As doenças reumáticas imunomediadas (DRIM) caracterizam-se por mani-festações heterogêneas e pleomórficas com acometimento de diversos órgãos e sistemas, incluindo o sistema cardiovascular, seja por lesão cardíaca direta(endocárdio, miocárdio, pericárdio ou sistema de condução) ou mesmo por aumento do risco cardiovascular com o desenvolvimento de aterosclerose precoce. Por sua vez, a aterosclerose é reconhecida como uma doença inflamatória, sendo um ponto comum entre diversas DRIM e um importante fator de morbidade e mortalidade cardiovascular, especialmente no lúpus eritematoso sistêmico (LES), na artrite reumatoide (AR) e nas espondiloartrites (EpA). A maior frequência de aterosclero-se nessas doenças não é atribuída apenas aos fatores de risco cardiovasculares (FRCV) tradicionais, sendo a imunodesregulação e o processo inflamatório crônico persistente importantes para a maior risco e precocidade da doença cardiovascular nesses pacientes. Neste artigo, abordaremos especificamente a aterosclerose no LES, AR e EpA, o manejo do risco cardiovascular em cada doença e como interpre-tar criticamente os escores de risco cardiovascular disponíveis na literatura nesse cenário. Deve-se estar atento a suas possíveis complicações, uma vez que muitas destas manifestações são silenciosas e indolentes e o reconhecimento precoce com controle da atividade de doença e dos FRCV são fundamentais. Além disso, os escores de risco para estratificação cardiovascular atualmente disponíveis devem ser interpretados com cautela nessa população, uma vez que o risco cardiovascular pode ser subestimado

BackgroundSystemic lupus erythematosus (SLE) is an autoimmune disease, which presents an immune disorder that leads to the production of autoantibodies with potential involvement of multiple organs. Infections are one of the most frequent causes of hospitalization and death in lupus patients, and SARS-CoV-2 infection has been a global threat since March 2020. Immunization of these patients has been strongly recommended, although vaccine evaluation studies have not included this profile of patients.ObjectivesTo evaluate the immunogenicity and safety after 2 doses of the vaccine against SARS-CoV2 in patients with SLE.MethodsSubgroup of SLE patients from the prospective multicenter cohort of patients with immune-mediated diseases “SAFER” – Safety and Efficacy on COVID-19 Vaccine in Rheumatic Disease, a phase IV study. Vaccination against SARS-CoV-2 took place with vaccines approved by Brazilian regulatory bodies CoronaVac (Inactivated SARS-CoV-2 Vaccine), ChadOx-1 (AstraZeneca) and BNT162b2 (Pfizer-BioNTech) and this project followed in line with the guidelines of the National Immunization Plan in Brazil. Patients aged 18 years or older with a previous diagnosis of SLE (according to the 2019 ACR/EULAR criteria) were included. Patients were evaluated by telephone contact and in a face-to-face visit on the 28th day after each dose. Patients were followed up by means of blood collection for measurement of IgG antibody against SARS-COV-2 by chemiluminescence and disease activity assessed using SLEDAI-2K score.ResultsA total of 367 individuals with SLE were included, of whom 207 received 2 doses of CoronaVac, 128 received 2 doses of ChadOx-1 and 32 received 2 doses of BNT162b2. 90% of the subjects were female with a mean age of 37 years. About 42% (154) of the individuals included did not have any other associated comorbidity. 50% (182) of patients were using oral glucocorticoids and azathioprine was the most frequent immunosuppressive therapy. Regarding disease activity parameters, 38% (140) of patients had zero SLEDAI-2K at baseline and 41% (147) had zero SLEDAI-2K 28 days after the 2nd dose. Anti-DNA positivity was 30.7% (16/52) at inclusion and 32.6% (17/52) 28 days after the 2nd dose. Complement consumption was present in 18% (10/55) at inclusion and in 14.5% (8/55) 28 days after the 2nd vaccine dose. The geometric mean titers of IgG antibodies against SARS-COV-2 increased in the different vaccine groups, log 2.27 BAU/mL at inclusion