Multicenter case-control study evaluating the safety of anti-SARS-CoV-2 vaccines in a cohort of patients with systemic vasculitis

Abstract

Objective: Data on the safety of anti-SARS-CoV-2 vaccines in patients with rare rheumatic diseases, such as systemic vasculitis (SV), are limited. Aim of this study was to evaluate the occurrence of a disease flare and the appearance of adverse events (AEs) following administration of anti-SARS-CoV-2 vaccine in a multicenter cohort of patients with SV. Methods: Patients with SV and healthy controls (HCs) from two different Italian rheumatology centers were asked to complete a questionnaire assessing disease flares occurrence, defined as new onset of clinical manifestations related to vasculitis needing an implementation of therapy, and local/systemic AEs appearance following anti SARS-CoV-2 vaccination.Results: 107 patients with SV (57 ANCA-associated) and 107 HCs were enrolled. A disease flare occurred in only one patient (0.93%) with microscopic polyangiitis after the first dose of an mRNA vaccine. Both after the first and the second vaccine dose administration, no significant differences in AEs between patients with SV and HCs were observed; no serious AEs were reported as well. Conclusions: This data suggest a good risk profile for anti-SARS-CoV-2 vaccine in patients with systemic vasculitis.