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Background Coronavirus disease 2019 (COVID-19) can increase the risk of thrombosis, cardiovascular events, and kidney injury, but risks among patients with inflammatory bowel disease (IBD) remain unknown. We aimed to characterize risk for these complications among patients with IBD who developed COVID-19. Methods We analyzed complications of COVID-19 in patients reported to the Surveillance Epidemiology of Coronavirus Under Research Exclusion in Inflammatory Bowel Disease (SECURE-IBD) database prior to November 15, 2021. Our primary outcome was a composite of thrombotic complications (peripheral venous thrombosis, pulmonary embolism, thrombotic stroke, and peripheral arterial thrombosis), cardiovascular complications (new arrhythmia, heart failure, myocarditis/pericarditis, and vasculitis), and renal complications (acute kidney injury). Covariates included cardiovascular disease (including stroke), cardiovascular risk factors (diabetes mellitus, hypertension, or smoking), pulmonary disease (asthma, chronic obstructive pulmonary disease, or other chronic lung disease), thrombotic risk conditions (cancer), chronic kidney disease, chronic liver disease, “other” comorbidities, and COVID-19 vaccination with at least one dose. Multivariable analyses assessed the independent effect of variables significant in univariate analyses. Results Among 4,923 patients reported to SECURE-IBD, 79 (1.6%) had thrombotic, cardiovascular, and/or renal complications. There were 45 (0.9%) reports of acute kidney injury, 24 (0.5%) of arrythmias, 8 (0.2%) of peripheral venous thrombosis, 5 (0.1%) each of heart failure, myocarditis/pericarditis, and pulmonary embolism, and 1 (0.02%) each of vasculitis, peripheral atrial thrombosis, and thrombotic stroke. In univariate analyses, complications were more common in patients who were older (p < 0.01), black (p < 0.01), and on corticosteroids (p < 0.01) (Table 1). Patients with severe IBD were more likely to have complications than patients in remission (p < 0.01), as were those with more comorbidities (p < 0.01). Cardiovascular disease, cardiovascular risk factors, pulmonary disease, and chronic renal disease were associated with increased risk (p < 0.01 each). There was no association with vaccination status (p = 1). In multivariate analyses, age (aOR 1.04 [1.03, 1.06]), black race (aOR 4.02 [1.53, 10.55]), severe IBD (aOR 3.21 [1.31, 7.86]), corticosteroid use (aOR 3.63 [1.85, 7.12]), and one (aOR 2.33 [1.10, 4.91]), two (aOR 4.24 [1.42, 12.65]), and three or more (aOR 13.36 [3.48, 51.32]) comorbidities were significant predictors of complications (Table 2). Discussion Thrombotic, cardiovascular, and renal complications from COVID-19 were uncommon among patients with IBD. Patients with older age, black race, corticosteroid use, severe IBD, and greater number of comorbidities may require closer monitoring if they develop COVID-19. (Table Presented)
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Background: Coronavirus disease 2019 (COVID-19) can cause gastrointestinal (GI) symp-toms, which may be associated with improved outcomes. There are limited data on COVID-19 and GI symptoms among inflammatory bowel disease (IBD) patients. We aimed to describe new GI symptoms and their association with clinical outcomes in IBD patients with COVID-19.Methods: We utilized data from the Surveillance of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD), an international, collaborative registry of IBD patients with confirmed COVID-19. Any new GI symptoms during the time of COVID-19 infection were recorded. We performed descriptive statistics and bivariate analyses to characterize patients with and without new GI symptoms. We also performed a sensitivity analysis of new GI symptoms comparing patients in remission versus those not in remission by physician global assessment. Multivariable logistic regression assessed independent associ-ation of any new GI symptoms with the odds of death due to COVID-19 adjusting for age, sex, race, number of comorbidities, baseline corticosteroid use, and tumor necrosis factor (TNF) antagonist use.Results: Of 2,917 IBD patients with COVID-19, 764 (26.2%) experienced new GI symptoms. The most commonly reported new GI symptom was diarrhea (Table 1). IBD was noted to be in remission in 382 (50%) patients at time of COVID-19 infection. New GI symptoms were common (23.3%) among IBD patients in remission though were more frequently observed in patients with active disease (29.4%). Patients with new GI symptoms were more likely to be older, female, have active disease, of