Patients with immune-mediated rheumatic diseases (IMRD) are at increased risk for infections due to both disease-related immune dysregulation and immunosuppressive therapy. Despite the benefits of vaccination, immunization rates in this population remain suboptimal, often due to concerns about safety, efficacy, and their potential for inducing disease flare. Regional-specific guidelines are necessary to address the particular epidemiological issues and aspects of the healthcare systems, especially in countries like Brazil. To provide updated, evidence-based, and nationally relevant recommendations on vaccination in adult patients with IMRD in Brazil, focusing on immunogenicity, safety and disease activity outcomes. A multidisciplinary task force from the Brazilian Society of Rheumatology conducted a systematic review and meta-analysis of studies addressing eleven clinical questions related to vaccine safety and efficacy in IMRD. Studies were selected using predefined PICO criteria. Risk of bias was assessed using JBI tools, and the certainty of evidence was evaluated with the GRADE approach. Statements were developed and submitted to a Delphi-based voting process; consensus was achieved if ≥80

Background COVID-19 is an infectious disease capable of causing dysregulation of the immune and inflammatory systems, mechanisms that are central to the pathophysiology of Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis (RA). Psychaological symptoms following COVID-19 may act as confounding factors for disease activity indices in SLE and RA. There remains controversy in the literature regarding the potential activation or exacerbation of these diseases after COVID-19. This study aimed to compare disease activity and psychological outcomes in patients with RA and SLE, with and without a history of COVID-19, after five years of follow-up. Method This multicenter, cross-sectional study analyzed previously collected data from the Brazilian Registry of Patients with Chronic Inflammatory Diseases infected with SARS-CoV-2 (ReumaCoV) and additional data obtained five years later from the same individuals. Clinical and epidemiological characteristics, disease activity indices, and scores for depression, fatigue, stress, and anxiety were assessed. Patients were also asked whether they perceived a worsening of RA or SLE following COVID-19. Data were analyzed using descriptive statistics; normality by Shapiro–Wilk; group comparisons with chi-square/Fisher, t-test or Mann–Whitney; repeated measures by Friedman test (p < 0.05). Results The study included 168 patients: 81 with RA and 87 with SLE, distributed between the groups with COVID-19 (n = 107) and without COVID-19 (n = 61). After five years of follow-up, no significant differences were observed between groups in the Clinical Disease Activity Index (CDAI) or Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) scores, as well as the fatigue, depression, or stress scores. However, patients with a history of COVID-19 had higher mean anxiety scores compared to controls (10.9 ± 11.0 vs. 7.6 ± 8.1; p = 0.031). Subjective worsening after COVID-19 was reported by 23.1% of patients with RA and 12.7% of those with SLE, and, in RA, it was associated with higher mean DASS-21 scores. Long COVID-19 was associated with higher mean anxiety scores (Long COVID-19: 18.7 ± 13.2 vs. without long COVID-19: 8.5 ± 9.7, p = 0.007). Conclusions Although no difference was observed in disease activity scores, higher anxiety levels were found among patients who had previous history of COVID-19, particularly those who met criteria for long COVID-19.

Objetivo: Relatar um caso de artrite psoriásica que evoluiu com sarcoidose após uso por sete anos de drogas antagonistas do fator de necrose tumoral (anti-TNF), adalimumabe e, posteriormente, etanercepte. Detalhamento de caso: Paciente feminino, 64 anos, diagnóstico de artrite psoriásica, fez uso de adalimumabe por dois anos e, após falha terapêutica, foi realizado troca por etanercepte, o qual estava em uso há cinco anos. Apresentava poliartralgia recorrente e fadiga persistente. Ao exame físico, artrite de tornozelo esquerdo, distrofia e pitting ungueais. Sem linfonodomegalias palpáveis e lesões de psoríase ativa. Tomografia de abdome evidenciou linfonodomegalias retroperitoneais, sendo optado pela realização de biópsia via laparotomia. Os achados histopatológicos foram de granulomas epitelióides não caseosos e a imuno-histoquímica evidenciou achados consistentes com linfadenite crônica granulomatosa, sugerindo sarcoidose. Considerações finais: Os anti-TNFs são utilizados ​​para tratamento da sarcoidose, entretanto acredita-se que essas drogas não inibem todas as vias de sinalização, resultando assim em rotas de "escape” e, em alguns casos, ocasionando sarcoidose secundária a estas drogas. Apesar de a paciente não apresentar sintomas respiratórios e lesões cutâneas granulomatosas, devemos ficar atentos à possibilidade de sarcoidose induzida por anti-TNF.