and log 5.58 BAU/mL 28 days after the 2nd dose. Antibody titers after second dose varied between different vaccines, 4.96 BAU/mL CoronaVac, 6.00 BAU/mL ChadOx-1 and 7.31 BAU/mL BNT162b2 vaccine, p < 0.001. Only 3.54% (13/367) patients had covid-19 infection after the 15th day of the second dose of immunization, 9 of them having received 2 doses of CoronaVac, 4 of them of ChadOx-1 and none of them receiving BNT162b2, with p-value of 0.63.ConclusionThis study suggests that vaccines against SARS-COV-2 are safe in SLE patients. Induction of immunogenicity occurred in different vaccine regimens. Only 3.5% of individuals had COVID-19 infection with no difference between the types of vaccines evaluated. Future analyzes to explore the association of the effect of immunosuppressive medication, as well as the impact of booster doses and longer follow-up on clinical outcome will be performed.References[1]Mason A, et al. Lupus, vaccinations and COVID-19: What we know now.Lupus. 2021;30(10):1541-1552.[2]Furer V, Eviatar T, Zisman D, et al. Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in adult patients with autoimmune inflammatory rheumatic diseases and in the general population: A multicentre study.Ann Rheum Dis. 2021;80(10):1330-1338.[3]Izmirly PM, Kim MY, Samanovic M, et al. Evaluation of Immune Response and Disease Status in SLE Patients Following SARS-CoV-2 Vaccination.Arthritis Rheumatol. Published online 2021.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

BackgroundThe ChAdOx1, Coronavac, BNT162B2 and Janssen vaccines are available for the primary and booster immunization of immunosuppressed patients. However, there are few studies in the literature that assess the immunogenicity and safety of the different platforms COVID-19 vaccines in patients with autoimmune diseases (AID).ObjectivesThe present study aims to evaluate the immunogenicity through anti-spike IgG antibodies 28 days after the booster dose in the heterologous boost groups compared with homologous regimen of the vaccine against COVID-19 in patients with AID.MethodsThese data are from SAFER study: “Safety and efficacy on Covid-19 Vaccine in Rheumatic Disease”, a multicentric prospective phase IV study, in real life, in Brazil, started on May 2021. Data from this analysis were from 8 centers, from all Brazilian areas, after 2 or 3 doses of vaccine against COVID-19 in patients with AID age ≥ 18 years. Exclusion criteria were pregnancy, previous severe adverse events (AE) to any vaccine or other imunosuppression causes. Demographics, diagnoses and therapeutic regimens were collected via participant report through the Research Electronic Data Capture tool. Available vaccines were adenoviral vectored vaccine (ChAdOx1, Astrazeneca and Ad26.COV2-S, Janssen), mRNA vaccine (BNT162b2, Pfizer–BioNTech) or inactivated SARS-COV-2 vaccine (Coronavac). Participants were followed up by means of blood collection for measurement of IgG antibody against SARS-CoV-2 spike receptor-binding domain by chemiluminescence (SARS-CoV-2-IgG-II Quant assay, Abbott-Laboratories) at baseline and 28 days after the first, 2nd and 3rd doses. The seropositivity was defined for titers IgG-Spike ≥7.1 BAU/mL. The ANOVA, the post-hoc Tukey and pairwise comparisons tests were used to compare the IgG-S titles between the groups. An alpha level of 5% significance was used in all analyses.ResultsA total of 1096 participants were included and followed from the first dose. 709 patients AID received the complete 3-dose regimen: systemic lupus erythematosus (N=238, 33.6%), rheumatoid arthritis (N=143, 20.2%), spondyloarthritis (N=96, 13.5%), primary Sjögren’s syndrome (N=56, 7.9),), inflammatory bowel disease (N=50, 7,1%), vasculitis (N=31, 4.4%), systemic sclerosis (N=25, 3.5%), Behçet syndrome (N= 19, 2.7%) myositis (N= 12, 1.7%), other systemic AID (N= 39, 5.5%). Mean age was 41.59 (12.2), female N=556, (78.4%) and admixed race (N=370, 52.2%). Primary immunization was performed with Coronavac in 265 (37.4%), ChAdOx1 in 403 (56.8%) and Pfizer in 41 (5.8%) AID patients. After