Asian race, and have at least one co-morbidity (Table 2). Patients on any medication, in particular TNF antagonist monotherapy, were less likely to report new GI symptoms. On bivariate analyses, IBD patients with new GI symptoms were more likely to be hospitalized (31.4% vs. 19.2%, p<0.001) but were not more likely to require intensive care/ventilator (5.8% vs. 4.6%, p=0.18) or die due to COVID-19 (2.0% vs 2.5%, p=0.39). On multivariable analysis, new GI symptoms were not significanlty associated with risk of death due to COVID-19 (adjusted OR 0.72, 95% CI 0.38-1.36).Conclusion: New GI symptoms are common among IBD patients with COVID-19. Diarrhea was the most predominant symptom. Patients in remission and those with active disease both frequently reported new GI symptoms. While IBD patients with new GI symptoms were more likely to be hospitalized, they were not more likely to die due to COVID-19.(Table Presented)Table 1. Description of Gastrointestinal (GI) Symptoms Among IBD Patients with COVID-19. New GI symptoms reported among all patients and stratified by disease activity at time of COVID-19 infection.(Table Presented)
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Background: Risk calculators can be an important tool for enabling shared decision making between patients and their health care providers. Demographics, comorbidities, medication use, geographic region, and other factors may increase the risk for complications from COVID-patients with inflammatory bowel disease (IBD). We developed a prognostic risk prediction tool for estimating the probability of hospitalization, intensive care unit (ICU) admission, and death due to COVID-19 in patients with IBD. Methods: Based on reports to Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) from March to October 2020, we modeled the probability of Hospitalization+ (a composite outcome of hospitalization, ICU and/or death), ICU+ (a composite outcome of ICU admission, intubation, and/or death) and Death separately using the Least Absolute Shrinkage and Selection set consisting of a random sample of cases reported between March 2020 and a pre-set cutoff date. Model validation was conducted using a test data set consisting of the remaining cases not in the training data plus all additional cases from one month past the cutoff date. We assessed the resulting models' discrimination using the area under the curve (AUC) of the receiver-operator characteristic (ROC) curves and corresponding 95% confidence intervals. Results: Overall, 2709 cases from 59 countries were included (mean age 41.3 years (s.d. 633 (24%) were hospitalized, 137 (5%) were admitted to ICU or intubated, and 69 (3%) died. The models have excellent discrimination, with an AUC and associated 95% confidence interval estimated on the test data set of 0.79 (0.75, 0.83) for Hospitalization+, 0.88 (0.82, 0.95) for ICU+, and 0.95 (0.91, 0.99) for Death. Age, comorbidities, corticosteroid use, and male sex were associated with higher risk of death while use of biologic therapies was associated with a lower risk of death (Figure 1). The online risk calculator is free and publicly available at https://covidibd.org/covid-19-riskcalculator/ for health care providers to facilitate discussion of the risk from COVID-19 with their IBD patients (Figure 2). After the physician inputs patient information, the prediction tool numerically and visually summarizes the patient’s probabilities of adverse outcomes intervals. Conclusion: Prognostic models can effectively predict who is at higher risk for COVID-19-related adverse outcomes in a population of IBD patients. The risk calculator could provide a basis for distinguishing between high and low-risk patients to aid in personalizing clinical guidance.
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Background: Comorbidities Increase The Risk Covid-19 Morbidity And Mortality. As Comorbidities Are Common In Patients With Inflammatory Bowel Diseases (Ibd), We Sought To Evaluate The Effect Of Comorbidities On Covid-19 Outcomes Among Ibd Patients. Methods: Data Were Obtained From Surveillance Epidemiology Of Coronavirus Under Research Exclusion For Inflammatory Bowel Disease (Secure-Ibd), An International Registry To Determine Characteristics And Outcomes Of Covid-19 In Ibd Patients. We Used Multivariable Regression To Analyze Associations Between Eleven Non-Ibd Comorbidities And Covid-19-Related Hospitalization Or Death. We First Modeled Each Comorbidity Individually, Adjusting Potential Confounders Such As Age, Gender, Race, Ethnicity And Medication Use. Then, To Determine The Independent Effects Of Each