Inflammatory Bowel Disease Registry Research Articles

Construct validity of EQ-5D-5L among patients with inflammatory bowel disease—a study based on real-world data from the Swedish Inflammatory Bowel Disease Registry

ObjectivesThe Swedish Inflammatory Bowel Disease Registry (SWIBREG) includes approximately 84% of all patients with inflammatory bowel disease (IBD) treated with immunomodulators, biologics or surgery in Sweden. Data on health-related quality of life (HRQoL) have been collected using EQ-5D-5L in the registry since 2012. Nevertheless, there are few studies assessing the validity of EQ-5D-5L in this patient population. Thus, the aim of this study was to assess the construct validity of EQ-5D-5L amongst patients with IBD (ulcerative colitis and Crohn’s disease).MethodsIndividual-level data on EQ-5D-5L and other disease-specific measures were extracted from SWIBREG. Known-groups validity was assessed by analysing whether the EQ-5D-5L captured expected differences between patient groups with different activity levels of the disease. Convergent validity was assessed by analysing whether the reported problems in the dimensions of EQ-5D-5L, EQ VAS, and the EQ-5D-5L index value correlated, as hypothesized, with the four dimensions in the Short Health Scale, a symptom index question, and the Physician Global Assessment (PGA) score.ResultsIn total, 9769 patients with IBD were included in the study. Patients with active IBD reported more health problems in the EQ-5D-5L descriptive system than patients being in remission. The effect sizes for the differences in reported problems between patients with active and inactive disease were at least small (≥0.1) or medium (≥0.3) in all dimensions except self-care. Differences in the mean EQ-5D-5L index and EQ-VAS score between patients with active and inactive disease were statistically significant (p < 0.001) and larger than pre-defined cut-offs for minimally important differences (>0.08 for the index and >11.0 for EQ-VAS). The analysis of convergent validity showed that EQ-5D-5L results correlated as expected with the disease-specific measures in 16 of the 21 analyses. In total, 22 (79%) of the 28 hypotheses were supported.ConclusionThe findings support the construct validity of EQ-5D-5L amongst patients with IBD and contribute to the scarce literature on the validity of the five-level version of EQ-5D in this patient population. These findings have important implications for the choice of HRQoL measure in routine health care registries like SWIBREG as well as for future clinical or health economic studies considering using EQ-5D-5L as a measure of HRQoL.

P1181 Prevalence and trend of anemia in a large cohort of children with inflammatory bowel disease

Abstract Background Anemia is a common extraintestinal manifestation in inflammatory bowel disease (IBD) with an impact on patients’ quality of life. Our aim was to determine the prevalence of anemia and its characteristics at the diagnosis in children with inflammatory bowel disease (IBD) and to investigate its trend during follow-up. Methods We conducted an observational, multicenter cohort study including data of IBD children with anemia at the diagnosis enrolled in the Italian Society of Pediatric Gastroenterology, Hepatology and Nutrition (SIGENP) IBD registry. Demographic, clinical, laboratory and endoscopic data were collected at the diagnosis and anemia trend was evaluated at 1-year follow-up. Anemia was diagnosed based on the WHO criteria and classified as mild, moderate, and severe accordingly. Results Five hundred eighty-nine [295 CD (50%) and 294 UC/IBDU (50%)] out of 1634 with IBD presented with anemia, resulting in a prevalence of 36%. Anemia rate was higher in CD than in UC (39% vs 33%, p = 0.009). Most patients presented at the diagnosis with moderate anemia (55%). The most common forms of anemia were iron deficiency anemia (IDA) and combined inflammatory and IDA anemia (InflIDA), both present in 42% of children. Only 15% of children had anemia of inflammation. Children with CD had higher rates of mild anemia than UC (38% vs 33%, p&amp;lt;0.0001), while severe anemia was more common in UC (13% vs 6%, p= 0.001) as well as IDA (53% vs 31%, p&amp;lt;0.0001). Younger age and lower albumin levels significantly correlated with the severity of the anemia in CD. In UC, females were more likely to experience severe anemia (69% vs 47%, p=0.02) and an extensive disease was more prevalent in children with moderate and severe anemia then in those with mild anemia (p=0.01 and p=0.03, respectively). At 1 year, 99 children (17%) were still anemic. At multivariable logistic regression analysis, baseline wPCDAI and SES-CD significantly correlated with the persistence of anemia at 1 year in CD. No variables correlated with the persistence of anemia in UC. Conclusion More than one-third of pediatric patients present with anemia at the diagnosis of IBD, most commonly moderate. A severe anemia is most common in UC compared to CD. Iron deficiency anemia (alone or in its form of InflIDA) is the most common cause of anemia in children with IBD. One out of five is still anemic after 1 year from the diagnosis.

