Imunogenicidade da vacinação contra SARS-CoV-2 em pacientes com esclerose sistêmica, síndrome de superposição, miopatias inflamatórias e doença mista do tecido conjuntivo : um estudo de coorte multicêntrico brasileiro

Abstract

Introduction: Patients with immune-mediated rheumatic diseases (IMRDs) are at high risk of severe COVID-19 outcomes, especially in scenarios of immunosuppression or multiple comorbidities. Objective: To analyze the immune response to vaccination against SARS-CoV-2 in patients with Systemic Sclerosis, Superposition Syndrome, Inflammatory Myopathies and Mixed Connective Tissue Disease. Methodology: Multicenter, observational and prospective study, carried out between June/2021 and Oct/2022, with 69 patients diagnosed with Systemic Sclerosis, Superposition Syndrome, Inflammatory Myopathies and Mixed Connective Tissue Disease, who are part of the SAFER Cohort study. The study evaluated the evolution of specific IgG levels against SARS-CoV-2 at four points in time (T1: before the first dose; T2: 28 days after the first dose; T3: 28 days after the second dose; T4: 28 days after the booster dose), considering factors such as the type of disease, previous exposure to SARS-CoV-2 and the booster dose. The frequency of seroconversion at the four time points was also analyzed, stratified by type of disease and drug class. We also investigated the influence of vaccination on disease activity and the variables involved in immunogenicity, such as the use of immunosuppressants and comorbidities. Results: IgG titers increased significantly over time, from 10.25 BAU/mL (T1) to 668.16 BAU/mL (T4). The comparative analysis between the BNT162b2 and ChAdOx1 nCoV-19 vaccines showed similar immune responses at T3, but at T4, BNT162b2 induced significantly higher IgG titers (908.22 vs. 280.01; p=0.009). Seroconversion (SV) in non-pre-exposed patients increased progressively, reaching 88% at T4, with variations between diagnostic groups: patients with CKD and MI had faster and higher SV, while those with SS and ES had lower rates at T2. With regard to drugs, patients without therapy or taking csDMARDs and corticosteroids achieved higher HR rates, while those on therapy with Rituximab, Abatacept and Tocilizumab showed reduced immune responses. Conclusion: The study showed that vaccination against SARS-CoV-2 induced an immune response in patients with MDRD, with a progressive increase in IgG titers, especially after the booster dose. Pre-exposed patients vaccinated with BNT162b2 showed more robust responses, while the use of bDMARDs was associated with lower seroconversion rates. Vaccination did not exacerbate disease activity, reinforcing its safety in this population.