RISK FACTORS for SHORT-TERM ADVERSE EVENT in PATIENTS with IMMUNE-MEDIATED INFLAMMATORY DISEASES

ABSTRACT

Background: Many countries are promoting booster SARS-CoV-2 vaccination campaigns as the COVID-19 pandemic continues. Incremental short-term adverse events after two SARS-CoV-2 vaccinations have been reported in healthy individuals.1,2 However, data on incremental short-term adverse events in patients with various immune-mediated infammatory diseases (IMIDs) after repeated SARS-CoV-2 vaccination is scarce. Objectives: We report risk factors for short-term adverse events in IMID patients after SARS-CoV-2 vaccination. Methods: Self-reported daily questionnaires on adverse events in the frst seven days after SARS-CoV-2 vaccination were obtained from individuals participating in an ongoing prospective multi-arm multicenter cohort study on SARS-CoV-2 vaccination in patients with various IMIDs in the Netherlands (T2B! immunity after SARS-CoV-2). Clinically relevant adverse events were defned as systemic adverse advents lasting longer than two days or hindering daily activities. Adjusted relative risks for developing clinically relevant adverse events were calculated using a logistic mixed-effects model. Results: Data of 2081 patients and 178 healthy controls were obtained. Infammatory bowel disease (N480), Multiple sclerosis (N343) and Rheumatoid arthritis (N266) were the largest disease groups. Adjusted relative risks for relevant adverse events are presented in Figure 1. Third vaccination was not associated with increased risk on adverse events when compared to a second vaccination (aRR 0.93 95% CI 0.84-1.02). Patients with IMIDs were at increased risk for developing adverse events after vaccination when compared to controls (aRR 1.16 95% CI 1.01-1.34). Female sex (aRR 1.43 95% CI 1.32-1.56), age below 50 (aRR 1.14 95% CI 1.06-1.23) and a preceding SARS-CoV-2 infection (aRR 1.14 95% CI 1.01-1.29) were also associated with increased risk of adverse events following vaccination. Allergic reactions and hospital admission were uncommon (0.67% and 0.19% respectively);7.4% and 6.8% of patients reported adverse events impacting daily life on day seven after second and third vaccination, respectively. Data on increase in disease activity of the IMID following vaccination are currently being investigated. Conclusion: A third SARS-CoV-2 vaccination was not associated with an increased risk on short-term clinically relevant adverse events when compared to a second vaccination. Although patients with IMIDs may be slightly more at risk to develop adverse events after SARS-CoV-2 vaccination, most adverse events were transient and disappeared within seven days. This message should reassure IMID patients who are hesitant on booster vaccination. Data on potential IMID fare-ups after vaccination will follow.