Search

Background Severe acute respiratory syndrome coronavirus 2 vaccination is recommended for all individuals with inflammatory bowel disease (IBD), including those on immunosuppressive therapies; however, little is known about vaccine safety and efficacy in these patients or the impact of vaccination on IBD disease course. Methods We evaluated coronavirus disease 2019 (COVID-19) vaccine–related adverse events (AEs) and the effect of vaccination on IBD disease course among participants in the PREVENT-COVID (Partnership to Report Effectiveness of Vaccination in populations Excluded from iNitial Trials of COVID) study, a prospective, observational cohort study. Localized and systemic reactions were assessed via questionnaire. Disease flare was defined by worsening IBD symptoms and change in IBD medications. Outcomes were stratified by vaccine type and IBD medication classes. Results A total of 3316 individuals with IBD received at least 1 COVID-19 vaccine. Injection site tenderness (68%) and fatigue (46% dose 1, 68% dose 2) were the most commonly reported localized and systemic AEs after vaccination. Severe localized and systemic vaccine-related AEs were rare. The mRNA-1273 vaccine was associated with significantly greater severe AEs at dose 2 (localized 4% vs 2%, systemic 15% vs 10%; P < .001 for both). Prior COVID-19 infection, female sex, and vaccine type were associated with severe systemic reactions to dose 1, while age Conclusions Our findings provide reassurance that the severe acute respiratory syndrome coronavirus 2 vaccine is safe and well tolerated among individuals with IBD, which may help to combat vaccine hesitancy and increase vaccine confidence.

Aim There are limited data on the impact of 2 vs 3 doses of COVID-19 vaccine in patients with inflammatory bowel disease (IBD). The primary aim of the study was to assess the efficacy of COVID-19 vaccine based on number of administered doses in patients with IBD. Methods We conducted a retrospective cohort study using TriNetX, a multi-institutional database to compare patients with IBD who received 1, 2, or 3 doses of BNT162b2 or mRNA-1273 to unvaccinated IBD patients (1.1.2020-7.26.2022) to assess the risk of COVID-19 after 1:1 propensity score matching. We also evaluated the impact of vaccine on a composite of severe COVID-19 outcomes including hospitalization, intubation, intensive care unit care, acute kidney injury, or mortality. Results After propensity score matching, vaccinated patients with 2 (adjusted OR [aOR], 0.8; 95% confidence interval [CI], 0.6-0.9) and 3 doses (aOR, 0.7; 95% CI, 0.5-0.9) were found to have a lower risk of COVID-19 compared with unvaccinated patients. Vaccinated patients with IBD had a lower risk of severe COVID-19 outcomes (aOR, 0.7; 95% CI, 0.6-0.9) compared with unvaccinated patients. There was no difference in the risk of COVID-19 in IBD patients with 2 compared with 3 doses (aOR, 0.97; 95% CI, 0.7-1.3). However, IBD patients with 2 doses were at an increased risk for hospitalization due to COVID-19 (aOR, 1.78; 95% CI, 1.02-3.11) compared with those that received 3 doses. Conclusion Vaccinated patients with IBD had a lower risk of severe COVID-19 outcomes compared with unvaccinated patients. A third dose of COVID-19 vaccine compared with 2 doses decreases the risk of hospitalization but not breakthrough infection in patients with IBD.

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.

Background Patients with Crohn disease (CD) often develop strictures that require surgery. Endoscopic balloon dilation (EBD) is an alternative treatment that can be safe and effective. The objective of this study was to assess factors associated with the need for repeat EBD and surgery after initial EBD for stricturing CD. Methods Patients with stricturing CD who underwent EBD from 2007 to 2017 were identified. Demographic and clinical information was obtained from the electronic medical record. A Cox proportional hazards regression model and Kaplan-Meier curves were generated for variables associated with repeat EBD and surgical resection. Results Ninety-nine patients underwent a total of 240 EBD proedures; 35% had a history of perianal disease, and 63% were on a biologic at the time of initial EBD. Fifty-one percent of patients had obstructive symptoms at the time of initial EBD, and 75% of the EBDs were successful. Complications occurred in 8 EBDs (3.3%). Repeat intervention after EBD was more likely in patients on biologics at baseline EBD (76% vs 54%; P = 0.029). Thirty-three percent of patients had surgical resection at a median of 5 months (interquartile ratio = 2.0-13.0 months) after initial EBD. The presence of obstructive symptoms at the time of EBD was associated with surgical resection (hazard ratio = 3.18; 95% confidence interval, 1.28-7.86). Conversely, a history of perianal disease was negatively associated with surgical resection (hazard ratio = 0.27; 95% confidence interval, 0.10-0.68). Conclusions Patients on biologic treatment at the time of EBD are more likely to need an intervention in the future. Patients with obstructive symptoms at the time of initial EBD and those without a history of perianal involvement are more likely to undergo surgical intervention.

