Inflammatory Bowel Disease Medications Research Articles

P0686 Steroid use in patients with inflammatory bowel disease – claims data indicate a decline in steroid use for the first time over a five-year observation period in Germany

Abstract Background Although maintenance and prolonged use of oral corticosteroids (OCS) in inflammatory bowel disease (IBD) is not recommended, it remains a common practice.1–3 This study evaluated the concomitant use and overuse of OCS among IBD patients in Germany from 2017 to 2022. Methods We retrospectively analysed German claims data (January 2017–December 2022). Patients over 18 years of age with continuous insurance and at least two quarterly diagnoses of Crohn’s disease (CD) and/or ulcerative colitis (UC) within two years were included. To increase the diagnostic certainty and clinical relevance, only patients with IBD who were currently receiving any form of IBD therapy (corticosteroids, aminosalicylates, calcineurin inhibitors, other immunosuppressants, biologics and/or small molecules) were included in the analysis. Oral corticosteroids (OCS) were defined as steroids for systemic use (ATC code: H02AB and H02BX). Concomitant use of an OCS use was assumed if a patient received a prescription for an IBD medication, excluding OCS monotherapy with OCS, alongside an OCS within the same quarter. OCS overuse was defined as receiving ≥2 OCS prescriptions within one year alongside an IBD medication. Subgroup differences were tested using Fisher’s exact test. Results The study identified 9,407 patients with confirmed CD and 11,772 patients with confirmed UC who were treated with IBD medications, during the observation period (Table 1). Of these, 42.8% of CD patients and 39.0% of UC patients were treated with concomitant OCS (CD vs. UC, p<0.0001), while 31.3% of CD patients and 29.4% of UC patients experienced OCS overuse (CD vs. UC, p<0.01) (Figure 1A). OCS use and OCS overuse decreased significantly from 2017 to 2022 in both CD and UC patients (p<0.0001) (Figure 1B). Conclusion This study provides real-world insights into the patterns of (over)use of OCS in IBD patients. It highlights the continued over-reliance on OCS, particularly in CD patients. Notably, steroid overuse has decreased significantly over the 5-year observation period.

N43 the "help-line telephone" form: a new telemedical support for managing patients with ibd

Abstract Background In the current healthcare economy, the implementation of telemedicine is rapidly evolving.The rationale for development and advancement in this area seems to be dual: first, to improve speed and efficiency in the supply of health counseling and decision making, and second, to provide access to patients in rural areas.IBD has a significant medical, social and financial impact considering the constant increasing worldwide in its incidence and prevalence.Our study aims to determine how much the "Help-line telephone" form that supports phone call could become a useful tool to the IBD nurse and physician to ensure a better and a faster patient care Methods A retrospective observational 12 months study was conducted in 2024.All phone calls were recorded on the help-line telephone card in 12 months were included.Descriptive statistics has been used to categorize the number of phone calls received and splitted into several categories: request for visit/change visit/reminder; requests for other investigations/blood tests/calprotectin/histology; colonoscopy request; worsening;improvement; biologic therapy; topical therapy;os therapy; covid Results A total of 1465 phone calls were recorded from November 2023 to October 2024.The average number of phone calls per month is 122.1.We present the percentage of the different items considered:32.6% "Request/Change Visit + Reminder",7.3% were for hematology and/or fecal calprotectin tests, 4.1% were for other investigations, and 0.8% were for histological reports and 4.6% for colonscopy. It emerges that worsening reporting of the patient's health status are about 4 times higher than calls for improvement. Calls regarding biologic therapy amounted to18.0% followed by topical therapy(3.5%)and oral therapy(4.6%).Calls to report Covid, flu and joint pain(6.6%) appear to be more frequent in cold months such as November 2023(n=17)and October 2024 (n=19)and almost absent in warm months such as May and June 2024(n=1)tracing a cyclical pattern. Conclusion Despite the fact that this service was adopted as an emergency measure during the pandemic period of SARS-COVID-19, it is still widely used in our Centre on daily basis. Beyond limiting the number of outpatient visits, it is essential for the day-to-day follow-up.The support of the ‘help-line telephone’ form is important for the internal management of the outpatient clinic as it enables the healthcare professionals to provide adequate answers to specific patient requests within a short period of time. In addition, it is proven to be effective in managing needs in order to eliminate any possible oversights.A continuation of the study is suggested for further data collection in order to optimize the form by further orienting it towards patients' needs. References DeBlois, D., Millefoglie, M. (2015). Telehealth: enhancing collaboration, improving care coordination. Nursing Management; 46:10–12. Huang, V., Reich, K., Fedorak, R. (2014). Distance management of inflammatory bowel disease: systematic review and meta-analysis. World Journal of Gastroenterology; 20:829–42.Win, A. (2015) Telehealth can bridge the gap for rural, disabled, and elderly patients. J Am Med Dir Assoc; 16:268–9. Turner, D., Ricciuto, A., Lewis, A., D'Amico, F., Dhaliwal, J., Griffiths, A.M., Bettenworth, D., Sandborn, W.J., Sands, B.E., Reinisch, W., Schölmerich, J., Bemelman, W., Danese, S., Mary, J.Y., Rubin, D., Colombel, J.F., Peyrin-Biroulet, L., Dotan, I., Abreu, M.T., Dignass, A. (2021). STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology; 160: 1570-1583. Jackson, C.A., Clatworthy, J., Robinson, A., Horne, R. (2010). Factors associated with non-adherence to oral medication for inflammatory bowel disease: a systematic review. Am J Gastroenterol; 105: 525-539. Del Hoyo, J., Millán, M., Garrido-Marín, A., Aguas, M. (2010). Are we ready for telemonitoring inflammatory bowel disease? A review of advances, enablers, and barriers. World journal of gastroenetology; 29(7):1139-1156.