Background The immune response and safety using different COVID-19 vaccine platforms in patients with immune mediated rheumatic diseases is still uncertain. The objective of this study is to compare the immunogenicity and safety after two doses of BNT162b2, CoronaVac and ChadOx-1 in SLE patients. Methods Prospective study including SLE patients who received a primary schedule to COVID-19 vaccination between May and August 2021. Immunogenicity, events supposedly attributable to vaccination or immunization (ESAVI) and disease activity were assessed at baseline and after each vaccine dose. Results 121 SLE patients were included in the cohort, 88 in the immunogenicity analysis and 118 in the safety analysis. The groups were homogenous concerning sex, age, and comorbidities. Seropositivity after two doses of vaccines was similar between CoronaVac (68%), ChadOx1 (80,6%) and BNT162b2 (88%) (p=0.231). However, CoronaVac and ChadOx-1 presented lower titers in comparison with BNT162b2. Regarding ESAVI, the most frequent reported following first and second vaccine doses were, respectively: injection site pain (65.2%/41.1%), headache (50.9%/29.9%) and arthralgia (37.5%/22.5%). Fever and myalgia were more related to ChAdOx1 than CoronaVac (23.3 vs. 5.0%; p=0.025). There was no difference in MEX-SLEDAI between vaccine platforms. No serious ESAVI were reported. Conclusion After two doses, the three COVID-19 vaccine platforms induced a significant increase in antibody titers against SARS-CoV-2. Patients who received BNT162b2 exhibited a higher serological response compared to the other vaccines. All three vaccine platforms demonstrated a favorable safety profile, with no serious ESAVI or worsening of disease activity. Clinical trial Number The study was registered in The Brazilian Registry of Clinical Trials (ReBEC) in 04/14/2021 with code RBR-108fyykd.

Abstract Background Neurological and psychiatric manifestations occur in patients with primary Sjogren’s disease (SjD) with a wide-ranging clinical presentation, affecting quality of life, social participation, and prognosis. Despite this, neither central nor peripheral neurological symptoms are systematically evaluated in the context of autoimmunity or identified as manifestations of SjD. The EULAR Sjogren’s Syndrome Disease Activity Index (ESSDAI) covers only part of them in the neurological domain. Methods We performed a systematic review of the diagnosis and prevalence of central, peripheral, and autonomic nervous system manifestations in primary SjD, following the recommendations proposed by the Cochrane Collaboration Handbook. Observational studies were included when their main issue was the diagnosis and the prevalence of the manifestations individually. We employed a generalized linear mixed model (GLMM) method with a random-effects model, and the results were computed using logit transformation, implemented through the ‘meta’ and ‘metafor’ packages in the R software (version 3.6.1). To present these recommendations, agreement among experts was investigated using the Delphi method in in-person meetings. Results We propose ten recommendations regarding the investigation and management of neurological involvement in SjD that had 100% agreement among participants. Conclusion These recommendations add to the literature on the clinical care of patients with SjD.

