David A. Schwartz

INTRODUCTION: Advanced therapies infrequently achieve complete fistula closure in patients with Crohn's disease (CD). The primary objective of the STOMP2 clinical trial was to determine whether the implantable autologous cell therapy AVB-114 is effective in inducing remission of persistent Crohn's perianal fistulas versus standard of care. METHODS: Eligible patients had a single perianal fistula tract and had failed previous treatment or had documented medication intolerance to biologic or conventional CD therapy. All enrolled subjects underwent surgical fistula optimization and adipose tissue biopsy collection (to manufacture AVB-114) followed by 1:1 randomization to either standard of care (repeat fistula optimization including seton replacement) or AVB-114 implantation. The primary end point was combined fistula remission at 36 weeks, defined as closure of the external opening, no drainage of fluid despite gentle finger compression, and no collections >2 cm in at least 2 of the 3 dimensions on MRI. RESULTS: Subjects at 14 US sites were equally randomized to SoC (N = 24) or AVB-114 (N = 24). Week 36 combined remission was 8.3% and 45.8% for subjects randomized to SoC and AVB-114, respectively (38% difference, 95% CI 11%–60%; P = 0.0078). At week 36, MRI revealed no subjects with collections >2 cm, radiological improvement (≥50% decrease in the Magnetic Resonance Novel Index for Fistula Imaging in Crohn's Disease (MAGNIFI-CD) score from baseline) in 1 SoC subject and 3 AVB-114 subjects, and radiological healing (complete resolution of T2-weighted hyperintensity in fistula tract) in 2 SoC subjects and 5 AVB-114 subjects. Through week 36, there were 40 and 56 treatment emergent adverse events for SoC and AVB-114, respectively. There were no serious treatment emergent adverse events in the AVB-114 group through week 36. DISCUSSION: A significantly higher proportion of patients treated with AVB-114 achieved combined remission vs SoC, and the treatment was well tolerated. These data support the safety and efficacy of AVB-114 in persistent Crohn's perianal fistulas.

Perianal fistula (PAF), a complication of Crohn’s disease (CD), is associated with substantial economic costs and poor prognosis. We determined prevalence of PAF CD in the United States and compared costs and health care resource utilization (HRU) of PAF CD patients with matched non-PAF CD patients. This was a retrospective cohort study of claims data from the IBM MarketScan Commercial Database from October 1, 2015, to September 30, 2018. Eligible patients were aged 18 to 89 years with ≥2 CD diagnoses. Patients with PAF CD had ≥1 PAF diagnosis or procedure code and were matched with non-PAF CD patients. Cumulative prevalence of PAF CD in the US population was calculated across total patients in MarketScan. All-cause and gastrointestinal (GI)-related costs and HRU were compared between groups using a generalized linear model (GLM). Cumulative 3-year prevalence of PAF was 7.70% of patients with CD (N = 81,862) and 0.01% of the US population. Among PAF CD (n = 1218) and matched non-PAF CD (n = 4095) patients, most all-cause costs and HRU were GI-related. Mean total all-cause and GI-related health care costs per patient and per year for PAF CD were $85,233 and $71,612, respectively, vs $40,526 and $29,458 for non-PAF CD (P < .0001). Among PAF CD vs non-PAF CD patients, GLM-adjusted proportions of patients with GI-related inpatient, outpatient, or pharmacy visits, mean GI-related inpatient length of stay, and mean GI-related surgeries were higher (P < .0001 for all comparisons). Costs and HRU are significantly higher for patients with PAF CD vs non-PAF CD patients, highlighting the economic burden of the disease.

