Inflammatory Bowel Disease Medications Research Articles

Conception, pregnancy and inflammatory bowel disease-Current concepts for the practising clinician.

The peak incidence of inflammatory bowel disease (IBD) coincides with a woman's prime reproductive years. The management of IBD during pregnancy can be challenging for healthcare professionals, underpinning the need for a multi-disciplinary approach with shared decision-making with the patient. Pre-conception counselling can address patient concerns, improve pregnancy specific IBD patient knowledge and provide a personalized risk assessment, to ensure optimal maternal and fetal outcomes. Most women with IBD have fertility rates comparable with the general population, although voluntary childlessness is common among women with IBD. IBD disease activity at conception and during pregnancy is a key determinant of the course of IBD during pregnancy. Active IBD during pregnancy is associated with adverse pregnancy-related outcomes, including spontaneous abortion, small for gestational age baby and preterm birth, emphasizing the importance of ensuring disease remission prior to conception. Most IBD medications (5-aminosalicylates, thiopurines if already initiated pre-conception, corticosteroids and biologic medications) are considered safe and low risk during pregnancy and breastfeeding, except for methotrexate, JAK-inhibitors, ozanimod and allopurinol and maintaining remission throughout gestation should be the priority. Most women with IBD can have a vaginal delivery, but cesarean section should be considered in active perianal disease and history of ileal pouch surgery. This narrative review outlines the current evidence for themanagement of IBD in pregnancy, as well as considering the pre-conceptual and post-partum period.

Insurer Medication Utilization Barriers are Associated with Decreased Insurance Satisfaction and Adverse Clinical Outcomes: An IBD Partners Survey

Background: Insurer-mandated barriers to timely initiation of advanced therapies used to treat inflammatory bowel disease (IBD) have been shown to worsen clinical outcomes and increase healthcare utilization, yet rarely alter the medication ultimately prescribed. Methods: We conducted a survey within the IBD Partners longitudinal cohort to evaluate the frequency and patient-reported impacts of medication utilization barriers on insurance satisfaction and clinical outcomes. Barriers included medication denials, prior authorizations, and forced medication switches. Variables associated with insurance satisfaction, measured on a 1-7 Likert scale, were identified. The association between insurance-related barriers and downstream clinical outcomes (surgery, corticosteroid requirement, and disease activity) were evaluated. Results: 2,017 patients (Age 45 [IQR 34-58], 73% female) were included. Seventy-two percent experienced an insurer-mandated barrier, most commonly prior authorizations (51%). Fifteen percent were denied an IBD medication by their insurer, 22% experienced an insurance-related gap in therapy, and 8% were forced by their insurer to switch from an effective medication. Insurance satisfaction was negatively associated with medication denials, prior authorization-related delays, gaps in therapy, and high-deductible health plan coverage. In the year following the initial survey, several insurance barriers were linked to negative downstream clinical outcomes, including prior authorizations associated with corticosteroid rescue (OR 2.24, 95%CI 1.25-4.00), forced medication switches associated with continued disease activity (OR 3.28, 95%CI 1.56-6.89), and medication denials associated with IBD-related surgery (OR 8.92, 95%CI 1.97-40.39). Conclusions: These data illustrate the frequency and negative impacts of insurer-mandated medication barriers on patients with IBD, including decreased insurance satisfaction and negative downstream clinical outcomes.

Vaccine adherence and adverse events of the SARS-COV vaccine in patients with inflammatory bowel disease

ObjectiveTo assess adherence to and the adverse effects of the SARS-COV vaccine in patients with inflammatory bowel disease (IBD). Patients and methodsThis is an observational, analytical, cross-sectional study. Sociodemographic and clinical data, SARS-COV vaccine data, medications for IBD with use during the vaccination period, and adverse events during the vaccination period were collected. Carried out logistic regressions with robust variance estimation to estimate the odds ratio with the respective 95% confidence intervals (95%CI) to assess the factors associated with non-serious adverse effects following vaccine doses as outcome variables. Results194 patients participated, with vaccine compliance of 78.3% for three doses of any vaccine (n=152). Local symptoms and mild systemic symptoms predominated, regardless of the type of vaccine. The first dose of the SARS-COV vaccine with AstraZeneca had a higher percentage of patients with vaccine symptoms. AstraZeneca vaccine increased the chance of non-serious adverse effects in IBD patients by 2.65 times (95% CI: 1.38–5.08; p=0.003), regardless of age, gender, physical activity, excess weight, use of disease-modifying drugs, immunobiological and corticosteroids. CoronaVac vaccine was associated with asymptomatic patients at the first dose and reduced the chance of adverse effects by 0.28 times (OR: 0.284; 95%CI: 0.13–0.62; p=0.002). ConclusionLocal symptoms and mild systemic symptoms predominated, regardless of the type of vaccine. Using CoronaVac in the first dose reduced the chances of adverse effects, while AstraZeneca increased the risk of adverse effects.