Objective: To evaluate the humoral response to and impact of SARS-CoV-2 vaccination in patients with systemic lupus erythematosus in a multicenter cohort design. Methods: Data for this analysis were obtained from the Study of Safety, Effectiveness and Duration of Immunity after Vaccination against SARS-CoV-2 in Patients with Immune-Mediated Inflammatory Diseases (SAFER), a prospective, multicenter, phase IV, real-world study conducted across different regions of Brazil from June/2021 to March/2024. Patients aged >18 years with systemic lupus erythematosus (SLE) who received any one of the SARS-CoV-2 vaccines approved by the Brazilian health regulatory agency (CoronaVac [inactivated SARS-CoV-2 vaccine], ChAdOx-1 [AstraZeneca], or BNT162b2 [Pfizer-BioNTech]) were included. Immunogenicity was assessed in pre- and post-vaccination blood samples, and patients were monitored in person and remotely for the occurrence and severity of COVID-19. Results: Two hundred and thirty-five patients with SLE who had completed their vaccination schedules (two doses + booster dose) were included in this study. Most patients were female (89.3%) and had low disease activity or were in remission (72.4%); the majority were also on some form of immunosuppressive therapy (58.1%). One hundred and sixteen patients received two doses of CoronaVac followed by one dose of BNT162b2 (Pfizer-BioNTech) vaccine, eighty-seven received two doses of ChAdOx1-S (AstraZeneca) followed by one dose of BNT162b2 (Pfizer-BioNTech) vaccine, and thirty-two received three doses of BNT162b2 (Pfizer-BioNTech) vaccine. Twenty-eight cases of COVID-19, none meeting criteria for severe COVID-19, were recorded in patients with respiratory symptoms after the second dose of a SARS-CoV-2 vaccine. Regarding immunogenicity, an increase in seroconversion rate was observed following consecutive vaccine doses, with no difference between vaccination schedules, reaching 97.57% seropositivity after a booster dose. The geometric mean IgG titers differed between the different vaccination schedules after the first and the second vaccine dose, being lowest for the CoronaVac-based schedule, but titers were similar after the administration of a booster dose. Conclusion: In patients with SLE, SARS-CoV-2 vaccines are immunogenic, inducing a robust humoral response. No severe outcomes associated with death or hospitalization were found in the evaluated patient sample. Complete vaccination schedules including a booster dose induced higher humoral responses than incomplete schedules, especially in patients initially immunized with an inactivated virus vaccine schedule and those with a suboptimal humoral response.

PV150 / #420 Poster Topic:AS17 - Miscellaneous Systemic lupus erythematosus (SLE) patients are at greater risk of different infections when compared to the general population, due to abnormalities in the immunological response. Vaccination is the most effective measure for preventing infectious diseases, however, there is still low vaccination coverage due to its acceptance, mainly due to fear of adverse events related to immunization. The objective of this study was to evaluate the safety of vaccines against SAR-CoV-2 available in the Brazilian Public Health system. Data from the multicenter study - SAFER “Study of safety, effectiveness and duration of immunity after vaccination against SARS-CoV-2 in patients with immune-mediated inflammatory disease,” a Brazilian, observational, prospective, phase IV cohort study were evaluated. Patients diagnosed with SLE who met the ACR/EULAR 2019 classification criteria and who received a complete vaccination schedule (2 doses + booster) against SARS-CoV-2, as recommended by the Brazilian National Immunization Plan, were included. All patients underwent clinical and laboratory evaluation before and after the vaccine dose associated with scheduled telephone monitoring and diary recording to monitor adverse events that could be related to the vaccine received. A total of 235 individuals with SLE with a complete vaccination schedule (initial scheme with 2 doses of CoronaVac, ChadOx-1 or Pfizer plus booster Pfizer) were included. Around 90% of participants were female with an average age of 38 years. The majority of patients without other significant comorbidities and a median time since disease diagnosis was 10 years. Based on SLEDAI-2K, the majority of patients were in remission or low disease activity (72.4%). Arthritis (15.74%), alopecia (14.04%), proteinuria (11.91%), consumption of complements (10.64%), anti-dsDNA antibody positivity (9.79%) and skin rash (9.36%) were the manifestations most frequently scored. Regarding the degree of immunosuppression, 135 (58.1%) were with a high degree of immunosuppression and 70 (30.1%) without immunosuppression. Of these participants, 116 patients received 2 doses of CoronaVac followed by 1 dose of BNT162b2 (PfizerBioNTech), 87 received 2 doses of ChadOx-1 (AstraZeneca) followed by 1 dose of BNT162b2 (PfizerBioNTech) and 32 received 3 doses of BNT162b2 (PfizerBioNTech). (Figure 1) The most common adverse events after receiving the vaccine were local hypersensibility, headache, musculoskeletal pain, these events being more frequent in both 3 doses received, but less commonly observed in patients in the group who received CoronaVac in the first and second doses when compared to those who received an initial regimen with Chadox-1 and Pfizer (p< 0.05) (Table 1). Evaluating the risk of flare of disease activity after vaccination, measured by SLEDAI-2K, a total of 136 patients were evaluated in relation to disease activity after the second dose and 69 after the third dose. No increase in disease activity was observed between groups (Table 2). Figure 1: Vaccine scheme according initial doses (1st and 2nd dose) Table 1. Table 2. This study reveals the safety profile of vaccines against SARS-CoV-2 in patients with SLE and a complete vaccination schedule. Outcome that demonstrates adverse events mainly related to symptoms at the site of vaccine application and systemic symptoms not serious commonly observed in vaccines against other agents. Most importantly, no worsening of disease activity after a complete vaccination schedule regardless of the vaccine platform.

