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Background Depression is common in patients with inflammatory bowel disease (IBD) and is known to be associated with poor adherence in the usual care setting. In the last decade, there has been an increase in the use of information technology (IT) for the delivery of IBD care, but the association between depressive symptoms (DS) and adherence to self-testing in this context is not known. We aimed to investigate this association among IBD patients managed via a text messaging-based telemedicine system. Methods This was a prospective study of participants in the 2 intervention arms of the Telemedicine for Patients with IBD (TELE-IBD) trial. Depressive symptoms were measured at baseline, and then participants received periodic text messages to initiate IBD-specific self-testing. Treatment plans were similarly conveyed, and adherence to self-testing was evaluated at the end of 1 year. Regression analyses were performed, and age-stratified models were constructed to evaluate for effect modification. Results Of the 193 study participants, 48% had DS at baseline. Overall, there was no significant association between DS and adherence to self-testing. However, upon stratification by age, adherence increased with depressive symptoms in those that were 40 years and younger (P = 0.02), but there was no association between depressive symptoms and adherence in the older group (P = 0.53). Conclusions Younger IBD patients with DS have high adherence when managed in a text messaging-based telemedicine program. Telemedicine interventions have the potential to improve health outcomes in this demographic-a group that is often thought to be difficult to manage due to nonadherence.

Background Effective treatments are available for patients with inflammatory bowel disease (IBD); however, suboptimal outcomes occur and are often linked to patients’ limited disease knowledge. The aim of this analysis was to determine if delivery of educational messages through a telemedicine system improves IBD knowledge. Methods TELEmedicine for Patients with IBD (TELE-IBD) was a randomized controlled trial with visits at baseline, 6 months, and 12 months; patient knowledge was a secondary aim of the study. Patients were randomized to receive TELE-IBD every other week (EOW), weekly (TELE-IBD W), or standard of care. Knowledge was assessed at each visit with the Crohn’s and Colitis Knowledge (CCKNOW) survey. The primary outcome was change in CCKNOW score over 1 year compared between the TELE-IBD and control groups. Results This analysis included 219 participants. Participants in the TELE-IBD arms had a greater improvement in CCKNOW score compared with standard care (TELE-IBD EOW +2.4 vs standard care +1.8, P = 0.03; TELE-IBD W +2.0 vs standard care +1.8, P = 0.35). Participants with lower baseline CCKNOW scores had a greater change in their score over time (P < 0.01). However, after adjusting for race, site, and baseline knowledge, there was no difference in CCKNOW score change between the control and telemedicine arms. Conclusions Telemedicine improves IBD-specific knowledge through text messaging, although the improvement is not additive with greater frequency of text messages. However, after adjustment for confounding variables, telemedicine is not superior to education given through standard visits at referral centers. Further research is needed to determine if revised systems with different modes of delivery and/or frequency of messages improve disease knowledge.

Background & Aims Systemic cellular immunity elicited by the Ty21a oral typhoid vaccine has been extensively characterized. However, very limited data are available in humans regarding mucosal immunity at the site of infection (terminal ileum [TI]). Here we investigated the host immunity elicited by Ty21a immunization on terminal ileum–lamina propria mononuclear cells (LPMC) and peripheral blood in volunteers undergoing routine colonoscopy. Methods We characterized LPMC-T memory (TM) subsets and assessed Salmonella enterica serovar Typhi (S Typhi)–specific responses by multichromatic flow cytometry. Results No differences were observed in cell yields and phenotypes in LPMC CD8+-TM subsets following Ty21a immunization. However, Ty21a immunization elicited LPMC CD8+ T cells exhibiting significant S Typhi–specific responses (interferon-γ, tumor necrosis factor-α, interleukin-17A, and/or CD107a) in all major TM subsets (T-effector/memory [TEM], T-central/memory, and TEM-CD45RA+), although each TM subset exhibited unique characteristics. We also investigated whether Ty21a immunization elicited S Typhi–specific multifunctional effectors in LPMC CD8+ TEM. We observed that LPMC CD8+ TEM responses were mostly multifunctional, except for those cells exhibiting the characteristics associated with cytotoxic responses. Finally, we compared mucosal with systemic responses and made the important observation that LPMC CD8+S Typhi–specific responses were unique and distinct from their systemic counterparts. Conclusions This study provides the first demonstration of S Typhi–specific responses in the human terminal ileum mucosa and provides novel insights into the generation of mucosal immune responses following oral Ty21a immunization., Graphical abstract

