abstract Background Since the number of treatment options for Ulcerative Colitis (UC) has expanded, patients and physicians face challenges regarding decisions about the medication options. In shared decision making, treating physicians help patients understand the trade-offs and their own preferences. We aimed to identify patients preferences about the relative risks and benefits of UC treatment options in patients with UC in the Netherlands. Furthermore, we assessed after how many failed treatment options, patients are willing to consider surgical treatment. Methods We conducted a web-based, discrete choice experiment (DCE) among adult UC patients. Patients were repeatedly asked to choose between two hypothetical treatment options with varying combinations of attribute levels (fig 1). Attributes were based on consecutively a literature search, patient interviews, surveys and a focus group. The six included attributes were: administration route, administration location, chance on symptom reduction (short and long term), chances on infection and on adverse events. A balanced overlap design was used. Patients were recruited via the patient association Crohn &amp; Colitis NL and in two academic hospitals. Data were analyzed by using Hierarchical Bayes estimation. Results A total of 172 patients participated in the DCE. Median disease duration was 8 (IQR 3-16) years. Most patients were anti-TNF experienced (52.9%). Symptom reduction after one year (relative importance (RI) 27.7 (95% CI 25.6-29.7)) was the most important when choosing between treatment options (table 1), followed by the chance of infection (22.3 (21.2 - 23.4)) and chance of symptom reduction after eight weeks (RI 19.5 (18.1 - 20.9)). The location of administration of the treatment and the chance of adverse events were the least important (8.7 (7.7 - 9.79) and 8.5 (7.9 - 9.2), respectively). Patients preferred oral administration over subcutaneous injections. Intravenous route of administration was least favorite. The differences in average utilities of patients previous treated with biologic therapy or small molecules or naïve patients are displayed in table 2. 133 patients filled in the trade off questions regarding surgery. Forty-four patients (33.1%) responded with unknown. Nineteen patients (14.3%) would not even consider surgery after failing all treatment options without any new available therapies left. Nine patients would consider surgery before trying any treatment options. Of the remaining patients, nine (6.8%) would consider surgery after failing six treatment options. Conclusion We found that symptom reduction after one year was the most important treatment attribute in UC patients. These outcomes can help understand the trade-offs and preferences of UC patients.

P401 Concomitant azathioprine treatment effects vedolizumab treatment persistence in Crohn’s Disease but not in Ulcerative Colitis

Abstract Background Vedolizumab is a monoclonal antibody against integrin α4β7 that is being used for the treatment of moderate to severe Ulcerative Colitis (UC) and Crohn’s Disease (CD). Recent studies have shown conflicting results for the effect of concomitant azathioprine use with vedolizumab monotherapy. In this single center cohort study, we investigated the effect of concomitant azathioprine treatment on vedolizumab drug persistence in UC and CD treatment. Methods We performed a retrospective review of all adult (≥18 years) UC and CD patients started on VDZ at our infusion center. Data collection included baseline demographics, concomitant azathioprine therapy, VDZ therapy and disease activity scores using the partial Mayo score and Harvey Bradshaw Score. Data were obtained from the digital medical record. The primary outcome measure was VDZ persistence, represented in Kaplan-Meier analysis. This analysis assessed persistence on every 8 week dose regimen. Results This single center cohort included 142 VDZ treated UC (n=64) and CD (n=78) patients. All patients had a history of at least one anti-TNF treatment: Mean age 38.9±12.5 years and male gender 84 (59.2%). Median disease duration was 6±1.6 years. 6 Patients were excluded from the analysis since VDZ therapy has been stopped due to side effects. Mean duration of VDZ treatment in Crohn’s disease was 96.5±69.2 weeks and in UC was 72.1±60.5 weeks. Concomitant azathioprine therapy in CD increased VDZ persistence rate. However, in UC concomitant azathioprine therapy did not effect VDZ persistence rate. Conclusion The real-world data collected in this study demonstrate that concomitant azathioprine treatment increase the VDZ persistence rate in Crohn’s disease. However, concomitant azathioprine treatment does not effect the VDZ persistence rate in UC patients.