P0749 Infection adverse events with tulisokibart over 50 weeks of treatment in the phase 2 Crohn’s disease APOLLO-CD trial

Abstract Background Biologic medications for inflammatory bowel disease are associated with increased risk of infections1. This analysis evaluates infection adverse events (AEs) with tulisokibart, an anti-tumor necrosis factor–like cytokine 1A (TL1A) monoclonal antibody, in APOLLO-CD, a Phase 2a trial in participants with Crohn’s disease (CD) in which tulisokibart was well tolerated and led to achievement of endoscopic response and other endpoints during a 12-week induction period and 36-week open-label extension (OLE) period2 Methods Participants (≥18 years of age, moderately to severely active CD and inadequate response to conventional therapy or approved biologic therapies) received open label intravenous (IV) induction tulisokibart treatment (1000 mg at baseline then 500 mg at Weeks 2, 6, and 10). Tulisokibart induction responders were able to enter the OLE study and randomized at week 14 to receive IV tulisokibart 100 mg or 250 mg every 4 weeks. Adverse events (AEs) related to infections during the 12-week induction and up to Week 50 in the OLE are reported. Results A total of 55 participants were treated in the induction period, of which 37 responders continued in the OLE (19 received tulisokibart 100 mg and 18 received tulisokibart 250 mg). During the induction period, 25 (46%) participants reported infection AEs; all were considered mild to moderate in severity, and the most common were COVID-19 and Urinary Tract Infection (Table). Two infections were serious (anal abscess and COVID-19 pneumonia), requiring hospitalization; both were deemed not drug related and resolved without treatment discontinuation. In the OLE at Week 50, 12 (63%) participants on 100 mg and 11 (61%) on 250 mg reported infection AEs, with none considered serious. The most common infection AEs were Urinary Tract Infection and COVID-19. There were two severe infection AEs (bronchitis and Clostridioides difficile) in the 250 mg dose group. No participants discontinued study treatment due to an infection AE during the entire 50 weeks of treatment (Table). No dose-dependent safety signal was observed. Conclusion Tulisokibart treatment over the 12-week induction demonstrated low incidence of serious infection AEs and no apparent increased risk of infection AEs when compared with biologic treatments for CD in prior clinical trials3,4. No new infection safety signals appeared in the OLE. All infection AEs resolved, most were considered non-serious and mild to moderate in severity, and no participant discontinued treatment due to an infection AE.

P0380 Mild Hyperemia in the Absence of Bowel Wall Thickening on Intestinal Ultrasound is Associated with Biochemical Disease Activity and Worse Disease Outcomes in Patients with Crohn’s Disease and Ulcerative Colitis

Abstract Background Bowel wall thickness (BWT) and hyperemia measured by intestinal ultrasound (IUS) predict endoscopic disease activity in Inflammatory Bowel Disease (IBD). The clinical significance of mild hyperemia (mLim1) without BWT is unknown. We previously described the short-term predictive value of mLim1 without BWT. Here we compare biochemical disease activity and longer-term outcomes in IBD pts with mLim1 to those with normal IUS. Methods We reviewed index IUS exams of pts with IBD at the University of Chicago from 7/18/2022 to 5/7/2024 and included pts with normal BWT (≤3.0mm) + mLim1 and compared them to pts with normal BWT + no hyperemia (mLim0). We excluded pts with mLim2 or 3, BWT>3mm anywhere on index IUS or pts with mLim1 at surgical anastomoses only. Clinical Harvey-Bradshaw Index (HBI) or Simple Clinical Colitis Activity Index (SCCAI)) and biochemical disease activity (faecal calprotectin (FCP) or C-reactive protein (CRP)) were assessed at the time of index IUS. Clinical remission was defined as HBI of <5 or SCCAI of ≤2, FCP<150 μg/g, CRP<5 mg/L. Primary analysis was poor disease outcome (PDO) within 12 mo of follow-up, defined as: IBD medication change/escalation, prescription of corticosteroids, IBD-related surgery, or IBD-related hospitalization. Results 45 pts with mLim1 (38 Crohn’s disease (CD), 7 Ulcerative colitis (UC)) and 61 pts with mLim0 (52 CD, 9 UC) at index IUS were included (Table 1). At baseline IUS, mLim1 pts had elevated median FCP but normal median HBI/SCCAI, while mLim0 pts had normal median FCP and HBI/SCCAI (Table 1). Of mLim1 CD pts, 14/38 (36.8%) had a PDO within 3 months (mo), 18/38 (47.4%) within 6 mo, and 18/30 (60%) within 12 mo, with median time to PDO of 37 d (IQR 28.5-112.5). Of the mLim0 CD pts, 5/52 (9.6%) had a PDO within 3 mo, 9/46 (19.6%) within 6 mo, and 14/45 (31.1%) within 12 mo, with median time to PDO of 91 d (IQR 93-184). Rates of PDO between mLim1 and mLim0 in CD pts at 12 mo were statistically significant (stat sig), p = 0.013. Of the mLim1 UC pts, 3/7 (42.9%) had a PDO within 3 mo and 2/3 (66.7%) had a PDO within 12 mo, with a median time to PDO of 139 d (IQR 93-184). Of the mLim0 UC pts, one had a PDO at 3 mo with no further events noted at 6 mo (0/8) or 12 mo (0/4). Rates of PDO between mLim1 and mLim0 in UC pts at 12 mo were not stat sig, (p = 0.270). Conclusion Mild hyperemia without BWT is associated with biochemical disease activity in both CD and UC and predicts PDO in CD. Although PDO in UC was numerically higher in mLim1 compared to mLim0, this was not stat sig likely due to small cohort size. These findings support the consideration of treatment adjustments when this isolated parameter is identified and inform future IUS treat-to-target strategies.

