S1105 Natural History and Predictors of Treatment Failure in Patients With Ulcerative Colitis on 5-Aminosalicylic Acid: A U.S. Population-Level Cohort Study
S1103 Comparative Effectiveness of Ozanimod and Vedolizumab as First-Line Advanced Therapies in Ulcerative Colitis: A Propensity-Matched Cohort Analysis
S1104 Updated Epidemiological Insights on the Association Between Eosinophilic Esophagitis and Inflammatory Bowel Disease: A United States Population-Based Cohort Study
Disproportionately Increasing Incidence of Inflammatory Bowel Disease in Female Patients and the Elderly: An Update Analysis from the Global Burden of Disease Study 2021
INTRODUCTION: To update the global burden of inflammatory bowel disease (IBD) using data from the Global Burden of Disease 2021. METHODS: Data from Global Burden of Disease 2021 were analyzed to assess the IBD burden. RESULTS: In 2021, there were 375,140 new cases and 3.83 million total cases of IBD. Elderly onset IBD accounted for 11% of incidences. 167 countries increased IBD incidence rate, with rates rising in female patients (APC: +0.06%) and the elderly (APC: +0.14%) but stable in male patients and the overall population. DISCUSSION: Although the global burden of IBD has decreased overall, it has increased in female patients and the elderly.
Clinical Trial Design Considerations for Hospitalised Patients With Ulcerative Colitis Flares and Application to Study Hyperbaric Oxygen Therapy in the NIDDK HBOT‐UC Consortium
ABSTRACTBackgroundPatients with ulcerative colitis (UC) who are hospitalised for acute severe flares represent a high‐risk orphan population.AimTo provide guidance for clinical trial design methodology in these patients.MethodsWe created a multi‐centre consortium to design and conduct a clinical trial for a novel therapeutic intervention (hyperbaric oxygen therapy) in patients with UC hospitalised for moderate–severe flares. During planning, we identified and addressed specific gaps for inclusion/exclusion criteria; disease activity measures; pragmatic trial design considerations within care pathways for hospitalised patients; standardisation of care delivery; primary and secondary outcomes; and sample size and statistical analysis approaches.ResultsThe Truelove‐Witt criteria should not be used in isolation. Endoscopy is critical for defining eligible populations. Patient‐reported outcomes should include rectal bleeding and stool frequency, with secondary measurement of urgency and nocturnal bowel movements. Trial design needs to be tailored to care pathways, with early intervention focused on replacing and/or optimising responsiveness to steroids and later interventions focused on testing novel rescue agents or strategies. The PRECIS‐2 framework offers a means of tailoring to local populations. We provide standardisation of baseline testing, venous thromboprophylaxis, steroid dosing, discharge criteria and post‐discharge follow‐up to avoid confounding by usual care variability. Statistical considerations are provided given the small clinical trial nature of this population.ConclusionWe provide an outline for framework decisions made for the hyperbaric oxygen trial in patients hospitalised for UC flares. Future research should focus on the remaining gaps identified.
Endoscopic Balloon Dilatation of Ileal Pouch-Anal Anastomosis Strictures in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis
Abstract Background Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the treatment of choice for medically refractory inflammatory bowel disease (IBD). In this systematic review and meta-analysis, we assess outcomes and safety of endoscopic balloon dilatation (EBD) for IPAA strictures. Methods A systematic search of numerous databases was performed through June 2023 to identify studies reporting on the outcomes of EBD in pouch-related strictures. Outcomes included technical success, clinical success at index dilation and in pouch retention, recurrence of symptoms post-EBD, and adverse events of EBD. Meta-analysis was performed using a random-effects model, and results were expressed in terms of pooled rates along with relevant 95% confidence intervals (CIs). Heterogeneity was assessed using Cochran Q statistical test with I2 statistics. Results Seven studies with 504 patients were included. The pooled rate of technical success and clinical success of index dilatation was 98.9% (95% CI, 94.8-99.8%; I20%) and 30.2% (95% CI, 7.1-71%; I20%), respectively. The pooled rate of clinical success in pouch retention without the need for additional surgery was 81.4% (95% CI, 69.6-89.3%; I272%). The pooled failure rate of EBD was 18.6% (95% CI, 10.7-30.4%, I272%). The pooled rate of recurrence of symptoms after index dilatation was 58.9% (95% CI, 33.3-80.5%; I213%). The pooled rate of serious adverse events was 1.8% (95% CI, 1-3.5%, I20%). No deaths related to EBD were reported. Conclusions Endoscopic balloon dilatation is safe and highly effective for management of IPAA strictures. Additional studies are needed to compare its efficacy with surgical interventions.