P177 C-reactive protein/albumin ratio: a novel biomarker for monitoring of the disease activity in Ulcerative Colitis patients

Abstract Background Fecal calprotectin (FC) is a reliable laboratory test for non-invasive assessment of disease activity in ulcerative colitis (UC) patients; it's high cost, absence of widespread availability and low patient adherence limits it's use as a potential surrogate for endoscopy. The association of higher C-reactive protein (CRP) and low albumin levels, both obtained from patient's sera, with disease acitivity in UC, is well established. C-reactive protein/albumin ratio (CAR) is suggested as a biomarker for evaluating disease activity in various inflammatory conditions. We aimed to evaluate association between CAR, FC, CRP and serum albumin values with disease activity in UC patients. Methods A single center, noninterventional retrospective chart review of adult UC patients treated with biologics at a tertiary center was performed. Routine clinical (stool frequency score – SFS, and rectal bleeding score – RBS), biochemical (CRP, serum albumin, FC), and endoscopic (Mayo Endoscopic Subscore – MES) findings were assessed prior to initiating biologics. Active UC was defined as SFS 2/3 + RBS 2/3 + MES 2/3. Differences between continuous variables were calculated using independent sample t-tests and Mann–Whitney U test. Sperman’s correlation and ROC curve analysis were carried out. The Z statistic was used to compare correlation coefficients and AUC. Results Total of 82 patients (52.2% females, mean age 40.3 ± 15.3 years, smokers 16.9%) with dominantly extensive UC (57.3%) were analysed. The CAR (0.175 vs 0.025; p=0.02) and FC (1363.5 vs 65.5; p=0.01) levels were significantly higher in active vs inactive UC patients. Positive correlation was observed between CAR (rs = 0.354, p = 0.01), FC (rs = 0.448, p = 0.001) and CRP (rs = 0.316, p = 0.005) with active UC. Although serum albumin (r's = - 0.093, p = 0.532) negatively correlated with disease activity it didn't reach statistical significance. There was no statistically significant difference between CAR and FC correlation coefficients. The area under the curve (AUC) for the diagnosis of active UC was 0.896 (SE: 0.058; 95% CI 0.73 - 0,983, p=0.015) and 0.994 (SE: 0.009; 95% CI 0.98 - 1, p=0.001) for CAR and FC, respectively. Although AUC for FC was higher compared to CAR it didn’t reach statistical significance (p = 0.1). The cut-off value associated with the active UC for CAR was 0.06 (sensitivity 77,2%, specificity 100%), and 120 mcg/g for FC (sensitivity 97.6%, specificity 100%). Conclusion There is good correlation between CAR and clinical as well as endoscopic disease activity in patients with UC, comparable to FC. CAR could be offered as a cheap and practical biomarker for detection of active UC disease.

P237 Superior predictive value of intestinal ultrasound over endoscopic severity for colectomy risk in patients with ulcerative colitis

Abstract Background Up to 15% of patients with ulcerative colitis (UC) do not respond to medical therapies and ultimately require colectomy for disease control. Baseline endoscopic severity and failure to achieve endoscopic healing, as defined by a Mayo Endoscopic Subscore (MES) ≤ 1, following therapy have been associated with an increased risk of colectomy. Intestinal ultrasound severity, as defined by a Milan ultrasound criteria (MUC) score &amp;gt; 6.2, has been associated with an increased risk of colectomy. The aim of this study is to evaluate and compare MES and MUC in predicting the need for colectomy in patients with UC. Methods This is a double-center prospective observational cohort study. All consecutive adult UC patients between January 2016 and January 2020 requiring colonoscopy received intestinal ultrasound within 20 ± 12 days in a blinded fashion. Colectomies were evaluated during the follow-up. Univariable and multivariable Cox regression analyses were used to identify variables independently associated with colectomy risk. ROC analysis was used to compare baseline MES and MUC scores' performances in predicting colectomy. Results A total of 141 patients were enrolled (Table 1). Overall 13 patients underwent colectomy during 256.41 person-years of observation time. At baseline, patients requiring colectomy had increased mean values of MUC as compared to patients not undergoing surgery (6.84 ± 2.49 vs 10 ± 1.9, p &amp;lt;0.001). At univariate analysis, MES (HR: 3.15, 95% CI:1.18 – 8.37, p = 0.02) and MUC (HR: 1.48, 95% CI:1.19 – 1.76, p &amp;lt;0.001) were associated with colectomy risk. At multivariable analysis, MUC but not MES was associated with colectomy risk (HR: 1.46, 95% CI: 1.06 – 2.02, p 0.02). As compared with MES, MUC score demonstrated a higher AUROC (0.83, 95% CI: 0.75 – 0.92 vs 0.71 95% CI: 0.62 – 0.80) and better performance for assessing the need for colectomy (p = 0.02) (Figure 1). The optimal MUC score cutoff for predicting colectomy, as assessed by the Youden index, was 7.72, with a sensitivity and specificity of 1 and 0.6, respectively. Conclusion Ultrasound severity, as assessed by the MUC score, is superior to endoscopic severity in predicting the need for colectomy in patients with UC. A baseline MUC score of &amp;lt; 7.72 may rule out colectomy risk in UC patients.