P1108 Endoscopic Sleeve Gastroplasty for management of Obesity in patient suffer from Inflammatory Bowel Disease

Abstract Background Obesity is a multifactorial, chronic, and relapsing disease, and its prevalence among patients with inflammatory bowel disease (IBD) is increasing, affecting 15–40% of them1,2. Limited data are available on the outcomes of endoscopic sleeve gastroplasty (ESG), a non-malabsorptive, organ-sparing endoscopic procedure, in patients with IBD3,4. Methods We conducted a retrospective review of a prospective dataset of subjects who underwent ESG at a tertiary center, including all subjects affected by IBD. Weight loss and IBD outcomes were assessed during early- and medium-term follow-up. Results Ten subjects (80% women) with IBD (5 with ulcerative colitis and 5 with Crohn’s disease) underwent ESG between October 2019 and May 2024 (mean BMI 37.6 ± 3.75 kg/m², mean age 49.4 ± 12.3 years). Four patients (40%) had previously undergone IBD-related surgery. Seven patients (70%) had received biological therapy, and six (60%) were in clinical remission at the time of ESG. No perioperative adverse events occurred. At the 6-month follow-up, nine subjects experienced total body weight loss (TBWL) of >10%, with a mean excess weight loss (EWL) of 55.9 ± 29.6%. Nine patients reached the 12-month follow-up, with a TBWL of 17.3 ± 10.5% (6 of them with TBWL >10%). At the final follow-up (mean 20.25 ± 3.46 months), the mean TBWL was 12.3 ± 10.2%, and the mean EWL was 38.2 ± 31.8%. Three patients underwent endoscopic revision for recurrent weight gain after a mean of 21 months. Two of these patients reached the 6-month follow-up with a mean TBWL of 9.89 ± 0.15% and EWL of 46.83 ± 1.79%. Overall, eight (80%) patients had no change in their IBD medication, one (10%) required treatment escalation due to loss of response. One subject, affected by chronic kidney disease and with a history of ileocecal resection, required emergency surgery for bowel obstruction caused by an incisional hernia 16 months after ESG. Unfortunately, four months later, he died due to septic shock. At the last follow-up, eight (89%) of the nine patients were in clinical remission, and all patients were in steroid-free remission. Conclusion We present the largest series on ESG in patients with IBD and obesity. Based on these retrospective data, ESG appears to be a promising bariatric procedure for these complex patients due to its safety and efficacy. However, prospective studies and clinical trials are needed to confirm these findings.

P1229 Updated Epidemiology of Osteoporosis in the Inflammatory Bowel Disease Population and Associated Risk Factors: Insights from a Retrospective Cohort Analysis

Abstract Background Osteoporosis is a prominent extra-intestinal complication in patients with inflammatory bowel disease (IBD), which includes ulcerative colitis (UC) and Crohn’s disease (CD). The prevalence of osteopenia and osteoporosis among patients with IBD varies widely, ranging from 22%-77% and 17%-41%, respectively, depending on population characteristics, geographic location, and study design [1]. Despite these variations, the burden of osteoporosis in IBD is unequivocal, impacting quality of life and increasing the risk of fractures. Methods We conducted a retrospective cohort study using the TriNetX database to assess the incidence of osteoporosis in patients with IBD between 2013 and 2023. Data were stratified by age, sex, and race. A comparative analysis of osteoporosis risk in IBD versus non-IBD populations was performed, along with an exploration of risk factors specific to UC and CD cohorts. Propensity score matching was employed to adjust for confounders, including age, sex, race, BMI, smoking, primary sclerosing cholangitis (PSC), steroid use, autoimmune diseases, IBD medications, and surgical history. Risk was quantified as adjusted odds ratios (aOR) with 95% confidence intervals (CI). Results A total of 120,396 patients with IBD (mean age 43.8 ± 19.4, female sex 53.073%, White race 79.01%) were analyzed. The five-year incidence of osteoporosis was significantly higher in the IBD cohort (aOR: 1.43, 95% CI: 1.38-1.48) compared to the non-IBD cohort. Among IBD subtypes, CD patients exhibited a higher risk (aOR: 1.53, 95% CI: 1.46-1.60) compared to UC patients (aOR: 1.38, 95% CI: 1.32-1.44) [Figure 1]. Osteoporosis incidence was notably higher in females (IBD: 9.78%, UC: 10.48%, CD: 9.38%) than in males (IBD: 3.55%, UC: 3.67%, CD: 3.87%) and increased significantly with age, reaching 21.67% in patients over 80 years old. Racial disparities were evident, with the highest incidence observed among White patients (7.35%). Significant risk factors for osteoporosis in IBD included long-term corticosteroid use (aOR: 2.29, 95% CI: 2.25-2.32), malnutrition (aOR: 1.56, 95% CI: 1.53-1.59), use of TNF-alpha inhibitors (aOR: 1.40, 95% CI: 1.36-1.43), PSC (aOR: 2.30, 95% CI: 2.08-2.54), intestinal surgery (aOR: 1.21, 95% CI: 1.18-1.23), hemoglobin levels of <10 g/dL (aOR: 1.20, 95% CI: 1.19-1.21), albumin levels of <2.5 g/dL (aOR: 1.07, 95% CI: 1.05-1.08), and mood disorders (aOR: 1.16, 95% CI: 1.15-1.17) [Figure 2]. Conclusion Osteoporosis is a significant concern for patients with IBD, with females, older adults, and CD patients being most at risk. Early and targeted interventions are crucial to reducing bone loss and improving long-term outcomes in this vulnerable population.

