ABSTRACT
Objectives: Patients with Systemic Lupus Erythematosus (SLE) are predisposed to serious infections due to immunocompromise, comorbidities, immunomodulatory and/or immunosuppressive therapy, as well as the lack of these medications faced by patients dependent on the Sistema Unico de Saude (SUS) during the COVID-19 pandemic. Studies revealed a low risk of worsening disease activity after vaccination against SARS-CoV-2 and safety in the continuity of immunomodulatory therapy during the vaccination stages. Thus, immunization against COVID-19 is an important pillar in reducingmorbidity and mortality related to infectious conditions and SLE. This study had the objective to understand the disease activity in SLE patients after vaccination against COVID-19. Method(s): This is an observational, longitudinal, ambidirectional study with follow-up of subgroups of patients with immune-mediated rheumatic diseases immunized with vaccines made available by the Programa Nacional de Imunizacao (Butantan Institute, Pfizer/BioNTech, BioManguinhos/Fiocruz and Janssen). Data from the SLE disease activity index 2000 (SLEDAI-2 K) and sociodemographic data were collected and stored via an online platform, with a comparison of the index before and after each dose. This study was approved by the local Research Ethics Committee, and it is associated to the SAFER Project from Brazilian Society of Rheumatology. Result(s): A total of 223 patients were included, of which 83% were female and 39% had SLE, 36.7 +/- 11.76 years old. Regarding the disease activity, at inclusion the mean PGA score(SD) was 2,61 +/- 2,77. After the 1st dose it was 1.38 +/- 2.17, after the 2nd dose it was 2,35 +/- 2,99, after the 3rd dose it was 2,19 +/- 2,58 and after the 4th dose 1.18 +/- 1.88. The mean SLEDAI-2 K score at inclusion was 7,27 +/- 9,70, after the 1st dose it was 2,75 +/- 5,29, after the 2nd dose it was 4,73 +/- 6,40, after the 3rd dose 3,33 +/- 5,51 and after the 4th dose 2.12 +/- 4.27. 6% of the patients referred worsening disease activity after the 1st dose, 14,3%after the 2nd dose, and no patient reportedworsening of disease activity after the 3rd and 4th doses. Conclusion(s): Vaccination did not contribute toworsening disease activity of the SLE patientss studied, according to the indices used to assess disease activity.
ABSTRACT
Objectives: Immunization against SARS-CoV-2 is an effective strategy to reduce morbidity and mortality in the face of the COVID-19 pandemic. People with Immune-mediated Rheumatic Diseases (IMRD) also benefited from this campaign. However, there is a limited amount of data on the outcome of vaccination in these patients, in terms of those who were infected by the virus. This study had the objective to evaluate the rate of COVID-19 cases in patients with IMRD after vaccination against SARS-CoV-2. Method(s): Observational, longitudinal and ambidirectional study with follow-up of subgroups of patients with IMRD immunized with vaccines made available by the National Immunization Plan (inactivated adsorbed vaccine registered by the Instituto Butantan (IB), recombinant vaccines registered by Bio Manguinhos/ Fiocruz and by Janssen, and Pfizer/BioNTech). Sociodemographic data and questionnaires on flu syndrome, laboratory confirmation of infection and need for hospitalization and outcomes were collected and stored via an online platform. This study is associated to the SAFER Project from the Brazilian Society of Rheumatology and it was approved by the local Research Ethics Committee. Result(s): A total of 223 patients aged over 18 years, mean age 42.79 +/- 15.18 years, were included. All were within the inclusion/exclusion criteria, with 83% being female. The main IMRD included were systemic lupus erythematosus (39%) and rheumatoid arthritis (33.6%). After the 1st dose, 1.45% of patients had COVID-19, 50% sought health services (emergency care), without the need for hospitalization and after the 2nd dose, 1.5% had the disease, of which none sought health services, required hospitalization or had a negative outcome. After the 3rd dose,: 2.9%were infected with SARS-CoV-2 one month later, 15.6% two to three months later and 5.5% four to six months later, all with laboratory confirmation;only 4% presenting any serious complication;there were no deaths. After the 4th dose, 9.1%of patients had COVID-19, of which 40%were hospitalized, without the need for assisted ventilation;half of these patients had a serious complication, but there no deaths. Conclusion(s): In this study, we observed the effectiveness of the vaccine in preventing severe cases of COVID-19 and complications of SARS-CoV-2 infection.