There is increased risk of cardiovascular disease in patients with chronic inflammatory disorders such as rheumatoid arthritis, psoriatic arthritis, and systemic lupus erythematosus. Studies have shown association between cardiovascular disease (eg, myocardial infarction, heart failure, stroke) and inflammatory bowel disease. Medications such as infliximab and adalimumab (monoclonal antibodies to tumor necrosis factor α) may help decrease the inflammatory burden and cardiovascular risk; however, there have been reports of hypertriglyceridemia and worsening of moderate to severe heart failure with these medications. Janus kinase inhibitors, such as tofacitinib, have been associated with hyperlipidemia and thromboembolism. We aim to discuss clinical and imaging modalities to assess cardiovascular risk in inflammatory bowel disease patients and review the role of various medications with respect to cardiovascular disease in this population.

Background A small proportion of patients with inflammatory bowel disease (IBD) consume a disproportionate amount of health care resources, with most of these spent on unplanned care in emergency room (ER) and hospital visits. Interventions in those at high risk in the outpatient setting could reduce the need for future inpatient care. We sought to describe the characteristics predictive of high health care utilization within 1 year after an initial IBD clinic encounter. Methods This was a retrospective study of new IBD patients seen at the outpatient clinics of 2 tertiary IBD centers in the United States. Baseline sociodemographic and clinical characteristics were collected, and the number of IBD-related ER and hospital visits were recorded over the 1-year period after the initial clinic encounter. Patients with ≥2 visits (high utilizers) were compared with those with no visits. Results Of the 735 patients included in the final analysis, 106 (14.4%) were high utilizers, and they had a mean of 2.9 visits (maximum = 10) in the 1 year after their initial encounter. In multivariate analysis, insurance coverage through medical assistance (odds ratio [OR] 3.57; 95% confidence interval [CI], 1.38–9.20), steroid use (OR 1.83; 95% CI, 1.11–3.04), short inflammatory bowel disease questionnaire score Conclusions Multidisciplinary care and resources should be preferentially channeled towards new clinic patients with severe disease and on medical assistance, as this could reduce future inpatient visits and result in cost savings.

Lay Summary We demonstrate low rates of breakthrough coronavirus disease 2019 (COVID-19) infection and mild course of illness following severe acute respiratory syndrome coronavirus 2 vaccination in a large cohort of inflammatory bowel disease patients. Residence in southern United States and lower median anti-receptor binding antibody level were associated with development of COVID-19.

The recent emergency use authorization of a third COVID-19 vaccine means that most patients with inflammatory bowel disease (IBD) will soon be eligible to be vaccinated. Gastroenterology clinicians should be prepared to address patients’ concerns regarding safety and efficacy of vaccines. They should also strongly recommend that all their patients be vaccinated with a COVID-19 vaccine. Additionally, they should be prepared to educate patients about logistics that will result in successful vaccination completion. All these measures will be crucial to ensure high uptake among their patients with IBD.

Lay Summary Dysplasia surveillance practice varies widely among high-volume inflammatory bowel disease providers. We surveyed high-volume inflammatory bowel disease providers about practice patterns to detect dysplasia. Regular use of dye-based chromoendoscopy was reported by 20%, virtual chromoendoscopy by 27%, and random biopsies by 58%.

Lay Summary Authors performed a chart review to identify cases of mycophenolate mofetil gastrointestinal toxicity at our institution. In this cohort, friability was associated with severe disease; and nausea and erythema were associated with poor prognosis.

Lay Summary It is recommended that all patients with IBD undergo vaccination against COVID-19. In this commentary, we encourage IBD providers to serve as vaccine advocates and suggest implementing different methods for battling misinformation, paying careful attention to minority population.