Inflammatory Bowel Disease and Associated Placental Histopathology [ID 2683599

INTRODUCTION: Inflammatory bowel disease (IBD) has been associated with adverse obstetric outcomes, but its effect on placental histopathology is not well studied. We sought to determine the placental histopathology findings associated with maternal IBD. METHODS: This is an IRB-approved retrospective cohort study of patients with IBD who delivered singleton live births at a single institution from October 2019 to April 2023 and had placental pathology available. Participants were identified using an ultrasound query for “Crohn’s” or “ulcerative colitis” (UC). Cases with fetal aneuploidy or major anomalies were excluded. Controls were matched 2:1 for maternal age, gestational age at delivery, and medical comorbidities. Demographics, pregnancy outcomes, and pathology findings were obtained from the electronic medical record. Mann–Whitney and Fisher's exact tests were used with significance set at P<.05. RESULTS: Placental pathology was compared between 18 IBD participants (11 Crohn's, seven UC) and 36 controls. Of 18 IBD participants, three were treated with sulfasalazine, seven with TNF-α inhibitors, and eight used no medication. Baseline demographics and cesarean delivery rates were similar between groups. Five participants per group had histologic evidence of acute chorioamnionitis and/or funisitis (27.8% versus 13.9%; P=.27). Three IBD participants demonstrated maternal vascular malperfusion (MVM) versus 15 controls (16.7% versus 41.7%; P=.07). There were no differences in placental weight, meconium, or fetal vascular malperfusion. CONCLUSION: Inflammatory bowel disease was not associated with adverse placental histopathology. Decreased incidence of MVM may result from IBD medications reducing systemic inflammation. Larger studies are warranted to further evaluate the effect of IBD on placental pathology.

Lactococcus lactis D4 Has Potential Effect to Alleviate Inflammation and Reverse Dysbiosis in Colitis Rat Model

BACKGROUND: Inflammatory bowel disease (IBD) is a prevalent chronic inflammatory disorder of the gastrointestinal tract that may lead to colorectal cancer if untreated. Several medications for IBD have adverse side effects. Thus, there are high interest for searching alternative treatment to treat IBD. Lactococcus lactis D4 isolated from dadih, a traditional fermented buffalo milk product, was investigated for the effect on gut inflammation and microbial composition in the colitis rat model.METHODS: Eighteen male Sprague-Dawley rats were divided into three groups; control rats, colitis-induced rats, and colitis-induced rats treated with L. lactis D4 isolate. The control group received water, while the colitis-induced rats were given azoxymethane (AOM) and dextran sodium sulphate (DSS). Rats’ feces were collected for the analysis of gut microbiota diversity by next-generation sequencing and for the measurement of transforming growth factor (TGF)-β, nuclear factor kappa-B (NF-κB), interleukin (IL)-6, and tumor necrosis factor (TNF)-α colonic expression using reverse transcription-quantitative polymerase chain reaction (RT-qPCR).RESULTS: L. lactis D4 administration was able to reduce inflammation in colitis by decreasing IL-6 expression (0.87 vs. 0.73), while expression of TGF-β, NF-κB, and TNF-α were increased compared to the model group, suggesting a complex immunomodulatory effect. Gut microbiota sequencing revealed a similarity between the control and treatment groups, suggesting L. lactis D4 has great potential to ameliorate gut microbiota dysbiosis in colitis rats.CONCLUSION: L. lactis D4 has a beneficial effect in decreasing pro-inflammatory cytokines and is able to reserve dysbiosis in colitis rat model. Thus, L. lactis D4 might be used as a therapeutic agent for IBD.KEYWORDS: colitis, gut microbiota, inflammation, inflammatory bowel disease, Lactococcus lactis D4, probiotic, proinflammatory cytokines

Medication adherence to inflammatory bowel disease medications in Aotearoa New Zealand and correlation with health outcomes: A nationwide database analysis.