Background Depression is common in patients with inflammatory bowel disease (IBD) and contributes to poor quality of life (QoL). The use of information technology for the remote management of patients with IBD is growing, but little is known about its impact on depressive symptoms (DS) and QoL. We aimed to evaluate the impact of telemedicine on DS and generic QoL in IBD patients. Methods We analyzed data from the Telemedicine for Patients with IBD (TELE-IBD) study. During this 12-month clinical trial, patients were randomized to receive text message-based telemedicine weekly (TELE-IBD W), every other week (TELE-IBD EOW), or to standard care. Depressive symptoms and QoL were assessed over time with the Mental Health Inventory 5 (MHI-5) and the Short Form 12 (SF-12), respectively. We compared the change in MHI-5 and SF-12 (with separate physical (PCS) and mental component summary (MCS) scores) between the study arms. Results A total of 217 participants were included in this analysis. After 1 year, there was no significant difference in the change in MHI-5 (TELE-IBD W +3.0 vs TELE-IBD EOW +0.7 vs standard care +3.4; P = 0.70), MCS (TELE-IBD W +1.4 vs TELE-IBD EOW +1.0 vs standard care +2.5; P = 0.89), and PCS scores (TELE-IBD W +0.4 vs TELE-IBD EOW +0.6 vs standard care +3.7; P = 0.06) between the groups. Conclusions Text message-based telemedicine does not improve DS or QoL when compared with standard care in IBD patients treated at tertiary referral centers. Further studies are needed to determine whether telemedicine improves DS or QoL in settings with few resources., Lay Summary This study showed that, in patients with inflammatory bowel disease, the use of information technology to deliver care via text messaging did not improve depressive symptoms or quality of life when compared with usual healthcare.

INTRODUCTION: Limitations in inflammatory bowel disease (IBD) care necessitate greater patient activation and self-efficacy, measures associated with positive health outcomes. METHODS: We assessed change in patient activation and general self-efficacy from baseline to 12 months through our TELEmedicine for IBD trial, a multicenter, randomized controlled trial consisting of a web-based monitoring system that interacts with participants via text messaging. A total of 222 adults with IBD who had experienced an IBD flare within 2 years prior to the trial were randomized into either a control arm that received standard care (SC) or an intervention arm that completed self-testing through the TELE-IBD system every other week (EOW) or weekly (W). RESULTS: Changes in self-efficacy scores were not significantly different between control and experimental groups. Patient activation scores were significantly different between standard care and the TELE-IBD EOW group only (p = 0.03). CONCLUSIONS: Use of remote monitoring did not improve self-efficacy or patient activation compared to routine care.

This manuscript is a secondary analysis of a large multicenter randomized controlled trial. The primary study is Cross RK et al., A Randomized Controlled Trial of TELEmedicine for patients with Inflammatory Bowel Disease (TELE-IBD). Am J Gastroenterol, 2019 Mar.

BACKGROUND Ustekinumab is a new biologic therapy targeting interleukin-12 and interleukin -23. It is currently approved for the treatment of psoriasis, but clinical trials have shown that it can induce and maintain remission in Crohn's disease (CD). We aim to evaluate effectiveness of ustekinumab in the treatment of CD. METHODS A retrospective chart review was performed including patients (pts) from 2 academic medical centers with complicated, refractory CD started on ustekinumab between June 2011 and June 2014. Pts were treated based on a novel subcutaneous dosing schedule designed to simulate the intravenous load used in clinical trials. RESULTS Forty-five pts were treated with ustekinumab during this study period. Of the pts who had clinical parameters available before and after medication start, 46% achieved clinical response (Harvey-Bradshaw index decrease ≥ 3) and 35% achieved clinical remission (Harvey-Bradshaw index ≤ 3). Short inflammatory bowel disease questionnaire scores increased significantly (46 [20, 68] to 55 [32, 70], P < 0.05). Erythrocyte sedimentation rate decreased significantly (20 [3, 54] to 12 [0, 42] mm/h, P < 0.05). C-reactive protein decreased significantly (4.9 [0.3, 111] to 3.3 [0.2, 226] mg/L, P < 0.05). Seventy-six percent of patients demonstrated an endoscopic response and 24% achieved complete endoscopic remission. Twelve patients (26%) were hospitalized for IBD-related issues. Four pts had infection-related complications. Six pts (13%) underwent surgery for IBD-related issues. Three pts stopped ustekinumab, 1 for pt preference and 2 for the lack of response. CONCLUSIONS Using a novel subcutaneous dosing schedule, ustekinumab was successful in improving clinical, laboratory, and endoscopic markers of disease activity in patients with severe, refractory CD.

Although classically pseudomembranous colitis is caused byClostridium difficile, it can result from several etiologies. Certain medications, chemical injury, collagenous colitis, inflammatory bowel disease, ischemia, and other infectious pathogens can reportedly cause mucosal injury and subsequent pseudomembrane formation. We present the case of a middle-aged woman with vascular disease who was incorrectly diagnosed with refractoryC. difficileinfection due to the presence of pseudomembranes. Further imaging, endoscopy, and careful histopathology review revealed chronic ischemia as the cause of her pseudomembranous colitis and diarrhea. This case highlights the need for gastroenterologists to consider non-C. difficileetiologies when diagnosing pseudomembranous colitis.

