Adverse Events Related to SARS-CoV-2 Vaccine in a Nationwide Cohort of Patients With Inflammatory Bowel Disease.

INTRODUCTION: There are limited data on the safety profile of the severe acute respiratory syndrome coronavirus-2 vaccine among patients taking immunosuppressive medications. Our aim was to evaluate the adverse events related to the vaccines in a nationwide cohort of patients with inflammatory bowel disease on diverse immunosuppressive medications. METHODS: This was a retrospective cohort study using data from the Veterans Health Administration. The primary outcome was any adverse event of special interest (cerebrovascular accident, venous thromboembolism, acute myocardial infarction, Bell palsy) within 90 days of vaccination. RESULTS: A total of 17,201 patients were included, and 12,351 patients (71.8%) received at least 1 vaccine dose. The most common adverse events were acute myocardial infarction and venous thromboembolism. In inverse probability treatment weighting-adjusted logistic regression, full vaccination was not significantly associated with increased adverse events through 90 days, relative to unvaccinated patients. DISCUSSION: Full severe acute respiratory syndrome coronavirus-2 vaccination was not associated with an increased rate of key adverse events relative to unvaccinated individuals among patients with inflammatory bowel disease.

COVID-19 Vaccine Effectiveness Against the Omicron Variant in a Veterans Affairs Cohort of Patients With Inflammatory Bowel Disease.

INTRODUCTION: With the advent of the Omicron variant, there are concerns about the efficacy of current vaccinations, especially among immunocompromised/immunosuppressed patients. Our aim was to determine the efficacy of the first booster dose against Omicron. METHODS: This was a retrospective cohort study using a well-established inflammatory bowel disease (IBD) cohort in the Veterans Health Administration. We followed patients on baseline IBD medications through the month of January 2022 during the Omicron COVID-19 wave and created adjusted models for vaccination and boosting effectiveness in reducing SARS-CoV-2 infection, hospitalization, and all-cause mortality. RESULTS: A total of 22,756 patients with IBD were included, of whom 34.9% had received a booster dose. During follow-up, 622 patients (2.7%) were diagnosed with SARS-CoV-2 infection. In adjusted models, booster status was associated with a 30% reduced hazard of SARS-CoV-2 infection (hazard ratio 0.70 vs unvaccinated status, 95% confidence interval 0.56-0.88, P = 0.002), translating to 25.05% effectiveness. Boosted status was also significantly associated with reduced COVID-19 hospitalization (hazard ratio 0.35, 95% confidence interval 0.16-0.74, P = 0.006), demonstrating a 65.06% effectiveness in adjusted models. There was no significant association between vaccination status and all-cause mortality in adjusted models. DISCUSSION: The boosted state was associated with a lower risk of SARS-CoV-2 infections and COVID-19-related hospitalization. Efficacy was lower than what has been seen against previous variants and decreased with prolonged duration from the booster. These findings suggest that patients with IBD, especially those who are immunosuppressed, should consider getting a second booster as per Centers for Disease Control and Prevention recommendations.

Risk of severe and opportunistic infections and the impact of SARS-COV-2 on this risk in a nationwide cohort of patients with inflammatory bowel disease.

BACKGROUND: The Inflammatory Bowel Disease (IBD) patients have adopted lifestyle modifications to prevent infection via SARS COV-2. AIMS: This study aims to examine rate of serious infections and opportunistic infections in the pre-pandemic and pandemic period, and to analyse if the risk associated with medications used to treat IBD were potentially modified by associated change in lifestyle. METHODS: We conducted a retrospective cohort study of patients from the US national Veteran Affairs Healthcare System (VAHS). Patients were stratified into two groups: pre-pandemic (prior to SARS COV-2 pandemic) and pandemic (during SARS COV-2 pandemic) and outcomes were measured in these groups. Primary outcome was occurrence of any serious infection. Secondary outcome was occurrence of any opportunistic infection. RESULTS: There were 17,202 IBD patients in the pre-pandemic era and 15,903 patients in the pandemic era. The pre-pandemic era had a significantly higher proportion of serious infections relative to the pandemic era (5.1% vs. 4.4%, p = 0.002). The proportion of opportunistic infections were similar between pre-pandemic and pandemic eras (0.3% vs. 0.3%, p = 0.82). Relative to 5-ASA, patients taking anti-TNF (HR = 1.50 (1.31-1.72)), anti-TNF+TP (HR = 1.56 (1.24-1.95)) or vedolizumab (HR = 1.81 (1.49-2.20)) had an increased hazard of serious infection (p > 0.001). CONCLUSION: In a nationwide cohort of IBD patients, we found that risk of serious infections could possibly be affected by behavioural modifications due to SARS-COV-2 pandemic.

Predictive Value of Isolated Symptoms for Diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 Infection in Children Tested During Peak Circulation of the Delta Variant.