Inflammatory bowel disease (IBD) management entails long-term medication therapy. Worse disease outcomes and reduced quality of life might arise from poor medication adherence (MA). This study is the first to investigate patients with IBD's adherence across Aotearoa New Zealand and its relationship with disease outcomes. Dispensing claims data (Pharmaceutical Collection) were used to calculate (3- and 5-year) adherence, using daily polypharmacy possession ratio. Using hospitalization data (National Minimum Dataset), the relationship between adherence and the numbers of hospitalizations and corticosteroid dispensings was investigated. In total, 4654 patients (53% female; 55% Crohn's disease [CD], 45% ulcerative colitis [UC]; median age-at-first-dispensing, 43 years) and 3148 patients (54% female; 55% CD, 44% UC; median age-at-first-dispensing, 44 years) were in the 3- and 5-year cohorts, respectively. The 3- and 5-year cohorts had mean 4.6 and 4.2 IBD-related hospitalizations and 6.9 and 9.2 corticosteroid dispensings, respectively. Average adherence estimates were 77.4% (95% confidence interval: 76.9-78.0%) and 74.9% (95% confidence interval: 74.1-75.6%; 3 and 5 years), while 54% and 51% of patients, respectively, had good adherence (MA ≥ 80%). There was no correlation between adherence and the numbers of hospitalizations (Pearson's R = -.0007; P = .65 and R = -.04; P = .02 [3 and 5years]) and corticosteroid dispensings (R = .08; P = <.0001 and R = .08; P = <.0001, respectively). MA of Aotearoa New Zealand patients with IBD is moderately high but just over half of patients meet the adherent threshold. There was no correlation between adherence and hospitalizations or corticosteroid dispensings; hence, research into longitudinal adherence patterns and associated factors is needed.

Clinical Phenotype and Disease Course of Inflammatory Bowel Disease in Iran: Results of the Iranian Registry of Crohn's and Colitis (IRCC).

Data on the epidemiology of inflammatory bowel disease (IBD) in the Middle East are scarce. We aimed to describe the clinical phenotype, disease course, and medication usage of IBD cases from Iran in the Middle East. We conducted a cross-sectional study of registered IBD patients in the Iranian Registry of Crohn's and Colitis (IRCC) from 2017 until 2022. We collected information on demographic characteristics, past medical history, family history, disease extent and location, extra-intestinal manifestations, IBD medications, and activity using the IBD-control-8 questionnaire and the Manitoba IBD index, admissions history, history of colon cancer, and IBD-related surgeries. In total, 9746 patients with ulcerative colitis (UC) (n=7793), and Crohn's disease (CD) (n=1953) were reported. The UC to CD ratio was 3.99. The median age at diagnosis was 29.2 (IQR: 22.6,37.6) and 27.6 (IQR: 20.6,37.6) for patients with UC and CD, respectively. The male-to-female ratio was 1.28 in CD patients. A positive family history was observed in 17.9% of UC patients. The majority of UC patients had pancolitis (47%). Ileocolonic involvement was the most common type of involvement in CD patients (43.7%), and the prevalence of stricturing behavior was 4.6%. A prevalence of 0.3% was observed for colorectal cancer among patients with UC. Moreover,15.2% of UC patients and 38.4% of CD patients had been treated with anti-tumor necrosis factor (anti-TNF). In this national registry-based study, there are significant differences in some clinical phenotypes such as the prevalence of extra-intestinal manifestations and treatment strategies such as biological use in different geographical locations.

Prescribing in pregnant women with inflammatory bowel disease and its relationship to congenital malformations in Japan.

Inflammatory bowel disease (IBD) frequently affects younger patients and poses various challenges concerning pregnancy and childbirth. Maintaining good disease control throughout pregnancy is crucial, but expectant and pregnant patients may worry about the fetal impact of medications, leading to treatment discontinuation due to uncertainty about this issue. This study investigated the real-world drug-prescribing practices for pregnant patients with IBD in Japan and their potential connection to major congenital malformations (MCMs). Overall, 277 female IBD patients who gave birth between 2010 and 2019 were selected from the JMDC claims database. The prescribing patterns of IBD medications and MCMs in the patients' offspring were analyzed. Among pregnant IBD patients, 74.4% received at least one medication from 90days before pregnancy to 90days after delivery. Trends in medication prescriptions during pregnancy in 2010-2019 revealed consistent use of oral 5-ASA, variable use of topical medications, a decrease in systemic steroids, and an increase in biologics. The prevalence of MCMs in children born to IBD-affected mothers did not differ significantly between those who did and did not receive IBD medications (8.6% vs 6.8%). Although circulatory system MCMs were slightly more common in the IBD medication group (4.9% vs 1.4%), this difference was not significant. Logistic regression analysis did not reveal an association between MCM risk and first-trimester use of IBD medications, including corticosteroids and biologics. This study provides insights into medication patterns in pregnant IBD patients and suggests no increased risk of MCMs associated with first-trimester IBD medication use.

Oral vancomycin is associated with improved inflammatory bowel disease clinical outcomes in primary sclerosing cholangitis-associated inflammatory bowel disease (PSC-IBD): A matched analysis from the Paediatric PSC Consortium.