Background Fistulizing disease occurs in up to 40% of patients with Crohn's disease (CD) . Symptoms, including anal pain, purulent discharge, and incontinence, are associated with high morbidity and impaired quality of life. Vedolizumab (VDZ) is a monoclonal antibody to alpha4beta7 integrin with demonstrated efficacy and safety in the treatment of patients with CD. The present exploratory analysis evaluated the efficacy of VDZ in the subpopulation of patients with fistulizing CD from a phase 3, randomized, placebo (PBO)-controlled trial (GEMINI 2).1 Methods In the GEMINI 2 study, patients who received 2 doses of VDZ during the induction phase and achieved a clinical response at week 6 received treatment with PBO or VDZ 300 mg every 8 weeks (Q8W) or every 4 weeks (Q4W) for an additional 46 weeks (maintenance intent-to-treat [ITT] population). Fistula closure, a prespecified exploratory endpoint, was assessed at each visit (2-6 week intervals) until week 52. The percentage of patients achieving fistula closure and mean time to fistula closure were calculated. Results Among the maintenance ITT population (N=461), 57 patients (12%) had 1 or more draining fistulae at study entry, with 74% of fistulae located perianally. Of these patients, 44-49% had failed prior anti-tumor necrosis factor therapy and 39-54% had prior surgery for CD. By week 14, 28% of patients treated with VDZ/VDZ (Q8W + Q4W combined) had achieved fistula closure versus 11% of those receiving VDZ/PBO (Table). This treatment difference was maintained up to week 52. Kaplan-Meier probabilities of fistula closure with VDZ treatment were 29.2% and 33.4% at 6 and 12 months, respectively; notably, the number of patients at risk was small (Figure). Conclusion In the GEMINI 2 maintenance ITT population, a greater percentage of patients with draining fistulae at study entry achieved fistula closure when they continued treatment with VDZ compared with those who were re-randomized to PBO. This effect was maintained through to week 52.These preliminary findings support the role of VDZ in the treatment of fistulizing disease and warrant further investigation in dedicated prospective studies in this population. Reference 1. Sandborn WJ, et al. N Engl J Med . 2013;369(8):711-721; NCT00783692. The clinical study was funded by Millennium Pharmaceuticals, Inc. (d/b/a Takeda Pharmaceuticals International Co.). Medical writing assistance was provided by inVentiv Medical Communications and supported by Takeda Pharmaceuticals International, Inc.

Telemedicine has been used successfully in monitoring patients with a variety of chronic illnesses. Studies in the field of gastroenterology have shown that telemedicine is a feasible and well accepted method of patient monitoring. Several inflammatory bowel disease (IBD) centers have developed telemedicine systems to improve the management of these com- plex diseases. Implementation of these systems is feasible, and telemedicine is well received by patients. Telemedicine has been shown to improve disease activity, quality of life, adherence with short-term treatment, and to shorten relapses. Telemedicine has also been shown to decrease health care utilization; however, use of telemedicine systems is also associated with increased "non-billable" encounters (phone calls and electronic messages). Telemedicine has also been shown to be an effective mechanism to provide remote care in areas without access to IBD spe- cialty care. It is likely that telemedicine will be increasingly utilized in the future as an adjunct to traditional monitoring, especially for patients at high risk for nonadherence, and for those with limited access to IBD centers of excellence, to improve patient self-management, and as a mechanism to provide education, health maintenance, and medication reminders to patients.

and suspect types were 4(7.4%), 23(42.6%), 27(50.0%) patients, respectively. The median dosage of corticosteroid was 0.58mg/kg (0.39-1.20). There were 25(46.3%) cases with complete remission, 23(42.6%) with partial remission, and 6(11.1%) patients showed no response to corticosteroid therapy after 1 month post-treatment. Three months after the treatment, 22(40.7%) showed prolonged response, 25(46.3%) showed steroid dependency, 3(5.6%) showed refractoriness and 4 (7.4%) received operation respectively. At 1 year, there were 26(48.1%) patients in prolonged response, 19(35.2%) in corticosteroids dependency, and 4(7.4%) that received operation. The cumulative probability of surgery was 17.5% and 49.1% at 1 and 3 years, respectively. Prolonged response at three months was independently associated with decreased risk of surgery in the long-term (P=0.009, HR 0.176, CI 0.0480.649). Conclusions: Short-term response rate to initial corticosteroid therapy in IBD was high, however the responses showed a decreasing tendency along with time. Prolonged response at three month was associated with decreased risk of surgery in the long-term.