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The COVID-19 pandemic, caused by SARS-CoV-2, has been the most significant global health crisis of the past century. The development of safe and effective vaccines has led to a reduction in COVID- 19-related hospitalizations and deaths;however, the clinical trials that led to US Food and Drug Administration Emergency Use Authorization and/or approval of the vaccines in the United States did not include individuals with inflammatory bowel disease (IBD). Because individuals with IBD are commonly treated with immunosuppressive medications, there had been concern for reduced vaccine efficacy in this population. This article provides an overview of the peer-reviewed literature addressing COVID-19 vaccination in individuals with IBD;details the perceptions of patients with IBD of COVID-19 vaccines, including how gastroenterologists can help to reduce vaccine hesitancy;and describes the humoral immune response to COVID-19 vaccines, with a majority of patients with IBD seroconverting following complete vaccination regardless of medication exposure. Additionally, low rates of IBD flare and similar rates of vaccine-related adverse events to those in the general population are described. Finally, the article provides current recommendations from the Centers for Disease Control and Prevention for COVID-19 vaccination in individuals with IBD.
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Introduction: Immunosuppressed individuals are at higher risk for COVID-19 and resulting complications, yet robust data in patients with Inflammatory Bowel Disease (IBD) are lacking. We evaluated the risk of COVID-19-related hospitalization and severe sequelae in a large, population-based U.S. cohort of patients with IBD. Methods: We conducted a retrospective cohort study utilizing insurance claims data from two large U.S. health plans (Anthem and Humana). Cohort follow-up began on 1 March 2020, the beginning of the COVID-19 pandemic in the US. We included IBD patients identified by two diagnosis codes for Crohn's disease (CD) or ulcerative colitis (UC) or one diagnosis code plus a treatment code for an IBD-specific medication in the six months prior to cohort entry. Use of IBD medications was ascertained in the 90 days prior to cohort entry. Study outcomes included COVID-19 hospitalization, mechanical ventilation, and inpatient death. Patients were followed until outcome of interest, death, disenrollment, or end of the study period. We described the occurrence of COVID-19 outcomes according to IBD treatment status ascertained prior to cohort entry. Results: The study population included 102,989 patients (48,728 CD, 47,592 UC) with a mean age of 53 years;55% were female. Overall, 412 (0.4%) patients were hospitalized for COVID-19. Individuals treated with systemic corticosteroids were more likely to be hospitalized than those treated with any other non-steroid medication (0.6% vs 0.3%, p=<.0001). Among patients not treated with corticosteroids, patients receiving anti-TNF were less likely to be hospitalized than those treated with other medication classes (0.2% vs 0.5%, p=<.0001) or no medications (0.5%, p=<.0001). Older age was associated with increased incidence of hospitalization for COVID-19. Overall, 71 patients (0.07%) required mechanical ventilation and 52 (0.05%) died at the hospital due to COVID-19 or resulting complications. The proportion of patients requiring mechanical ventilation or dying was higher amongst users of corticosteroids versus those treated with any other non-steroid medication (1.9% vs 0.05%, p=<.0001 and 0.1% vs 0.04%, p=0.0015) respectively). Associations between corticosteroid use all outcomes were similar across age groups. Conclusion: Among patients with IBD, those treated with systemic corticosteroids had more frequent hospitalization, mechanical ventilation, and death from COVID-19 as compared to patients on other treatments or no treatment at all. Anti-TNF therapy was associated with a decreased occurrence of hospitalization. This finding reinforces previous guidance to taper and/or discontinue corticosteroids to reduce the risk of infections, including COVID-19. Use of steroid-sparing maintenance treatments such as anti-TNF agents appears to be safe.
