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: In the Chronic Inflammatory Immune-mediated Diseases (CIMD), infections mainly occur in the respiratory tract and their occurrence is related to drug-induced immunosuppression, underlying diseases and comorbidities. To reduce this morbidity and mortality, vaccination is an effective means of prevention. However, the available studies on SARS-CoV-2 vaccines have not addressed this group of patients with CIMD, and there are still many doubts regarding the indications, adverse effects, safety and efficacy of these vaccines. Objective(s): to evaluate the adverse effects of vaccines against SARS-CoV-2 in adolescent patients with CIMD. Method(s): Research associated to the SAFER Project from Brazilian Society of Rheumatology. It is an observational, longitudinal, ambidirectional study, with follow-up of groups of vaccinated adolescent patients with CIMD, vaccine by Pfizer/BioNTech. Sociodemographic data were collected, stored on an online platform, and adverse events were presented by filling in diaries issued for each patient. This study was approved by the local Research Ethics Committee. Result(s): We included 19 adolescents, aged between 12 to 17 years, who met the inclusion and exclusion criteria. The mean age was 14.63 +/- 2.01 years. Of these, 68.4% were female. In relation to CIMD, 31.6% have Juvenile Idiopathic Arthritis and 68.4% have Systemic Lupus Erythematosus. All were vaccinated with the Pfizer vaccine. In the 1st dose, the main adverse effects presented were Pain at the injection site (85.7%), Headache (42.9%), Tiredness (33.3%) and Edema and skin induration at the injection site (26, 7%). After the 2nd dose, the only adverse effect reported was Pain at the injection site (57.1%), with no other complaints. Conclusion(s): The adverse effects reported are of mild tomoderate reactogenicity;no serious adverse events were reported.
ABSTRACT
Objectives: Patients with immune-mediated rheumatic diseases (IMRDs) develop more severe outcomes of Coronavirus disease 2019 (COVID-19). Recent studies have contributed to understand the safety and efficacy of COVID-19 vaccines in IMRDs, suggesting that different diseases and therapies may interfere on immunization efficacy. In this study we analyze the immunogenicity of COVID-19 vaccines in patients with Systemic Vasculitides (VASC), the rate of COVID-19 and the frequency of disease relapse following immunization. Method(s): We included patients with VASC (n = 73), a subgroup of the SAFER study (Safety and Efficacy on COVID-19 Vaccine in Rheumatic Disease), a longitudinal, multicenter, Brazilian cohort.We analyzed the geometric means of IgG antibody against receptor-biding domain of protein spike of SARS-CoV-2 (anti-RBD) after two shots of CoronaVac (Inactivated vaccine), ChadOx-1 (AstraZeneca) or BNT162b2 (Pfizer-BioNTech). IgG anti-RBD was measured by chemiluminescence test. We assessed new-onset COVID-19 episodes, adverse events (AE) and disease activity for each VASC. Result(s): The sample included Behcet's disease (BD) (n = 41), Takayasu arteritis (TAK) (n = 15), antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) (n = 14), polyarteritis nodosa (n = 7) and other small vessel VASC(n = 6). The majority of patients were female (69%) without comorbidities (49%) and a median age of 37 years. The most common medication was conventional synthetic disease-modifying anti-rheumatic drugs, followed by biologic drugs. No patient received rituximab at baseline. Most patients received CoronaVac (n = 25) or ChadOx-1 (n = 36), while four received BNT162b2. Baseline IgG-RBD means were 1.34 BAU/mL. They increased to 3.89 and 5.29 BAU/mL after the 1st and 2nd vaccine dose, respectively. ChadOx-1 had higher antibody titers than CoronaVac (p = 0.002). There were no differences between different VASC. There were 3 cases of COVID-19 after immunization with CoronaVac. BD patients had a tendency for more cutaneous-articular activity following ChadOx-1. There were no severe relapses and no serious adverse events. Conclusion(s): Our results show the safety of different SARS-CoV-2 vaccines in VASC population. A progressive increase of IgG-RBD antibodies was observed after each dose. ChadOx-1 led to higher IgG-RBDgeometricmeans compared toCoronaVac. Finally, even though ChadOx-1 presented a tendency of triggering mild disease activity, there were no significant disease activity following vaccination in VASC patients. .
ABSTRACT
Objectives: Patients with immune-mediated rheumatic diseases (IMRD) constitute an important subgroup of immunosuppressed patients at risk of developing severe infections. Since coronavirus 19 infection (COVID-19) is an international public health emergency, it is necessary to observe the relationship between this viral infection and the development or intensification of the clinical course of IMRD and the persistence of new associated symptoms. The aim of this study is to trace this population's epidemiological profile and evaluate the frequency of chronic fatigue syndrome in patients with IMRD and COVID-19 compared to uninfected patients. Method(s): This is a descriptive cross-sectional observational study with a comparison group. The sociodemographic, clinical, and FACIT-F Fatigue Scale data were from patients with IMRD of Project Reumacov, organized by the Brazilian Society of Rheumatology, locally inManaus/Amazonas. The statistical analysis was performed through the inferential method to demonstrate the prevalence. Result(s): 268 patients were evaluated, those who had contact with COVID-19 had fatigue according with the fatigue assessment scale compared to unexposed patients. There was a statistically significant correlation between fatigue post-COVID-19 infection in the patients studied. Conclusion(s): Clinically relevant fatigue was a prevalent and commonly reported symptom in the post-COVID-19 period in the evaluated population. These data should direct attention to the reported manifestations as they affect the functioning of individuals' socioeconomic and health well-being throughout the pandemic period and beyond.