Objective The impact of medications on COVID-19 MESHD vaccine efficacy in IBD MESHD patients is unknown, as patients with immunosuppressed states and/or treated with immunosuppressants were excluded from vaccine trials. To address this, we evaluated serological responses to COVID-19 MESHD vaccination with the SARS-CoV-2 spike MESHD SARS-CoV-2 spike PROTEIN (S) mRNA BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (NIH-Moderna) vaccines in IBD MESHD patients enrolled in an ongoing SARS-CoV-2 sero-survey at the Icahn School of Medicine at Mount Sinai in New York City. Design We obtained sera from 48 patients who had undergone vaccination with one or two vaccine doses. Sera were tested for SARS-CoV-2 anti-RBD total immunoglobulins and IgG (Siemens COV2T and sCOVG assays), anti-Spike IgG (in-house ELISA), and anti-nucleocapsid antibodies (Roche). Results All IBD MESHD patients (15/15) who completed two-dose vaccine schedules achieved seroconversion to high levels. Two IBD MESHD patients with history of COVID-19 MESHD infections and who were seropositive at baseline seroconverted to high levels after the first dose. Concurrent biologic use was 85% (41/48), including 33% of patients (16) on TNF HGNC antagonist monotherapy, 42% (17) on vedolizumab monotherapy, 6% (3) on vedolizumab combination therapy with thiopurine, and 8% (4) ustekinumab; 1 patient was receiving guselkumab for psoriasis MESHD. Three patients (6%) were on oral steroids at the time of vaccination. Conclusion IBD MESHD patients receiving biologics can seroconvert with robust serological responses after complete Pfizer-BioNTech and NIH-Moderna COVID-19 MESHD vaccination. In IBD-patients with previous SARS-CoV-2 seroconversion, a single dose of either vaccine can induce high index values, mirroring findings from the general population.

Patients with immune-mediated inflammatory diseases (IMIDs) and acquired and genetic immunodeficiencies MESHD receiving therapeutic infusions are considered high risk for SARS-CoV-2 infection MESHD. However, the seroprevalance in this group and the safety of routine administrations at outpatient infusion centers are unknown. To determine the infection rate and clinical-social factors related to SARS-CoV-2 in asymptomatic patients with IMIDs MESHD and immunodeficiencies MESHD receiving routine non-cancer therapeutic infusions, we conducted a seroprevalence study at our outpatient infusion center. We report the first prospective SARS-CoV-2 sero-surveillance of 444 IBD/IMID, immunodeficiency MESHD, and immune competent patients at an outpatient infusion center in the U.S. showing lower seroprevalence in patients compared with the general population and provide clinical and social characteristics associated with seroprevalence in this group. These data suggest that patients can safely continue infusions at outpatient centers.

Importance Risk calculators can facilitate shared medical decision-making. Demographics, comorbidities, medication use, geographic region, and other factors may increase the risk for COVID-19 MESHD-related complications among patients with IBD MESHD. Objectives Develop an individualized prognostic risk prediction tool for predicting the probability of adverse COVID-19 MESHD outcomes in patients with IBD MESHD. Design, Setting, and Participants This study developed and validated prognostic penalized logistic regression models using reports to Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease MESHD (SECURE-IBD) from March-October 2020. Model development was done using a training data set (85% of cases reported March 13 - September 15, 2020), and model validation was conducted using a test data set (the remaining 15% of cases plus all cases reported September 16 - October 20, 2020). Main Outcomes and Measures COVID-19 MESHD related: Hospitalization+: composite outcome of hospitalization, ICU admission, mechanical ventilation, or death MESHD ICU+: composite outcome of ICU admission, mechanical ventilation, or death Death MESHD We assessed the resulting models' discrimination using the area under the curve (AUC) of the receiver-operator characteristic (ROC) curves and reported the corresponding 95% confidence intervals (CIs). Results We included 2709 cases from 59 countries (mean age 41.2 years [s.d. 18], 50.2% male). A total of 633 (24%) were hospitalized, 137 (5%) were admitted to the ICU or intubated, and 69 (3%) died. 2009 patients comprised the training set and 700 the test set. The models demonstrated excellent discrimination, with a test set AUC (95% CI) of 0.79 (0.75, 0.83) for Hospitalization+, 0.88 (0.82, 0.95) for ICU+, and 0.94 (0.89, 0.99) for Death MESHD. Age, comorbidities, corticosteroid use, and male gender were associated with higher risk of death MESHD, while use of biologic therapies was associated with a lower risk. Conclusions and Relevance Prognostic models can effectively predict who is at higher risk for COVID-19 MESHD-related adverse outcomes in a population of IBD MESHD patients. A free online risk calculator (https://covidibd.org/ covid-19 MESHD-risk-calculator/) is available for healthcare providers to facilitate discussion of risks due to COVID-19 MESHD with IBD MESHD patients. The tool numerically and visually summarizes the patient's probabilities of adverse outcomes and associated CIs. Helping physicians identify their highest-risk patients will be important in the coming months as cases rise in the US and worldwide. This tool can also serve as a model for risk stratification in other chronic diseases MESHD.

Background There has been great concern amongst clinicians and patients that immunomodulatory treatments for IBD may increase risk of SARS-CoV-2 susceptibility or progression to severe disease. Methods Sera from 640 patients attending for maintenance infliximab or vedolizumab infusions between April and June 2020 at the John Radcliffe Hospital (Oxford, UK) and Royal London Hospital (London, UK) were tested using the Abbott SARS-CoV-2 IgG assay. Demographic and clinical data were collated from electronic patient records and research databases. Results Seropositivity rates of 3.0% (12/404), 7.2% (13/180), and 12.5% (7/56) were found in the Oxford and London adult IBD cohorts and London paediatric IBD cohorts respectively. Seroprevalence rates in the Oxford adult IBD MESHD cohort were lower than that seen in non-patient facing health-care workers within the same hospital (7.2%). Seroprevalence rates of the London paediatric IBD cohort were comparable to a contemporary healthy cohort collected at the same hospital (54/396, 13.6%). Conclusions SARS-CoV-2 seropositivity rates are not elevated in patients with IBD receiving maintenance infliximab or vedolizumab infusions. There is no rationale based on these data for elective interruption of maintenance therapy, and we recommend continuation of maintenance therapy. These data do not address the efficacy of vaccination in these patients.