P347 A Trend Analysis of Inflammatory Bowel Disease in Non-Endemic Era (1993-2023)

Abstract Background In this study, we aimed to evaluate the demographic and epidemiological trends of Ulcerative Colitis (UC) and Crohn’s Disease (CD) in non-endemic era for inflammatory bowel disease (IBD) during the past three decades. Methods UC and CD patients who had follow-up at least 6 months between June 1993 and February 2023 were evaluated retrospectively. Electronic medical databases, personal queries and IBD registries have all been used to collection data on the clinical and demographic characteristic of all patients. Results A total of 1549 adult patients with UC and CD were admitted to study. UC was diagnosed in 873 (56.4%) patients (Male 538, 61.6%) and CD was diagnosed in 676 (43.6%) patients (Male 404, 59.8%). The median follow-up duration was 8.3 years for UC patients and 6.8 years for CD patients. In patients with UC, proctitis was 154 (17.6%), left sided colitis was 410 (47%) and extensive colitis was 309 (35.4%). In CD patients, ileal involvement was found in 297 (43.9%), colonic in 76 (11.2%), ileo-colonic in 299 (44.2%) and isolated upper GI involvement in 4 (0.6%) cases. 529 (78.3%) patients had non-stenosing non-penetrating behavior, 45 (6.7%) had stenosing behavior, 102 (15.1%) had penetrating behavior, as well as 196 (29%) patients had perianal disease. Mesalazine 658 (75.4%) and thiopurine 397 (45.5%) were the most frequently used conventional treatments for UC, while thiopurine 304 (45%) was most commonly used for CD patients. In the last two-decade, proportion of the biologic usage were 27.9% and 32.1% in UC patients 28.5% and 31.4% in CD patients respectively. Over the three decades, abdominal surgery was 49.2%, 27.8% and 36.3% in CD and colectomy rates was 2.0%, 2.7% and 3.7% in UC patients. While the rate of UC patients has slightly decreased to 98 (61.6%), 401 (58.5%) and 374 (53%) frequency of CD patients has increased to 61 (38.4%), 284 (41.5%) and 331 (47%). Over the course of three decades, there were more UC patients than CD patients, however proportion of UC/CD has been continuously decreased (1.61, 1.41 and 1.13) for three decades respectively. Conclusion Our study showed that the frequency of UC and CD has significantly increased during the previous three decades in non-endemic era for IBD. While the frequency of UC patients has slightly decreased, that of CD patients has steadily increased over the past three decades. Although the use of biologics has significantly increased, proportions of the abdominal surgeries and colectomies has not prominently changed.

P779 Long term efficacy of azathioprine monotherapy in patients with Inflammatory Bowel Disease

Abstract Background ECCO guidelines recommend monotherapy with azathioprine (AZA) as maintenance therapy of patients with inflammatory bowel disease (IBD) mainly in steroid-dependent disease. However, in the era of the new advanced treatments AZA is not considered as a preferable option, mainly because of the referred side effects and its use is limited in combination with biologic agents. Methods This is a retrospective observational study using data from the longitudinal, prospective IBD registry of University Hospital of Heraklion, Greece. Our aim was to study IBD patients who started on monotherapy with AZA, the profile of adverse effects they developed, the treatment persistence in monotherapy, as well as the possible related factors of treatment success [including age, gender, smoking status, body mass index, disease type, disease phenotype for Crohn’s disease (CD), history of IBD related surgery and the presence of extraintestinal manifestations]. Results Of 168 IBD patients treated with AZA, 89 (53%) were under AZA monotherapy [38 (43%) female, 67 (74%) CD, median age (IQR) 47 (32-56) years, mean (±SD) disease duration 17 (±8.4) years, median (IQR) time receiving AZA 72 (7-120) months]. Thirty (34%) patients continue their treatment till now (23 CD, 7 ulcerative colitis-UC), with a median time (IQR) of 108 (81-132) months. Of these, 18 (60%) (15 with CD and 3 with UC) present endoscopic remission and 11 (36%) (8 with CD, 3 with UC) mild endoscopic activity (based on SES-CD Score for CD and Mayo endoscopic score for UC). Of the 59 who discontinued, 33 (37%) experienced adverse events, 5 (5.5%) developed malignancy, 5 (5.5%) did not respond at baseline, 6 (6.5%) had loss of response (at a median of 91 months), 3 (3%) discontinued due to advanced age, 3 (3%) discontinued their medication on their own and 2 because of treatment de-escalation due to deep remission. Using logistic regression analysis, patients who responded to AZA monotherapy were patients without a history of IBD surgery or any extraintestinal manifestation, P=0.001 and 0.004, respectively. In the multivariate analysis, these associations remained statistically significant (P=0.01 and 0.006 respectively). Conclusion About one third of patients with IBD under AZA monotherapy experience long term response and about two thirds of them prolonged disease remission. Patients without either a history of IBD surgery or extraintestinal manifestations seem to respond better to AZA monotherapy.