PV149 / #422 Poster Topic:AS17 - Miscellaneous The study aimed to evaluate flares in systemic lupus erythematosus (SLE) patients over a period of 6 months after COVID-19. A multicenter, observational, and prospective cohort study. SLE adult patients with COVID-19 (case group) were compared to SLE patients without COVID-19 (control group). Assessments were performed at baseline (V0), immediately after COVID-19 (V1), and 3 and 6 months after infection (V2 and V3). Disease activity was evaluated by patient global assessment (PGA) and the modified SLE Disease Activity Index 2000 (SLEDAI-2K). A flare was defined as an increase in SLEDAI-2K score greater than 3 and persistent disease activity was measured by SLEDAI-2K greater than 3 over 2 consecutive visits. 715 patients were included, 363 in the case group and 352 in the control group. The case group had a higher mean age (SD) compared with the control group [41 years (12.38) vs 38.8 years (12.07), p=0.017]. There were no differences between groups at baseline regarding sex, comorbidities, treatment, or disease activity scores. The control group showed a significant reduction in PGA [0.24 (95% CI: -0.39 to -0.09), p=0.001] and SLEDAI-2K [0.85 (95% CI: 0.76 to 0.96) p=0.010] throughout the visits while in the case group the scores remained stable. The frequency of new SLE manifestations was higher in the case group compared with patients in the control group at V2 [20 (9.4%) vs 5 (3.0%), p=0.012] and V3 [22 (9.6%) vs 4 (2.8%), p=0.012]. In the case group, 11 severe disease manifestations (nephritis, neurological, vasculitis, pneumonitis, and myositis) were described at V2 and eight at V3, while in the case group there was only severe disease manifestation (nephritis). Patients with COVID-19 were 3.7 (95% CI: 1.2 to 10.9) times more likely to have new SLE disease manifestations compared to patients without COVID-19. Case group presented more frequent flares or persistent disease activity [74 (18.5%) vs 33 (10.5%), p=0.001]. COVID-19 at any time in the study was linked to a higher chance of a flare and persistent disease activity [OR=1.70 (95% CI: 1.06 to 2.74), p=0.029]. COVID-19 was associated with new SLE disease manifestations and worse outcomes (flares and persistent disease activity) in SLE patients.Acknowledgments:We thank the researchers involved in the centers participating in ReumaCoV-Brasil, the Brazilian Society of Rheumatology and the Conselho Nacional de Desenvolvimento Científico e Tecnológico – CNPq.