Comorbidity, We Fit A Model Including All Comorbidities As Covariates. Results: 2,035 Patients From 58 Countries Were Included (Mean Age Was 42.7 Years, 50.6% Male). A Total Of 538 Patients (26.4%) Experienced Covid-19-Related Hospitalization Or Death. Of Eleven Comorbidities Analyzed, All But A History Of Stroke And Obesity Were Associated With Hospitalization Or Death In Our Initial Analysis, With Adjusted Odds Ratio (Aor) Ranging From 1.9 (Asthma And Cardiovascular Disease) To 3.7 (Chronic Kidney Disease). After Adjusting For Age, Sex, Medications, And Comorbidites Found To Significantly Influence Severe Covid-19 In The Initial Analysis, The Independent Associations For Most Comorbidities Remained Significant And Were Strongest For Chronic Kidney Disease (Aor 3.02, 95% Ci 1.45-6.31) And Chronic Obstructive Pulmonary Disease (Copd) (Aor 2.92, 95% Ci 1.32-6.48) (Table 1). Conclusion: Comorbidities Are Associated With Covid-19 Hospitalization And Death Among Ibd Patients. These Data Can Be Used To Risk-Stratify Ibd Patients And Guide Treatment And Lifestyle Decisions During The Ongoing Pandemic. (Table Presented) Independent Effects Of Individual Comorbidities On The Risk Of Hospitalization Or Death From Covid-19 In Patients With Inflammatory Bowel Diseases
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Background: Cases of Coronavirus disease 2019 (COVID-19) have emerged in discrete waves across different regions in the world. We explored temporal trends in the reporting of COVID-19 in patients with inflammatory bowel disease (IBD), in a large global database. Methods: The Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) is an international registry to study the character-istics and outcomes of patients with IBD diagnosed with COVID-19. Joinpoint regression models calculated the average percent change (APC) with 95% confidence intervals (CI) in weekly reported cases of COVID-19 in patients in the registry stratified by geographic regions (Asia, Europe, Latin America, and North America) during two time periods: March 22 to September 12 and September 13 to November 14, 2020. We also determined the APC in US regions (Midwest, Northeast, South and West) during the two time periods. Results: Across 63 countries and dependencies, 3,195 cases of COVID-19 in people with IBD were reported over an 8-month period. Overall, COVID-19 reporting steadily decreased throughout the world by 4.5% per week (95% CI: −5.7, −3.2) from March 22 to September 12, 2020 but then steadily climbed by 12.4% per week (95% CI: 6.8, 18.3) from September 13 to November 14, 2020. After stratification by geographic region, weekly reporting declined before September 13 in North America (APC = −2.0%;95% CI: −3.7, −0.4), Asia (APC =− 4.4%;95% CI: −7.8, −0.9), and Europe (APC = −8.6%;95% CI: −10.6, −6.6), but escalated in Latin America (APC = 3.4%;95% CI: 0.7, 6.1) (Figure 1). After September 12, the rate of weekly cases decreased in Latin America (APC = −19.0%;95% CI: −33.3, −1.7) and Asia (APC = −19.3%;95% CI: −34.6, −0.5), while increased in North America (APC = 10.7%;95% CI: 4.3, 17.4) and Europe (APC = 28.0%;95% CI: 17.3, 39.6) (Figure 1). Within the US, temporal trends differed by region: Midwest (stable APC: −0.8%;95% CI: −3.5, 1.9 then increase APC: 27.3%;95%: 16.1, 39.6), Northeast (decrease APC: −9.1%;95% CI:− 11.8, −6.2 then stable APC: 2.4%;95% CI: −9.9, 16.5), South (increase APC: 5.3%;95%CI: 2.5, 8.3 then decrease APC: −12.0;95% CI: −18.4, −5.0), and West (stable APC: 0.2%;95% CI: −3.0, 3.5 then stable APC: 9.0%;95% CI: −13.8, 37.9) (Figure 2). Conclusion: COVID-19 reporting to SECURE-IBD declined steadily during the first wave of the pandemic throughout the world except Latin America. Starting in September, reports to SECURE-IBD rose in both Europe and North America, consistent with the second wave of the pandemic in these countries.(Figure presented)Figure 1. Global regional temporal trends in reporting of COVID-19 in patients with IBD from the SECURE-IBD registry: A. Asia, B. Europe, C. Latin America, and D. North America: March 22–28 to September 6-12 and September 13-19 to November 8–14, 2020(Figure presented)Figure 2. United States regional temporal trends in reporting of COVID-19 in patients with IBD from the SECURE-IBD registry: A. Midwest, B. Northeast, C. South, and D. West: March 22–28 to September 6-12 and September 13-19 to November 8–14, 2020
