Autoimmune and Chronic Inflammatory Disease Patients with COVID-19.

OBJECTIVE: There are limited data on the impact of coronavirus disease 2019 (COVID-19) on hospitalized patients with autoimmune and chronic inflammatory disease (AICID) compared with patients who do not have AICID. We sought to evaluate whether patients with AICID who have confirmed COVID-19 presenting to the hospital are at higher risk of adverse outcomes compared with those patients without AICID who are infected with COVID-19 and whether immunosuppressive medications impact this risk. METHODS: We performed a multicenter retrospective cohort study with patients presenting to five hospitals in a large academic health system with polymerase chain reaction-confirmed COVID-19 infection. We evaluated the impact of having an AICID and class of immunosuppressive medication being used to treat patients with AICID (biologics, nonbiologic immunosuppressives, or systemic corticosteroids) on the risk of developing severe COVID-19 defined as requiring mechanical ventilation (MV) and/or death. RESULTS: A total of 6792 patients with confirmed COVID-19 were included in the study, with 159 (2.3%) having at least one AICID. On multivariable analysis, AICIDs were not significantly associated with severe COVID-19 (adjusted odds ratio [aOR] 1.3, 95% confidence interval [CI]: 0.9-1.8). Among patients with AICID, use of biologics or nonbiologic immunosuppressives did not increase the risk of severe COVID-19. In contrast, systemic corticosteroid use was significantly associated with an increased risk of severe COVID-19 (aOR 6.8, 95% CI: 2.5-18.4). CONCLUSION: Patients with AICID are not at increased risk of severe COVID-19 with the exception of those on corticosteroids. These data suggest that patients with AICID should continue on biologic and nonbiologic immunosuppression but limit steroids during the COVID-19 pandemic.

Low Rates of Breakthrough COVID-19 Infection After SARS-CoV-2 Vaccination in Patients With Inflammatory Bowel Disease.

We demonstrate low rates of breakthrough coronavirus disease 2019 (COVID-19) infection and mild course of illness following severe acute respiratory syndrome coronavirus 2 vaccination in a large cohort of inflammatory bowel disease patients. Residence in southern United States and lower median anti-receptor binding antibody level were associated with development of COVID-19.

Humoral Immune Response and Safety of SARS-CoV-2 Vaccination in Pediatric Inflammatory Bowel Disease.

INTRODUCTION: Children with inflammatory bowel disease (IBD) may respond differently to COVID-19 immunization as compared with healthy children or adults with IBD. Those younger than 12 years receive a lower vaccine dose than adults. We sought to describe the safety and humoral immune response to COVID-19 vaccine in children with IBD. METHODS: We recruited children with IBD, ages 5-17 years, who received ≥ 2 doses of the BNT162b2 vaccine by a direct-to-patient outreach and at select sites. Patient demographics, IBD characteristics, medication use, and vaccine adverse events were collected. A subset of participants had quantitative measurement of anti-receptor binding domain IgG antibodies after 2-part immunization. RESULTS: Our study population included 280 participants. Only 1 participant required an ED visit or hospitalization because of an adverse event. Of 99 participants who underwent anti-receptor binding domain IgG antibody measurement, 98 had a detectable antibody, with a mean antibody level of 43.0 µg/mL (SD 67) and a median of 22 µg/mL (interquartile range 12-38). In adjusted analyses, older age ( P = 0.028) and antitumor necrosis factor monotherapy compared with immunomodulators alone ( P = 0.005) were associated with a decreased antibody level. Antibody response in patients treated with antitumor necrosis factor combination vs monotherapy was numerically lower but not significant. DISCUSSION: Humoral immune response to COVID-19 immunization in children with IBD was robust, despite a high proportion of this pediatric cohort being treated with immunosuppressive agents. Severe vaccine-related AEs were rare. Overall, these findings provide a high level of reassurance that pediatric patients with IBD respond well and safely to SARS-CoV-2 vaccination.