Background: To prospectively evaluate the safety and clinical impact of SARS-CoV-2 vaccines in patients with systemic lupus erythematosus (SLE). Methods: Subanalysis of the Brazilian multicenter observational study “Safety, Effectiveness and Duration of Immunity after Vaccination against SARS-CoV-2 in Patients with Immune-Mediated Inflammatory Diseases (SAFER)”, which included SLE patients vaccinated with CoronaVac, ChAdOx1, or BNT162b2. Patients with HIV infection, pregnant women, or those with immunosuppression not related to SLE were excluded. Safety data related to adverse events and underlying disease activity were assessed. Additionally, COVID-19 cases were monitored throughout the follow-up period. Results: The study included 373 patients with systemic lupus erythematosus (SLE), with a mean age of 36 years, the majority being women (89.8%). The most common adverse events after SARS-CoV-2 vaccination were injection site reactions and headache, observed both after the first and subsequent doses. The ChAdOx-1 vaccine was associated with a higher frequency of adverse events compared to CoronaVac. At baseline, 38.3% of patients were in remission, 32.8% had low disease activity, and 28.9% had moderate to high activity. Following CoronaVac vaccination, there was an increase in remission rates (from 34.6% to 51.1%) and a significant reduction in moderate to high activity (from 37.6% to 15.0%) after the first dose, with this reduction partially maintained after the second dose. In contrast, patients vaccinated with ChAdOx-1 showed an increase in moderate to high activity (from 14.5% to 38.2% after the first dose), a trend that persisted after the second dose. No statistically significant changes in disease activity were observed among those who received BNT162b2. During follow-up, 44 cases of COVID-19 were reported, all mild, with no deaths or need for intensive care unit admission. Conclusions: Vaccination against SARS-CoV-2 demonstrated a favorable safety profile in patients with SLE, with a low frequency of serious adverse events. While analysis of disease activity revealed variations across vaccine platforms, most notably an increased proportion of moderate to high disease activity among those receiving ChAdOx-1 compared with CoronaVac and BNT162b2, the overall occurrence of COVID-19 during follow-up was limited to mild cases, with no severe outcomes. These findings highlight that, despite potential risks of disease exacerbation, the clear protection against severe COVID-19 supports vaccination as a beneficial strategy for this immunocompromised population.

Abstract Objectives To compare the impact of COVID-19 on the clinical status and psychological distress of patients with immune-mediated rheumatic disease (IMRD) caused by SARS-CoV-2 infection with that of noninfected IMRD controls during a 6-month follow-up period. Methods The ReumaCoV Brazil is a longitudinal study designed to follow IMRD patients for 6 months after COVID-19 (patients) compared with IMRD patients without COVID-19 (controls). Clinical data, disease activity measurements and current treatments regarding IMRD and COVID-19 outcomes were evaluated in all patients. Disease activity was assessed through validated tools at inclusion and at 3 and 6 months post-COVID-19. Fatigue, using FACIT-F (Functional Assessment of Chronic Illness Therapy) and psychological distress, using DASS 21 (Depression, Anxiety and Stress Scale − 21 Items), used to evaluated psychological distress, were evaluated at 6 months after COVID-19 in both groups. The significance level was set as p < 0.05, with a 95% confidence interval. Results A total of 601 patients were evaluated—321 patients (IMRD COVID-19 + patients) and 280 controls (IMRD COVID-19- patients)—who were predominantly female with similar median ages. Disease activity assessment over a 6-month follow-up showed no significant difference between cases and controls. Although the mean activity scores did not differ significantly, some patients reported worsened disease activity post-COVID-19, particularly in rheumatoid arthritis (RA) (32.2%) and systemic lupus erythematosus (SLE) patients (23.3%). Post-COVID-19 worsening in RA patients correlated with medical global assessment (MGA) and CDAI scores, with a moderate to large effect size. Diabetes mellitus showed a positive association (OR = 7.15), while TNF inhibitors had a protective effect (OR = 0.51). Fatigue, depression, anxiety, and stress were significantly greater in patients than in controls. Worse disease activity post-COVID-19 correlated with worse FACIT-F and DASS-21 scores in RA patients. No significant associations were found between COVID-19 outcomes and post-COVID-19 disease activity, FACIT-F or DASS-21. Conclusions Post-COVID-19 IMRD patients exhibited significant fatigue, depression, anxiety, and stress, which can be mistaken for disease activity, despite having similar disease activity scores. The variability in reports on IMRD flares and the potential triggering of SARS-CoV-2 for autoimmune manifestations underscore the need for detailed clinical assessment and a comprehensive approach to managing them.