P1188 Epidemiology and direct healthcare costs of patients with Inflammatory Bowel Disease (IBD) in an Asian cohort in the first year following diagnosis

Abstract Background Inflammatory Bowel Disease (IBD) is a chronic condition requiring multi-disciplinary care with significant investigation and treatment burden. Indeed, the global treatment market has exceeded US$ 20 billion and is expected to exceed 27 billion in 2030. We aim to study the epidemiology and direct healthcare costs of newly diagnosed IBD patients in their first year of diagnosis in Singapore General Hospital (SGH) and identify factors associated with high direct healthcare costs. Methods The study included patients identified from a prospectively maintained IBD registry of SGH. We enrolled patients newly diagnosed with IBD from 2015 to 2022. Patients who received prior treatment or investigation at other institutions were excluded. Data on clinical characteristics and direct costs (investigations, medications, clinic visits, hospitalisations and surgeries) were collected. Results A total of 199 patients were enrolled across 2015 - 2022. 96 patients had Ulcerative Colitis (UC) and 103 had Crohn’s disease (CD) (Table 1). There were 26 (20-28) new cases of IBD diagnosed at SGH yearly. Direct healthcare costs of patients in their first year of diagnosis remained steady with an overall 7.1% change in total expenditure from 2015 through 2022. A drop in expenditure happened in 2020 and 2021 due to COVID outbreak and country lockdown. (Fig 1A) The mean cost per patient-year (PPY) was US$12995 for CD US$104345 for UC. 10 (8-11) patients required admission within the first year of diagnosis, with a mean hospitalisation cost PPY of $269717 (± 73771). Overall, inpatient costs accounted for 39.3 % (IQR 34.8 - 44) of yearly expenditure (Fig 1B). A median of 16.7% (14.6-22.1) of patients were started on biologics within the first year of diagnosis. Patients with CD had significantly greater mean expenditure than those with UC on imaging ($1036 vs $328, p = 0.001) and biologics ($1535 vs $603, p = 0.033). Patients above the 75th percentile of mean cost PPY were defined as having high healthcare cost. This was $12265 and $15957 for UC and CD respectively. Factors associated with high costs were hospitalisation (p &amp;lt; 0.001), biologics (p = 0.001), surgery (p = 0.01) for both UC and CD. UC extent, CD behaviour, history of smoking and age&amp;gt; 40 were not predictive of high costs. Conclusion Patients with CD have greater expenditure compared to patients with UC in the first year following diagnosis. Biologics use, surgery and hospitalisation are significant drivers of costs. The proportion of newly diagnosed patients requiring admission and their corresponding costs have remained consistent during our period of study. These findings encourage early identification of at-risk patients with institution of treatment to minimise hospitalisation and surgical burden.

Growth development of children and adolescents with inflammatory bowel disease in the period 2000–2014 based on data of the Saxon pediatric IBD registry: a population-based study

BackgroundThe incidence of inflammatory bowel disease (IBD) in children is on the increase worldwide. Growth disorders are common in pediatric patients with inflammatory bowel disease. The aim of this paper is to investigate anthropometric indicators, including height and weight in children with inflammatory bowel disease in Saxony, one of the German federal states, and to evaluate growth trends in patients by comparing their height and weight with that of healthy children in Germany.MethodsIn Saxony, all children and adolescents with IBD were registered in the Saxon Pediatric IBD Registry from 2000 to 2014. The data used are therefore based on a total area-wide survey over 15 years. For this study, 421 datasets of children and adolescents aged 0–14 years with Crohn’s disease (CD) (n = 291) or ulcerative colitis (UC) (n = 130) were analyzed.Z-score and percentile calculations were used to compare differences between IBD patients and the general population.ResultsThe children with CD or UC (both sexes) had a significant lower weight at diagnosis (the mean weight z-score had negative values) versus the general population. The weight values lay mostly below P50 (the 50th percentile, median), more precisely, mostly between P10 and P50 of the body weight child growth curve for corresponding sexes (KiGGS 2003–2006).The height values of both sexes at diagnosis lay also mostly below P50 (the 50th percentile, median) of the child body growth curve for corresponding sexes (KiGGS 2003–2006), i.e. the mean height z-score was negative. But only the children with CD had a significant lower height, more precisely, mostly between P25 and P50 versus the general population (KIGGS). For children with UC the difference was not significant.ConclusionIn pediatric patients with IBD the possibility of growth disturbance, mainly in the form of weight retardation, is very probable.

Clusters of Disease Activity and Early Risk Factors of Clinical Course of Pediatric Crohn's Disease.

This study aimed to define clusters of disease activity and prognostic factors of disease course in a well-characterized cohort of children with Crohn's disease (CD). All patients from the SIGENP IBD (Italian Society of Pediatric Gastroenterology Hepatology and Nutrition Inflammatory Bowel Disease) registry with a 5-year follow-up and 6-monthly evaluation were included. Active disease was defined for each semester as follows: clinical activity (weighted Pediatric Crohn's Disease Activity Index ≥12.5 or Mucosal Inflammation Noninvasive Index ≥8) and active disease on endoscopy (Simple Endoscopic Score for Crohn's Disease >3 or fecal calprotectin >250 µg/g) or imaging. Formula-based clusters were generated based on previously published patterns in adults. Data from 332 patients were analyzed. A total of 105 (32%) experienced a quiescent disease course; 49 (15%) and 31 (9%) a moderate-to-severe chronically active and chronic intermittent disease, respectively; 104 (31%) and 43 (13%) had active disease in the first 2 years after diagnosis and remission thereafter and vice versa, respectively. Surgery at diagnosis was significantly associated with a quiescent course (odds ratio [OR], 10.05; 95% confidence interval [CI], 3.05-25.22; P=.0005), while growth impairment at the diagnosis and active disease requiring corticosteroids at 6 months were inversely related to the quiescent group (OR, 0.48; 95% CI, 0.27-0.81; P= .007; and OR, 0.35; 95% CI, 0.16-0.71; P= .005, respectively). Perianal involvement at diagnosis and moderate-severe activity at 6 months correlated with disease progression (OR, 3.85; 95% CI, 1.20-12.85; P=.02). During the first 5 years of follow-up, one-third of children with CD experience a quiescent course. However, another one-third have a moderate-to-severe disease course. Surgery at the diagnosis is related to a quiescent course, while growth impairment and lack of response to induction therapy correlate with more severe disease activity during follow-up.