Effect of 2 vs 3 Doses of COVID-19 Vaccine in Patients With Inflammatory Bowel Disease: A Population-based Propensity Matched Analysis.

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.

Effects of COVID-19 on Patients with Inflammatory Bowel Disease.

Patients with inflammatory bowel disease (IBD) may take medications that affect their immune system, altering their ability to fight infection or making them less responsive to vaccines. Many of these patients were excluded from original studies regarding COVID-19, which creates a challenge for gastroenterologists to use evidence-based medicine to guide their management. We reviewed the available literature regarding patients with IBD and COVID-19 outcomes and response to vaccinations. Of all IBD patients, 0.3-24% acquired COVID-19 infection and 7-67% of those patients required hospitalization. Many studies have analyzed the effects of COVID-19 on patients with IBD. Observational studies suggest most IBD patients are not at higher risk from COVID-19 infection and that the COVID-19 vaccines are safe, effective and recommended. However, patients being treated with a TNF-α inhibitor with an immunomodulator and patients being treated with steroids should be monitored closely and efforts should be made to wean patients off of systemic steroids if possible. Patients treated with these regimens had lower antibody responses to vaccination and were at higher risk of acquiring severe COVID-19 infection. Antibody responses were robust after the second dose of mRNA vaccines with 85-100% of individuals showing seroconversion, albeit with lower levels of antibodies compared to the general population.

COVID-19 is not associated with worse long-term inflammatory bowel disease outcomes: a multicenter case-control study.

Background: Inflammatory bowel disease (IBD) is not associated with worse coronavirus disease 2019 (COVID-19) outcomes. However, data are lacking regarding the long-term impact of severe acute respiratory syndrome coronavirus 2 infection on the disease course of IBD. Objectives: We aimed to investigate the effect of COVID-19 on long-term outcomes of IBD. Design: We performed a multicenter case-control study of patients with IBD and COVID-19 between February 2020 and December 2020. Methods: Cases and controls were individuals with IBD with presence or absence, respectively, of COVID-19-related symptoms and confirmatory testing. The primary composite outcome was IBD-related hospitalization or surgery. Results: We identified 251 cases [ulcerative colitis (n = 111, 45%), Crohn's disease (n = 139, 55%)] and 251 controls, with a median follow-up of 394 days. The primary composite outcome of IBD-related hospitalization or surgery occurred in 29 (12%) cases versus 38 (15%) controls (p = 0.24) and on multivariate Cox regression, COVID-19 was not associated with increased risk of adverse IBD outcomes [adjusted hazard ratio (aHR): 0.84, 95% confidence interval [CI]: 0.44-1.42]. When stratified by infection severity, severe COVID-19 was associated with a numerically increased risk of adverse IBD outcomes (aHR: 2.43, 95% CI: 1.00-5.86), whereas mild-to-moderate COVID-19 was not (aHR: 0.68, 95% CI: 0.38-1.23). Conclusion: In this case-control study, COVID-19 did not have a long-term impact on the disease course of IBD. However, severe COVID-19 was numerically associated with worse IBD outcomes, underscoring the continued importance of risk mitigation and prevention strategies for patients with IBD during the ongoing COVID-19 pandemic.

Impact of COVID-19 on Healthcare Resource Utilisation Among Patients with Inflammatory Bowel Disease in the USA.