P0632 Analysis of serological responses to SARS-Cov-2 vaccination in patients with Inflammatory Bowel Disease in India identifies low BMI as an independent determinant of vaccine non-response

Abstract Background Studies of patients with inflammatory bowel diseases (IBD) from Western countries have demonstrated that serological responses to mRNA and vector-based vaccines are differentially impacted by IBD therapies. Little is known regarding antibody responses in patients with IBD residing in low- and middle-income countries (1). In this study, we investigate the factors which may influence the inhibitory and total antibody responses to SARS-CoV-2 in two centers in Northern India. Methods We studied 180 IBD patients in Chandigarh and New Delhi, India, who received two doses of a COVID-19 vaccine. All patients received Oxford-AstraZeneca equivalent Covishield (n=149) or inactivated virus vaccine Covaxin (n=31) between January 2021 and December 2022. We measured anti-S and anti-N antibody levels and performed inhibition assays to measure the inhibition of ACE2 on SARS-CoV-2 binding against alpha, delta, and omicron variants after first and second vaccine doses. Univariate and multivariate analyses were performed to identify determinants of vaccine response. Results On univariate analysis, IBD patients taking steroids (p= 0.019), immunomodulators (p= 0.047), or infliximab (p= 0.0057) had lower responses after dose 2 for any vaccine compared to those not on these medications or receiving 5-ASAs. Low BMI was associated with reduced rates of seroconversion in univariate analysis. For every fall in BMI by 1, the average ACOV2S V2 anti-Spike level was reduced by 8.2 (Figure 1). Additionally, 97% (28/29) of vaccinated IBD patients with a BMI greater than or equal to 25 reached the maximum anti-Spike value after their second dose of a COVID-19 vaccine. Multivariate analysis comparing gender, IBD type, smoking status, comorbidities, IBD medications, and a history of COVID-19 diagnosis revealed that low BMI (dose 1: OR: 1.12 [CI: 0.084, 0.136]; dose 2: 1.11 [0.076, 0.128]), infliximab (dose 1: 1.67 [-.92, 1.94]), and patients on steroids (dose 1: 1.50 [-1.384, 2.195]; dose 2: 0.200 [-3.76 0.54]) were each independent determinants of lower seroprevalence levels after receiving a dose of Covishield or Covaxin. Conclusion Immunosuppressive drug therapy and reduced BMI emerge as determinants of sub-optimal seroconversion rate in this patient population. The association with low BMI represents a unique finding in this population, and directly contrast with studies reported in Europe & North America. These data are useful for future pandemic vaccine considerations in patients with IBD. References (1)Wong SY, Wellens J, Helmus D, et al. Geography Influences Susceptibility to SARS-CoV-2 Serological Response in Patients With Inflammatory Bowel Disease: Multinational Analysis From the ICARUS-IBD Consortium. Inflamm Bowel Dis. 2023;29(11):1693-1705. doi:10.1093/ibd/izad097

P0984 Treatment with allopurinol and low-dose azathioprine during pregnancy in patients with Inflammatory Bowel Disease. A Danish single center experience

Abstract Background Low-dose azathioprine in combination with allopurinol (LD-AZA/ALLO) is a widely used treatment option in inflammatory bowel disease (IBD). Data on pregnancy and birth outcomes from exposure to combination therapy are sparse. The aim of this study was to provide data on safety and risk for adverse pregnancy and birth outcomes in women with IBD treated with LD-AZA/ALLO at the Gastrounit, Hvidovre Hospital, Copenhagen. Methods The study was a retrospective single center study. Inclusion criteria were established IBD diagnosis and treatment with LD-AZA/ALLO (AZA 50-75 mg/ ALLO 100 mg) during conception and pregnancy between 2013-2023. Data was collected from electronic medical charts and by questionnaire to all included women. Data registered was; demographics, diagnosis, disease characteristics, disease activity, IBD medications and number of pregnancies. Pregnancy outcomes were neonatal characteristics, obstetric complications, lactation and congenital malformations, disease, infections and admission to the hospital during the first year of life. Results In all, 44 women with 62 pregnancies (one twin pregnancy) and 59 live births were included. There were 1 spontaneous and 3 provoked abortions due to genetic disorders (1 trisomy 21 and 2 spinocerebellar ataxia). Obstetric complications were present in 8 (13%) pregnancies, (1 pre-eclampsia, 1 HELLP syndrome, 6 hypertension and/or gestational diabetes mellitus). 7 (11%) women had an IBD flare during pregnancy, none resulting in obstetrical complications. 5 (9 %) children were born prematurely, 4 (7 %) had low birth weight. No congenital malformations were reported. One child was born with facial nerve paralysis and later diagnosed with hyper-IgD syndrome. 8 (14 %) were admitted to neonatal ward (hours to days), mainly due to immature lungs. During the first year of life, one child was admitted to the hospital due to COVID. One child was suspected to have an immune defect, but all symptoms and biochemical abnormalities resolved and interpreted as side effect to LD-AZA/ALLO. 5 children (9%) were treated with antibiotics due to minor infections. In total 84 % of the children were breastfed during LD-AZA/ALLO treatment. Conclusion In this large single center experience with 62 pregnancies in women treated with LD- AZA/ALLO, no malformations or indications of increased risk of complications of pregnancy and birth were observed. The majority of children were breastfed and no serious signals or complications were reported first year of life. Treatment with LD-AZA/ALLO during pregnancy and breastfeeding seems safe.