S17 Treatment Patterns Among Moderate-to-Severe Ulcerative Colitis Patients in TARGET-IBD

Background: The treatment paradigm for Ulcerative Colitis (UC) is becoming increasingly complex with more treatment options available. There is a growing need to discern patterns of UC treatments in real-world settings. The objectives of this study were to identify a real-world moderate-to-severe UC patient population and estimate the risk of treatment modification (i.e. drug switching, dose escalation, treatment augmentation) among patients initiating advanced or conventional therapies. Methods: TARGET-IBD, a non-interventional cohort of IBD patients enrolled from one of 34 participating academic and community-based gastroenterology US sites, was used to identify the study population. Enrolled patients consented to the collection of up to 3 years of retrospective and 5 years prospective data. Patients were considered moderate to severe if they were ever hospitalized due to UC, received advanced treatments (biologics or Janus kinase inhibitor [JAKi]), an immunomodulator (IMM), or took corticosteroids for >2 months of the year prior to enrollment. To assess treatment modification, patients had to initiate an advanced treatment, or conventional therapy (IMM and 5-aminosalicylic acids) 3 years prior to or after enrollment and have a follow-up duration of at least 1 day. The incidence proportion was defined as the number of patients that experienced a treatment modification in the study period divided by the number of patients at risk. Kaplan Meier curves and cumulative incidence functions were produced for both treatment classes. Fine Gray sub-distribution hazard regression models were used to estimate the unadjusted and multivariable-adjusted hazard rate ratios for treatment modification, with 95% confidence intervals. Results: Out of 1,854 adult UC patients enrolled in TARGET-IBD, 1,332 patients met criteria for moderate to severe UC, of which 1,096 (82%) used an advanced treatment by the date of enrollment. Compared to patients on conventional therapies, patients on advanced treatments were younger (39 vs 50 years old), less likely to be on Medicare (11.6% vs 18.6%), and disproportionately treated at academic sites (70% vs 56%). A total of 660 patients initiated advanced (n=366, 55.5%) or conventional (n=294, 44.5%) therapy during the observation periods and were evaluated for treatment modification. The incidence proportion of treatment modification was lower in patients with advanced treatment compared patients with conventional therapy [47.6% (95% CI = 41.3, 53.8) vs 64.8% (95% CI = 58.3, 71.2), respectively]. Kaplan Meier curve showed that the probability of treatment modification increased with time on treatment for both groups, but was significantly more likely for patients on conventional therapies (median survival = 11.3, 95% CI = 8.80, 13.19) compared to that of patients on advanced treatments (median survival = 13.0, 95% CI = 9.72, 16.90). Both univariate and multivariable models showed that use of an advanced treatment was associated with decreased likelihood of treatment modification (HR = 0.73, 95% CI = 0.56, 0.95). Conclusion(s): In this large, real-world cohort analysis, moderate-to-severe UC patients initiating advanced treatments were significantly less likely to experience treatment modifications than those receiving conventional therapies. This study highlights the importance of therapy selection for patients with moderate-to-severe UC and the need for additional, more efficacious, and durable treatments.

Transanal ileal pouch anal anastomosis for ulcerative colitis in children and adults: a systematic review and meta-analysis.

The incidence of pediatric onset ulcerative colitis (UC) is increasing, with increasing rate of children eventually requiring surgical treatment. Total proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the preferred surgical treatment. Although transanal IPAA (ta-IPAA) is becoming widely accepted for adult UC patients, data regarding this procedure in children are scarce. Nevertheless, some adult publications also include patients under 18years old. This systematic review and meta-analysis aimed to summarize surgical and functional outcomes following ta-IPAA, and extract conclusion regarding pediatric UC patients. PubMed, Cochrane Library databases, Embase, Web of science and Google Scholar databases were searched, using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses [PRISMA] guidelines. The final search was updated in April 2022. Four comparative cohorts (n = 868) and 11 non-comparative case series (n = 241) were included. Six reports included children. Anastomotic leak, complications, operative time, conversion rate, length of stay and functional outcomes were examined. A total of 1103 patients, ranging 9-79years were included in this review. We found no difference in risk for anastomotic leak (OR 1.36, 95% CI 0.46-4.06), minor and major complications (OR 0.92, 95% CI 0.48-1.76 and OR 0.78 95% CI 0.36-1.69, respectively) comparing ta-IPAA to transabdominal IPAA. Short- and long-term follow-up showed satisfying functional outcomes and quality of life. Our review suggests that ta-IPAA is not inferior to transabdominal IPAA. Implementation of this method in children is technically feasible due to familiarity with the dissection plane. Long-term functional outcomes and quality of life are paramount in the pediatric population and should be particularly investigated. Multicenter prospective studies are required to investigate pediatric UC patients undergoing ta-IPAA.

