Farraye, Francis A.

Abstract Introduction The COVID-19 pandemic caused by SARS-CoV-2 continues to result in significant morbidity and mortality on a global scale. Prior studies have examined the effectiveness of non-COVID vaccines in setting of sleep disturbances. This study evaluated data from a large national database to examine the relationship between the risk of breakthrough COVID-19 infections in patients with certain sleep related disturbances. Methods Real-time search and analysis using the TriNetX platform to evaluate risk of COVID-19 breakthrough infections (BTI) for patients having ICD-10 diagnoses relating to insomnia, circadian rhythm disorders, and inadequate sleep. The sleep disorder and control cohorts underwent propensity matching including factors for age, gender, race, ethnicity, and multiple co-morbid conditions. Results Of 24,720 patients identified as having a sleep disturbance relating to insomnia, circadian rhythm disorder, or inadequate sleep, 815 (3.2%) were found to have a developed a BTI. There was a significant increased risk of BTI noted between the sleep disorder and control cohorts (adjusted odds ratio (aOR) of 1.40, 95% confidence interval (CI) of 1.23-1.58). Subgroup analysis showed an elevated risk for BTI receiving two doses (aOR 1.53, 95% CI 1.24 – 1.89) versus three doses (aOR 1.45, 95% CI 1.24 – 1.69). Patients with the sleep disturbance were not found to be at an increased risk of hospitalization, intubation, death, or composite outcome of death and intubation. Conclusion The presence of having a diagnosis of insomnia, circadian rhythm disorder, or inadequate sleep was associated with increased risk of COVID-19 breakthrough infection. Support (if any)

Abstract: Background and Aims The BNT162b2 and mRNA-1273 COVID-19 vaccines are efficacious in patients with inflammatory bowel disease; but there is a lack of data examining if holding immunosuppressive therapy around vaccination improves immune response. We studied the effect of holding IBD medications around the time of vaccination on antibody response and breakthrough COVID-19 infection. Methods Partnership to Report Effectiveness of Vaccination in populations Excluded from iNitial Trials of COVID is a prospective cohort of individuals with IBD receiving COVID-19 vaccination. Quantitative measurement of anti-receptor binding domain IgG antibodies to SARS-CoV-2 was performed 8 weeks after completing a vaccination series. Results A total of 1854 patients were included; 59% were on anti-tumour necrosis factor [TNF] [10% of these on combination therapy], 11% on vedolizumab, and 14% on ustekinumab; 11% of participants held therapy before or after vaccine administration for at least 2 weeks. Antibody levels were similar in participants continuing versus holding anti-TNF monotherapy before or after the second vaccine [BNT162b2: 10 μg/mL vs 8.9 μg/mL; mRNA-1273: 17.5 μg/mL vs 14.5 μg/mL]. Comparable results were seen in those on combination therapy. Antibody titres in those on ustekinumab or vedolizumab were higher compared with anti-TNF users, but there was no significant difference if the drug was held or continued [BNT162b2: 22.5 μg/mL vs 23 μg/mL; mRNA-1273: 88 μg/mL vs 51 μg/mL]. Holding therapy was not associated with decreased rate of COVID-19 infection compared with those not holding therapy [BNT162b2: 28% vs 29%; mRNA-1273: 19% vs 31%]. Conclusion We recommend continuing IBD medications while receiving mRNA COVID-19 vaccination without interruption.

Abstract Background and Aims The FDA-approved multitarget stool-DNA [mt-sDNA] test is a successful colorectal cancer [CRC] screening tool in average-risk individuals but is not indicated for patients with inflammatory bowel disease [IBD]. We determined the performance of the mt-sDNA assay without the haemoglobin component [mt-sDNAHgb-] in patients with IBD, while measuring sensitivity for colorectal cancer and advanced colorectal neoplasia [ACRN]. Methods This was a multi-centre, proof-of-concept investigation in persons aged 18–84 years with a diagnosis of IBD, or primary sclerosing cholangitis [PSC] with IBD. Enrolment occurred between March 2013 and May 2016. Stool was tested with the mt-sDNA molecular markers only, minus the immunochemical haemoglobin component. Results The analysis set contained 355 samples. The median age was 52 [range 39–62] years, 45.6% were female and 93% were White. Two-thirds [63%] had ulcerative colitis [UC] and 10.1% had PSC/IBD. Colonoscopy revealed cancer in 8.5% [N = 30], advanced precancerous lesions [APLs] in 9.3% [N = 33] and non-advanced precancerous lesions in 7.6% [N = 27], and three-quarters [74.7%, N = 265] had negative findings. mt-sDNAHgb- sensitivity was 73.3% for any stage cancers, and 76.2% for ACRN. Sensitivity was highest for IBD-associated high-grade dysplasia at 100% and 84.6% for IBD-associated low-grade dysplasia ≥1 cm. The test showed higher sensitivity and lower specificity in UC than in Crohn’s disease. Increasing inflammation score was associated with a significant decrease in mt-sDNAHgb- test score [ = 0.028] amongst neoplasia-negative individuals, but not in patients with ACRN. Conclusions These data highlight the potential of multitarget stool-DNA marker testing as an important addition to colorectal cancer surveillance by complementing colonoscopic evaluations in IBD patients.