N10 “I probably am being a naughty boy, but…” Exploring reasons for non-adherence to prescribed medication, as perceived by people living with Inflammatory Bowel Disease: A Qualitative Study

Abstract Background Inflammatory bowel disease (IBD) is treated with medications to induce and maintain remission. However, many people with IBD do not take treatments as prescribed. Identifying and understanding reasons behind medication adherence and non-adherence in IBD is critical. Methods In-depth, semi-structured interviews were audio or video-recorded and transcribed verbatim. Braun and Clarke’s (Braun & Clarke, 2006) principles of thematic data analysis were followed to analyse data. Results Twenty people living with IBD were purposively selected and interviewed. Four main themes were identified (Table1) with related sub-themes; 1) The Context within which adherence needs to happen 2) Battles throughout the IBD “journey” 3) Multiple medical treatment issues and 4) Knowledge, learning, understanding and experience of IBD as a condition and its treatment. From diagnosis and throughout their IBD “journey,” medication adherence in many participants was variable. Adherence was impacted by the context of healthcare received by individuals, their daily activities, physical and emotional well-being and relationships with others. Participants regularly described themselves as experiencing a battle using intense terms such as battling with their IBD, their healthcare professionals (HCPs) and/or their IBD medication. Treatment type (including drug category, for example steroids or immunosuppressants, associated risks and side effects), treatment effectiveness and requirements for taking it, all influenced adherence, as did an individual’s treatment values and beliefs. Gaining knowledge, developing understanding regarding medication and its necessity from the start of diagnosis was critical for adherence. This had strong potential to impact adherence positively and/or negatively, based upon what participants were told, when, and by whom. Yet, treatment information was frequently not offered by HCPs, leading individuals to self-educate and develop a personal understanding of their condition and medication. This, combined with the experiencing of living with IBD, influenced their adherence. Conclusion Medication adherence is a journey, affected by multiple determinants. Determinants may be patient-centred, influenced by HCPs and/or determined by an individual’s knowledge and experience level. Diagnosis is a critical stage where individuals require compassionate care from their personal networks and multidisciplinary HCPs. Clear medical treatment information should also be provided by HCPs, with self-education encouraged via trusted resources. To promote adherence and establish treatment routines, patients must feel fully informed, supported, confident and comfortable in their shared decision-making about treatment, that will suit their lifestyle. References -Braun, V. & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3 (2), 77-101

P0845 Safety and Adverse Events of the Adjuvanted Herpes Zoster Vaccine (Shingrix) in Inflammatory Bowel Disease Patients: A Comparison of Age Groups Under and Over 50 Years

Abstract Background This study investigates the safety profile of the adjuvanted herpes zoster (HZ) vaccine (Shingrix) in patients with inflammatory bowel disease (IBD), particularly comparing adverse events (AEs) in those under 50 years old versus those 50 and above. IBD patients, due to immune-modulating treatments, face an elevated risk for herpes zoster infection, yet data on the vaccine’s safety in this population remain limited. Methods A total of 244 IBD patients were enrolled and received the HZ vaccine. Participants were divided into two groups: those under 50 years and those aged 50 or older. Baseline demographic and clinical characteristics, including IBD type, medication history, and prior HZ infection, were collected. Post-vaccination local and systemic AEs, including any serious AEs (SAEs) and IBD-specific responses, were monitored following both doses. Results The mean age of participants was 45.3 years (range 18–78), with 146 individuals under 50 and 98 over 50. Common local AEs included injection site pain (51.2%) and redness (2.0%), with no notable age-related differences. Systemic AEs were predominantly myalgia (34.0%) and fatigue (19.3%), with the younger group (<50 years) experiencing significantly higher rates of myalgia (39.0%) and shivering (17.1%) compared to those aged 50 and older. Only one SAE was recorded: a disease flare-up requiring hospitalization in the older age group after the first dose. No SAEs were observed following the second dose. Conclusion The Shingrix vaccine is generally safe for IBD patients, with AE profiles consistent across age groups. While younger patients reported more systemic AEs like myalgia and shivering, there was no increase in severe or IBD-specific AEs. These results support broader immunization efforts in IBD patients, including those under 50 years.

P0699 Comparative Effectiveness and Safety of Denosumab Versus Bisphosphonates in Osteoporosis Management Among Patients with Inflammatory Bowel Disease: A U.S. Propensity Matched Cohort Study

Abstract Background Denosumab, a fully monoclonal antibody, is approved for the treatment of osteoporosis, including glucocorticoid-induced osteoporosis. Denosumab is an alternative to bisphosphonate therapy and has been shown to improve bone mineral density, and reduce the incidence of new fractures, however there is limited data in patients with inflammatory bowel disease (IBD). Through this study we evaluate the effectiveness of denosumab versus bisphosphonates in reducing osteoporosis-related fractures and safety related to IBD-specific outcomes. Methods We conducted a retrospective cohort study using a U.S. multi-institutional database (TriNetX), examining patients with IBD with osteoporosis who were initiated on denosumab or bisphosphonates from 2013 to 2022. The primary aim of the study was to assess the 1- and 2-year risk of de-novo fractures (spine and/or hip) in the denosumab cohort compared to bisphosphonate cohort. Cox proportional hazard model was used to identify predictors of denosumab failure. The secondary aim was to evaluate the 2-year risk of IBD-related outcomes which included corticosteroid use, advanced therapy initiation, and surgery. 1:1 propensity score matching (PSM) was performed for demographics, comorbid conditions, BMI, hemoglobin, albumin, calcium/vitamin D supplementation, IBD medications including steroid use. Results Among 2,423 patients with IBD and osteoporosis (mean age 62.8, female sex 67.3%, Crohn’s disease 48.5%), 520 received denosumab and 1,903 received bisphosphonates. After PSM, there was no difference in the 1-year (2.33% vs 3.49%, aOR 0.65, 95% CI 0.31-1.38) and 2-year risk (4.65% vs 6.78%, aOR 0.65, 95% CI 0.39-1.14) of fractures between the denosumab cohort compared to the bisphosphonates cohort. In terms of IBD-related outcomes, denosumab was associated with a lower risk of prednisone use (aOR 0.73, 95% CI 0.56–0.96) but no significant difference in the risk of de-novo advanced therapy use (aOR: 0.76, 95% CI 0.442–1.334), IV steroid use (aOR 1.13, 95% CI 0.78–1.64) and surgery (aOR 0.79, 95% CI 0.49-1.27) [Table 1]. After cox regression analysis, chronic steroid use (HR 1.99, 95% CI 1.26-3.1), prednisone use (HR 1.71, 95% CI: 1.07–2.72) and history of falls (HR 3.00, 95% CI 1.34-4.09) as significant predictors of treatment failure with denosumab [Figure 1]. Conclusion Our study highlights the comparable effectiveness of denosumab compared to bisphosphonates in reducing the risk of fractures in patients with IBD and osteoporosis. There were no IBD-related safety signals related to denosumab use compared to bisphosphonates. Further prospective studies are needed to optimize osteoporosis management in this high-risk population.

