Avaliação da Segurança e Imunogenicidade do Esquema Primário e Booster das vacinas contra Covid-19 na Artrite Reumatoide

Abstract

Introduction: Patients with rheumatoid arthritis (RA) are at high risk of developing the severe form of COVID-19, due to immunosuppression and comorbidities. These patients were excluded from pivotal studies of the vaccine against SARS-CoV-2, hence the importance of real-life studies to evaluate the safety and immunogenicity of vaccines in this population. Objective: To evaluate the safety and immunogenicity of the booster dose, in primary patients vaccinated with ChAdOx1 (Oxford/AstraZeneca) and Coronavac (Sinovac/Butantan). Methods: The data from this study are part of SAFER, “Safety and Efficacy on COVID-19 Vaccine in Rheumatic Diseases”, a multicenter observational, longitudinal Cohort 1 (prospective) study. All centers were evaluated after two doses of ChAdOx1 (Oxford/AstraZeneca) or Coronavac (Sinovac/Butantan), with mNRA BNT162B2 (Pfizer/BioNTech) boost. Results: This study included 107 patients with RA. In the two-dose vaccination schedule, plus booster, 66 patients received two CoronaVac doses + mNRA BNT162B2 booster (Pfizer) and 41 patients received two ChAdOx1 doses + mNRA BNT162B2 booster (Pfizer). The average age was 46.02 ± 12.04 years, the majority were female (89.72%), mixed race (42.99%). The results demonstrated that after the vaccine there was no increase in inflammatory activity. The Events Supposedly Attributable to Vaccination or Immunization (ESAVI) observed were mild. Regarding immunogenicity, patients with two doses of Coronavac + mNRA BNT162B2 (Pfizer) compared to patients with two doses of ChAdOx1 + mNRA BNT162B2 (Pfizer) obtained the following results: LOG (mean logarithm of IgG), after 1st dose (4.20 x 5.03 p>0.11); 2nd dose (4.67 x 6.03 p>0.001) and after 3rd dose (7.06 BAU/mL x 7.28 p> 0.56). When comparing the antibody titers in patients vaccinated with the 1st and 2nd doses, we observed that the antibody titers of the ChAdOx1 vaccine were higher than CoronaVac and after the 3rd dose of the Pfizer vaccine, the antibody titers of the two vaccination schedules were equivalent. Conclusion: ESAVI were mild, well tolerated by patients, with ChAdOx1 having a greater number of events. There was no worsening in the degree of disease activity. The immunogenicity of ChAdOx1 was greater in the primary regimen, but the booster dose equalized the antibody titer of both vaccine regimens.