LINKED CONTENTThis article is linked to Caldera et al papers. To view these articles, visit https://doi.org/10.1111/apt.17454 and https://doi.org/10.1111/apt.17490

Abstract Background and Aims Technological advances have provided innovative, adaptive, and responsive models of care for inflammatory bowel diseases [IBD]. We conducted a systematic review to compare e-health interventions with standard care in management of IBD. Methods We searched electronic databases for randomised, controlled trials [RCT] comparing e-health interventions with standard care for patients with IBD. Effect measures were standardised mean difference [SMD], odds ratio [OR], or rate ratio [RR], calculated using the inverse variance or Mantel–Haenszel statistical method and random-effects models. Version 2 of the Cochrane tool was used to assess the risk of bias. The certainty of evidence was appraised with the GRADE framework Results Fourteen RCTs [n = 3111; 1754 e-health and 1357 controls] were identified. The difference in disease activity scores (SMD 0.09, 95% confidence interval [CI]: -0.09-0.28) and clinical remission (odds ratio [OR] 1.12, 95% CI: 0.78-1.61) between e-health interventions and standard care were not statistically significant. Higher quality of life [QoL] [SMD 0.20, 95% CI: 0.05-0.35) and IBD knowledge [SMD 0.23, 95% CI: 0.10-0.36] scores were noted in the e-health group, and self-efficacy levels [SMD -0.09, 95% CI: -0.22-0.05] were comparable. E-health patients had fewer office [RR 0.85, 95% CI: 0.78-0.93] and emergency [RR 0.70, 95% CI: 0.51- 0.95] visits, with no statistically significant difference in endoscopic procedures, total health care encounters, corticosteroid use, and IBD related hospitalisation or surgery. The trials were judged to be at high risk of bias or to have some concerns for disease remission. The certainty of evidence was moderate or low. Conclusion E-health technologies may have a role in value-based care in IBD.

AbstractBackgroundPatients with inflammatory bowel disease (IBD) are at increased risk of herpes zoster (HZ). We evaluated the incidence of HZ in ulcerative colitis (UC) and Crohn’s disease (CD) patients and compared this with HZ incidence in a non-IBD population.MethodsWe conducted a retrospective cohort study (GSK study identifier: VEO-000043) of adults aged ≥18 years with UC and CD and without IBD who were identified from claims recorded in a US healthcare database between October 2015 and February 2020. Crude HZ incidence rates/1,000 person-years (PY) were calculated, and comparisons of HZ incidence rates between UC or CD and non-IBD cohorts were made using adjusted generalized linear models.ResultsThe study population comprised a total of 29,928 UC, 25,959 CD, and 11,839,329 non-IBD patients. Crude overall HZ incidence rates were 13.64/1,000 PY (UC), 15.94/1,000 PY (CD), and 7.95/1,000 PY (non-IBD). UC and CD patients had increased HZ incidence rates, with adjusted incidence rate ratios of 1.35 (95% confidence interval [CI], 1.26–1.44) and 1.66 (95% CI, 1.56–1.77), respectively, compared with non-IBD patients. Stratified analysis indicated increased relative rates of HZ in progressively younger age strata in the UC and CD patients compared with non-IBD patients. HZ incidence rates were higher in UC and CD patients who had previously received thiopurines or methotrexate, TNF-inhibitors, or corticosteroids than in UC and CD patients who did not take those medicines.ConclusionUC and CD patients had increased HZ incidence rates compared with patients without IBD, demonstrating the importance of HZ prevention in IBD patients.

INTRODUCTION: Use of the electronic health record (EHR) has become increasingly widespread. Higher EHR burden is associated with burnout, but this has not been specifically investigated among gastroenterology (GI) providers. METHODS: We retrospectively collected measures of EHR use for outpatient GI providers during a 6-month period. We compared metrics across provider sex, subspecialty, and training (physicians vs nonphysician providers [NPPs]). RESULTS: Data collected represented more than 16,000 appointments from 41 providers across the Division of Gastroenterology and Hepatology. Inflammatory bowel disease (IBD) and hepatology specialists spent more time per appointment in the EHR, clinical review, and outside regular hours compared with other subspecialists. NPPs spent more EHR time than physicians. DISCUSSION: IBD and hepatology specialists and NPPs may have disproportionally high EHR burden. More work is needed to understand differences in provider workload to combat burnout.

Summary Background Recombinant zoster vaccine (RZV) is recommended for all adults ≥19 years of age who are at increased risk for HZ, including patients with inflammatory bowel disease (IBD). Methods A Markov model was constructed to compare the RZV cost‐effectiveness with no vaccination in patients with Crohn's Disease (CD) and ulcerative colitis (UC). A simulated cohort of 1 million patients was used for each IBD group at ages 18, 30, 40, and 50. The primary objective of this analysis was to compare RZV cost‐effectiveness in patients with CD and UC, comparing vaccination to no vaccination. Results Overall, vaccination is cost‐effective for both CD and UC, with the incremental cost‐effectiveness ratio (ICERs) below $100,000/quality‐adjusted life years (QALY) for all age cohorts. For patients with CD, 30 years of age and older, and those with UC 40 years and older, vaccination was both more effective and less expensive than the non‐vaccinated strategy (CD ≥30: ICERs $6183–$24,878 and UC ≥40: ICERs $9163–$19,655). However, for CD patients under 30 (CD 18: ICER $2098) and UC patients under 40 (UC = 18: ICER $11,609, and UC = 30: $1343), costs were greater for vaccinated patients, but there was an increase in QALY. One‐way sensitivity analysis of age indicates that cost break‐even occurs at age 21.8 for the CD group and 31.5 for the UC group. In probabilistic sensitivity analysis, 92% of both CD and UC simulations indicated that vaccination was preferred. Conclusion In our model, vaccination with RZV was cost‐effective for all adult patients with IBD.