Background/Purpose: The rapid spread of the COVID-19 pandemic has created the need for mass vaccination of patients with autoimmune rheumatic disease (AIIRD) despite the lack of information on the effect of BNT162b2 mRNA vaccine on the underlying autoimmune disease and the possible generation of autoantibodies. Our objective was to investigate the generation of autoantibodies following BNT162b2 mRNA vaccine and its association with disease flares in AIIRD patients compared with the general population.

Methods: We investigated the generation of autoantibodies as a part of a prospective study aimed to monitor immunogenicity, efficacy, and safety of the two-dose regimen BNT162b2 mRNAvaccine in adult patients with AIIRD including immune-mediated arthritis, connective tissues diseases (CTD), systemic vasculitis, and idiopathic inflammatory myositis (IIM) compared to control subjects from the general population. Sera were taken prior to vaccination and 2-6 weeks following the second vaccine dose to examine titers of antinuclear antibodies (ANA) measured by immunofluorescence and multiplex, antiphospholipid antibodies (aPL) and rheumatoid factor (RF). Data on generation of autoantibodies was calculated for each type of autoantibody individually based on number of patients with available data. Post-vaccination seroconversion was defined as any first-time ANA, aPL, or RF seropositivity. Pre- and post-vaccination disease activity indices were assessed as appropriate for each disease, and any signs or symptoms of new-onset AIIRD were noted in controls.

Results: A total of 166 AIIRD patients and 59 controls participated in the study, 72.9% (n=121) female. AIIRD patients were significantly older than controls, mean age 58.0±14.6 vs 50.8 ±14.7, respectively (p=0.008). Disease representation in AIIRD group included RA (47.0%), PsA (20.5%), AS (12.0%), SLE (11.4%), vasculitis (5.4%), IIM (2.4%), Sjogren’s (0.6%), IGG4-RD (0.6%). A total of 94.6% (n=157) AIIRD patients were treated with immunomodulatory medications. Immunoserologic data before and following vaccination was available for ANA serology in 137 (82.5%) AIIRD patients and 45 (76.3%) controls; aPL serology for 134 (80.7%) AIIRD patients and 51 (86.2%) controls, and RF serology for 138 (83.1%) AIIRD patients and 50 (84.7%) controls. The ANA seroconversion rate was 10.2% (n=14) in patients with AIIRD compared to 6.7% (n=3) in controls (p=0.570); the aPL seroconversion rate was 1.5% (n=2) in AIIRD compared to 0% in controls (p >0.99). No cases of RF seroconversion were observed in AIIRD patients or controls. There was no statistically significant difference in age or sex among individuals who experienced seroconversion to those who did not, regardless of AIIRD status. Post-vaccination disease activity remained stable in patients who generated autoantibodies and no new signs of disease onset were seen in healthy controls who underwent seroconversion in the followup period.

Conclusion: Vaccination with the BNTb262 vaccine resulted in the generation of autoantibodies in a minority of AIIRD patients and controls. Autoantibody generation was not associated with disease flares or new-onset disease.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/generation-of-autoantibodies-and-their-association-with-rheumatic-disease-flares-in-adult-patients-with-autoimmune-inflammatory-rheumatic-diseases-and-general-adult-population-following-bnt162b2-mrna/