Data on oral vancomycin for primary sclerosing cholangitis (PSC)-associated inflammatory bowel disease (IBD) are limited. Using data from the Paediatric PSC Consortium, to examine the effect of vancomycin on IBD activity. In this retrospective multi-centre cohort study, we matched vancomycin-treated and untreated patients (1:3) based on IBD duration at the time of primary outcome assessment. The primary outcome was Physician Global Assessment (PGA) of IBD clinical activity after 1 year (±6 months) of vancomycin. We used generalised estimating equations (GEE) to examine the association between vancomycin and PGA remission, adjusting for IBD type, severity and medication exposures. Secondary outcomes included serum labs and endoscopic remission (global rating of no activity) among those with available data and also analysed with GEE. 113 PSC-IBD patients received vancomycin (median age 12.7 years, 63% male). The matched cohort included 70 vancomycin-treated and 210 untreated patients. Vancomycin was associated with greater odds of IBD clinical remission (odds ratio [OR] 3.52, 95% CI 1.97-6.31; adjusted OR [aOR] 5.24, 95% CI 2.68-10.22). Benefit was maintained in sensitivity analyses restricted to non-transplanted patients and those with baseline moderate-severe PGA. Vancomycin was associated with increased odds of endoscopic remission (aOR 2.76, 95% CI 1.002-7.62; N = 101 with data), and with lower CRP (p = 0.03) and higher haemoglobin and albumin (both p < 0.01). Vancomycin was associated with greater odds of IBD clinical and endoscopic remission. Additional, preferably randomised, controlled studies are needed to characterise efficacy using objective markers of mucosal inflammation, and to examine safety and define optimal dosing.

Inflammatory Bowel Disease and Breastfeeding: A Narrative Review.

Inflammatory bowel disease (IBD) frequently affects women of childbearing age who may consider breastfeeding. Although breastfeeding has numerous benefits, there remain concerns regarding the safety of breastfeeding among women with IBD. Breastfeeding is important in developing the immune system of infants and has been shown to protect against the development of IBD. The risk of developing an increase in disease activity postpartum is the same regardless of breastfeeding status. Most IBD medications are also considered safe in breastfeeding and have no major risks to infants. Despite this, breastfeeding rates remain low among women with IBD, mostly due to concerns about the safety of IBD therapy with breastfeeding. Many women self-discontinue their IBD medications to breastfeed, and there is often uncertainty among health professionals to make recommendations about therapy. Dedicated IBD clinics can greatly support mothers during pregnancy and breastfeeding periods to enhance their knowledge, optimize their medication adherence, and improve their postpartum outcomes. This review aims to provide the most recent evidence-based literature regarding the safety of breastfeeding in women with IBD and the current recommendations about medical therapies with breastfeeding.

Parental perspectives on pediatric inflammatory bowel disease: Unraveling concerns, and study participation willingness.

The impact of disease burden extends beyond pediatric inflammatory bowel disease (IBD) patients to include their parents. Previous studies, predating the biologic era, have highlighted parental concerns about potential side effects associated with IBD medications. However, there is a notable gap in the literature regarding parents' perceptions of clinical studies involving pediatric IBD patients. This study aims to explore the specific concerns troubling parents of children with IBD, identifying factors influencing these concerns, and assesses parental willingness to allow their child's participation in clinical studies. Utilizing social media, we disseminated an anonymous questionnaire to parents of pediatric IBD patients. The questionnaire encompassed queries about parental willingness for their child to partake in clinical studies, aspects of the disease deemed bothersome, and the sense of coherence scale (SOC). Responses were obtained from 101 parents, with a mean age of 46.4, of whom 82.2% were female. Concerns about potential future side effects of their child's medications surpassed worries about disease symptoms (80.04% vs. 73.47%). Linear regression analysis revealed that parents with lower SOC scores, limited medical care accessibility, and a higher age of the child at diagnosis, exhibited heightened concerns about the future impact of the disease on their child (p = 0.016, 0.003, and 0.045, respectively). While a majority rejected participation in studies involving new medications (54.5%), there was greater agreement for studies on nutritional therapies (84.2%) and complementary medicine (91.1%). Classification tree analysis indicated that women were more inclined to permit their child's participation in studies focusing on complementary medicine (adjusted p = 0.002). Parents of IBD patients express greater apprehension about potential side effects from IBD medications and display reluctance toward their child participating in clinical studies related to medications.

Navigating the Gut-Cardiac Axis: Understanding Cardiovascular Complications in Inflammatory Bowel Disease.