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Background The impact of immune-modifying therapies on outcomes of the Coronavirus disease 2019 (COVID-19) may vary depending on their mechanism of action. The purpose of this study was to determine the impact of vedolizumab (VDZ), a gut-selective anti-integrin, on COVID-19 outcomes in inflammatory bowel disease (IBD) patients. Methods Utilizing data from the Surveillance of Coronavirus Under Research Exclusion for IBD (SECUREIBD), an international, collaborative registry of IBD patients with confirmed COVID-19, we studied the impact of VDZ use compared to non-use, and VDZ monotherapy compared to anti-tumor necrosis factor (TNF) monotherapy, on hospitalization and severe COVID-19 (intensive care unit stay, mechanical ventilation and/or death) in adult IBD patients using multivariable logistic regression analyses. Backward selection of covariates was performed to obtain parsimonious models. P values #0.05 were considered significant for all analyses. Results Of 2,631 adult patients with confirmed COVID-19 on any IBD medication in the registry as of November 11, 2020, 312 (11.9%) patients were on VDZ of whom 236 (9.0%) were on VDZ monotherapy. A total of 731 (27.8%) patients were on an anti-TNF monotherapy. COVID-19 outcomes were similar for VDZ users versus non-users [adjusted odds ratio (aOR) 0.91, 95% confidence interval (CI) 0.74 to 1.09 for hospitalization and 1.12, 95% CI 0.60 to 2.10 for severe COVID-19, Table]. However, compared to anti-TNF monotherapy, VDZ monotherapy was positively associated with hospitalization and severe COVID-19 (aOR 1.66, 95% CI 1.17 to 2.35 and 4.71, 95% CI 1.65 to 13.45, respectively). Discussion VDZ use, compared to non-use, was not associated with adverse COVID-19 outcomes. However, when compared to anti-TNF monotherapy, VDZ monotherapy was associated with increased risk of hospitalization and ICU requirement/death. These findings suggest the comparable safety of VDZ relative to most other IBD therapies. The observed effect of anti-TNF may be related to improved safety and/or a possible protective effect against more aggressive COVID-19.(Table presented) Table: Multivariable regression analyses with backward selection of covariates for COVID-19 outcomes by medication class from adult cases in the SECURE-IBD registry
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Introduction In the United States (US), race and ethnicity impact outcomes of chronic diseases including inflammatory bowel disease (IBD). The aim of this study was to evaluate racial and ethnic disparities in the coronavirus disease 2019 (COVID-19) outcomes among IBD patients and to assess the degree to which observed disparities may be attributed to non-IBD comorbidities. Methods Using data from the Surveillance of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD), an international, collaborative registry of IBD patients with confirmed COVID-19, we used multivariable logistic regression to evaluate associations between race and ethnicity and COVID-19 outcomes. These included hospitalization and severe COVID-19 defined as a composite of intensive care unit stay, mechanical ventilation and/or death. Results We analyzed 988 US cases (96 [9.7%] Hispanic;141 [14.3%] non-Hispanic Black;680 [68.8%] non-Hispanic White). Bivariate analyses of outcomes are reported in the Table. Compared to non-Hispanic White patients, Hispanic patients had higher odds of hospitalization [adjusted odds ratio (aOR) 2.01, 95% CI 1.07 to 3.79] but not severe COVID-19 (2.75, 95% CI 0.93 to 8.10). Compared to non-Hispanic White patients, non-Hispanic Black patients had higher odds of hospitalizations (aOR 2.47, 95% CI 1.48 to 4.11) and severe COVID-19 (2.50, 95% CI 1.01 to 6.20) after adjusting for age, sex, and IBD activity (Figure). Upon adjusting for comorbidities, the odds of hospitalization and severe COVID-19 remained unchanged in Hispanic individuals compared to non-White Hispanic individuals (aOR 2.14, 95% CI 1.09 to 4.18 for hospitalizations and 2.69, 95% CI 0.77 to 9.38 for severe COVID-19), but decreased in Black individuals compared to non-White Hispanic individuals (aOR 2.21, 95% CI 1.30 to 3.76 for hospitalization and 2.13, 95% CI 0.81 to 5.59 for severe COVID-19). Conclusions The odds of adverse COVID-19 outcomes are higher in Hispanic and non-Hispanic Black, compared with non-Hispanic White individuals with IBD, accounted for partially by underlying comorbidities. (Table presented) COVID-19 Outcomes for United States cases reported to SECURE-IBD, overall and stratified by race/ethnicity (Figure presented) Odds ratios of A) hospitalization due to COVID-19 and B) severe COVID-19 outcomes (ICU stay, mechanical ventilation or death) among Hispanic vs. non-Hispanic White individuals and among non-Hispanic Black vs. non-Hispanic White individuals