BACKGROUND AND AIMS: The impact of the COVID-19 pandemic on patients with inflammatory bowel disease [IBD] is largely unknown. We characterised the impact of COVID-19 on IBD care by conducting an analysis of US health care claims data. METHODS: We obtained de-identified, open-source, health insurance claims data, from January 2019 to December 2020, from the Symphony Health Integrated Dataverse for US adults with IBD, and measured the rates per 1000 patients of five outcomes: colonoscopies; new biologic or small molecule treatment initiations or treatment switches; new biologic or small molecule treatment initiations or treatment switches in patients who had a colonoscopy within the previous 60 days; IBD-related surgeries; and telehealth consultations. RESULTS: For 2019 and 2020, 1.32 million and 1.29 million patients with IBD, respectively, were included in the analysis. In March-April 2020, the rates of colonoscopies [17.39 vs 34.44], new biologic or small molecule treatment initiations or switches in patients who had a colonoscopy within the previous 60 days [0.76 vs 1.18], and IBD-related surgeries [2.33 vs 2.99] per 1000 patients were significantly decreased versus January-February 2020; significant year on year decreases versus 2019 were also observed. Telehealth utilisation increased in March 2020 and remained higher than in 2019 up to December 2020. CONCLUSIONS: Reduction in colonoscopies and subsequent initiation/switching of treatments during the COVID-19 pandemic suggest lost opportunities for therapy optimisation which may have an impact on longer-term patient outcomes. Increased utilisation of telehealth services may have helped address gaps in routine clinical care.

Effectiveness and Safety of COVID-19 Vaccines in Patients With Inflammatory Bowel Disease.

Vaccines against SARS-CoV-2 are important for protection from COVID-19; however, patients with immune-mediated conditions and patients taking immunosuppressive medications, including patients with inflammatory bowel disease (IBD), were excluded from studies demonstrating the safety and efficacy of these vaccines. This article provides an overview of the research and recommendations currently published on vaccines against COVID-19 in adult populations with IBD, including studies evaluating effects of commonly used medications. COVID-19 vaccines are strongly recommended for patients with IBD. Messenger RNA (mRNA) and adenovirus vector vaccines are safe in patients with IBD, and reports of severe reactions or IBD flares are rare. Studies assessing antibody response, T-cell immunity, and real-world experience demonstrate positive outcomes for mRNA and adenovirus vector vaccines in patients with IBD, although mRNA vaccines may have a slight advantage. Studies assessing inactive COVID-19 vaccines are still needed. Immunosuppressive therapies used in IBD, especially tumor necrosis factor antagonists, combination therapy, and corticosteroids, may reduce antibody responses and durability, but the impact on infection, hospitalizations, and death requires further evaluation. Educating patients with this evidence-based information will likely help to reduce concerns and vaccine hesitancy.

Outcomes of COVID-19 in Patients with Inflammatory Bowel Disease: Comparison with Household Members and the Role of IBD Medications.

BACKGROUND: Most data on the effect of inflammatory bowel disease (IBD) and its treatments on coronavirus disease 2019 (COVID-19) outcomes have not had non-IBD comparators. Hence, we aimed to describe COVID-19 outcomes in IBD compared to non-IBD patients. METHODS: We conducted a prospective cohort study of registered IBD patients with confirmed COVID-19 from six provinces in Iran from February to April 2020. Proven COVID-19 patients were followed up at four weeks and the frequency of outcomes was assessed. Multivariable logistic regression was used to assess associations between demographics, clinical characteristics and COVID-19 outcomes. RESULTS: Overall, 2159 IBD patients and 4721 household members were enrolled, with 84 (3.9%) and 49 (1.1%) participants having confirmed COVID-19, respectively. Household spread of COVID-19 was not common in this cohort (1.2%). While hospitalization was significantly more frequent in IBD patients compared with non-IBD household members (27.1% vs. 6.0%, P=0.002), there was no significant difference in the frequency of severe cases. Age and presence of IBD were positively associated with hospitalization in IBD compared with non-IBD household members (OR: 1.06, 95% CI: 1.03-1.10; OR: 5.7, 95% CI: 2.02- 16.07, respectively). Age, presence of new gastrointestinal symptoms, and 5-aminosalicylic acid (5-ASA) use were associated with higher hospitalization rate in IBD patients (OR: 1.13, 95% CI: 1.05-1.23; OR: 6.49, 95% CI: 1.87-22.54; OR: 6.22, 95% CI: 1.90-20.36, respectively). Anti-tumor necrosis factor (TNF) was not associated with more severe outcomes. CONCLUSION: Age, presence of new gastrointestinal symptoms and use of 5-ASA were associated with increased hospitalization rate among IBD patients, while anti-TNF therapy had no statistical association.