the 2nd dose (28 days), the booster was performed with Coronavac (N=10, 1.4%), ChAdOx1 (N=226, 31.9%), Pfizer (N=464, 65.4%) and Janssen (N=9, 1.3%). Anti-spike IgG antibodies were analyzed in the 657 patients who received the three doses. All patients had a substantial increase in IgG antibody concentrations 28dy after the booster vaccine with median 275.9 BAU/ml (88.8 - 1000.9) vs. 1217.2 (402.3 - 3213.7) booster vaccine. All heterologous regimens (N=515) had anti-spike IgG responses at day 28 that were superior to homologous booster (N=194) with median titers 1596.5 (543.9-3769.4) vs. 620.3 BAU/mL (180.3-1987.0), p<0.001 (figure 1). The seropositivity rates were higher and similar in both groups (Heterologous 98.4% vs. Homologous 95.9%, p=0.07).ConclusionAll vaccines administered as third dose induced an increase in IgG-S titers antibodies, which could improve protection against COVID-19 in AID patients. Heterologous booster vaccination produced greater humoral immune responses than homologous booster, which is relevant in this immunosuppressed population.Reference[1]Machado PM et al. Safety of vaccination against SARS-CoV-2 in people with rheumatic and musculoskeletal diseases: results from the EULAR Coronavirus Vaccine (COVAX) physician-reported registry. Ann Rheum Dis. 2022;81(5):695- 709.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

No abstract

BACKGROUNDVaccines against SARS-CoV-2 were an important strategy for controlling the COVID-19 pandemic. Data on the safety of the different vaccines available in systemic lupus erythematosus (SLE) patients are still scarce. The aim of this study is to evaluate the safety of BNT162b2, Sinovac and ChAdOx1 vaccines in SLE patients including adverse events (AEs) and disease activity after vaccination. METHODS"Safety and Effectiveness on COVID-19 Vaccine in Rheumatic Disease-SAFER study" is a prospective, phase 4, multicenter Brazilian study to evaluate the real-life COVID-19 vaccine in immune-mediated rheumatic diseases. In the current study, SLE patients (SLICC, 2012), over 18 years old, from a tertiary rheumatology center, who received two doses of the same vaccine, between May and August 2021, were included. Disease activity were measured by MEX-SLEDAI, AEs (28-day symptom diary) and serological response to vaccination (chemiluminescent immunoassay, Beckman Coulter) before and after the two doses. Chi-square, Fischer and Kruskal-Wallis tests were performed according to variables analysis. RESULTSA total of 118 SLE patients were included (88.1% female) with a mean age of 36.6 ± 11.2 years. Forty-four (37.2%) patients received Sinovac, 45 (38.2%) ChAdOx1 and 29 (24.6%) BNT162b2. The groups were homogeneous and comparable regarding age, sex, race, and exposure to COVID-19 before vaccination. There was no difference regarding the level of immunosuppression between the three groups, including use of immunosuppressant and the degree of immunosuppression (high or low). After the first and second doses, the most frequent AEs were, respectively: pain at the injection site (65.2% and 41.1%), headache (50.9% and 29.9%) and pruritus (41.2% and 40.0%), with less pain in the Sinovac group (p = 0.031 and p = 0.03). Fever was more common with ChAdOx1 than Sinovac (23.3% vs. 5.0%; p = 0.025). There was no difference in MEX-SLEDAI, although there was an increase with ChAdOx1 and a decrease in the other vaccines (p > 0.05). There was no difference on the first and second dose in local or systemic adverse events between those who presented or not previous COVID-19. Evaluating all vaccines, those who had a serological response to the second dose presented more local and systemic adverse events, but there was no difference when the three vaccines were analyzed separately. No serious AEs were reported. CONCLUSIONBNT162b2, Sinovac and ChAdOx1 vaccines are safe in SLE patients with no severe AEs or worsening of disease activity. There was no difference regarding immunosuppression and AEs. Pain was less described in Sinovac and fever was more frequent with ChAdOx1.