Systemic lupus erythematosus (SLE) directly impacts pregnancy outcomes, and few studies have analyzed the related risk factors for maternal and fetal/perinatal complications in Brazil. We described and analyzed the risk factors for maternal and fetal complications in SLE pregnancies at an outpatient clinic in the State of Amazonas, Northern Brazil. Pregnancies that occurred after the SLE diagnosis between 2001 and 2020 were analyzed. Risk factors for adverse outcomes were determined using logistic regression. A total of 155 pregnancies from 109 women were included; the mean age was 28.2 ( ± 5.5) years, the median disease duration was 72 [36; 108] months, 56 (36.1

BACKGROUND: About 5–10% of patients with Sjögren’s Disease (SjD) will develop non-Hodgkin’s lymphoma, with a 16 to 44 increased risk compared to the general population. The relationship between SjD and other types of cancer is poorly described in the literature. AIM: To characterize patients with SjD from the Brazilian Sjögren’s Disease Registry (BRAS) who developed hematological and solid neoplasms, analyzing the organ primarily involved, subtypes, occurrence of metastatic disease, timing of diagnosis and correlation with demographic, serologic aspects, and labial salivary gland inflammation. METHODS: Among consecutive patients included in the Brazilian Sjögren’s Disease Registry (BRAS) and fulfilling the 2002 or 2016 classification criteria for SjD, those who developed neoplasia were retrospectively identified and categorized according to the National Cancer Institute (Ministry of Health, Brazil). RESULTS: 1,010 patients were included; of them, 975 were women (96.5%), with an average age of 55.6 ± 13.6 years. Disease duration was 11.9 ± 7.9 years. We found that 114 out of 1,010 patients (11.3%) had cancer, with a higher prevalence in those over 55 years old (p < 0.001). The most prevalent malignancies were skin cancer [24/858 (2.7%)], breast cancer [27/1010 (2.6%)], lymphoma [15/1010 (1.5%)], and thyroid cancer [8/1010 (0.8%)]. Further, 0.9% of patients had more than one type of cancer. Cancer diagnosis followed SjD diagnosis in 66.7% of lymphoma cases, 53.6% of other malignancies, and 75.0% of skin cancer. The presence of cancer was associated with age (OR 1.04). In the case of skin cancer, the duration of SjD was an additional risk factor (OR 1.08). For thyroid cancer, inflammation of the labial minor salivary glands was identified as an associated risk factor (OR 10.1). CONCLUSIONS: Other types of cancer were more prevalent than lymphoma in our population of SjD patients. Breast neoplasia emerged as the most prevalent after skin cancer, and thyroid cancer was the second most prevalent solid neoplasia. Aging, disease duration and labial salivary gland inflammation were associated risk factors. Prospective cohort studies are essential for assessing other risk factors for cancer development in SjD patients.

Cohort studies are essential for elucidating disease progression, guiding research priorities, and identifying gaps in diagnosis and treatment. This manuscript presents the protocol and preliminary findings of the Brazilian Registry on Sjögren’s Disease (BRAS), a national, prospective cohort supported by the Brazilian Society of Rheumatology (SBR). BRAS aims to collect comprehensive data on patients with Sjögren’s Disease (SjD) who meet the 2002 AECG and/or 2016 ACR-EULAR classification criteria, fostering high-quality research initiatives. Data collection is conducted via REDCap and includes demographic, laboratory, and clinical parameters such as disease activity (ESSDAI), damage (SSDDI), comorbidities, cardiovascular risk (Framingham score), labial salivary gland biopsy, salivary gland ultrasound, and therapeutic approaches. Patient-reported outcome measures (PROMs) include ESSPRI, PROFAD, HADS, ESE, IPAQ-SF, and EQ-5D. To date, 1,082 patients have been enrolled (mean age 55.3 ± 13.3 years; 96.6 Clinical trial number Not applicable.