The Multiple Waves of COVID-19 in Patients With Inflammatory Bowel Disease: A Temporal Trend Analysis.

BACKGROUND: Cases of coronavirus disease 2019 (COVID-19) have emerged in discrete waves. We explored temporal trends in the reporting of COVID-19 in inflammatory bowel disease (IBD) patients. METHODS: The Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) is an international registry of IBD patients diagnosed with COVID-19. The average percent changes (APCs) were calculated in weekly reported cases of COVID-19 during the periods of March 22 to September 12, September 13 to December 12, 2020, and December 13 to July 31, 2021. RESULTS: Across 73 countries, 6404 cases of COVID-19 were reported in IBD patients. COVID-19 reporting decreased globally by 4.2% per week (95% CI, -5.3% to -3.0%) from March 22 to September 12, 2020, then climbed by 10.2% per week (95% CI, 8.1%-12.3%) from September 13 to December 12, 2020, and then declined by 6.3% per week (95% CI, -7.8% to -4.7%). In the fall of 2020, weekly reporting climbed in North America (APC, 11.3%; 95% CI, 8.8-13.8) and Europe (APC, 17.7%; 95% CI, 12.1%-23.5%), whereas reporting was stable in Asia (APC, -8.1%; 95% CI, -15.6-0.1). From December 13, 2020, to July 31, 2021, reporting of COVID-19 in those with IBD declined in North America (APC, -8.5%; 95% CI, -10.2 to -6.7) and Europe (APC, -5.4%; 95% CI, -7.2 to -3.6) and was stable in Latin America (APC, -1.5%; 95% CI, -3.5% to 0.6%). CONCLUSIONS: Temporal trends in reporting of COVID-19 in those with IBD are consistent with the epidemiological patterns COVID-19 globally.

Factors Affecting Initial Humoral Immune Response to SARS-CoV-2 Vaccines Among Patients With Inflammatory Bowel Diseases.

INTRODUCTION: Although an additional coronavirus disease 2019 vaccine dose for immunocompromised persons has been recommended in some countries, further data to guide vaccination strategies for patients with inflammatory bowel disease (IBD) are urgently needed. We sought to identify factors affecting initial humoral immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines among patients with IBD. METHODS: In this prospective cohort of SARS-CoV-2 immunized patients with IBD, we evaluated associations between participant age, sex, vaccine type, medication use, and the presence of a detectable antireceptor binding domain antibody and quantitative antibody level. RESULTS: In total, 1,909 participants were included (1,123, 692, and 94 received BNT162b2, mRNA-1273, and Ad26.COV2.S, respectively) of whom 96% achieved a positive antibody response. On multivariable analysis, factors associated with lack of antibody response were older age (P = 0.043), BNT162b2 vs mRNA-1273 (odds ratio [OR] 2.1, 95% confidence interval [CI] 1.0-3.9), and combination therapy with anti-TNF and 6MP, azathioprine, or methotrexate (OR 4.2, 95% CI 2.4-7.3). The use of 5-aminosalicylate or sulfasalazine (OR 0.3, 95% CI 0.1-0.8) and ustekinumab (OR 0.2, 95% CI 0.05-0.8) was associated with decreased odds of lacking antibody response. DISCUSSION: Most patients with IBD mount an initial response to SARS-CoV-2 vaccination; however, older patients and those treated with anti-TNF and immunomodulator have blunted responses and may benefit the most from an additional vaccine dose. Patients treated with other classes of immunosuppressive medications have more robust initial immune responses to vaccination. These data should inform key decisions about patient selection for additional coronavirus disease 2019 vaccine doses in patients with IBD.