P1157 Limited Willingness to Switch from Intravenous to Subcutaneous treatment in Pediatric Inflammatory Bowel Disease

Abstract Background Recent advances in inflammatory bowel disease (IBD) therapies have provided patients with a variety of medications with different routes of administration. We aimed to assess parental preferences regarding medication administration routes and to identify factors influencing these preferences Methods This cross-sectional study surveyed parents of children with IBD using a comprehensive questionnaire that focused on treatment experiences, preferences, and attitudes towards switching from intravenous (IV) to subcutaneous (SC) administration. The questionnaire explored various regimens, including oral pills, SC injections at different intervals, and IV infusions Results This study included 147 parents of pediatric IBD patients. The median age of the children was 16 years (IQR 14-18), and 64 (43.5%) were female. Most children (94, 63.9%) had CD. The median duration of the disease was 4 years (IQR 2-6). When the parents were asked to indicate their preferred medication route and schedule, the highest score was assigned to SC administration every 8 weeks although this difference was not statistically significant when compared to PO administration daily (2.93 and 2.86 respectively, p=0.68). Both SC every 8 weeks and oral administration were significantly more favored than IV administration every 8 weeks and SC every 2 weeks (p<0.01 for all these pairwise comparisons). There was no statistically significant difference in preference between IV every 8 weeks and SC every 2 weeks (2.16 and 2.05 respectively, p=0.44). [Fig. 1]. Despite new options allowing for SC administration, 67% of parents preferred not to switch from IV, citing concerns about self-injection, desire for nurse presence, and longer intervals between infusions [Fig. 2]. No significant correlation was found between treatment preferences and disease-related factors such as disease type or activity. Medication doses were most frequently missed via the oral route, indicating challenges with adherence or patient preferences for this administration. Conclusion We evaluated the role of parental preferences on the choice of IBD medication administration routes in children, while highlighting the influence of prior treatment experience. The strong resistance to switching from IV to SC treatment, despite the availability of SC options, necessitates a patient-centered approach to clinical decision-making. Clinicians should actively involve parents in shared decision-making processes

P0504 The Impact of Disease Activity and Medications on Pregnancy and Fetal Outcomes in Women With Inflammatory Bowel Disease: A Cohort Study From the IBD-ME Group

Abstract Background Women with Inflammatory bowel disease (IBD) and their children may face a higher risk of adverse outcomes during and after pregnancy. The primary aim was to examine the association between IBD and adverse pregnancy outcomes: preterm birth, small for gestational age, birth weight, congenital anomalies, and stillbirth. The secondary aim was to assess the impact of maternal IBD and medications used on children’s outcomes: adverse reactions to vaccinations and development of IBD in the offspring up until seven years of age. Methods We performed a multicenter retrospective study in Saudi Arabia and Kuwait. Three participating hospitals enrolled women with IBD who gave birth between 2016 and 2023. Information regarding disease characteristics, medication use, pregnancy outcomes, and long-term health outcomes of children until age fourteen was collected. Results This study analyzed data from 167 patients with a median age of 37.0 years (IQR: 33.0 to 44.0). Crohn’s disease was the most common type of IBD (51.2%), followed by ulcerative colitis (46.3%). Of note, 42.7% of the women were on mesalamine, while 25.1% of the study population were on both anti-TNF agents and Azathioprine. The most frequent pregnancy outcome was low birth weight (22.5%), and 8.2% of the offsprings were diagnosed with IBD. A history of having six or more pregnancies significantly predicted IBD in an offspring (OR = 4.02, 95% CI, 1.19 to 14.8, p < 0.01). In contrast, disease control before pregnancy significantly reduced the risk of adverse infant outcomes (OR = 0.10, 95% CI, 0.01 to 0.61, p < 0.01). None of the IBD medications predicted poor pregnancy outcomes. Conclusion Infants of women with active IBD have an increased risk of prematurity and being small for gestational age. Number of pregnancies was a significant predictor for IBD in an offspring. Controlling disease activity at conception is essential to improve both pregnancy and fetal outcomes.

Wound Healing After Vaginal Delivery, Episiotomy, and Cesarean Section Delivery Among Women With IBD: Results From the PIANO Registry.

Women with inflammatory bowel disease (IBD) face complexities of disease management during pregnancy and childbirth. Apprehension regarding vaginal delivery in pregnant individuals with IBD persists due to concern for perianal disease and perineal trauma. The incidence of poor wound healing after obstetric anal sphincter injury is approximately 4% in the general population. In an IBD population, risk of developing and difficulty healing perineal tears and episiotomy is not well described. In a multicenter prospective cohort of pregnant individuals with IBD, we collected demographic information, IBD disease and treatment history, pregnancy and labor history, and reports of delayed wound healing >1 month from episiotomy, vaginal tear, or Cesarean (C-) section. Prospective data were collected using questionnaires that were administered each trimester of pregnancy, at delivery, and in the year postpartum. There were 743 patients in the PIANO registry who answered questions pertaining to postpartum wound healing, with 330 (44%) reporting a C-section and 413 (56%) reporting a vaginal delivery. Of 119 C-section deliveries assessed for delayed wound healing, only 1 (0.8%) patient reported this complication. Episiotomies were reported in 59 (14%) patients, with 9 (15%) reporting delayed wound healing. Vaginal tears were reported in 252 (64%) patients. Delayed wound healing from vaginal tear was reported in 9% of patients. Use of immunomodulators was associated with delayed wound healing from episiotomy (33% vs 0% for those on no medications, P = .024). No difference was seen in wound healing time for episiotomy with other medications, including corticosteroids, anti-tumor necrosis factor, or anti-integrin use. Delayed wound healing from vaginal tear was not associated with any class of IBD medication. Episiotomy was a common occurrence in patients with IBD. Immunomodulator, but not biologic, use was found to be associated with delayed wound healing. This association could reflect a direct medication effect on episiotomy wound healing or inadequate treatment of underlying active disease prior to delivery. Vaginal tears were also common but delayed wound healing was not associated with IBD therapy. C-section occurred at high rates, particularly in Crohn's disease patients, with no reported delays in postpartum wound healing.