A quality assessment of inflammatory bowel disease nursing care in Finland: a nationwide cross-sectional descriptive study

Objectives of the article Inflammatory bowel disease (IBD) nursing has been identified as a crucial component in the IBD service delivery. This article aims to provide a comprehensive overview of the state of IBD nursing care in Finland, and to identify areas that would benefit from further research. Materials and methods Tertiary IBD outpatient clinics nationwide were invited to participate in a cross-sectional descriptive study conducted using an electronic survey. The quality of IBD nursing services was assessed using the Nursing Care Quality in IBD (NCQ-IBD) evaluation tool. Results Of the 34 identified clinics, 27 participated (79.4%) in the study. The NCQ-IBD tool classifies the clinics in four categories, where A indicates the highest level of quality, and D the lowest. In this study, 26 clinics (96.3%) were classified at level C, and one clinic (3.7%) at level D. Nursing responsibilities in IBD management and informing the patients were at a high level of quality, whereas nursing research in IBD was at a low level. An IBD database (i.e. clinical IBD registry) was in use only in 10 clinics. Although training in the clinical aspects of IBD was readily available, there was a lack of training plans for IBD, and clinics seldom held an annual review of the IBD nursing activities and outcomes. There were very few clinics using structured indices and questionnaires, and only 16 clinics (59.3%) applied a written IBD protocol. Conclusion In the Finnish IBD nursing service, as measured with the NCQ-IBD tool, several areas for future improvement were identified.

Maternal and Neonatal Outcomes in Vedolizumab- and Ustekinumab-Exposed Pregnancies: Results From the PIANO Registry.

Pregnancy outcomes in patients with inflammatory bowel disease with quiescent disease are similar to those in the general population. Data from the Pregnancy Inflammatory bowel disease And Neonatal Outcomes registry have demonstrated the safety of antitumor necrosis factor (TNF) α agents and thiopurines in pregnancy. The objective of this study was to provide information from the Pregnancy Inflammatory bowel disease And Neonatal Outcomes registry on maternal and fetal outcomes in patients exposed to the newer biologics ustekinumab (UST) and vedolizumab (VDZ). In this multicenter prospective observational study, we included pregnant women with singleton pregnancies and a diagnosis of inflammatory bowel disease. Questionnaires were administered to women at study intake, each subsequent trimester, delivery, and 4, 9, and 12 months after birth. Bivariate analyses were used to determine the independent effects of specific drug classes on outcomes. The exposure cohorts were VDZ, UST, anti-TNF, immunomodulators, and combination with anti-TNF and immunomodulators. All were compared with no exposure and with biologics/immunomodulators. There were 1,669 completed pregnancies with 1,610 live births. The maternal mean age was 32.1 (SD 4.6) years at delivery with 66 VDZ exposed and 47 UST exposed. Women on UST were more likely to have Crohn's disease. There was no increased risk of spontaneous abortion, small for gestational age, low birth weight, neonatal intensive care unit stay, congenital malformations, or intrauterine growth restriction with in utero VDZ or UST exposure. The rate of preterm birth was lower (0.0%) for the UST-exposed cohort when compared with other cohorts including VDZ (13.8%), anti-TNF (8.2%), combination therapy (14.2%), immunomodulators (12.3%), and unexposed (9.7%) ( P = 0.03). Rates of serious infections at birth, 4 months, and within the first 12 months of life were comparable among all cohorts. Nonserious infections were lower at 12 months in UST-exposed pregnancies. There was no increased risk signal for placental complications in the VDZ cohort. UST infant concentrations at birth were increased whereas VDZ concentrations were overall decreased compared with maternal serum drug concentration. This analysis of UST and VDZ exposure during pregnancy suggests no increase in complications compared with TNF, immunomodulators, and combination TNF/immunomodulators. No signal was found for increased placental events with either therapy. Continuation of UST and VDZ throughout pregnancy is recommended.

Extraintestinal Manifestations of Inflammatory Bowel Disease Are Associated With Increased Biologic Cycling.

Extraintestinal manifestations (EIMs) of inflammatory bowel disease (IBD) are a common, frequently debilitating complication of the disease. Biologics are indicated and often required in patients with EIMs to control disease; however, little is known about whether patients with EIMs cycle through more therapies than their counterparts without EIMs. To address this question, we performed a retrospective analysis of patients enrolled in the Study of Prospective Adult Research Cohort with IBD registry seen at our University Medical Center, on data from December 2016 to January 2021. Four hundred fifty-six participants with information on EIMs and biologic use available were included, and demographic and clinical characteristics were analyzed. Three hundred thirty-eight and 118 participants without and with EIMs were identified, respectively. Those with EIMs were likelier to have biologic exposure, and cycle through more biologics, both in univariate and multivariate analyses controlling for age, disease duration, sex, corticosteroid use, and IBD type (P-value = .006). In a subanalysis of patients with Crohn's disease (CD), EIMs were associated with increased biologic cycling in ileocolonic disease (P-value = .050). To our knowledge, this is the first study assessing biologic cycling in patients with EIMs. Our findings that patients with EIMs are likelier to cycle through biologics, particularly CD patients with ileocolonic disease, highlights the need for more research on which biologics may be most effective for specific subsets of IBD patients, including those with concurrent EIMs. The presence of EIMs is a marker of harder-to-treat IBD and may indicate earlier initiation of advanced therapies.

