Background/Purpose: Little is known regarding autoantibody generation and clinically manifest autoimmunity following BNT162b2 mRNA vaccination. Our objective was to investigate the development of autoantibodies following BNT162b2 mRNA vaccine and its association with disease flares/new-onset autoimmunity in AIIRD patients in comparison to the general population.

Methods: We compared the incidence of appearance of autoantibodies (ANA, aPL, and RF) in the sera of AIIRD adult patients (≥18 years) compared to general population controls prior to, and 2-6 weeks following, the second and the third vaccine doses and at 1-year of follow-up.

Data on the development of autoantibodies was analyzed based on the number of patients with available serology following each vaccine dose. Post-vaccination seroconversion was defined as any first-time ANA, aPL or RF seropositivity in patients with available pre-vaccination tests. Pre- and post-vaccination disease activity indices and signs/symptoms of new-onset disease were assessed, and any increase in disease activity score was verified by clinic visit notes to ascertain post-vaccine disease flares.

Results: This prospective study included 184 AIIRD patients, 18 of whom were excluded (2 had COVID-19 infection, 2 did not complete at least two vaccine doses, 7 lacked prior serologic data in all 3 autoantibody categories, and 7 were lost to follow-up) and 59 controls, of whom 4 were lost to follow-up. Female patients constituted 74.7% (n=124) of patients and 69.1% (n=38) of the controls (p< 0.001). Compared to controls, patients were significantly older [mean age 59.7±14.3 vs 50.9 ±14.7, respectively (p< 0.001)]. The majority of patients and controls received a third vaccine dose [(95.8%, n=159) and (98.2%, n=54), respectively].

AIIRD patients included RA (42.8%), PsA (18.7%), AS (10.2%), SLE (19.0%), vasculitis (6.0%), and myositis (2.4%), with 92.2% (n=153) treated with immunosuppressants. Seroconversion rates in AIIRD patients vs controls following initial two vaccines were 8.5% (n=14) vs 6.4% (n=3) (p=0.77) for ANA; 1.3% (n=2) vs 0% (n=0) (p=1.0) for aPL, with one patient undergoing dual ANA and aPL seroconversion in the AIIRD group. Seroconversion following the third vaccine dose was 5.0% (n=6) for ANA and 1.8% (n=2) for aPL in AIIRD patients vs 0% (n=0) in controls for both serologic tests (p=0.35 and p=1.0, respectively). No cases of RF seroconversion were observed after any vaccine dose. There was no significant difference in sex or age among individuals who underwent seroconversion to those who did not, regardless of AIIRD status or immunosuppressant use. Among AIIRD patients, no disease flares occurred following initial two vaccine doses. Following the third vaccine dose, 13.9% (n=23) AIIRD patients experienced a disease fare, while no signs of new-onset inflammatory or autoimmune disease were reported in controls with or without seroconversion.

Conclusion: BNT162b2 vaccination resulted in the development of autoantibodies in a minority of AIIRD patients and controls. No new-onset autoimmune disease was observed in patients or controls, regardless of seroconversion.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/development-of-autoantibodies-and-their-association-with-flare-ups-of-rheumatic-diseases-in-adult-patients-with-autoimmune-inflammatory-rheumatic-diseases-aiird-and-the-general-population-following/