Metformin Is Associated With Improved Inflammatory Bowel Disease Outcomes in Patients With Type 2 Diabetes Mellitus: A Propensity-Matched Cohort Study
Abstract Background Metformin exerts anti-inflammatory properties through a positive effect on oxidative stress, gut barrier integrity, and the gut microbiota. Our aim was to evaluate the influence of metformin on inflammatory bowel disease (IBD) outcomes in patients with type 2 diabetes mellitus (T2DM). Methods We conducted a retrospective cohort study using the TriNetX database in patients with IBD and T2DM who initiated metformin vs oral hypoglycemics or insulin (control cohort) between August 31, 2002, and August 31, 2022. One-to-one propensity score matching was performed. Primary outcomes were need for intravenous (IV) steroid use or IBD-related surgery within 1, 2, and 3 years after metformin initiation. Results Our cohorts included 1323 patients with ulcerative colitis (UC) (mean age 58.7 ± 12.2 years, 50.1% female, 77.3% White) and 1278 patients with Crohn’s disease (CD) (mean age 56.3 ± 12.6 years, 58.2% female, 76.5% White). At 1 year, patients with UC and CD were less likely to require IV steroids (UC: adjusted odds ratio [aOR], 0.45; 95% confidence interval [CI], 0.34-0.59; P < .01; CD: aOR, 0.67; 95% CI, 0.53-0.85; P < .01). The decreased need for IV steroids persisted in all metformin groups at 2 and 3 years. Patients with CD were at a lower risk for IBD-related surgery at year 1 (aOR, 0.5; 95% CI, 0.31-0.81; P < .01), and this finding persisted at 3 years (aOR, 0.62; 95% CI, 0.43-0.89; P < .01). Metformin did not affect risk for surgery in patients with UC. Conclusions Patients with IBD and T2DM on metformin had a decreased likelihood of worse IBD outcomes.
Comparative Effectiveness of Upadacitinib and Tofacitinib in Ulcerative Colitis: A US Propensity-Matched Cohort Study
INTRODUCTION: There are limited real-world data comparing the effectiveness of upadacitinib and tofacitinib in patients with ulcerative colitis (UC). METHODS: We conducted a retrospective cohort study using TriNetX, a multi-institutional database, to compare the effectiveness of upadacitinib and tofacitinib in patients with UC. The primary aim was to assess the risk of a composite outcome of hospitalization requiring intravenous steroids and/or colectomy within 6 and 12 months. One-to-one propensity score matching was performed for demographics, comorbid conditions, mean hemoglobin, C-reactive protein, albumin, and calprotectin, and prior UC medications including recent oral or intravenous steroid use between the cohorts. Risk was expressed as adjusted odds ratio (aOR) with 95% confidence intervals (CI). RESULTS: There were 526 patients in the upadacitinib cohort (mean age 40.4 ± 16.3, 44.8% female sex, 76.6% White race) and 1,149 patients in the tofacitinib cohort (mean age 42 ± 17.1, 41.9% female sex, 76% White race). After propensity score matching, there was no significant difference in the risk of the composite outcome of need for intravenous steroids and/or colectomy within 6 months (aOR 0.75, 95% CI 0.49–1.09). However, there was a lower risk of the composite outcome (aOR 0.63, 95% CI 0.44–0.89) in the upadacitinib cohort compared with the tofacitinib cohort within 12 months. There was no difference in the risk of intravenous steroid use (aOR 0.70, 95% CI 0.48–1.02) but lower risk of colectomy (aOR 0.46, 95% CI 0.27–0.79). In sensitivity analysis, there was also a lower risk of the composite outcome (aOR 0.64, 95% CI 0.44–0.94), including lower risk of intravenous steroid use (aOR 0.67, 95% CI 0.45–0.99) and colectomy (aOR 0.49, 95% CI 0.26–0.92) in the upadacitinib cohort compared with the tofacitinib cohort within 12 months. DISCUSSION: This study utilizing real-world data showed that upadacitinib was associated with improved disease-specific outcomes at 12 months compared with tofacitinib in patients with UC.