S864 Corticosteroid Use Among Patients With Crohn’s Disease and Ulcerative Colitis on Advanced Therapy From the CorEvitas Inflammatory Bowel Disease Registry

S864 Corticosteroid Use Among Patients With Crohn’s Disease and Ulcerative Colitis on Advanced Therapy From the CorEvitas Inflammatory Bowel Disease Registry

The First Saint Petersburg Regional Inflammatory Bowel Diseases Registry on the Basis of the Regional Health Information System: Principles of Functioning, Testing Results, Plan of Development

Aim: to present the principles of functioning of the regional registry of inflammatory bowel disease (IBD) patients in Saint Petersburg on the basis of the City Health Information System (Saint Petersburg IBD Registry).Key points. The Saint Petersburg IBD Registry consists of General Statistical Module and Clinical Module. The General Statistical Module is intended to analyze the prevalence of ulcerative colitis and Crohn's disease, the number of patient visits to medical institutions; to assess the burden on the healthcare system, demographic characteristics, routing and mortality for the whole region. The Clinical Module allows to assess the IBD features in prospective observation. The register case report form is integrated into the patient's status in the Medical Information System of the medical institution. Saint Petersburg IBD Registry operates on the basis of the Saint Petersburg Medical Center of Information and Analysis within the framework of the Regional Medical Data Collection System of the Russian state information system “Regional Fragment of the Unified State Information System in the Healthcare Branch”. The accumulation of prospective data in the Clinical Module continues, which in the near future will make it possible to test and configure the automated analytical block of the registry.Conclusion. The functioning of the Saint Petersburg IBD Registry allows to achieve following primary goals within region: assessment of the epidemiological features of IBD in Saint Petersburg; dynamic assessment of the disease features; assessment and planning of health care resources required to provide care to IBD patients; improvement of approaches to the treatment taking into account the specifics of the region; assessment of the effectiveness and tolerability of specific treatment including biologics.

Alterations in the Fungal Microbiome in Ulcerative Colitis.

Although gut fungi have been implicated in the immunopathogenesis of inflammatory bowel disease, the fungal microbiome has not been deeply explored across endohistologic activity and treatment exposure in ulcerative colitis. We analyzed data from the SPARC IBD (Study of a Prospective Adult Research Cohort with Inflammatory Bowel Disease) registry. We evaluated the fungal composition of fecal samples from 98 patients with ulcerative colitis across endoscopic activity (n = 43), endohistologic activity (n = 41), and biologic exposure (n = 82). Across all subgroups, we assessed fungal diversity and differential abundance of taxonomic groups. We identified 500 unique fungal amplicon sequence variants across the cohort of 82 patients, dominated by phylum Ascomycota. Compared with endoscopic remission, patients with endoscopic activity had increased Saccharomyces (log2 fold change = 4.54; adjusted P < 5 × 10-5) and increased Candida (log2 fold change = 2.56; adjusted P < .03). After adjusting for age, sex, and biologic exposure among patients with endoscopic activity, Saccharomyces (log2 fold change = 7.76; adjusted P < 1 × 10-15) and Candida (log2 fold change = 7.28; adjusted P< 1 × 10-8) remained enriched during endoscopic activity compared with quiescence. Endoscopic inflammation in ulcerative colitis is associated with an expansion of Saccharomyces and Candida compared with remission. The role of these fungal taxa as potential biomarkers and targets for personalized approaches to therapeutics in ulcerative colitis should be evaluated.

P264 Machine learning can accurately predict development of Inflammatory Bowel Disease

Abstract Background Prediction of inflammatory bowel disease (IBD) development is the subject of intense study. We have previously shown that significant changes occur in routine laboratory tests in the 5 years preceding IBD diagnosis. Using routinely collected laboratory results, we developed machine learning models to predict development of IBD. Methods We extracted data from the electronic medical records of Maccabi Health Services and included patients with IBD ≥ 16 years of age with a minimum of 5 years follow up and an age and sex matched healthy cohort. The outcome measured was entry into the IBD registry. The study population was split into training and validation cohorts and using laboratory values in the 5 years prior to IBD diagnosis as features, we assessed the performance of supervised learning models and performed interpretability analysis with unsupervised dimensionality reduction. Results 5643 patients with IBD and 17199 healthy people were included in this study. 3039 (53.8%) had Crohn’s disease (CD), 2322 (41.1%) ulcerative colitis (UC) and 282 (5%) indeterminate colitis. The mean age of the IBD and healthy cohorts at study inclusion was 39.3 ± 16.5 and 38.5 ± 15.6 years, respectively. Weighted nearest neighbour imputation was used to correct for data missingness. Unsupervised Uniform Manifold Approximation Projection dimensionality reduction correctly separated the cohort into healthy and IBD clusters (Figure 1A). Furthermore, this algorithm identified two distinct groups correlating to CD or UC diagnosis (Figure 1B). Supervised learning models, namely neural net (AUC 0.95), linear support vector machine (SVM) (AUC 0.93), radial basis function SVM (AUC 0.85) and logistic regression (AUC 0.93) models, accurately predicted IBD diagnosis (Figure 2). These models were repeated without C-reactive protein and the predictive value was not significantly changed. Moreover, we excluded data in the 2 years preceding IBD diagnosis to determine whether model performance was reduced and the predictive value remained the same. Interestingly, using only data from 3-5 years preceding IBD diagnosis, the model could better distinguish between CD and UC (Figure 3). Conclusion In this study, machine learning models could accurately predict a diagnosis of IBD using laboratory data from the 5 years preceding IBD diagnosis. Prospective studies are needed to test these models in a real world setting.