Inflammatory bowel disease (IBD) presents a complex interplay of chronic inflammation in the gastrointestinal tract and is associated with various extraintestinal manifestations, including cardiovascular complications (CVCs). IBD patients face an elevated risk of CVCs, including coronary artery disease, heart failure, arrhythmias, stroke, peripheral artery disease, venous thromboembolism, and mesenteric ischemia, necessitating comprehensive cardiovascular risk assessment and management. The intricate interplay between chronic inflammation, genetic predisposition, environmental factors, and immune dysregulation likely contributes to the development of CVCs in IBD patients. While the exact mechanisms linking IBD and CVCs remain speculative, potential pathways may involve shared inflammatory pathways, endothelial dysfunction, dysbiosis of the gut microbiome, and traditional cardiovascular risk factors exacerbated by the chronic inflammatory state. Moreover, IBD medications, particularly corticosteroids, may impact cardiovascular health by inducing hypertension, insulin resistance, and dyslipidemia, further amplifying the overall CVC risk. Lifestyle factors such as smoking, obesity, and dietary habits may also exacerbate cardiovascular risks in individuals with IBD. Lifestyle modifications, including smoking cessation, adoption of a heart-healthy diet, regular exercise, and optimization of traditional cardiovascular risk factors, play a fundamental role in mitigating CVC risk. Emerging preventive strategies targeting inflammation modulation and gut microbiome interventions hold promise for future interventions, although further research is warranted to elucidate their efficacy and safety profiles in the context of IBD. Continued interdisciplinary collaboration, advanced research methodologies, and innovative interventions are essential to address the growing burden of CVCs in individuals living with IBD and to improve their long-term cardiovascular outcomes.

Switching from Intravenous to Subcutaneous Biological Therapy for Inflammatory Bowel Disease Patients Remains a Challenge.

Biological inflammatory bowel disease (IBD) medications, once limited to intravenous (IV) administration, can now be administered both via IV and subcutaneously (SC). This study investigates patient preferences, willingness to switch from IV to SC, and associated factors. A questionnaire covering demographics, disease-related inquiries, quality of life, and IBD medication preferences was distributed via email, the Israeli Crohn's Disease and Ulcerative Colitis Foundation, infusion centers, and clinics. From 454 IBD patients (median age: 42 years; 55.7% female), responses revealed a preference for SC every 8 weeks, which is comparable to daily oral dosing. Both options were significantly favored over IV every 8 weeks and SC every 2 weeks, with no statistically significant differences between the latter two. However, among patients who were experienced with both SC and IV administration, a clear preference for SC administration every 2 weeks over IV every 8 weeks surfaced. Among IV-treated patients, 54.5% resisted switching to SC. Key reasons for this included medical staff presence (57.7%), a fear of needles (46.4%), belief in infusion efficacy (37.1%), and longer intervals between infusions (36.1%). Findings suggest that transitioning from IV to SC treatment is challenging due to patient resistance, which is influenced by specific factors. Identifying and addressing these obstacles is crucial for optimizing IBD management.

A270 RISK FACTORS FOR COLORECTAL NEOPLASIA DEVELOPMENT IN INFLAMMATORY BOWEL DISEASE PATIENTS WITH PRIMARY SCLEROSING CHOLANGITIS: A CASE-CONTROL STUDY

Abstract Background Patients with inflammatory bowel disease (IBD) and concomitant primary sclerosing cholangitis (PSC-IBD) have a 25-year cumulative risk of up to 50% to develop colorectal neoplasia (CRN). Mucosal inflammation is an important driver of CRN development in IBD, but it is unknown whether this also applies to PSC-IBD patients. Aims We aimed to assess the impact of active mucosal inflammation per colonic segment and endoscopic remission on CRN risk. Methods This is a single-center case-control study, including cases with PSC-IBD with CRN, and controls with PSC-IBD without CRN. Exclusion criteria were a CRN diagnosis prior to IBD or PSC diagnosis, familial CRC syndromes, and insufficient endoscopic follow-up (ampersand:003C2 available colonoscopy reports, and for cases, ampersand:003C2 available endoscopy reports before CRN diagnosis). Data was collected on demographics, IBD and PSC disease characteristics, and IBD medication use. Data from all available colonoscopy and sigmoidoscopy reports between 2002 and 2023, including endoscopic and histologic disease severity, disease extent, and CRN lesions, was collected. The primary outcome was a diagnosis of CRN, secondary outcomes included CRN grade and location, inflammatory burden per colonic segment harboring CRN, and colonic surgery. Results We included 247 PSC-IBD patients (163 ulcerative colitis, 80 Crohn’s disease) with a median follow-up of 6.3 years (IQR: 4.1-12.6) and 6 endoscopic procedures (IQR: 4.0-8.0). Median disease duration was 19 years for IBD (IQR: 11.0-26.0) and 13 years for PSC (IQR: 7.0-18.0). In 50 cases a total of 113 CRN lesions were observed, of which 11 (10%) were advanced CRN (aCRN; HGD or CRC). 23 patients (45%) were diagnosed with ampersand:003E 1 lesion while 45 lesions (40%) were identified in the right-sided colon, 27 (24%) in the transverse colon, 28 (25%) in the left-sided colon, and 10 (9%) in the rectum (3 lesions unknown). Endoscopic remission was observed in 24 cases (48%) during the 2 endoscopies prior to lesion detection vs. in 83 controls (42%) for their last 2 endoscopies. Of all CRN lesions, 39 (35%) were found in a colonic segment with confirmed previous endoscopic and/or histologic inflammation during the 1-2 endoscopies prior to lesion detection (31 low-grade and 8 aCRN). Of the 32 patients who underwent (sub)total colectomy or proctocolectomy, 20 (63%) had an indication due to CRN diagnosis. Mortality was 13% (n=32) during follow-up. Conclusions The risk for CRN and associated colectomy is high in PSC-IBD. Active mucosal inflammation preceded CRN in the affected colonic segment in only 35% of the lesions. Future expansion and additional analysis of our cohort will focus on the impact of persistent endoscopic remission and impact of biologic therapy on CRN risk in PSC-IBD. Funding Agencies None

