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BackgroundPatients with immune-mediated rheumatic diseases (IRD) have poorer outcomes of SARS-CoV-2 infection compared to the general population.ObjectivesTo assess and compare clinical course, severity and complications of SARS-CoV-2 infection in patients with rheumatic immune-mediated inflammatory diseases (IMIDs) from Mexico and Argentina.MethodsData from both national registries, CMR-COVID (Mexico) and SAR-COVID (Argentina), were combined. Briefly, adult IRD patients with SARS-CoV-2 infection were recruited between 08.2020 and 09.2022 in SAR-COVID and between 04.2020 and 06.2022 in CMR-COVID. Sociodemographic data, comorbidities, and DMARDs were recorded, as well as clinical characteristics, complications, and treatment for SARS-CoV-2 infection. Descriptive analysis. Chi square, Fisher, Student T, Mann Whitney U tests and multiple logistic regression analyses were performed.ResultsA total of 3709 patients were included, 1167 (31.5%) from the CMR-COVID registry and 2542 (68.5%) from the SAR-COVID registry. The majority (82.3%) were women, with a mean age of 50.4 years (SD 14.4). The most frequent IRD were rheumatoid arthritis (47.5%) and systemic lupus erythematosus (18.9%). Mexican patients were significantly older, had a higher female predominance and had higher prevalence of rheumatoid arthritis, antiphospholipid syndrome, and axial spondyloarthritis, while the Argentine patients had more frequently psoriatic arthritis and ANCA-associated vasculitis. In both cohorts, approximately 80% were in remission or low disease activity at the time of infection. Mexicans took glucocorticoids (43% vs 37%, p<0.001) and rituximab (6% vs 3%, p<0.001) more frequently. They also reported more comorbidities (48% vs 43%, p=0.012).More than 90% of patients presented symptoms related to SARS-CoV-2 infection. The frequency of hospitalization was comparable between the groups (23.4%), however, the Mexicans had more severe disease (Figure 1) and a higher mortality rate (9.4% vs 4.0%, p<0.0001). After adjusting for risk factors, Mexicans were more likely to die due to COVID-19 (OR 2.2, 95%CI 1.5-3.1).ConclusionIn this cohort of patients with IRD from Mexico and Argentina with SARS-CoV-2 infection, the majority presented symptoms, a quarter were hospitalized and 6% died due to COVID-19. Mexicans presented more severe disease, and after considering risk factors they were two times more likely to die.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsCarolina Ayelen Isnardi Grant/research support from: SAR-COVID is a multi- sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or infuenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database, Deshire Alpizar-Rodriguez: None declared, Marco Ulises Martínez-Martínez: None declared, Rosana Quintana: None declared, Ingrid Eleonora Petkovic: None declared, Sofia Ornella: None declared, Vanessa Viviana Castro Coello: None declared, Edson Velozo: None declared, David Zelaya: None declared, María Severina: None declared, Adriana Karina Cogo: None declared, Romina Nieto: None declared, Dora Aida Pereira: None declared, Iris Jazmin Colunga-Pedraza: None declared, Fedra Irazoque-Palazuelos: None declared, GRETA CRISTINA REYES CORDERO: None declared, Tatiana Sofía Rodriguez-Reyne: None declared, JOSE ANTONIO VELOZ ARANDA: None declared, Cassandra Michele Skinner Taylor: None declared, INGRID MARIBEL JUAREZ MORA: None declared, Beatriz Elena Zazueta Montiel: None declared, Atzintli Martínez: None declared, Cesar Francisco Pacheco Tena: None declared, Guillermo Pons-Estel: None declared.