P768 The prevalence and risk factors for malignancies in patients with inflammatory bowel disease in Crete : a case control study

Abstract Background There is evidence that about 30% of the patients with inflammatory bowel disease (IBD) develop malignancies whichconstitute the second cause of death, after cardiovascular diseases, such as in general population. Methods The aim of this study was to investigate the prevalence and risk factors for malignancies in IBD patients followed in two tertiary centers. It was a retrospective analysis of prospectively recorded data in an established IBD registry for seven years (06/2015 to 06/2022). IBD patients with malignancies were compared with controls-IBD patients without malignancies [matching 1:3 according to sex, IBD diagnosis (Ulcerative Colitis; UC, Crohn’s Disease; CD) and age (±5 years)] so as to elucidate possible risk factors for cancer (CA) development in these individuals. Results From a total of 2.382 IBD patients of the IBD registry in University Hospital and Venizeleio General Hospital of Heraklion in Crete, 107 (4.5 %) were diagnosed with CAs during their follow-up whereas 22 (0.92 %) had a history of CA before IBD diagnosis. Demographic, clinical and therapeutic data for the total of 428 patients (107 with CA and 321 without CA) are presented in Table 1. Among patients with CA, 49 (45.8%) were females, 54 (50.5%) had CD, the median age of CA diagnosis was 61 years (51.3-69.8) and the median IBD duration was 10 years (3-20). Thirty-two (29.9 %) of the CA-IBD patients had known familial history of CA and 28 (26.1 %) were active smokers whereas 46 (42.9 %) were ex-smokers. Twenty-nine patients (27.1 %) were exposed to immunomodulators, 32 (29.9 %) to anti-TNFs, 20 (18.7 %) to other biologics and 16 (14.9 %) to combination treatment. The majority of CA cases were extra-intestinal, only 12 (11.2 %) had colorectal cancer (CRC) and 11 (10.3 %) had a CA recurrence whereas 19 (17.8 %) died from the CA. In the univariate analysis the median IBD duration (OR 0.96, CI 95%0.94- 0.99), inflammatory phenotype in CD (OR 0.46, CI 95% 0.23-0.93) and treatment with other biologics (other than ant-TNFs) (OR 0.50, CI 95%0.29- 0.86) were protective factors, whereas colonic location in CD (OR 3.24, CI 95% 1,49-7,04) found to be a risk factor for CA development(Table 1). No association with disease characteristics, smoking habits, family history of CA and extra intestinal manifestations was found. In the multivariate analysis only CD inflammatory phenotype (OR 0.28, CI 95%0.09-0.58) was a protective factor whereas colonic location (OR 4.8, CI 95% 1.81-12.79) remained a risk factor for malignancies (Table 2). Conclusion The prevalence of malignancy in IBD patients in Crete is 4.5%. It seems that in CD disease phenotype is associated with the development of malignancies. Non association with the used medications was found.

P231 Impact of age of Inflammatory Bowel Disease diagnosis on disease phenotype and severity in elderly patients