BACKGROUND: Coronavirus disease 2019 (COVID-19) testing policies for symptomatic children attending US schools or daycare vary, and whether isolated symptoms should prompt testing is unclear. We evaluated children presenting for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing to determine if the likelihood of having a positive SARS-CoV-2 test differed between participants with 1 symptom vs ≥2 symptoms, and to examine the predictive capability of isolated symptoms. METHODS: Participants aged <18 years presenting for clinical SARS-CoV-2 molecular testing in 6 sites in urban/suburban/rural Georgia (July-October, 2021; Delta variant predominant) were queried about individual symptoms. Participants were classified into 3 groups: asymptomatic, 1 symptom only, or ≥2 symptoms. SARS-CoV-2 test results and clinical characteristics of the 3 groups were compared. Sensitivity, specificity, positive predictive values (PPVs), and negative predictive values (NPVs) for isolated symptoms were calculated by fitting a saturated Poisson model. RESULTS: Of 602 participants, 21.8% tested positive and 48.7% had a known or suspected close contact. Children reporting 1 symptom (n = 82; odds ratio [OR], 6.00 [95% confidence interval {CI}, 2.70-13.33]) and children reporting ≥2 symptoms (n = 365; OR, 5.25 [95% CI, 2.66-10.38]) were significantly more likely to have a positive COVID-19 test than asymptomatic children (n = 155), but they were not significantly different from each other (OR, 0.88 [95% CI, .52-1.49]). Sensitivity and PPV were highest for isolated fever (33% and 57%, respectively), cough (25% and 32%), and sore throat (21% and 45%); headache had low sensitivity (8%) but higher PPV (33%). Sensitivity and PPV of isolated congestion/rhinorrhea were 8% and 9%, respectively. CONCLUSIONS: With high Delta variant prevalence, children with isolated symptoms were as likely as those with multiple symptoms to test positive for COVID-19. Isolated fever, cough, sore throat, or headache, but not congestion/rhinorrhea, offered the highest predictive value.

Prevalence of SARS-COV-2 Vaccination and Factors Impacting Likelihood of Vaccination in a Nationwide Veterans Affairs Cohort of IBD Patients.

Despite all efforts, about one-third of IBD patients are still not vaccinated. Although there is an emphasis on the booster dose, there is still a large population that has received no vaccination. Younger, healthy smokers with CD and on anti-TNF agents residing in the South and Midwest are less likely to get vaccinated. Targeted efforts should be made at this subset of IBD patients to increase vaccination rates.

Can Mediastinal Lymphadenopathy Signal Pericarditis, Pericardial Effusion, and Severe Disease in a COVID-19 Patient?

Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) has created a global pandemic. As we try to understand the virus, we are learning that it can affect many organ systems. Most commonly coronavirus disease 2019 (COVID-19) virus affects the respiratory tract and the lungs impairing oxygen transport to the systemic circulation. Its effect on the cardiovascular system can be equally as devastating. Patients can develop pericarditis, myocarditis, and pericardial effusion that can at times lead to tamponade. Here we present an unusual case of a patient with COVID-19 pneumonia who presented with pericardial effusion along with enlarged mediastinal lymph nodes.

Detection of COVID-19 in Chest X-ray Images: A Big Data Enabled Deep Learning Approach.

Coronavirus disease (COVID-19) spreads from one person to another rapidly. A recently discovered coronavirus causes it. COVID-19 has proven to be challenging to detect and cure at an early stage all over the world. Patients showing symptoms of COVID-19 are resulting in hospitals becoming overcrowded, which is becoming a significant challenge. Deep learning's contribution to big data medical research has been enormously beneficial, offering new avenues and possibilities for illness diagnosis techniques. To counteract the COVID-19 outbreak, researchers must create a classifier distinguishing between positive and negative corona-positive X-ray pictures. In this paper, the Apache Spark system has been utilized as an extensive data framework and applied a Deep Transfer Learning (DTL) method using Convolutional Neural Network (CNN) three architectures -InceptionV3, ResNet50, and VGG19-on COVID-19 chest X-ray images. The three models are evaluated in two classes, COVID-19 and normal X-ray images, with 100 percent accuracy. But in COVID/Normal/pneumonia, detection accuracy was 97 percent for the inceptionV3 model, 98.55 percent for the ResNet50 Model, and 98.55 percent for the VGG19 model, respectively.

Effectiveness of SARS-CoV-2 Vaccination in a Veterans Affairs Cohort of Patients With Inflammatory Bowel Disease With Diverse Exposure to Immunosuppressive Medications.