Background/objectivesPatients with systemic vasculitis faced the risk of severe COVID-19 and high mortality during the pandemic. Although SARS-CoV-2 vaccination mitigates these outcomes, vaccine hesitancy persists, and data on immunogenicity and safety in vasculitis is still limited. This study aims to assess response to primary and booster doses of SARS-CoV-2 vaccination in systemic vasculitis.MethodsThis multicenter cohort study including systemic vasculitis included patients from SAFER study (Safety and Efficacy of COVID-19 Vaccines in Rheumatic Diseases). We evaluated serum IgG levels against the SARS-CoV-2 spike protein receptor-binding domain (IgG anti-RBD) at baseline and 28 days post-vaccination, disease activity scores, new cases of COVID-19 infections, and adverse events.ResultsSeventy-three patients with systemic vasculitis were included. Behçet’s disease (n=39), Takayasu arteritis (n=15), and antineutrophil cytoplasmic antibody-associated vasculitis (n=14) were the most common vasculitis forms. The majority of the patients had no comorbidities and were in remission. Seventy patients received one, 65 two, and 60 three vaccine doses. ChAdOx1 nCoV-19 (AstraZeneca/Oxford) (n=36) and CoronaVac (Sinovac) (n=25) were primarily the most common vaccines, while BNT162b2 (Pfizer–BioNTech) was usually the booster vaccine. ChAdOx1 nCoV-19 induced higher IgG anti-RBD than CoronaVac after two doses (p=0.002), but this difference disappeared after the booster dose. No differences in vaccine response were noted between heterologous and homologous regimens or vasculitis types. The new cases of COVID-19 (16.9%), hospitalization (1.5%), and mortality (1.5%) rates were relatively low following vaccination. Disease activity remained stable, and adverse events were mostly mild. Only one severe adverse event was observed.ConclusionDifferent SARS-CoV-2 vaccines demonstrated immunogenicity and clinical effectiveness in systemic vasculitis. The three-dose schedule was safe without increasing relapse risk.

Abstract Background There is a remarkable variability in the frequency of HLA-B27 positivity in patients with spondyloarthritis (SpA), which may be associated with different clinical presentations worldwide. However, there is a lack of data considering ethnicity and sex on the evaluation of the main clinical and prognostic outcomes in mixed-race populations. The aim of this study was to evaluate the frequency of HLA-B27 and its correlation with disease parameters in a large population of patients from the Brazilian Registry of Spondyloarthritis (RBE). Methods The RBE is a multicenter, observational, prospective cohort that enrolled patients with SpA from 46 centers representing all five geographic regions of Brazil. The inclusion criteria were as follow: (1) diagnosis of axSpA by an expert rheumatologist; (2) age ≥18 years; (3) classification according to ASAS axial. The following data were collected via a standardized protocol: demographic data, disease parameters and treatment historical. Results A total of 1096 patients were included, with 73.4% HLA-B27 positivity and a mean age of 44.4 (±13.2) years. Positive HLA-B27 was significantly associated with male sex, earlier age at disease onset and diagnosis, uveitis, and family history of SpA. Conversely, negative HLA-B27 was associated with psoriasis, higher peripheral involvement and disease activity, worse quality of life and mobility. Conclusions Our data showed that HLA-B27 positivity was associated with a classic axSpA pattern quite similar to that of Caucasian axSpA patients around the world. Furthermore, its absence was associated with peripheral manifestations and worse outcomes, suggesting a relevant phenotypic difference in a highly miscegenated population.