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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: Current recommendations in many countries support additional COVID-19 vaccine doses in patients with inflammatory bowel disease (IBD) who are treated with immunosuppressants, yet real-world data on the effectiveness and safety of additional vaccine doses is lacking. We sought to quantify the humoral immune response to an additional (third) dose of mRNA vaccines in adolescents and adult patients with IBD. Methods: We performed a direct-to-patient, internet-based cohort study of patients with IBD in the United States who have received any SARS-CoV-2 vaccine granted EUA. Participants completed baseline and follow-up surveys and had blood work obtained approximately 8 weeks following completion of the initial vaccination series and 6 weeks following administration of an additional (third) vaccine dose. We performed quantitative measurement of antireceptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2 using the LabCorp Cov2Quant IgG™ assay. Results: A total of 659 participants were included [415 participants (63%) initially received BNT162b2, 243 participants (37%) initially received mRNA-1273, and 5 participants (1%) initially received Ad26.COV2.S]. Demographic, clinical, and treatment characteristics of the study population are provided in Table 1. Over 98% of those receiving an initial mRNA vaccine received the same type additional dose. Whereas 93% had detectable antibody after the initial vaccination series, 99.5% had detectable antibodies following an additional dose. Mean (SD) increase in antibody level was 61 ug/mL (103) in those receiving BNT162b2 and 78 ug/mL (143) for those receiving mRNA-1273 (Figure 1). Importantly, of 47 of patients without initial antibody response, 45 (96%) had detectable antibodies following an additional dose. Additional vaccination was generally well tolerated in this population, with 44%, 24%, 25%, and 6% reporting no, mild, moderate, and severe side effects respectively. Discussion: These findings demonstrate robust immunogenicity to additional doses of SARS-CoV-2 vaccine, even amongst patients with undetectable antibody following the initial series. Adverse event rates were low. These data can be used to inform vaccine decisions in patients with a broad array of immune-medicated conditions frequently managed by immunosuppression. (Table Presented) (Figure Presented)
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Background - Patients with Inflammatory Bowel Disease (IBD) require long-term followup and potentially immunosuppressive medications. We sought to assess these patients' experiences during the COVID-19 pandemic as well as the pandemic's impact on patients' access to and behavior around seeking clinical care. We hypothesized that the COVID-19 pandemic had a significant impact on how patients with IBD seek and prefer to obtain health care. Methods - We conducted a repeated cross-sectional survey within the IBDPARTNERS Internet-based cohort from April 2020 to June 2021. Follow-up surveys occurred at weeks 2, 4, 6, 8, 26, and 52. Surveys included questions about residence, demographics, experience with telemedicine, COVID vaccination status, health care behavioral changes, and medication changes throughout the pandemic. Statistical Analysis - Descriptive statistics were used to summarize the cohort. Ordered logistic regression was used to examine the associations between baseline characteristics and levels of concern regarding the pandemic. Logistic regression was used to examine the relationships between levels of concern and changing patient behaviors. Due to the repeated longitudinal nature of the data and potential intra-subject correlation, all regression analysis was done on panel data. Results - A total of 2,121 patients (Table 1) completed the baseline survey with a response rate of >90% for each follow-up survey. The general level of concern regarding the pandemic and the level of concern regarding IBD medications during the pandemic decreased significantly over the survey period (Figures 1A-1B). Older age, female sex, higher education, higher Patient- Reported Outcomes Measurement Information System (PROMIS) scores, presence of non- IBD comorbidities, and COVID vaccination were significantly associated with levels of general concern regarding COVID (Figure 1C). The overall perception of telemedicine was positive (Figure 1D), although preferences for telemedicine or in-person visit varied based on the type of care (routine visit, IBD medication change, addressing IBD flare, etc.) needed. While news media and the CDC remained the most common sources of coronavirus information, patient websites such as Crohn's and Colitis Foundation increased slightly over the study period. Conclusion - During the study period (April 2020 - June 2021), the general and IBD-specific levels of concern among adults with IBD decreased significantly. Preferences for telemedicine or in-person care varied based on the reasons for seeking care. These data give clinically relevant insights that can inform immediate and future adjustments regarding patient care, such as investing in the development of telemedicine and improving the accessibility of patient websites, as we move the practice of gastroenterology into the post- COVID-19 era. (Table Presented) (Figure Presented) Figure 1. Each of the panel figures (1A-1D) highlights a major finding of the study.
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Background: Current recommendations in many countries support additional COVID-19 vaccine doses in patients with inflammatory bowel disease (IBD) who are treated with immunosuppressants, yet real-world data on the effectiveness and safety of additional vaccine doses is lacking. We sought to quantify the humoral immune response to an additional vaccine dose in patients with IBD. Methods: We performed a direct-to-patient, internet-based cohort study of patients with IBD in the United States who have received any SARS-CoV-2 vaccine granted EUA. Participants completed baseline and follow-up surveys and had blood work obtained approximately 8 weeks following completion of the initial vaccination series and 6 weeks following administration of an additional vaccine dose. We performed quantitative measurement of anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2 using the LabCorp Cov2Quant IgG™ assay. Results: A total of 659 participants were included [415 participants (63%) initially received BNT162b2, 243 participants (37%) initially received mRNA-1273, and 5 participants (1%) initially received Ad26.COV2.S]. Demographic, clinical, and treatment characteristics of the study population are provided in Table 1. Over 98% of those receiving an initial mRNA vaccine received the same type additional dose. Whereas 93% had detectable antibody after the initial vaccination series, 99.5% had detectable antibodies following an additional dose. Mean (SD) increase in antibody level was 61 ug/mL (103) in those receiving BNT162b2 and 78 ug/mL (143) for those receiving mRNA-1273 (Figure 1). Importantly, of 47 of patients without initial antibody response, 45 (96%) had detectable antibodies following an additional dose. Additional vaccination was generally well tolerated in this population, with 44%, 24%, 25%, and 6% reporting no, mild, moderate, and severe side effects respectively. Conclusion: These findings demonstrate robust immunogenicity to additional doses of SARS-CoV-2 vaccine, even amongst patients with undetectable antibody following the initial series. Adverse event rates were low. These data can be used to inform vaccine decisions in patients with a broad array of immune-medicated conditions frequently managed by immunosuppression.