Abstract Background Up to fifteen percent of inflammatory bowel disease (IBD) patients are diagnosed after the age of 60 years (elderly onset-EO). Additionally, due to the ageing of population and the increasing prevalence of IBD the number of elderly patients (&amp;gt;60) with an earlier diagnosis (adult onset-AO) is rapidly increasing. We aimed to compare disease characteristics and management between EO and AO elderly IBD patients. Methods Data of a prospective longitudinal registry of IBD patients followed in a tertiary center over a ten-year period (2012-2022) were analyzed. Consecutive IBD patients aged over 60 years at study entry were included. They were divided into two groups according to their age at diagnosis &amp;lt;60 (AO) and ≥ 60 (ΕΟ) years. The two groups were compared as for their demographic and clinical characteristics, their treatment and outcomes (disease related surgeries, development of malignancy, death). Results Out of 1104 patients recorded in the IBD registry, 325 were currently ≥ 60 years old (29%) and among them 267 had complete data and were included in the study (Table 1). ΕΟ had 100 (37%) and ΑΟ 167 (63%). Median age at diagnosis (IQR) was 47 years (37-53) for AO and 66 years (62-71) for EO (p&amp;lt;0.0001) whereas median disease duration was 23 (15-31) and 9 (5-14) years respectively (P&amp;lt;0.0001). Male gender (AO:61%, EO:68%) and ulcerative colitis (UC) (AO: 60%, EO: 53%) predominated in both groups. Family history of IBD and extraintestinal manifestations were lower in the EO than the AO group (p=0.02 and p=0.01 respectively). UC localization was most commonly proctitis and left sided in both groups. CD was most often ileal in EO patients when compared with AO (p=0.028) and inflammatory phenotype was more prevalent in both groups (ΑΟ:69% and ΕΟ:79% respectively). Immunomodulators were less frequently used in EO (17% vs 40.8%, p=0.0001) which was not the case for biologics (40.1% vs 32%, p=0.18) and prednisolone (21.5% vs 16%, p=0.27). During a median disease duration of 16 (8-25) years, comparable rates of IBD-related surgeries (12.5% ΑΟ vs 9% EO) and total malignancies (18.5% ΑΟ vs 14% ΕΟ) were observed but there were more deaths in the ΕΟ group (20% vs 8.3%; p=0.0063). Conclusion There are some distinct differences in demographic, clinical characteristics, treatment and mortality between EO and AO elderly IBD patients. The comparable rates of biologic use and IBD-related surgeries probably indicate that EO-IBD does not have a mild disease course. The clinical implication of these findings needs further validation.

P647 Outcomes following the use of vedolizumab first line versus second line in Ulcerative Colitis: a single centre experience

Abstract Background With the introduction of an increasing number of biological therapies for Ulcerative Colitis (UC), decisions regarding the sequencing of treatment continues to dominate current management strategies. In this single centre study, we assessed outcomes in patients with UC following first line treatment with the α4β7 integrin blocker vedolizumab (VDZ) therapy vs second line VDZ therapy following anti-Tumour Necrosis Factor (anti-TNF) exposure. Methods All patients exposed to VDZ either first line or second line were identified via our Inflammatory Bowel Disease (IBD) registry. Data was collected retrospectively between June 2015 and June 2021. Baseline demographics, disease extent and activity scores, treatment continuation, and colectomy rates were analysed over a 52-week period. Results A total of 100 patients were included in the study, age (median [IQR]) 52 [37-64] years; 52% male 48% female). VDZ as first line biologic included 38 patients, age (median [IQR]) 51 [34-65] years; 50% male and 50% female). The VDZ as second line (Ant-TNF exposed) group included 62 patients, age (median [IQR]) 52 [38-61] years; 53% male and 47% female). The Anti-TNF exposed group included infliximab 26 (43.3%), adalimumab 22 (35.5%), golimumab 12 (19.2%) and both infliximab and adalimumab 2 (3%). Disease extent (Montreal classification: E1:proctitis, E2: left-sided or E3: extensive disease) in the VDZ first line group (E1 (13.1%), E2 (61.6%) and E3 (26.3%)) versus VDZ second line (E1 (11.3%), E2 (61.3%) and E3 (27.4%)). In the VDZ first line group (38 cases), the outcomes at 52 weeks were: Treatment continuation 24 (63%), colectomy 2 (5%) and treatment switch in 12 (32%) to infliximab (4), Adalimumab (3), Ustekinumab (4) and Tofacitinib (1). In comparison, the Anti-TNF exposed group (62 cases) outcomes at 52 weeks were: Treatment continuation 46 (74%), colectomy 5 (8%) and treatment switch in 11 (18%) to Adalimumab (2), Ustekinumab (4) and Tofacitinib (5). A total of 7 of patients underwent colectomy during the 52 week follow up period. By 52 weeks, 94.8% (36/38) were colectomy free in the VDZ first line group versus 92% (57/62) in the anti-TNF exposed group, which was not statistically significant (odds ratio (OR) of having a colectomy in the VDZ1st line group vs the VDZ 2nd line group was 0.61(p=0.58)). Conclusion Our study evaluated real-world treatment continuation and colectomy-free outcomes for VDZ as first and second line biologic therapy (Anti-TNF exposed) in patients with ulcerative colitis and confirmed its effectiveness in both treatment groups.

P480 Ustekinumab Dose Intensification Is Effective in One-Third of Asian Inflammatory Bowel Disease Patients, Results From A Tertiary Inflammatory Bowel Disease Centre