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Objectives: To describe the clinical characteristics and outcomes of SARSCoV-2 infection in patients with systemic vasculitis. Method(s): Observational, multicenter, cross-sectional analytical study in patients 18 or older diagnosed with systemic vasculitis with confirmed SARSCoV-2 infection (RT-PCR or serology) included in the SAR-COVID registry. Patients were evaluated from July 2020 to February 2022. Patients diagnosed with ANCA-associated vasculitis (AAV), other systemic vasculitides (Giant cell arteritis, Takayasu), and a control group of patients with other rheumatological diseases matched by age, sex, comorbidities, and date of SARS-CoV-2 infection. The survival curve of the groups was studied by Kaplan-Meier and compared through the Log-Rank Test. A Cox regression model will be performed to adjust survival for different variables (sex, age, treatments for underlying disease, treatments for viral infection, smoking, obesity, d-dimer level, and disease activity). Result(s): A total of 282 out of 2694 patients in the SAR-COVID registry were included, 57.4%women with a mean age of 55.7 years (SD 14.1). Fifty-four patients in the AAV group, 32 in the other vasculitis group, and 196 controls were studied. Hospitalization was required in 53.7% of the AAV group, 37.5% in other vasculitides, and 26.2% in the control group. 5.6% of patients in the control group presented acute respiratory distress syndrome (ARDS), 15.6% in the other vasculitis group, and 22.2% in the AAV group (p alpha 0.001). Complete recovery was observed in 82.3% of patients in the control group, 75%in the other vasculitis group, and 63%in the AAV group.We observed that 5.7% of the patients in the control group died from COVID-19, 9.4%from other vasculitides, and 27.8% in the AAV group (p alpha 0.001). We found a lower survival in the AAV group compared to the control group (p alpha 0.005). In the multivariate Cox regression model, older age (HR:1.05 IC95%1.01-1.09 p = 0.01), BMI > 40 (HR:13.2 IC95% 2.1-83.2 p = 0.01), and high activity of the underlying disease (HR:16 95% CI 3.7-69.4 p alpha 0.005) were associated with lower survival. Conclusion(s): In conclusion, patients diagnosed with AAV presented a worse disease course during SARS-CoV-2 infection with a more frequent requirement for invasive mechanical ventilation. Likewise, these patients showed lower survival compared to patients with other autoimmune diseases.
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Background: Currently there is little information on the efficacy and safety of SARS-CoV-2 vaccination in patients with immune-mediated diseases and/or under immunosuppressive treatment in our country, where different types of vaccines and mix regimens are used. For this reason, the Argentine Society of Rheumatology (SAR) with the Argentine Society of Psoriasis (SOARPSO) set out to develop a national register of patients with rheumatic and immune-mediated infammatory diseases (IMIDs) who have received a SARS-CoV-2 vaccine in order to assess their efficacy and safety in this population. Objectives: To assess SARS-CoV-2 vaccine efficacy and safety in patients with rheumatic and IMIDs. Methods: SAR-CoVAC is a national, multicenter and observational registry. Adult patients with a diagnosis of rheumatic or IMIDs who have been vaccinated for SARS-CoV-2 were consecutively included between June 1st and September 17th, 2021. Sociodemographic data, comorbidities, underlying rheumatic or IMIDs, treatments received and their modifcation prior to vaccination and history of SARS-CoV-2 infection were recorded. In addition, the date and place of vaccination, type of vaccine applied, scheme and indication will be registered. Finally, adverse events (AE), as well as SARS-CoV-2 infection after the application of the vaccine were documented Results: A total of 1234 patients were included, 79% were female, with a mean age of 57.8 (SD 14.1) years. The most frequent diseases were rheumatoid arthritis (41.2%), osteoarthritis (14.5%), psoriasis (12.7%) and spondy-loarthritis (12.3%). Most of them were in remission (28.5%) and low disease activity (41.4%). At the time of vaccination, 21% were receiving glucocorti-coid treatment, 35.7% methotrexate, 29.7% biological (b) Disease Modifying Anti-Rheumatic Drugs (DMARDs) and 5.4% JAK inhibitors. Before vaccine application 16.9% had had a SARS-CoV-2 infection. Regarding the frst dose of the vaccine, the most of the patients (51.1%) received Gam-COV-ID-Vac, followed by ChAdOx1 nCoV-19 (32.8%) and BBIBP-CorV (14.5%). In a lesser proportion, BNT162b2 (0.6%), Ad26.COV2.S (0.2%) and Coro-naVac (0.2%) vaccines were used. Almost half of them (48.8%) completed the scheme, 12.5% were mix regimenes, the most frequent being Gam-COVID-Vac/mRNA-1273. The median time between doses was 51days (IQR 53). More than a quarter (25.9%) of the patients reported at least one AE after the frst dose and 15.9% after the second. The fu-like syndrome and local hypersensitivity were the most frequent manifestations. There was one case of mild anaphylaxis. No patient was hospitalized. Altogether, the incidence of AE was 246.5 events/1000 doses. BBIBP-CorV presented signifcantly lower incidence of AE in comparison with the other types of vaccines. (118.5 events/1000 doses, p<0.002 in all cases) Regarding efficacy, 63 events of SARS-CoV-2 infection were reported after vaccination, 19% occurred before 14 days post-vaccination, 57.1% after the frst dose (>14 days) and 23.8% after the second. In most cases (85.9%) the infection was asymptomatic or had an outpatient course and 2 died due to COVID-19. Conclusion: In this national cohort of patients with rheumatic and IMIDs vaccinated for SARS-CoV-2, the most widely used vaccines were Gam-COVID-Vac and ChAdOx1 nCoV-19, approximately half completed the schedule and in most cases homologously. A quarter of the patients presented some AE, while 5.1% presented SARS-CoV-2 infection after vaccination, in most cases mild.