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Background: Coronavirus disease 2019 (COVID-19) tends to cause mild disease in children, although severe disease occurs rarely. Children with inflammatory bowel disease (IBD) often receive immunosuppressive medications that may increase risk of infectious complications. Little is known about the severity of breakthrough infection after COVID-19 vaccination in children with IBD. We describe COVID-19 outcomes among children with IBD, including those with breakthrough infection. Methods: The Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) is a database created to evaluate COVID-19 outcomes in IBD patients. We included children (age ≤18) from the SECURE-IBD database through November 17th, 2021. We used descriptive statistics to summarize demographic/disease characteristics of the study population, both overall and stratified by hospitalization status, and performed bivariate comparisons. We reported demographic and clinical details of patients requiring an intensive care unit stay and those with breakthrough infection (defined as ≥1 COVID-19 vaccination prior to infection), respectively. Results: We analyzed 606 pediatric IBD COVID-19 cases from 37 countries. The most common IBD medications were tumor necrosis factor (TNF) antagonist monotherapy (48%) and sulfasalazine/ mesalamine (20%). Most patients (85%) had no non-IBD comorbidities. No patients died, and 28 children (5%) were hospitalized. Factors associated with hospitalization included non-IBD comorbid conditions (43% hospitalized vs 13% not;p <0.01), moderate/severe IBD disease activity (61% vs 15%;p <0.01 overall), gastrointestinal symptoms (68% vs 16%, p <0.01), and steroid use (29% vs 6%, p <0.01). TNF antagonist monotherapy was associated with a decreased likelihood of hospitalization (29% vs 49%;p value 0.03) (Table 1). Seven patients needed intensive care, and three (0.5%) required mechanical ventilation (Table 2). There were nine fully vaccinated and five partially vaccinated patients who developed breakthrough infection, of whom only one required hospitalization but did not need a ventilator (Table 3). The majority of patients with breakthrough infection (13/14) were on systemic immunosuppressants at the time of COVID-19 infection (10/14 on TNF antagonists). Conclusion: We found that children with IBD have a relatively low risk of severe COVID-19 outcomes. Among children with IBD who developed COVID-19 after vaccination, the majority were on immunosuppressants and had mild disease that did not require hospitalization. These data may reassure families and providers of children with IBD during the COVID-19 pandemic and support public health recommendations for COVID-19 vaccination among eligible children with IBD.
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Background: Patients with inflammatory bowel disease (IBD) may be at risk for development of COVID-19 infection due to innate immune dysfunction and/or immunosuppressive medication use. We sought to 1) evaluate the incidence of COVID-19 infection in a large, U.S. cohort of patients with IBD and 2) evaluate associations between demographic, clinical, and treatment-related factors and the development of COVID-19 infection. Methods: Participants in 3 adult IBD studies sponsored by the Crohn's & Colitis Foundation, IBD Partners, IBD QORUS (Improving the Quality of Care for Adults with Inflammatory Bowel Disease), and SPARC IBD (Study of a Prospective Adult Research Cohort with IBD), were invited to participate in a prospective, direct-to-patient cohort study about COVID-19 from April 23, 2020 until August 30, 2021. Each cohort received online surveys with questions on comorbidities, medication utilization and development of laboratory confirmed COVID-19 at times 0, 2, 4, 6, 8 weeks and then every 6 months. We calculated the incidence rate of COVID-19 and performed bivariate and multivariate analyses to describe associations between age, immunosuppression use, obesity, and race on the development of COVID-19. Results: A total of 3953 patients with IBD were followed for a mean duration of 212 days (SD 157). Demographic, clinical and treatment factors are shown in Table 1. A total of 103 individuals developed COVID-19 during follow up (2.6%, rate of 45 per 1,000 person-years). Severity of infection was generally mild. Clinical characteristics were similar among those who developed COVID-19 as compared to not. African American race was associated with incident COVID-19 infection (OR 3.37, 95% CI 1.18-9.59). Immunosuppression use was not associated with development of COVID-19 (OR 1.19, 95% CI 0.72- 1.75), nor was age (OR 1.00, 95% CI 0.99-1.02), nor obesity (OR 1.01, 95% CI 0.61-1.66). Conclusion: The overall incidence of COVID-19 infection among this large U.S. cohort of IBD patients was relatively low. Immunosuppression use did not increase the risk of development of COVID-19. Therapeutic management of IBD should not be altered to prevent a risk of developing COVID-19.