Prevalence and Appropriateness of Polypharmacy in Older Adults with Inflammatory Bowel Diseases.

Despite the growing prevalence of older adults with inflammatory bowel diseases (IBD), polypharmacy, an important geriatric construct, is poorly understood. We described polypharmacy and its implications in older adults with IBD. In a cross sectional study of adults ≥ 60years with IBD, we obtained medication lists from the medical record and patients. We assessed medications by the Beer's criteria, anti-cholinergic burden and drug-drug interactions. We constructed multi-variate logistic regression models to assess association between polypharmacy with low quality-of-life, controlling for age, sex, IBD-type, number of comorbidities and depression. In 100 adults ≥ 60years with IBD, with a median age of 68years, 56% met criteria for remission by a validated disease activity index. Polypharmacy, defined as ≥ 5 concomitant medications, was noted in 86% of the cohort and 45% had severe polypharmacy, defined as ≥ 10 concomitant medications. In this cohort, 48% were on ≥ 1 medication that met Beer's criteria for potentially inappropriate in older adults and 24% had a cumulative anti-cholinergic drug burden score of ≥ 3, the threshold for serious adverse events attributed to anti-cholinergic burden. Serious drug-drug interactions were found in 26% with 7% involving an IBD medication. Controlling for potential confounders, polypharmacy, defined both numerically (OR 22.79, p < 0.01) and by medication appropriateness (OR 1.95, p < 0.01), was significantly associated with low quality of life. Polypharmacy is prevalent in older adults with IBD and independently associated with low quality of life. Describing polypharmacy can guide de-prescription strategies tailored to GI clinic for older adults with IBD.

P395 The frequency of SARS-CoV-2 infection and the impact of vaccination on the disease morbidity in Polish pediatric patients with Inflammatory Bowel Disease treated with biologic therapies

Abstract Background Little is known about morbidity of Covid-19 infection in pediatric patients with inflammatory bowel diseases (IBD) treated with biologic medications. The aim of this study was to evaluate the frequency of SARS-CoV-2 infection in children with IBD who received biologic therapies. Methods A prospective, observational cohort study to evaluate coronavirus disease 2019 (COVID-19) vaccination state, and its effect on the disease course among pediatric patients with IBD. The questionnaire included information concerning numbers of vaccine doses, patients’ medication and disease activity. Disease flare was defined by worsening IBD symptoms and change in IBD medications. Outcomes were stratified by vaccine type and IBD medication classes. Results A total of 320 children with IBD, 169 with Crohn’s disease (CD)-52,8%, 150 with ulcerative colitis (UC) - 46,9%, 1 unclassified -0,3%, responded to the questionnaire concerning COVI-19 vaccination. In our cohort 141 (49,7%) patients received biologic therapy: 13 patients (9,2%) adalimumab (ADA), 54 (38,3%) infliximab (IFX), 27 (19,1%) vedolizumasb (vedo), 29 (20,6%) ustekinumab (ust), 6 - vedo + ADA (4,3%), 1 - IFX + vedo (0,7%), 11 - ust + ADA (7,8%). 32 (22,7%) patients had COVID-19 infection during biological therapy (ust 6- 4,3%, vedo 7- 5,0%, ada 2-1,4%, ifx 12- 8,5%, ust + ada 2- 1,4%, vedo + ada 3- 2,1%). Among the patients on biologic treatment suffering from COVID-19, 25 (78,1%) children had mild course of the infection, 4 moderate (12,5%), 2 severe (6,3%), and 1 unknown (3,1%). A total of 127 (39,7%) patients received at least 1 COVID-19 vaccine, and among them 8 (6,3%) patients who received 1 dose of COVID-19 vaccine got the infection during biologic therapy. In our group, 193 (60,3%) patients have not been vaccinated against COVI-19, and 24 (12,4%) suffered from the disease during biologic therapy. Conclusion Based on the outcomes from our questionnaire concerning COVID-19 vaccination state on the large cohort of pediatric patients with IBD, we conclude that unvaccinated patients get sick more often than vaccinated ones, and that the use of biological treatment has no impact the frequency of covid infections or their course.