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Background: Patients with rheumatic diseases (RD) have been excluded from SARS-CoV-2 vaccine trials, though data appear to show safety and efficacy, mostly evidence remains in mRNA vaccines. In our country, adenovirus-vector, inactivated and heterologous scheme vaccines are frequently used. Objectives: To describe the safety of SARS-CoV-2 vaccines in patients with RD from the national registry SAR-CoVAC and to assess sociodemographic and clinical factors associated to AE and disease fares after vaccination. Methods: Adult patients with RD who have been vaccinated for SARS-CoV-2 from de Argentine Society of Rheumatology Vaccine Registry (SAR-CoVAC) were consecutively included between June 1st and December 21st, 2021, This is a national multicentric observational registry that includes patients that have received at least one dose of any SARS-CoV-2 available vaccines in Argentina. Data is voluntarily collected by the treating physician. Naranjo scale was use to assess the association between the AE and vaccination. Homologous and heterologous schedules were defned according to whether both vaccines received were the same or different, respectively. Descriptive statics, Chi2 test, Fischer test, T test, ANOVA and multivariate regression logistic model were used. Results: A total of 1679 patients, with 2795 SARS-CoV-2 vaccine doses were included. Vaccines more frequently used were: Gam-COVID-Vac (1227 doses, 44%), ChAdOx1 nCov-19 (872 doses, 31%), BBIBP-CorV (482 doses, 17%) and mRAN-1273 (172 doses, 6%). Altogether, 510 EA were experienced by 449 (27%) patients. Pseudo-fu syndrome was the most frequent (11%), followed by injection site reaction (7%). They were signifcantly more frequent after the frst dose in comparison to the second one (13% vs 7% and 9% vs 5%, respectively, p<0.001 in both cases). All were mild or moderate and no patient was hospitalized due to an AE. One case of moderate anaphylaxis was reported by a patient who received Gam-COVID-Vac. No cases of vaccine-induced thrombotic thrombocytopenia were observed. There were 25 disease fares reported, 17 (68%) cases of arthritis. Among patients with two doses, those with heterol-ogous schedule presented AE more frequent after the second dose (39% vs 17%).Total incidence of EA was 182.5 events/10 00 doses, it was signifcantly lower for BBIBP-CorV (105.9 events/1000 dosis, p<0.002 for all cases). The higher incidence of AE was observed for mRAN-1273 (261.6 events/1000 doses) and ChAdOx1 nCov-19 (232.8 events/1000 doses). Patients with AE were younger [mean 55 years (SD 14) vs 59 years (SD 14), p <0.010], not Caucasian ethnicity [48% vs 35%, p<0.001], had higher education level [mean 13.8 years (SD 4) vs 11.9 years (SD 5), p<0.001], were more frequently employed [54% vs 44%, p<0.001], lived mostly in urban area [99% vs 95% p <0.001, had more frequently dyslipidemia [38% vs 28% p 0.012], and less frequently arterial hypertension [49% vs 65%, p<0.001]. Systemic lupus erythematosus [11% vs 7%, p=0.039] and Sjögren syndrome [6% vs 1.8%, p<0.001] were more frequent among them, while non infammatory diseases were less prevalent [19% vs 31%, p<0.001]. They were taking steroids [24 vs 18%, p=0.007], antimalarials [17% vs 10%, p<0.001] and methotrexate [41% vs 31%, p <0.001] more frequently. In the multivariable analysis, mRAN-1273 and ChAdOx1 nCov-19 were associated with AE, while BBIBP-CorV with lower probability of having one. (Figure 1) Conclusion: The incidence of AE was 1825 events/1000 doses, were signif-cantly higher for mRAN-1273 and ChAdOx1 nCov-19 and lower for BBIBP-CorV. Most common AE was pseudo-fu syndrome. Female sex, being younger, higher education level, ChAdOx1 nCov-19 and mRAN-1273 vaccines, the use of meth-otrexate and antimalarials were related of EA in patients with RD.