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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
ABSTRACT
Introduction: Individuals on immunosuppression were excluded from COVID-19 vaccine clinical trials which led to their emergency use authorization (EUA). As a result, patients with inflammatory bowel disease (IBD) who are frequently treated with immune suppressing medications have questions about COVID-19 vaccine effectiveness. Data of vaccine effectiveness and immune response in the IBD population are urgently needed to guide vaccination strategies. This study aimed to assess serologic response after completion of COVID-19 vaccine series in a large IBD population across the US. Methods: Partnership to Report Effectiveness of Vaccination in populations Excluded from iNitial Trials of COVID (PREVENT-COVID) is a prospective observational cohort study of IBD patients who received any COVID-19 vaccine granted EUA in the US. Enrolled participants had the option to provide serum samples to evaluate antibody development 8 weeks following completion of COVID-19 vaccine series. Quantitative analysis of anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2 was performed using the LabCorp Cov2Quant IgG assay. Qualitative assessment of nucleocapsid antibodies as an indicator of past infection was also completed. This analysis included participants who completed vaccination series and laboratory testing prior to 6/17/ 21. Individuals who reported prior COVID infection and/or had positive nucleocapsid antibody were excluded. Descriptive statistics were performed to characterize the study population and antibody response. Results: A total of 788 participants with IBD (mean age 48 yrs, 73% female) were included, and 752/ 788 [95.4%, 95% confidence interval (CI) 93.7-96.7%] had detectable anti-RBD antibodies. Additional demographic characteristics and distribution of antibody response across medication classes are shown in Table 1. Antibody response was generally similar across age group, vaccine type, and IBD medication class (Figure 1);however, individuals receiving corticosteroids (n=35) had reduced antibody response with 85.7% (95% CI 70.6-93.7) having detectable antibodies vs 95.9% (95% CI 94.2-97.1) in non-steroid users. Conclusion: A vast majority of our IBD cohort including those on immunosuppressive therapies demonstrated humoral immune response after completion of COVID-19 vaccine series. Longer term data are needed to assess durability of antibody response, but this emerging data provides reassurance that most IBD medications do not significantly diminish response to COVID-19 vaccination.
ABSTRACT
Background: Children who develop coronavirus disease 2019 (COVID-19) tend to have a mild disease course, although a small percentage develop more severe disease and/or multi-organ inflammatory syndrome. Children with inflammatory bowel diseases (IBD) are often treated with immune suppressive medications that may increase their risk of complications from infection. We describe the disease course of COVID-19 in children with IBD based on updated data from the SECURE-IBD database. Methods: The Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) was created in March 2020 to monitor outcomes of COVID-19 occurring in IBD patients and includes cases from the parallel Paediatric IBD Porto group of the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN). We included all subjects ≤18 years of age from the SECURE-IBD database through May 18th, 2021. We used descriptive statistics to summarize the demographic and disease characteristics of the study population, both overall and stratified by hospitalization status (hospitalized versus outpatient only), and performed bivariate comparisons. We performed a post-hoc logistic regression analysis evaluating the association of sulfasalazine/mesalamine use and hospitalization while adjusting for disease activity. Results: We collected 540 COVID-19 cases in pediatric IBD patients from 35 countries. The most common IBD treatment was TNF antagonist monotherapy (48%), followed by sulfasalazine/mesalamine (21%). Most patients (86%) had no comorbidities other than IBD. There were no deaths in the study population, and 14 children (4%) were hospitalized, of whom only two (0.4%) required mechanical ventilation. Both children requiring mechanical ventilation were on mesalamine, had ulcerative colitis, and were 6 and 7 years old, respectively. Factors associated with hospitalization included comorbid conditions other than IBD (35% hospitalized vs 13% not;p value <0.01), moderate/severe IBD disease activity (57% vs 14%;p value <0.01 overall), gastrointestinal symptoms (65% vs 16%, p value <0.01), Hispanic ethnicity (30% vs 14%;p value 0.03), sulfasalazine/mesalamine use (39% vs 21%;p value 0.03), and steroid use (26% vs 6%, p value <0.01). TNF antagonist monotherapy was associated with a decreased likelihood of hospitalization (22% vs 49%;p value 0.01) (Table). Sulfasalazine/mesalamine use was not a significant a risk factor after adjusting for disease activity (aOR 2.19, 95% confidence interval 0.86-5.55). Discussion: In this updated and expanded analysis of an international COVID-19 reporting registry, we observed that children with IBD have a relatively low risk of severe COVID-19, even while receiving immune suppressive IBD treatments. These findings may reassure families of children with IBD and inform decisions regarding return to school and activity.