Objective It is difficult to predict relapse in quiescent ulcerative colitis (UC), but newer endoscopic and histological indices could improve this. This study aimed to determine in UC patients in clinical remission (1) the prevalence of active endoscopic and histological disease; (2) the correlation between endoscopic and histological scores; and (3) the predictive power of these scores for clinical relapse. Design This multicenter prospective cohort study conducted by the Crohn’s and Colitis Foundation Clinical Research Alliance included 100 adults with UC in clinical remission undergoing surveillance colonoscopy for dysplasia. Endoscopic activity was assessed using the Mayo endoscopic score (MES), ulcerative colitis endoscopic index of severity (UCEIS), and ulcerative colitis colonoscopic index of severity (UCCIS). Histology was assessed with the Riley index subcomponents, total Riley score, and basal plasmacytosis. Results Only 5% of patients had an MES of 0, whereas 38% had a score of 2 to 3; using the UCEIS, the majority of patients had at least mild activity, and 15% had more severe activity. Many patients also had evidence of histological disease activity. The correlations among endoscopic indices, histological subcomponents, and total score were low; the highest correlations occurred with the subcomponent architectural irregularity (ρ = 0.43–0.44), total Riley score (ρ = 0.35–0.37), and basal plasmacytosis (ρ = 0.35–0.36). Nineteen patients relapsed clinically over 1 year, with the subcomponent architectural irregularity being the most predictive factor (P = 0.0076). Conclusions This multicenter prospective study found a high prevalence of both endoscopic and histological disease activity in clinically quiescent UC. The correlations between endoscopy and histology were low, and the power to predict clinical relapse was moderate.

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.

Inflammatory bowel disease (IBD), comprised of Crohn's disease and ulcerative colitis, affects 1.6 million people in the United States. Although effective medical treatments exist to treat the disease, outcomes are still suboptimal. The reasons for poor outcomes vary but include nonadherence to therapy, inadequate monitoring of patients, limited access to IBD specialty care, concurrent psychiatric disease, limited patient knowledge of the disease and treatments, and patient provider discordance. Telemedicine is a candidate intervention that can be used to improve patient outcomes through more frequent monitoring, patient self-management, delivery of education (patient and provider), and to increase access to multidisciplinary IBD care. Telemedicine includes remote monitoring, telehealth, teleconsultation, and teleconferencing. Telemedicine systems have been used in patients with IBD with widespread patient acceptance of the technology. However, early clinical trials demonstrated high attrition rates among intervention patients. In general, use of telemedicine systems have been associated with improved quality of life, improved patient knowledge, and decreased utilization of health care resources. Early studies evaluating telehealth visits report high patient satisfaction, decreased indirect costs to patients, and no decrease in quality of care delivered. Due to widespread access to computers and smart phones among patients, telemedicine will continue to expand in the care of patients with IBD. To optimize use and effectiveness of telemedicine, barriers for use including concerns over increased liability, need for informed consent, licensure restrictions to providing interstate telehealth visits, and cybersecurity need to be addressed.

Background Extra-intestinal manifestations (EIMs) can impact morbidity in patients with inflammatory bowel diseases (IBD; Crohn's disease [CD] and ulcerative colitis [UC]). This study compared incidence rates of EIMs in patients with moderate to severe IBD receiving gut-selective vedolizumab (VDZ) vs those receiving systemic anti-tumor necrosis factor (anti-TNF) therapies. Methods Adult IBD patients receiving VDZ or anti-TNFs were identified from the MarketScan claims database from September 28, 2012, through September 30, 2016. Incidence rates of EIMs were compared between the 2 cohorts. Descriptive analyses were performed for all courses of treatment. Generalized linear models estimated the impact of treatment on the likelihood of developing EIMs. Results Compared with patients receiving anti-TNF therapy, VDZ-treated CD patients were 28% more likely to develop "any EIMs" (adjusted incident rate ratio [IRR], 1.28; 95% confidence interval [CI], 1.02-1.62). Specifically, CD patients treated with VDZ were more likely to develop erythema nodosum (IRR, 4.29; 95% CI, 1.73-10.64), aphthous stomatitis (IRR, 3.73; 95% CI, 1.51-9.23), episcleritis/scleritis (IRR, 2.51; 95% CI, 1.02-6.14), arthropathy (IRR, 1.45; 95% CI, 1.15-1.84), primary sclerosing cholangitis (PSC) (IRR, 7.79; 95% CI, 3.32-18.27), and uveitis/iritis (IRR, 2.89; 95% CI, 1.35-6.18). UC patients receiving VDZ did not have a statistically significant increase in "any EIMs" vs patients receiving anti-TNFs, but were more likely to develop specific EIMs (aphthous stomatitis: IRR, 3.67; 95% CI, 1.30-10.34; pyoderma gangrenosum: IRR, 4.42; 95% CI, 1.00-19.45; and PSC: IRR, 3.44; 95% CI, 1.23-9.68). Conclusions IBD patients receiving VDZ may be more likely to develop EIMs vs patients receiving anti-TNF therapies. The gut-selective inflammatory control of VDZ may potentially limit its clinical effect on EIM prevention.