ABSTRACT
Objectives: Chronic Inflammatory Immune-mediated Diseases (CIMD) can cause pain and severe discomfort to the patient, leading to significant reductions in his/her quality of life. Vaccination against COVID-19 has proven to be an efficient method in preventing cases and serious repercussions. However, there is insufficient evidence on the safety of these vaccines in the CIMD population. Objective(s): To assess disease activity in adolescent patients with CIMD after vaccination against SARS-CoV-2. Method(s): Observational, longitudinal, ambidirectional study with follow-up of groups of adolescent patients with CIMDwho received the vaccine provided by the National Immunization Program -Pfizer/BioNTech. Sociodemographic and clinical disease activity data were collected before and after each vaccine dose. Data were stored through an online platform (REDCap). This study is associated to the SAFER Project from the Brazilian Society of Rheumatology and was approved by the local Research Ethics Committee. Result(s): Nineteen adolescents aged between 12 and 17 years were included, all of whom met the inclusion/exclusion criteria. Of the total, 31.6% have Juvenile Idiopathic Arthritis (JIA)-14.33 +/- 2.25 years of age, whose subtypes included persistent oligoarticular JIA (16.7%), Polyarticular Rheumatoid Factor (RF) negative (33.3%), Polyarticular RF positive (16.7%) and Systemic (33.3%);68.4% have Systemic Lupus Erythematosus (SLE) -14.77 +/- 1.96 years of age. Regarding JIA patients, at inclusion, the mean disease activity assessed by the physician was 3 +/- 3.83 and 3.25 +/- 3.77 as assessed by the patient. After the 1st dose, the mean activity assessed by the physician was 2.8 +/- 3.9 and after the 2nd dose it was 3 +/- 4.24. Themean activity after the first dose as assessed by the patient was 3.2 +/- 3.96, and after the 2nd dose it was 2.8 +/- 3.11. In the SLE patients, at inclusion, the mean degree of disease activity was 1.92 +/- 1.83 and of the SLEDAI-2 K was 4.67 +/- 5.14. After the 1st dose, the mean disease activity was 1.11 +/- 1.96, and after the 2nd dose, it was 2.25 +/- 2.76. After the 1st dose, the SLEDAI-2 K was 1.11 +/- 1.76, and after the 2nd dose it was 4.25 +/- 5.28. No reports of worsening of disease activity after the vaccine were found. Conclusion(s): The vaccination proved not to contribute to worsening of clinical activity of rheumatic diseases in adolescents, without significant changes in SLE assessment indices and in the personal and medical assessment of JIA patients.
ABSTRACT
Objectives: To evaluate the safety and immunogenicity of CoronaVac and ChAdOx1 vaccines against SARS-CoV-2 in patients with Rheumatoid Arthritis (RA). Method(s): These data are from the 'SAFER (Safety and Efficacy on COVID-19 Vaccine in Rheumatic Diseases)' study, a Brazilian multicentric longitudinal phase IV study to evaluate COVID-19 vaccine in immunomediated rheumatic diseases (IMRDs). Adverse events (AEs) in patients with RA were assessed after two doses of ChAdOx1 or CoronaVac. Stratification of postvaccination AEs was performed using a diary, filled out daily. The titers of neutralizing antibodies against the receptor-biding domain of SARS-CoV-2 (anti-RBD) were measured by chemilumine scence test after each dose of immunizers. Proportions between groups were compared using the Chi-square and Fisher's exact tests for categorical variables. Clinical Disease Activity Index (CDAI) before and after vaccination was assessed using the McNemar test. Result(s): A total of 188 patients with RA were included in the study, most of them were female. CoronaVac was used in 109 patients and ChAdOx1 in 79. Only mild AEs were observed. The more common AEs after the first dose were pain at injection site (46,7%), headache (39,4%), arthralgia (39,4%) and myalgia (30,5%), and ChAdOx1 had a higher frequency of pain at the injection site (66% vs 32 %, p alpha 0.001) arthralgia (62% vs 22%, p alpha 0.001) and myalgia (45% vs 20%, p alpha 0.001) compared to CoronaVac. The more common AEs after the second dose were pain at the injection site (37%), arthralgia (31%), myalgia (23%) and headache (21%). Arthralgia (41,42 % vs 25 %, p = 0.02) and pain at injection site (51,43% vs 27%, p = 0.001) were more common with ChAdOx1. No patients had a flare after vaccination. The titers of anti-RBDafter two doses of ChAdOx1 were higher compared to two doses of CoronaVac (6,03 BAU/mL vs 4,67 BAU/mL, p alpha 0,001). Conclusion(s): The frequency of local adverse effects, particularly pain at injection site, was high. AEs were more frequent with ChAdOx1, especially after the first dose. The use of the immunizers dis not change the degree of inflammatory activity of the disease. In patients with RA, ChAdOx1 was more immunogenic than CoronaVac. .