Gender Differences and Other Factors Associated with Weight Gain Following Initiation of Infliximab: A Post Hoc Analysis of Clinical Trials.

BACKGROUND: In our clinical practice, women often report excess weight gain with infliximab (IFX) use. There are currently no studies investigating weight gain after antitumor necrosis factor therapy in patients with inflammatory bowel disease. The objective of this study was to evaluate the association of clinical factors, with a particular focus on sex and weight gain in patients with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) initiating IFX. METHODS: Data was extracted from ACCENT I, ACCENT II, ACT 1, and SONIC; included patients received IFX for induction or maintenance of remission of CD or UC. Patients treated with azathioprine (IFX 0 mg/kg) were included as controls. Baseline demographics, clinical characteristics, and weight at each follow-up for the study duration were collected. In addition to descriptive statistics, adjusted mixed effects models were used to test the association between clinical variables and weight gain. RESULTS: There were 1273 patients included for analysis; the majority was white (91%), with CD (81%), and half of patients (50%) were women. Upon univariate analysis, IFX dose, African American race, diagnosis of CD, elevated C-reactive protein, and low hematocrit and albumin were associated with weight gain (P < 0.001). Upon adjusted analysis, sex was significantly associated with weight gain (P = 0.009), with women experiencing a lower percentage increase from baseline weight than men (3.9% increase vs 4.3% increase). CONCLUSIONS: When starting IFX, those with markers of severe disease and with a diagnosis of CD are likely to gain more weight. Adjusting for confounding variables, women actually gain less weight than men after IFX treatment, although this difference is not clinically relevant.

Effect of TELEmedicine for Inflammatory Bowel Disease on Patient Activation and Self-Efficacy.

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.

Correction to: Effect of TELEmedicine for Inflammatory Bowel Disease on Patient Activation and Self-Efficacy.

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.

The Telemedicine for Patients With Inflammatory Bowel Disease (TELE-IBD) Clinical Trial: Qualitative Assessment of Participants' Perceptions.

BACKGROUND: Inflammatory bowel disease (IBD), comprising Crohn disease and ulcerative colitis, affects 1 to 3 million people in the United States. Telemedicine has shown promise in IBD. The objective of this study, telemedicine for patients with IBD (TELE-IBD), was to compare disease activity and quality of life (QoL) in a 1-year randomized clinical trial of IBD patients receiving telemedicine versus standard care. Treatment groups experienced improvements in disease activity and QoL, but there were no significant differences between groups. Study adherence to the text-based intervention was less than 80%, the targeted goal. OBJECTIVE: To understand adherence to remote monitoring, the goal of this qualitative assessment was to obtain TELE-IBD trial participants' perceptions, including their recommendations for future monitoring. METHODS: In this study, patients attending 3 tertiary referral centers with worsening IBD symptoms in the previous 2 years were eligible for randomization to remote monitoring via SMS text messages (short message service, SMS) every other week, weekly, or standard care. Participants (n=348) were evenly enrolled in the treatment groups, and 259 (74.4%) completed the study. For this study, a purposive sample of adherent (N=15) and nonadherent (N=14) patients was drawn from the TELE-IBD trial population. Adherence was defined as the completion of 80% (278/348) or more of the weekly or every other week self-assessments. Semistructured interviews conducted by phone surveyed (1) the strengths and benefits of TELE-IBD, (2) challenges associated with using TELE-IBD, and (3) how to improve the TELE-IBD intervention. Interviews were recorded, professionally transcribed, and coded based on a priori concepts and emergent themes with the aid of ATLAS.ti, version.7 qualitative data analysis software. RESULTS: Participants' discussions centered on 3 elements of the intervention: (1) self-assessment questions, (2) action plans, and (3) educational messages. Participants also commented on text-based platform, depression and adherence, TELE-IBD system in place of office visit, and their recommendations for future TELE-IBD systems. Adherent and nonadherent participants prefer a flexible system that is personalized, including targeted education messages, and they perceive the intervention as effective in facilitating IBD self-management. CONCLUSIONS: Participants identified clear benefits to the TELE-IBD system, including obtaining a better understanding of the disease process, monitoring their symptoms, and feeling connected to their health care provider. Participants' perceptions obtained in this qualitative study will assist in improving the TELE-IBD system to be more responsive to patients with IBD.

Inflammatory Bowel Disease Telemedicine Clinical Trial: Impact of Educational Text Messages on Disease-Specific Knowledge Over 1 Year.

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.