P898 Hesitancy on COVID-19 Vaccination Among Patients with Inflammatory Bowel Disease in South Korea: A Multicenter Survey

Abstract Background Despite many clinicians recommending COVID-19 vaccination to patients with inflammatory bowel disease (IBD) due to high susceptibility, COVID-19 vaccine hesitancy was a worldwide phenomenon. Although previous studies to identify the cause of this vaccine hesitancy are being published, few studies have been done on COVID-19 vaccine hesitancy among IBD patients in South Korea. Therefore, the aim of our study was to find out the factors that cause vaccine hesitancy in patients with IBD in South Korea. Methods An electronic survey was conducted on IBD patients with receiving treatment at 5 hospitals in Daejeon-Chungchung province from September 2022 to January 2023. Basal characteristics, factors for vaccine hesitancy was evaluated. Survey was designed as a voluntary and anonymous manner. Results A total of 272 patients participated in the survey, of which 119 patients had Crohn’s disease (CD) and 153 patients had ulcerative colitis (UC). COVID-19 vaccine hesitancy tended to decrease with age (r=-0.158, p=0.011). In IBD medication, comparing patient group using 5-aminosalisylic acid and using biologics, hesitancy was higher in the biologics group (p=0.017). Hesitancy was high in patients who preferred Moderna (p=0.049). 102 patients answered that the cause of vaccine hesitancy was concern about safety of vaccines, with the largest share. Conclusion The study found that the main reason of hesitancy was concerns about the safety of the vaccine. Hesitancy tended to decrease with age and was higher in patients using biologics. This study may be helpful to educate patients with more specific targets to prepare for the current COVID-19 as well as other possible future pandemics.

P274 Renal failure in children with inflammatory bowel disease

Abstract Background Renal manifestations may occur in children with inflammatory bowel disease (IBD). The cause of renal manifestations is often unclear, but may occur as an extra-intestinal manifestation or due to IBD treatment. Renal complications can lead to acute renal failure, a severe complication and associated with a risk of developing chronic kidney disease (CKD). Current paediatric ECCO/ESPGHAN guidelines recommended to regular monitor renal function with calcineurin inhibitors. However, these recommendations are based on limited knowledge of renal manifestations in paediatric IBD. The aim of this study was to investigate the diagnosis and underlying causes of renal failure in children with IBD. Methods Cases of renal failure in children &amp;lt;19 years with IBD were collected from the international, prospective PIBDSETQuality Safety Registry1. A monthly survey was sent to participating paediatric gastroenterologists throughout the world asking to report cases of renal failure within their clinical practice. Renal failure was defined as an estimated glomerular filtration rate (eGFR) &amp;lt;60 mL/min/1.73m2 based on the Schwartz formula. Upon reporting a case of renal failure, a follow-up form was automatically sent to obtain more information about renal failure, IBD characteristics and outcomes (including CKD, defined as an eGFR &amp;lt;60 for &amp;gt;3 months). Results From November 2016 until August 2023, 220 gastroenterologists from 36 countries participated in the Safety Registry and 38 cases of renal failure were included. Characteristics at time of renal failure are reported in Table 1. Reported causes and diagnoses of renal failure are represented in Figure 1. Most frequently reported causes were IBD medication (n=12) and IBD itself (n=10). IBD medication included 5-ASA (n=5), tacrolimus (n=2) and one case of azathioprine or ibuprofen, vedolizumab, adalimumab, cyclosporine A and ciprofloxacin. Of the cases most likely caused by IBD itself, disease activity was remission (n=4), mild (n=2), moderate (n=3) or severe (n=1). In the majority of cases (n=26, 68%) creatinine was measured during routine follow-up, and not due to kidney-related symptoms. In 13/37 patients creatinine remained elevated after a median follow-up of 82 weeks [41-136 weeks]. Nine patients developed CKD, two patients required renal replacement therapy. Conclusion This is the first prospective study to report cases of renal failure in children with IBD. Renal failure can occur without symptoms, and may lead to CKD. Timely identification of cases of renal failure is important to adequately treat and monitor patients. We recommend to monitor creatinine in all children with IBD, independent of drug use, every 6 months.

