Desai, Aakash

Abstract Background Tixagevimab and cilgavimab (Evusheld) are 2 fully human monoclonal antibodies that received emergency-use authorization on December 21, 2021, for pre-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in patients who are moderate–severely immunocompromised. The real-world efficacy of Evusheld in patients with inflammatory bowel disease (IBD) is not known. Methods We conducted a retrospective cohort study using TriNetX, a multi-institutional database in patients with IBD who received Evusheld compared to patients with IBD who did not receive Evusheld (12.1.2021–10.28.2022). The primary outcome was to assess the risk of COVID-19 within 6 months. One-to-one propensity score matching (PSM) was performed for demographic parameters, comorbid conditions, IBD medications, and history of COVID-19. Risk was expressed as adjusted odds ratio (aOR) with 95% confidence interval (CI). Results Four hundred and eight patients (0.19%) with IBD received Evusheld (mean age 58.6 ± 15.4 years old, female 47.7%) during the study period. After PSM, there was no difference in the risk (aOR 0.88, 95% CI, 0.33–2.35) of COVID-19 in the Evusheld cohort compared to the IBD control cohort. No patients required ICU care or intubation/respiratory support or were deceased in the Evusheld cohort. Conclusions Our study did not show that Evusheld decreases the risk of COVID-19 in patients with IBD. Prevention of moderate–severe COVID-19 in these patients should focus on vaccination strategies and early COVID-19 therapies.

Abstract Background There is evidence that SARS-CoV2 infection can increase the risk of herpes zoster (HZ) in the general population. However, the risk in patients with inflammatory bowel disease (IBD) is not known. Methods The TriNetX database was utilized to conduct a retrospective cohort study in patients with IBD after SARS-CoV2 infection and patients without a SARS-CoV2 infection (IBD control cohort). The primary outcome was to evaluate the risk of HZ between the 2 cohorts. One-to-one (1:1) propensity score matching was performed for demographic parameters, HZ risk factors and IBD medications between the 2 cohorts. Adjusted odds ratio (aOR) with 95% confidence interval (CI) were calculated. Results After propensity score matching, patients with IBD with a SARS-CoV2 infection were at an increased risk for HZ (aOR, 2.16; 95% CI, 1.53-3.04) compared with IBD control cohort in the pre-COVID-19 vaccine era. There was no difference in the risk (aOR, 0.87; 95% CI, 0.44-1.75) of a composite outcome of HZ complications (hospitalization, post-herpetic neuralgia, and neurologic complications) between the 2 cohorts. The IBD SARS-CoV2 cohort was also at an increased risk for HZ (aOR, 3.04; 95% CI, 1.48-6.24) compared with IBD control cohort in the postvaccine era. However, the risk of HZ in the postvaccine era was decreased (aOR, 0.45; 95% CI, 0.27-0.76) compared with IBD SARS-CoV2 cohort in the prevaccine era. Conclusions Our study showed that SARS-CoV2 infection is associated with an increased risk of HZ in patients with IBD.

Introduction and Aim: A growing body of evidence suggests a negative impact of obesity on the disease activity of inflammatory bowel disease (IBD). The primary aim of the study was to evaluate disease outcomes of IBD in patients after bariatric surgery (BS). Methods: Patients with IBD and morbid obesity who underwent BS were compared with patients with IBD and morbid obesity without BS in a retrospective, propensity-score matched cohort study using TriNetX, a multi-institutional database. The primary aim was to assess the 2-year risk of a composite of disease-related complications, which included intravenous steroid use or IBD-related surgery. Risk was expressed as adjusted odds ratios (aOR) with 95% confidence intervals (CI). Results: In all, 482 patients (3.4%) with IBD and morbid obesity underwent BS (mean age 46.9±11.2 y old, mean BMI 42.1±7.72 kg/m2, Crohn’s disease 60%). After propensity-score matching, the BS cohort had a lower risk (aOR 0.31, 95% CI 0.17-0.56) of a composite of IBD-related complications compared with the control cohort. After propensity-score matching, the BS cohort with sleeve gastrectomy had a decreased risk (aOR 0.45, 95% CI 0.31-0.66) of a composite of IBD-related complications. There was no difference in the risk (aOR 0.77, 95% CI 0.45–1.31) of a composite of IBD-related complications between the BS cohort with Roux-en-Y gastric bypass (RYGB) compared with the control cohort. Conclusion: Sleeve gastrectomy but not Roux-en-Y gastric bypass is associated with improved disease-specific outcomes in patients with IBD and morbid obesity.

SummaryBackgroundThere is limited real‐world data on comparative effectiveness of different biologic or small molecule agents as second‐line therapies in patients with ulcerative colitis (UC) with prior exposure to a tumour necrosis factor inhibitor (TNFi).MethodsWe conducted a retrospective cohort study using TriNetX, a multi‐institutional database to assess the efficacy of tofacitinib, vedolizumab and ustekinumab in patients with ulcerative colitis (UC) with prior exposure to a TNFi. Failure of medical therapy was defined as a composite outcome of intravenous steroids or colectomy within 2 years. One‐to‐one propensity score matching was performed for demographics, disease extent, mean haemoglobin, C‐reactive protein, albumin and calprotectin, prior IBD medications and steroid use between cohorts.ResultsAmong 2141 patients with UC and prior exposure to TNFi, 348 (16.2%), 716 (33.4%) and 1077 (50.3%) were switched to tofacitinib, ustekinumab and vedolizumab, respectively. After propensity‐score matching, there was no difference in the composite outcome (aOR: 0.77, 95% CI: 0.55–1.07) but higher risk of colectomy (aOR: 2.69, 95% CI: 1.31–5.50) in the tofacitinib cohort than the vedolizumab cohort. There was no difference in the risk of composite outcome (aOR: 1.29, 95% CI: 0.89–1.86) but higher risk of colectomy (aOR: 2.63, 95% CI: 1.24–5.58) in the tofacitinib cohort than the ustekinumab cohort. The vedolizumab cohort had a higher risk of composite outcome (aOR: 1.67, 95% CI: 1.29–2.16) than the ustekinumab cohort.ConclusionUstekinumab might be the preferred second‐line therapy over tofacitinib and vedolizumab in patients with UC that were previously exposed to a TNFi.

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 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.

Abstract Background Data on efficacy of hepatitis-B vaccine (HBV) in patients with inflammatory bowel disease (IBD) is limited. Our aim was to review the literature and perform meta-analysis of available studies to quantify efficacy of HBV in patients with IBD. Methods We conducted a comprehensive search of several databases (inception to July 2020) to identify studies evaluating efficacy of HBV in patients with IBD. Random effects model was used to calculate the pooled rates and I2 percentage values were used to assess the heterogeneity. Results A total of 14 studies (2375 patients) were included. Four data sets were available from 2 studies that compared HBV response in patients with IBD against healthy controls. The pooled odds ratio of HBV response in IBD patients was 0.13 (95% CI, 0.05–0.33, P = 0.001). The pooled proportion of adequate immune response (AIR) was 64% (95% CI, 55–72.1, P = 0.003) from 13 data sets, and effective immune response (EIR) was 39.7% (95% CI, 30.7–49.5, P = 0.04) from 10 data sets. Conclusion Patients with IBD on immunosuppression demonstrated significantly reduced HBV response as compared with general population.