The Use of Immunomodulators, Biologic Therapies, and Small Molecules in Patients With Inflammatory Bowel Disease and Solid Organ Transplant.

Patients with inflammatory bowel diseases (IBDs) may require solid organ transplants (SOTs) for multiple reasons, making its prevalence slightly higher than the general population. Although immunosuppression used in SOT may help control IBD-related inflammation, many patients still require additional immunosuppressive medications. We aim to assess the effectiveness and safety of the combination of SOT-related immunosuppression and IBD medications in patients with liver, kidney, or heart transplantation. We conducted a clinical review using PubMed, Scopus, MEDLINE, Embase, and Google Scholar databases for our search. We included data from systematic reviews, meta-analyses, case series, and case reports to assess the safety, effectiveness, and side effect profile of immunomodulators, biologic therapies, and small molecules in patients with SOT. Our review encompassed 25 liver, 6 kidney, and 1 heart transplant studies involving patients with IBD. Common liver transplant immunosuppressants included tacrolimus, mycophenolate mofetil, cyclosporine, and steroids. Anti-TNF agents, widely used in all SOT types, showed no significant safety issues, though infections and malignancies were noted. Patients with liver transplant on tacrolimus responded well to anti-integrins and ustekinumab without major complications. For kidney transplants, cyclosporine and tacrolimus were prevalent, and their combination with anti-TNF or ustekinumab was generally safe, with rare reports of malignancy or infection. Hence, the use of anti-TNF, anti-integrin agents, and ustekinumab appears to be safe in patients with SOT, regardless of their transplant related immunosuppression. More studies are needed in patients with kidney and heart transplants and in patients treated with small molecules for their IBD.

Pregnancy in Inflammatory Bowel Disease: Data from a Real-World Cohort in Germany.

Background: Inflammatory bowel disease (IBD) frequently manifests at a young age, during the peak fertility years. Understanding the risks of negative pregnancy outcomes associated with IBD is crucial for effective pregnancy management and support. Additionally, it is essential to provide patients with the necessary knowledge to make informed choices and foster their confidence in navigating pregnancy while maintaining effective disease management. Although IBD frequently appears during the peak fertility years, knowledge about managing pregnancy in the context of IBD remains limited and often inaccurate among both physicians and patients. Our study aims to assess the complications occurring during pregnancy in patients with IBD, considering the level of disease activity, and to evaluate the standard of care provided to patients with chronic inflammatory conditions through a cohort analysis. Methods: Patients with IBD who had children were included in this single-center mixed-method (retrospective and prospective) study. Clinical data, disease progression, course of pregnancy, and complications were examined in women. Outcomes for children of men with IBD were also analyzed. To supplement the data, a survey addressing various pregnancy-related topics, including all patients from the university outpatient clinic for IBD, was conducted over a period of six months. Results: A total of 410 patients were screened retrospectively between 2010 and 2021. In total, 134 patients who had children were included in the study: 51.4% (n = 69) had Crohn's disease, 44% (n = 59) had ulcerative colitis, and 4.6% (n = 6) had unclassified inflammatory bowel disease. Of the women, 85% (n = 34) were in remission for at least three months before pregnancy, 14.6% (n = 6) experienced an acute flare-up during pregnancy, and 10.3% (n = 4) and 7.7% (n = 3) had active disease at the time of delivery and during breastfeeding, respectively. Patients with IBD who were in remission before pregnancy did not experience a higher risk of pregnancy complications (no cases of pre-eclampsia or placental abruption were reported in this group). However, the rates of gestational diabetes and fever during pregnancy were 10% for those in remission, compared to 25% for those with active disease. Conclusions: Patients with IBD in remission did not present an increased risk of pregnancy complications. However, our survey indicates that those with active disease at conception were more likely to experience complications such as gestational diabetes and fever. These findings underscore the importance of adequate patient education regarding the safety of various IBD medications during pregnancy in order to avoid pregnancy-related complications.

Genetics of Inflammatory Bowel Disease: Current Understanding and Future Directions

Aim: to present literature data on the genetic underpinnings of inflammatory bowel disease (IBD), focusing on key genetic variants such as NOD2, ATG16L1, and IL23R; The objective of this was to understand how these genetic factors contribute to immune dysregulation, epithelial barrier dysfunction, and mucosal homeostasis in IBD.Key points. IBD, encompassing Crohn's disease and ulcerative colitis, is intricately shaped by a nexus of genetic and environmental factors, and its global prevalence is increasing. Genetic research has identified pivotal variants — NOD2, ATG16L1, and IL23R — linked to IBD, influencing key pathways, such as autophagy, interleukin signaling, and bacterial management. These genetic variants, integral to IBD's etiology of IBD, have functional significance because they perturb immune regulation, compromise epithelial barrier integrity, and disrupt mucosal homeostasis, collectively contributing to intestinal inflammation through diverse mechanisms. Early detection of IBD is paramount for arresting disease progression and underscoring the importance of prognostic testing and genetic screening, especially in cases with familial predispositions or very early onset IBD. Additionally, the use of certain IBD medications, such as corticosteroids, azathioprine, and infliximab, may have implications for male fertility, necessitating a nuanced understanding of these potential effects for informed decision-making in IBD management. This comprehensive understanding of the genetic landscape, functional implications, and diagnostic strategies is vital for advancing personalized treatments and improving outcomes in individuals with IBD.Conclusion. IBD is a complex gastrointestinal disorder influenced by a combination of genetic and environmental factors. Genetic variants, including NOD2, ATG16L1, and IL23R, contribute to dysregulation of immune responses, epithelial barrier function, and mucosal homeostasis. While progress has been made in understanding the genetic landscape of IBD, ongoing research is needed to elucidate the functional consequences of these variants, identify causal genes, and explore gene-environment interactions. This deeper understanding holds the potential for more precise diagnostics and personalized treatments, ultimately improving outcomes in individuals living with IBD.