Background/Aims: Performance of diagnostic or therapeutic endoscopic procedures in inflammatory bowel disease (IBD) patients can be challenging during a viral pandemic; the main concerns being the safety and protection of patients and health care providers (HCP). The aim of this study is to identify endoscopic practice patterns and outcomes of IBD and coronavirus disease 19 (COVID-19) with a worldwide survey of HCP.Methods: The 20-item survey questionnaire was sent to physician members of the American Society for Gastrointestinal Endoscopy Special Interest Group in Interventional IBD, Chinese IBD Society Endoscopy Interest Group, and the China Crohn’s and Colitis Foundation. Results: A total of 141 respondents submitted valid responses. Nighty-five respondents (67.9%) reported that at least 25% of their scheduled emergent endoscopic procedures were canceled or postponed during the pandemic. Fifty-six respondents (40.0%) have performed emergent endoscopy during the pandemic. A few respondents (9/140, 6.4%) estimated that more than 25% of their patients had worsened disease due to delayed or canceled emergent endoscopy procedures. More than 80% of respondents believed that personal protective equipment (PPE) for the endoscopy team, room sterilization, and pre-procedure screening of patients for COVID-19 were necessary. Out of 140 respondents, 16 (11.4%) reported that several of their patients had COVID-19. Eight clinicians (5.7%) reported that they or their endoscopy colleagues developed work-related COVID-19. Conclusions: Cancellation of elective and emergent endoscopy in IBD care during the pandemic was common. Few respondents reported that their patients’ disease conditions worsened due to the cancellation of the endoscopy procedure. Most respondents voiced the need for proper PPE during the procedure regardless of patients’ COVID-19 status and screening the patients for COVID-19.

Background While the pathogenesis of inflammatory bowel disease (IBD) is incompletely understood, disruption of epithelial integrity is suspected to play a prominent role in disease initiation and progression. Currently, there is no convenient way to measure this in vivo. Aims Our aim is to determine whether a mucosal integrity (MI) testing device that has been used to measure MI in the esophagus can also be used to measure barrier function in the colon during colonoscopy. Methods Mucosal integrity testing was measured in patients with IBD (n = 17) and controls (n = 7) during colonoscopy. During the procedure, an MI catheter was passed down the working channel of the colonoscope and placed along the mucosal wall to measure MI in the rectum, left, transverse, and right colon. In patients with IBD, MI measurements and biopsies were taken in areas which appeared inflamed when present. We then determined if there was a significant difference in MI between patients with IBD and controls. Results MI was significantly higher in the rectum of patients with IBD (CD and UC combined) versus control colons [767 (618–991) vs. 531 (418–604) ohms, P < 0.01]. There were no significant differences in MI among patients with IBD versus controls in the right, transverse, or left colon. Within the IBD group, there were no significant differences in MI between inflamed versus non-inflamed rectums. There was no correlation between quality of life scores or endoscopic severity with MI, though this study was likely underpowered to detect these differences. Conclusion Rectal MI is significantly higher in patients with IBD versus controls. Future studies are needed to determine how this information can be used clinically.

Background: Hospital admission during radiotherapy (ADRT) is associated with increased cost, interrupted treatment, and inferior outcomes. The purpose of this study was to benchmark patient ADRT rates, define socioeconomic predictors for ADRT, and geographically map ADRT rates on the neighborhood level across a large Mid-Southern catchment region served by a single academic cancer referral center. Methods: Demographic, clinical and treatment information were collected for all patients treated with radiation therapy (RT) at our center from January 1, 2015 to December 31, 2017. Occurrence of ADRT included inpatient and emergency room admissions. ADRT was categorized as causing “minor interruption” if ADRT was associated with postponement in 1-4 RT treatments. “Major interruption” was defined as postponement in 5 or more treatments. Patients with Medicaid or no insurance were categorized as “At-Risk”. Patient predicted income (PPI) was modeled using 2017 US Census data for annual household income by patient residence census tract, categorized into low (<$34k), middle, and high (>$67k) thirds. ADRT rates were compared across variables, analyzed using Pearson’s Chi square testing, and geomapped by patient residence at the neighborhood (census tract) level. Results: 3,729 patients were included. 2,032 (54.5%) were Caucasian, 1,577 African American (42.3%), and 120 (3.2%) other. Insurance status was defined as Commercial, Medicare, or At Risk in 1,794 (48.1%), 1,503 (40.3%), and 432 (11.6%) patients. The mean PPI was $49,951 (range $10,871-$177,857). A total of 83,306 fractions (median 24, IQR 11-30) were delivered with 7,107 (8.5%) total interruptions. 727 interruptions (mean 0.19, range 0-21) were due to ADRT in 197 patients (5.3%). Minor interruption rates were significantly elevated in At Risk patients v. those with Commercial or Medicare insurance (7.4% v 3.5% p=Citation Format: Daniel V Wakefield, Matthew Carnell, Bo Jiang, Austin Dove, Wesley Garner, Drucilla Edmonston, Adam Hubler, Esra Ozdenerol, Ryan Hanson, Maria Pisu, David L Schwartz, David L Schwarts. Neighborhood, race and insurance predict for hospital admission during radiation therapy [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr A124.