T1241 Promotion of CD4+CD25+FOXP3+ Regulatory Cells by Oral Administration of Locally Acting Delayed Release Low-Dose 6MP Formulation Alleviated Crohn's Disease: Results of Phase I/II Clinical Trial

Abstract

Introduction: Clinical outcomes are suboptimal in patients with ulcerative colitis (UC). Nonadherence, side effects, ineffective monitoring, limited education, and restricted access to care contribute to poor outcomes. Use of telemedicine for inflammatory bowel disease (IBD) is feasible and improves outcomes. Our goals were to evaluate the effect of a home telemanagement system for UC (UC HAT) on disease activity, quality of life (QoL), and adherence compared to best available care (BAC). Methods: Adults with UC evaluated at either the University of Maryland or the VA were invited to participate. Participants in UC HAT underwent weekly self-testing. Self-testing consisted of answering questions regarding disease activity, adherence, side effects, and measurement of weight. An educational curriculum was delivered at the end of each session. Alerts and action plans were generated based on the results. The BAC arm underwent routine follow up, received written action plans and were given educational fact sheets. Seo Index scores, IBDQ scores, and Morisky Medication Adherence scale scores were measured every 4 months for 1 year. Results: 25 patients were randomized to UC HAT and 22 to BAC. At baseline, 56% of UC HAT participants were on immune suppressants (IS) compared to 27% in BAC (p=0.05). BAC participants had higher QoL scores (191 vs. 172, p=0.02) and lower depression scores (16 vs. 21, p=0.01) than UC HAT participants at baseline. Adherence was poor at baseline (45% BAC and 40% UC HAT, p=NS). After 12 months, 11 (44%) participants withdrew in UC HAT compared to 5 (24%) in BAC. Disease activity, QoL, and adherence were not significantly different between groups at any time point post baseline. In UC HAT, decreased disease activity was seen at 8 and 12 months (-11 and -10 respectively, p=0.07) compared to baseline. Analysis of trial completers, adjusting for baseline disease activity and QoL, demonstrated improved QoL in UC HAT compared to BAC at 12 months (194 vs. 178, p=0.12). UC HAT participants experienced a 12 point increase in QoL scores compared to a 5 point decrease in BAC (p= 0.10). Conclusions: UC HAT did not improve disease activity or self-reported adherence compared to BAC after 1 year. However, significant differences in IS use, QoL, and depression scores were present at baseline between the arms which may have impacted the results. This is supported by a per-protocol analysis adjusted for baseline disease activity and QoL; UC HAT participants had a trend towards improved QoL compared to BAC. Our results suggest a potential benefit of UC HAT. Further research is indicated to determine if telemedicine improves outcomes in patients IBD.