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Background: In Argentina we have witnessed two COVID 19 waves between 2020 and 2021. The frst wave occurred during the spring of 2020 and it was related to the wild type of the virus, the second occurred during the fall/winter of 2021 when the gamma variant showed a clear predominance. During the frst wave, patient with rheumatic diseases showed a higher frequency of hospitaliza-tion and mortality (4% vs 0.26%) when compared to the general population1;at that time, however, vaccination was not yet available. Objectives: To compare sociodemographic and disease characteristics, course and outcomes of SARS-CoV-2 infection in patients with immune-mediated/auto-infammatory diseases (IMADs) during the frst and second waves in Argentina. Methods: SAR-COVID is a national, multicenter, longitudinal and observational registry, in which patients ≥18 years of age, with a diagnosis of a rheumatic disease who had confrmed SARS-CoV-2 infection (RT-PCR or positive serol-ogy) were consecutively included since August 2020. For the purpose of this report, only patients with IMADs who had SARS-CoV-2 infection during the frst wave (defned as cases occurred between March 2020 and March 2021) and the second wave (cases occurred between April and August 2021) were examined. Sociodemographic characteristics, disease diagnosis and activity, comorbidities, immunosuppressive treatment and COVID 19 clinical characteristics, complications and outcomes: hospitalization, intensive care unit (ICU) admission, use of mechanical ventilation and death were compared among groups. Descriptive statistical analysis was performed. Variables were compared with Chi squared test and Student T test or Mann Whitney test. Multivariable logistic regression models with forward and backward selection method, using hospitalization, ICU admission and death as dependent variables were carried out. Results: A total of 1777 patients were included, 1342 from the frst wave and 435 of the second one. Patients had a mean (SD) age of 50.7 (14.2) years and 81% were female. Both groups of patients were similar in terms of socio-de-mographic features, disease diagnosis, disease activity, the use of glucocorti-coids ≥ 10 mg/day and the immunosuppressive drugs (Table 1 below). Patients infected during the frst wave have higher frequency of comorbidities (49% vs 41%;p= 0.004). Hospitalizations due to COVID 19 (31% vs 20%;p <0.001) and ICU admissions (9% vs 5%;p= 0.009) were higher during the frst wave. No differences in the use of mechanical ventilation (16% vs 16%;p= 0.97) nor in the mortality rate (5% vs 4%;p= 0.41) were observed. In the multivariable analysis, after adjusting for demographics, clinical features and immunosup-pressive treatment, patients infected during the second wave were 40% less likely to be hospitalized (OR= 0.6, IC95% 0.4-0.8) and to be admitted to the ICU (OR= 0.6, IC95% 0.3-0.9). Conclusion: The impact of COVID 19 in Argentina, in terms of mortality in patients with IMADs was still higher compared to the general population during the second wave. However, the frequency of hospitalizations and ICU admissions was lower. These fndings could be explained by the introduction of the SARS COV 2 vaccination and, probably, by the cumulative knowledge and management improvement of this infection among physicians.
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Objectives: To compare characteristics of patients with rheumatic disease and COVID-19 in Argentina (SAR-COVID Registry), in contrast to the data reported at the Latin American and global level (Global International Alliance RheumCOVID Registry). Methods: A national, multicenter, longitudinal and observational registry was carried out. Patients older than 18 years, with a diagnosis of rheumatic disease and SARS-CoV-2 infection by PCR or positive serology, were included between August 13, 2020 and April 11, 2021. Demographic data, underlying rheumatic disease, comorbidities, clinical-laboratory characteristics of the SARS-CoV-2 infection, as well as treatments and outcomes. Characteristics of the patients included were compared with the data reported at the Latin American and global level. Descriptive statistics were performed. Comparisons between groups were made using ANOVA, chi2 or Fisher's test. Results: 863 patients from Argentina, 74 patients from Latin America and 583 from the rest of the world were included, mostly women in the three groups (79.4%, 73% and 71% respectively). The most frequent rheumatic diseases in the three groups were rheumatoid arthritis (45.8%, 35%, and 39%, respectively) and systemic lupus erythematosus (18%, 22%, and 14%) (Table 1). In Argentina, fewer patients received specific pharmacological treatment for COVID-19 in relation to the other 2 groups (41.4%, 68% and 43% respectively, p < 0.0001), and there was a lower requirement for non-invasive/invasive mechanical ventilation than in the rest of Latin America and theworld (8.6%vs 31% vs 13%, p < 0.0001). Hospitalization requirement in Argentina was lower than in the rest of Latin America and the rest of theworld (32.8%vs 61% vs 45%, p < 0.0001), as well as mortality (5.8%, 12%and 11%;p 0.0010). 86.9% of patients did not present any complications in Argentina, with a statistically significant difference with the rest of the groups (62% and 77%, with p < 0.0001) (Figure 1). Conclusion: Patients with rheumatic diseases and SARS-CoV-2 infection from Argentina reported in this registry received less specific pharmacological treatment for COVID-19 than those registered in other countries, presented fewer complications and required less ventilatory support. In relation to mortality, although a lower mortality was found in the Argentine registry. The fact that registries have information collected at different periods of the pandemic and different local epidemiological situations, does not allow major conclusions to be drawn.