Kaur, Manreet

Abstract Background While biologic and small molecule therapies have expanded treatment options for moderate to severe ulcerative colitis (UC), prior research revealed that only 26% of patients in routine practice would have qualified for pivotal randomized controlled trials (RCTs) due to stringent eligibility criteria. This study aimed to evaluate contemporary clinical trial eligibility for UC patients in a tertiary care setting based on more recently approved therapies. Methods We performed a retrospective cohort study of adult patients with moderate to severe UC (total Mayo score ≥6) seen between January 2022 and February 2023. Inclusion and exclusion criteria from seven phase III RCTs conducted between 2012 and 2022 (eg, VARSITY, UNIFI, OCTAVE, LUCENT) were applied to determine patient eligibility and identify reasons for ineligibility. Results Of 150 patients (mean age 44.9 years; 55.7% male), only 42.7% were eligible for at least one RCT. The most common exclusion factor was current or prior medication use, followed by anemia, dysplasia, and disease extent. Trial eligibility did not significantly differ by age, gender, or disease duration. Conclusions Despite modest improvements since 2012, over half of real-world UC patients remain ineligible for current RCTs. Expanding inclusion criteria, especially regarding prior medication exposure, and adopting more inclusive trial designs may enhance external validity. Addressing disparities in trial access and participation remains essential to ensuring equitable representation and improving clinical applicability of RCT findings.

Abstract Objectives Oral extraintestinal manifestations (OEIMs) of inflammatory bowel disease (IBD) may impact IBD treatment. The aims of this study were to: (1) determine which OEIMs are most prevalent among patients with IBD, (2) investigate the presence of a temporal association between GI luminal disease activity and OEIMs, and (3) determine how often changes in therapeutic management of IBD are needed in the presence of OEIMs. Study Design A retrospective cohort study was performed for adult patients with IBD evaluated between January 2017 and November 2021 with at least 1 oral complaint. Demographic data were collected from the charts of these patients. Kruskal-Wallis test for continuous measures and Fisher’s Exact test for categorical measures were used. Results A total of 116 patients with IBD who had presented with at least 1 oral finding during the study time period were identified. Aphthous ulcers were the most common oral presentation in both Crohn’s disease (CD) (85.1%) and ulcerative colitis (UC) (75.0%). OEIMs were associated with CD activity in the small intestine (P = .004) and colon (P < .001). UC pancolitis was associated with OEIMs (P = .002). In 32.7% of patients, OEIMs led to either an increase in dose or frequency of IBD therapy. In an additional 16.4% of patients, new systemic agents were started because of the OEIMs. Conclusions This study provides evidence that patients with IBD may develop OEIMs synchronous with IBD flares and may require escalation of IBD therapy when OEIMs occur.

Abstract Background Clinical and molecular subcategories of inflammatory bowel disease (IBD) are needed to discover mechanisms of disease and predictors of response and disease relapse. We aimed to develop a study of a prospective adult research cohort with IBD (SPARC IBD) including longitudinal clinical and patient-reported data and biosamples. Methods We established a cohort of adults with IBD from a geographically diverse sample of patients across the United States with standardized data and biosample collection methods and sample processing techniques. At enrollment and at time of lower endoscopy, patient-reported outcomes (PRO), clinical data, and endoscopy scoring indices are captured. Patient-reported outcomes are collected quarterly. The quality of clinical data entry after the first year of the study was assessed. Results Through January 2020, 3029 patients were enrolled in SPARC, of whom 66.1% have Crohn’s disease (CD), 32.2% have ulcerative colitis (UC), and 1.7% have IBD-unclassified. Among patients enrolled, 990 underwent colonoscopy. Remission rates were 63.9% in the CD group and 80.6% in the UC group. In the quality study of the cohort, there was 96% agreement on year of diagnosis and 97% agreement on IBD subtype. There was 91% overall agreement describing UC extent as left-sided vs extensive or pancolitis. The overall agreement for CD behavior was 83%. Conclusion The SPARC IBD is an ongoing large prospective cohort with longitudinal standardized collection of clinical data, biosamples, and PROs representing a unique resource aimed to drive discovery of clinical and molecular markers that will meet the needs of precision medicine in IBD.