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

Abstract

ObjectiveData on the safety of anti-SARS-CoV-2 vaccines in patients with rare rheumatic diseases, such as systemic vasculitis (SV), are limited. The 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 multicentre cohort of patients with SV. Methods Patients with SV and healthy controls (HC) from two different Italian rheumatology centres 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 HC were enrolled. A disease flare occurred in only one patient (0.93%) with microscopic polyangiitis after the first dose of an mRNA vaccine. After both the first and the second vaccine dose administration, no significant differences in AEs between patients with SV and HC were observed; no serious AEs were reported as well. ConclusionThese data suggest a good risk profile for anti-SARS-CoV-2 vaccine in patients with systemic vasculitis.

The impact of coronavirus‐19 vaccination on anti‐nuclear cytoplasmic antibody vasculitis hospitalisations in a Sydney health network

“…8 The safety of different COVID-19 vaccinations, specifically within a vasculitis population, was assessed in a recent case-control study. 9 Of the 57 cases with AAV included in their review, only one case (a 77-year-old male) had a flare of MPA a few days following vaccination.…”

“…There were no reports of AAV following COVID‐19 vaccination during the phase III clinical trials that formed the basis for Therapeutic Drug Administration approval; however, these studies were not powered to detect such rare adverse effects 8 . The safety of different COVID‐19 vaccinations, specifically within a vasculitis population, was assessed in a recent case–control study 9 . Of the 57 cases with AAV included in their review, only one case (a 77‐year‐old male) had a flare of MPA a few days following vaccination.…”

Molecular Mimicry and HLA Polymorphisms May Drive Autoimmunity in Recipients of the BNT-162b2 mRNA Vaccine: A Computational Analysis

“…Notwithstanding these intriguing results, most data from either clinical trials or real-life cohort studies of people with autoimmune diseases do not evidence an increased safety risk after COVID-19 vaccine administration in terms of disease flares or worsening, as shown in Table 6 [ 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 45 , 46 ]. However, these results may be confounded by concomitant immunosuppressive treatments that limit the magnitude of the immune response to both the vaccine and self-epitopes [ 47 ].…”

“…These events include connective tissue diseases, autoimmune arthritis, myocarditis, and vasculitis [ 3 , 4 ]. On the other hand, anti-SARS-CoV-2 vaccines have been shown to be safe in patients with previously diagnosed autoimmune diseases in both clinical trials and real-life studies [ 5 , 6 , 7 , 8 , 9 , 10 ]. These seemingly contradictory data may be explained by a different pharmacological background of the two cohorts studied (no immunosuppressive therapy in patients with de novo developing diseases).…”

BA.1/BA.5 Immunogenicity, Reactogenicity, and Disease Activity after COVID-19 Vaccination in Patients with ANCA-Associated Vasculitis: A Prospective Observational Cohort Study

“…However, in the current study, no AAV patient experienced a disease flare and kidney function remained stable during follow-up. In a multicenter case-control study of 107 individuals with systemic vasculitis, including 57 AAV patients, Simoncelli et al recently reported only one disease flare after a first mRNA SARS-CoV-2 vaccine dose and no further episodes after the second or third vaccination [ 53 ]. It should be noted that neither the study by Simoncelli et al nor our current study are powered or designed to definitively exclude safety concerns in AAV patients after mRNA vaccination.…”