Anti-Inflammatory Diet Prevents Subclinical Colonic Inflammation and Alters Metabolomic Profile of Ulcerative Colitis Patients in Clinical Remission.

A relationship between ulcerative colitis (UC) and diet has been shown in epidemiological and experimental studies. In a 6-month, open-label, randomized, placebo-controlled trial, adult UC patients in clinical remission were randomized to either an “Anti-inflammatory Diet (AID)” or “Canada’s Food Guide (CFG)”. Menu plans in the AID were designed to increase the dietary intake of dietary fiber, probiotics, antioxidants, and omega-3 fatty acids and to decrease the intake of red meat, processed meat, and added sugar. Stool was collected for fecal calprotectin (FCP) and microbial analysis. Metabolomic analysis was performed on urine, serum, and stool samples at the baseline and study endpoint. In this study, 53 patients were randomized. Five (19.2%) patients in the AID and 8 (29.6%) patients in the CFG experienced a clinical relapse. The subclinical response to the intervention (defined as FCP < 150 µg/g at the endpoint) was significantly higher in the AID group (69.2 vs. 37.0%, p = 0.02). The patients in the AID group had an increased intake of zinc, phosphorus, selenium, yogurt, and seafood versus the control group. Adherence to the AID was associated with significant changes in the metabolome, with decreased fecal acetone and xanthine levels along with increased fecal taurine and urinary carnosine and p-hydroxybenzoic acid levels. The AID subjects also had increases in fecal Bifidobacteriaceae, Lachnospiraceae, and Ruminococcaceae. In this study, we found thatdietary modifications involving the increased intake of anti-inflammatory foods combined with a decreased intake of pro-inflammatory foods were associated with metabolic and microbial changes in UC patients in clinical remission and were effective in preventing subclinical inflammation.

Overweight and abdominal fat are associated with normal bone mineral density in patients with ulcerative colitis.

BACKGROUNDLow bone mineral density (BMD) is common in patients with inflammatory bowel disease. However, nutritional risk factors for low BMD in the ulcerative colitis (UC) population are still poorly understood.AIMTo investigate the association of anthropometric indicators and body composition with BMD in patients with UC.METHODSThis is a cross-sectional study on adult UC patients of both genders who were followed on an outpatient basis. A control group consisting of healthy volunteers, family members, and close people was also included. The nutritional indicators evaluated were body mass index (BMI), total body mass (TBM), waist circumference (WC), body fat in kg (BFkg), body fat in percentage (BF%), trunk BF (TBF), and also lean mass. Body composition and BMD assessments were performed by dual-energy X-ray absorptiometry.RESULTSThe sociodemographic characteristics of patients with UC (n = 68) were similar to those of healthy volunteers (n = 66) (P > 0.05). Most patients (97.0%) were in remission of the disease, 58.8% were eutrophic, 33.8% were overweight, 39.0% had high WC, and 67.6% had excess BF%. However, mean BMI, WC, BFkg, and TBF of UC patients were lower when compared to those of the control group (P < 0.05). Reduced BMD was present in 41.2% of patients with UC (38.2% with osteopenia and 2.9% with osteoporosis) and 3.0% in the control group (P < 0.001). UC patients with low BMD had lower BMI, TBM, and BFkg values than those with normal BMD (P < 0.05). Male patients were more likely to have low BMD (prevalence ratio [PR] = 1.86; 95% confidence interval [CI]: 1.07-3.26). Those with excess weight (PR = 0.43; 95%CI: 0.19-0.97) and high WC (PR = 0.44; 95%CI: 0.21-0.94) were less likely to have low BMD.CONCLUSIONPatients with UC in remission have a high prevalence of metabolic bone diseases. Body fat appears to protect against the development of low BMD in these patients.

Anti–Integrin αvβ6 Antibody as a Diagnostic Marker for Pediatric Patients With Ulcerative Colitis

Anti–Integrin αvβ6 Antibody as a Diagnostic Marker for Pediatric Patients With Ulcerative Colitis