BACKGROUND & AIMS: Vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly expanded; however, clinical trials excluded patients taking immunosuppressive medications such as those with inflammatory bowel disease (IBD). Therefore, we explored real-world effectiveness of coronavirus disease 2019 (COVID-19) vaccination on subsequent infection in patients with IBD with diverse exposure to immunosuppressive medications. METHODS: This was a retrospective cohort study of patients in the Veterans Health Administration with IBD diagnosed before December 18, 2020, the start date of the Veterans Health Administration patient vaccination program. IBD medication exposures included mesalamine, thiopurines, anti-tumor necrosis factor biologic agents, vedolizumab, ustekinumab, tofacitinib, methotrexate, and corticosteroid use. We used inverse probability weighting and Cox's regression with vaccination status as a time-updating exposure and computed vaccine effectiveness from incidence rates. RESULTS: The cohort comprised 14,697 patients, 7321 of whom received at least 1 vaccine dose (45.2% Pfizer, 54.8% Moderna). The cohort had median age 68 years, 92.2% were men, 80.4% were White, and 61.8% had ulcerative colitis. In follow-up data through April 20, 2021, unvaccinated individuals had the highest raw proportion of SARS-CoV-2 infection (197 [1.34%] vs 7 [0.11%] fully vaccinated). Full vaccination status, but not partial vaccination status, was associated with a 69% reduced hazard of infection relative to an unvaccinated status (hazard ratio, 0.31, 95% confidence interval, 0.17-0.56; P < .001), corresponding to an 80.4% effectiveness. CONCLUSIONS: Full vaccination (> 7 days after the second dose) against SARS-CoV-2 infection has an ∼80.4% effectiveness in a broad IBD cohort with diverse exposure to immunosuppressive medications. These results may serve to increase patient and provider willingness to pursue vaccination in these settings.

SARS-CoV-2-Associated Guillain-Barre Syndrome Obscured by Diabetes Mellitus Peripheral Neuropathy.

Multiple neurological complications, including Guillain-Barre syndrome (GBS), have been reported in association with the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outbreak. GBS has well-known associations with viruses such as influenza, human immunodeficiency virus, Zika, severe acute respiratory syndrome, Middle East respiratory syndrome, Epstein-Barr virus, and cytomegalovirus. Till date, there have been around 50 distinct published cases of GBS occurring concurrently or shortly after SARS-CoV-2 infection. This report describes the case of a 53-year-old male who presented with bilateral extremity paresthesias two weeks after a positive SARS-CoV-2 test. His symptoms were originally thought to be due to underlying diabetic peripheral neuropathy, but as they progressed, he was eventually diagnosed with SARS-CoV-2-associated GBS. Though GBS may not be a common sequelae of SARS-CoV-2 infection, the prevalence of diabetes mellitus-associated peripheral neuropathy is high enough to warrant awareness and prompt recognition of neurological symptoms that deviate from the baseline in individuals with recent, confirmed SARS-CoV-2 infection.

Risk factors for SARS-CoV-2 infection and course of COVID-19 disease in patients with IBD in the Veterans Affair Healthcare System.

OBJECTIVE: Our aim was to explore the risk of infection with all classes of inflammatory bowel disease (IBD) medications and the impact of these medications on the disease course in a nationwide cohort of patients with IBD. DESIGN: This was a retrospective national cohort study of patients with IBD in the Veterans Affairs Healthcare System. We categorised IBD medication use immediately prior to the COVID-19 pandemic and used survival analysis methods to study associations with SARS-CoV-2 infection, as well as a combined secondary outcome of COVID-19 hospitalisation or COVID-19-related mortality. RESULTS: The analytical cohort of 30 911 patients was primarily male (90.9%), white (78.6%) and with ulcerative colitis (58.8%). Over a median follow-up of 10.7 months, 649 patients (2.1%) were diagnosed with SARS-CoV-2 infection and 149 (0.5%) met the combined secondary outcome. In adjusted models, vedolizumab (VDZ) use was significantly associated with infection relative to mesalazine alone (HR 1.70, 95% CI 1.16 to 2.48, p=0.006). Patients on no IBD medications had increased risk of the combined secondary outcome relative to mesalazine alone (sub-HR 1.64, 95% CI 1.12 to 2.42, p=0.01), however, no other IBD medication categories were significantly associated with this outcome, relative to mesalazine alone (each p>0.05). Corticosteroid use was independently associated with both SARS-CoV-2 infection (HR 1.60, 95% CI 1.23 to 2.09, p=0.001) and the combined secondary outcome (sub-HR 1.90, 95% CI 1.14 to 3.17, p=0.01). CONCLUSION: VDZ and corticosteroid were associated with an increased risk of SARS-CoV-2 infection. Except for corticosteroids no medications including mesalazine were associated with an increased risk of severe COVID-19.

Are Patients With Inflammatory Bowel Disease at an Increased Risk of Developing SARS-CoV-2 than Patients Without Inflammatory Bowel Disease? Results From a Nationwide Veterans' Affairs Cohort Study.

INTRODUCTION: The clinic course of SARS-CoV-2 among patients with inflammatory bowel disease (IBD) has been extensively studied. However, there is a paucity of data on whether patients with IBD have an increased risk of developing SARS-CoV-2 with compared with patients without IBD. METHODS: We conducted a nationwide retrospective cohort study in the US Veterans' Affairs healthcare system from January 1, 2020, to June 30, 2020. We matched each patient with IBD with 2 patients without IBD on age, sex, race, location, and comorbidities. The outcome of interest was development of SARS-CoV-2. RESULTS: Among 38,378 patients with IBD and 67,433 patients without IBD, 87 (0.23%) and 132 (0.20%) patients developed incident SARS-CoV-2 infection, respectively (P = 0.29). DISCUSSION: Patients with IBD are not at a significantly increased risk of developing SARS-CoV-2 infection when compared with patients without IBD.