Biologics and Oral Small Molecules Are Not Associated With Increased Major Adverse Cardiovascular Events or Venous Thromboembolism in Inflammatory Bowel Disease.

Biologics and oral small molecules (OSM) effectively treat inflammatory bowel disease (IBD), but some are linked to higher risks of major adverse cardiovascular events (MACE) and venous thromboembolism (VTE). This study evaluates the MACE and VTE risks in IBD patients treated with biologics or OSM. Using the TrinNetX multi-institutional database, we examined MACE and VTE in adult IBD patients on biologics and compared them to IBD patients not on biologics. We also compared IBD patients on OSM to those not on OSM. We performed 1:1 propensity score matching. MACE (myocardial infarction [MI], stroke, and all-cause mortality) and VTE were assessed from 30 days to 3 years after drug prescription. After matching, IBD patients on biologics had reduced risk of MI, stroke, and all-cause mortality at 1 year, compared to those not on biologics (P < .05). No significant difference in VTE was observed (P = .5). At 3 years, biologic-treated patients had lower risks of MI, stroke, all-cause mortality, and VTE (P < .05). Inflammatory bowel disease patients on OSM showed no significant differences in MI, stroke, or VTE at 1 and 3 years, but had lower all-cause mortality (P < .05). In older IBD patients with at least 1 cardiovascular risk factor, OSM usage showed no significant difference in MI, stroke, or VTE risk compared to nonusers; however, all-cause mortality was decreased at 3 years (P < .05). Inflammatory bowel disease patients treated with biologics or OSM were not at increased risk of MACE or VTE. Although further studies and longer follow-up periods are needed to confirm these findings, our results provide reassurance regarding the safety of these medications in IBD.

Beyond the gut: Exploring neurological manifestations in inflammatory bowel disease

Neurological manifestations in inflammatory bowel diseases (IBD), such as Crohn&amp;rsquo;s disease and ulcerative colitis, are increasingly recognized as significant contributors to both disease burden and patient morbidity. This comprehensive review delves into the spectrum of neurological complications linked with IBD, highlighting the involvement of both the central and peripheral nervous systems. The neurological impairments range from more common conditions such as peripheral neuropathy, characterized by nerve damage leading to pain and numbness, and cerebrovascular diseases, which include strokes and transient ischemic attacks, to less frequent but intensely severe conditions such as multiple sclerosis and myasthenia gravis, which involve the immune system attacking components of the nervous system. The complex pathophysiology underlying these manifestations integrates various factors including immune-mediated responses, vascular abnormalities such as thromboembolism, nutritional deficiencies often exacerbated by malabsorption and chronic inflammation, and the adverse effects elicited by IBD medications such as corticosteroids and immunomodulators. This review underscores the importance of adopting a multidisciplinary management approach. By integrating the expertise of gastroenterologists with that of neurologists, rheumatologists, and other specialists, patient outcomes can be significantly optimized. Further emphasis is placed on the necessity for heightened clinical awareness and the implementation of early diagnostic interventions to effectively identify and mitigate the neurological complications associated with IBD. In conclusion, ongoing research aimed at elucidating the underlying mechanisms that connect IBD with neurological disorders is imperative to facilitate the development of more effective preventative and therapeutic strategies for these challenging complications.

Self-Efficacy, Patient Activation, and the Burden of Inflammatory Bowel Disease on Patients' Daily Lives.

The effective management of inflammatory bowel disease (IBD) requires complex self-management behaviors. Both patient activation (the degree to which patients are willing and able to engage in care) and self-efficacy (one's confidence in performing certain behaviors) are thought to play an important role in chronic disease self-management, but patient activation is a broad concept that can be more difficult to precisely target than self-efficacy. We aimed to describe the relationship between patient activation, self-efficacy, and the burden of IBD on patients' daily lives. Patients with IBD were recruited from a single center to complete a survey including the Patient Activation Measure (PAM-13®), the IBD Self-Efficacy Scale (IBD-SES), and an IBD-specific patient-reported outcome measure. Using multivariable linear regression, we examined the relationship between IBD burden, self-efficacy, and patient activation, adjusting a priori for age, gender, IBD type, IBD medications, active corticosteroid use, anxiety, and depression. We performed a post-hoc mediation analysis to examine self-efficacy as a potential mediator in the relationship between patient activation and the burden of IBD on patient's daily lives. A total of 132 patients with IBD completed the survey (59% Crohn's disease, 41% ulcerative colitis, 52% female). Higher levels of patient activation and higher levels of self-efficacy were each associated with lower IBD burden (patient activation: ß = -1.9, p < 0.001, self-efficacy: ß = -2.6, p < 0.001). Post hoc mediation analysis confirmed that the relationship between patient activation and daily IBD burden was mediated by self-efficacy (Average Causal Mediation Effect = -1.00, p < 0.001, proportion mediated = 0.62, p < 0.001). The relationship between patient activation and IBD burden is highly mediated by self-efficacy, suggesting that self-efficacy could be a more precise target for intervention. Future studies could focus on targeting self-efficacy to build individuals' confidence in IBD self-management and testing of IBD-tailored self-management programs to ultimately improve disease outcomes.