ABSTRACT
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.
ABSTRACT
INTRODUCTION: Despite reports suggesting an association between COVID-19 mRNA vaccination and pericarditis and myocarditis, detailed nationwide population-based data are sparsely available. We describe the incidence of pericarditis and myocarditis by age categories and sex after COVID-19 mRNA vaccination from a nationwide mass vaccination programme in Singapore. METHODS: The incidence of adjudicated cases of pericarditis and myocarditis following COVID-19 mRNA vaccination that were reported to the vaccine safety committee between January to July 2021 was compared with the background incidence of myocarditis in Singapore. RESULTS: As of end July 2021, a total of 34 cases were reported (9 pericarditis only, 14 myocarditis only, and 11 concomitant pericarditis and myocarditis) with 7,183,889 doses of COVID-19 mRNA vaccine administered. Of the 9 cases of pericarditis only, all were male except one. The highest incidence of pericarditis was in males aged 12-19 years with an incidence of 1.11 cases per 100,000 doses. Of the 25 cases of myocarditis, 80% (20 cases) were male and the median age was 23 years (range 12-55 years) with 16 cases after the second dose. A higher-than-expected number of cases were seen in males aged 12-19 and 20-29 years, with incidence rates of 3.72 and 0.98 case per 100,000 doses, respectively. CONCLUSION: Data from the national registry in Singapore indicate an increased incidence of pericarditis and myocarditis in younger men after COVID-19 mRNA vaccination.