Abstract Background Ustekinumab (UST) is an effective biologic for treatment of Inflammatory Bowel Disease (IBD). However, some patients treated with UST have suboptimal clinical response with standard induction and maintenance doses. In some patients, strategies such as dose intensification (DI) and reinduction have been used to improve response. The aims of this study are to identify factors associated with DI for our IBD cohort and also effectiveness of reinduction during DI. Methods This was a retrospective cohort study on patients with Crohn’s disease (CD) and ulcerative colitis (UC) who received UST from September 2017 to October 2022 in a tertiary center. Patients were identified from a prospectively maintained IBD registry. Patient’s demographics, biochemical profile, disease phenotype, UST intervals and previous use of biologics were retrieved. Statistical analysis was performed to identify factors which are predictive of UST DI and effectiveness of UST DI. Results A total of 63 patients with IBD on UST were identified, with most being bio-experienced (76.2%). Forty two patients (34 CD, 8 UC) underwent UST DI to either 6-weekly (n=19, 45.2%) or 4-weekly (n=23, 35.9%). The median duration of UST treatment is 108.0 weeks (IQR 44.7-185.9) while the median time to intensification was 31.1 weeks (IQR 17.8-65.7). Presence of perianal disease in CD (HR 4.9; 1.47 – 16.4) was associated with DI. However, prior usage of biologics (HR 1.61; 0.80 - 3.24) and usage of steroids during induction (HR 1.85; 0.69 – 4.91) were not significant factors for DI. After DI, there were 14 (33.3%) patients who achieved treatment end points (corticosteroid-free clinical remission, biochemical remission, endoscopic healing (for UC) or transmural healing (for CD) by week 52. In patients who had UST DI, UST re-induction was given to 13 (10 CD, 3 UC) and 4 achieved treatment endpoints but this was not statistically significant (p=0.99). There were 26 patients who failed to achieved end point at week 52 of which 8 patients were continued on UST at dose intensified regime while 11 patients were switched to other biologics. Conclusion Two third of IBD patients undergo DI while on UST treatment and the median time to DI is about 6 months after induction. CD patients with perianal disease is more likely to undergo DI. One third of dose intensified patients achieved remission at week 52 while reinduction of UST during DI did not improve outcome for patients.

SEX-BASED DIFFERENCES IN DRUG DURABILITY AMONG PATIENTS WITH INFLAMMATORY BOWEL DISEASES

Abstract BACKGROUND With an increasing number of therapeutic options to treat IBD, identification of patient-specific factors predictive of drug efficacy is crucial. Sex has been postulated to play a role in response to therapy with possible proposed mechanisms including sex-based hormones and microbiome and epigenetic differences. However, prior clinical data on drug durability stratified by sex are mixed and limited. METHODS Using the SPARC IBD (Study of a Prospective Adult Research Cohort with Inflammatory Bowel Disease) registry, we analyzed time to drug discontinuation for female versus male patients started on a new IBD medication (including biologic and small molecule therapy) after enrollment between 2016 and August 2022. Drug persistence was examined using Kaplan-Meier plots. A Cox regression model was used to adjust for baseline differences in Crohn’s disease phenotype, rates of perianal disease, and concurrent immunomodulator use. A marginal means/rates model was used to adjust for within-patient correlation given that 252 patients had multiple medication starts. RESULTS A total of 1185 patients were identified with 1492 unique new medication starts (n=830 female, 662 male). In this sample, male patients had more complex Crohn’s disease phenotype and higher rates of perianal disease and concurrent immunomodulator use. No significant difference was seen in 12 month drug therapy survival rates based on sex (67.5% females, 65.7% males). Median drug continuation time was 33.5 months in females (95% CI 25.8, 37.4) and 24.5 months in males (95% CI 20.3, 32.8). No difference was seen in anti-TNF and small molecule subgroup analyses. Cox model adjusted for baseline differences in disease severity showed no significant different in probability of drug discontinuation per unit time in females compared to males [HR (95% CI) = 0.95 (0.75-1.21)]. CONCLUSION Both males and females have similar rates of IBD drug durability over time. The reasons for drug discontinuation should be explored in further studies as this may aid physicians in clinical decision-making.

Implementing electronic patient reported outcomes in inflammatory bowel disease: patient participation, score reliability and validity

BackgroundPatient-reported outcome measures (PROMs) are recommended for assessing patient-centered outcomes in inflammatory bowel disease (IBD). The main aims were to assess the level of participation in an electronic PROM (ePROM) data collection system among patients with IBD, and evaluate reliability and validity of the resulting scores.MethodsPatients included in the IBD registry of Maccabi Healthcare Services, a state-mandated healthcare provider for over 2.6 million people in Israel, were invited to complete the IBD-Control measure and a general health item, with follow-up ePROMs at 3 and 6 months including a global rating of change item. Descriptive statistics were used to compare patient characteristics by participation rate, and assess survey completion time. Initial scores were assessed for internal consistency reliability using Cronbach's alpha. Test–retest reliability was assessed using the intraclass correlation coefficient from paired scores of patients identified as unchanged between the initial and first follow-up. Construct validity was assessed by the ability of IBD-control scores to discriminate between patient sub-groups in expected ways. Empirical validity was assessed using ePROM score correlations with laboratory markers of disease activity. Score coverage was also assessed.ResultsA total of 13,588 patients were invited to participate [Mean age = 49 years (SD = 17); females = 51%]. Participation rate was 31.5%. Participants compared to non-participants were slightly older, were more likely to be female, to have a history of biologic treatment, to have higher socio-economic status, and to be more experienced in the usage of the digital patient portal. Median survey completion time was approximately 1:30 min. Internal consistency and test–retest reliability were 0.86 and 0.98, respectively. Scores discriminated between patient sub-groups in clinically expected ways, with expected correlations to laboratory markers of disease activity. A notable ceiling effect was observed (> 15%) for IBD-Control scores.ConclusionsFeasibility, reliability, and validity of the ePROM system was supported for measuring the level of perceived disease control in patients diagnosed with IBD in Israel. Additional research is needed to identify ways to increase patient participation, assess clinical implications of the identified measurement ceiling of the IBD-control, and evaluate the added value of the derived scores in support of clinical decision making.