Background/Purpose: Recent studies have shown high rates of autoantibody production in patients hospitalized with COVID-19, including antinuclear antibodies (ANA) and antibodies associated with antiphospholipid syndrome. However, the long-term implications of these phenomena remain unknown. Similarly, whether vaccination against SARS-CoV-2 with novel mRNA constructs may lead to an increase in autoantibody production (or clinically evident autoimmunity) is yet to be elucidated. Here, we describe the incidence of ANA seroconversion in a cohort of patients with immune-mediated inflammatory diseases (IMID) after mRNA COVID-19 vaccination.

Methods: As part of the NYU Langone SAGA (Serologic Testing and Genomic Analysis of Autoimmune, Immune-mediated, and Rheumatic patients with COVID-19) cohort, 72 subjects (n=27 healthy controls and n=45 patients with IMID) were assessed for autoantibody production via serum ELISA. Time-points included pre/post COVID-19 infection as well as pre/post mRNA COVID-19 vaccination with time points up to 3 months post initial dose of mRNA vaccine. Spike IgG antibody titers were also assessed by in-house laboratory-based ELISA.

Results: In the SAGA cohort of healthy controls and IMID patients, 12 participants had documented prior COVID-19 infection. Of these, one patient with IMID converted from a negative to a positive ANA. Sixty participants, none of whom had previous COVID-19 infection, completed their 2-dose mRNA COVID-19 vaccination series. The overall incidence of de novo ANA positivity in these patients at 4-5 weeks post vaccination was 5% (3/60, 1 healthy control and 2 IMID). In the 3 participants who demonstrated ANA positivity, the healthy control was also Scl-70 positive on an extended autoantibody ELISA panel whereas the other 2 participants were negative for dsDNA, Smith, SS-A, SS-B, Scl-70, CENP, and Jo-1. Further, ANA antibodies were no longer present at the 3-month time point. Four patients (one of whom developed positive ANA) reported a flare of their disease after vaccination. No participant developed clinical manifestations of new autoimmune disease. There was no difference in the level of the SARS-CoV-2 spike IgG antibody response between those who transiently seroconverted after vaccination and those who did not (p = 0.496).

Conclusion: In a cohort of healthy controls and patients with IMID, the rate of ANA positivity after COVID-19 mRNA vaccination was low. In patients who developed a positive ANA, this finding was transient, resolving by the 3-month time point. While our findings are reassuring regarding the risk of developing autoimmunity after vaccination, the sample size is small and follow up is limited. Larger, long-term studies are critically needed to better characterize possible autoimmune manifestations after vaccination.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/low-incidence-and-transient-elevation-of-autoantibodies-post-mrna-covid-19-vaccination/