P393 The frequency of COVID-19 infection and the impact of vaccination on the disease morbidity in Polish pediatric patients with Inflammatory Bowel Disease

Abstract Background Little is known about morbidity of Covid-19 infection in pediatric patients with inflammatory bowel diseases (IBD). The aim of this study was to evaluate the frequency of SARS-CoV-2 infection in children with IBD. Methods A prospective, observational cohort study to evaluate morbidity of coronavirus disease 2019 (COVID-19) among pediatric patients with IBD. The questionnaire included information concerning numbers of vaccine doses, patients’ medication and disease activity. Disease flare was defined by worsening IBD symptoms and change in IBD medications. Results A total of 320 children with IBD, 169 with Crohn’s disease (CD)-52,8%, 150 with ulcerative colitis (UC) - 46,9%, 1 unclassified -0,3%, responded to the questionnaire concerning COVI-19 vaccination. Among the participants 114 (35,6%) patients have suffered from COVID19 (62 CD- 54,4%, 51 UC- 44,7%, 1 unclassified - 0,9%). In 79 cases (69,3%) COVID-19 course was mild, in 31 (27,2%) it was moderate, and 3 (2,6%) children had severe disease. There was no statistically significant difference in morbidity among patients with CD and UC. A total of 127 (39,7%) patients received at least 1 COVID-19 vaccine, and among them 22 (17,3%) children got COVID-19 infection after vaccination. 91 (47.2%) of unvaccinated patients got COVID 19 infection. Following SARS-CoV-2 disease, 22 (19.3%) patients reported exacerbation of IBD during or after COVID 19. In 82 (71.9%) patients COVID-19 infection had no effect on the course of their IBD. Among patients with exacerbation during/after SARS-CoV-2 disease, 3 (13.6%) were vaccinated and 19 (86.4%) of them were not vaccinated. Conclusion Based on the outcomes from our questionnaire concerning COVID-19 vaccination state on the large cohort of pediatric patients with IBD, we conclude that unvaccinated patients get sick more often than vaccinated ones, and there is no difference in the frequency of SARS-CoV-2 infection between children with CD and UC. Also, there is no statistically significant difference in the severity of COVID-19 infection between vaccinated and unvaccinated patients. Vaccination against COVID-19 has no effect on the exacerbation of IBD during/after infection.

P1079 Mindfulness-based cognitive therapy to reduce psychological distress in patients with Inflammatory Bowel Disease: first results of a multicentre randomised controlled trial (MindIBD)

Abstract Background Many patients with Inflammatory Bowel Diseases (IBD) suffer from psychological distress and fatigue. Moreover they report a reduced quality of life. The availability of psychosocial treatment options is limited. As mindfulness-based cognitive therapy (MBCT) has been shown to reduce psychological distress and fatigue, and improve quality of life in other populations, MBCT might also be effective in patients with IBD. Methods The MindIBD study was a prospective, multicentre, randomised controlled trial, conducted in one academic and three general hospitals in the Netherlands. Patients of 16 years and older with a confirmed IBD diagnosis were eligible if the IBD was in remission (based on faecal calprotectin &amp;lt;250 mg/kg and no changes in IBD medication for at least three months) and they experienced at least mild psychological distress (based on Hospital Anxiety and Depression Scale (HADS) total score ≥ 11). Participants were allocated in the intervention group (MBCT plus treatment as usual) or control group (treatment as usual alone). Assessments were conducted at baseline, post-intervention (3 months) and at 6, 9 and 12 months after baseline. Primary outcome was the effect on psychological distress post-intervention. Secondary outcomes included fatigue, perceived disease control, disease activity, disease-specific quality of life and positive mental health. This trial was registered at ClinicalTrials.gov: NCT04646785. Results A total of 142 IBD patients were randomly assigned to the intervention group (n=70) or the control group (n=72). The study population had a median age of 50 years (IQR 39-59 years), consisted of 91 women (64%) and 68 participants (48%) were diagnosed with Crohn’s disease. Post-intervention, participants in the intervention group showed a mean decrease on the HADS total of 4.7 ± 6.3 points compared to a mean decrease of 1.2 ± 5.2 points in the control group. This difference in improvement of psychological distress was statistically significant (p&amp;lt;0.001), and this benefit was maintained during follow-up (p=0.005). MBCT did also result in a significant improvement on fatigue (p=0.022) and positive mental health (p=0.022) post-intervention. These improvements remained in favour of the intervention group during follow-up, although not significantly different. No differences were found on perceived disease control, disease activity and disease-specific quality of life. Conclusion MBCT reduces psychological distress and improves fatigue and positive mental health. Therefore MBCT can be considered as a valuable addition to the limited psychosocial interventions for patients with IBD to improve psychological distress, fatigue and positive mental health.