BackgroundPatients 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. However in our country, adenovirus and inactivated vaccines, as well as heterologous schemes are frequently used.ObjectivesTo describe clinical characteristics and outcomes of SARS-CoV-2 infection after vaccination in patients with RD from de the SAR-CoVAC registry and to compare them with patients who got infected before vaccination. Additionally, factors associated with COVID-19 unfavorable outcome were assessed.MethodsAdult patients with RD who have been vaccinated for SARS-CoV-2 were consecutively included between June 1st and December 21st, 2021. Confirmed SARS-CoV-2 infection (RT-PCR o serology) was reported by the treated physician. Infection after an incomplete scheme was defined when the event was diagnosed at least 14 days after first dose; and after a complete scheme when it occurred > 14 days after second dose. Homologous scheme is defined by two same doses of vaccine and heterologous by two different doses. Patients with previous SARS-CoV-2 infection were excluded. To compare SARS-CoV-2 infection characteristics in not vaccinated patients, subjects from the SAR-COVID registry, which includes patients with RD and SARS-CoV-2 infection, were matched 2:1 by gender, age and RD.WHO-Ordinal Scale ≥5 was used to define unfavorable infection outcome. Descriptive statics, Chi2 test, Fischer test, T test and ANOVA were used.ResultsA total of 1350 patients from the SAR COVAC registry were included, 67 (5%) presented SARS-CoV-2 infection after vaccination. The later were mostly (72%) females with a mean age of 57 (SD 15) years old. The most frequent RD were rheumatoid arthritis (41%), psoriatic arthritis (12%) and systemic lupus erythematosus (10%). At vaccination, most of them (75%) had low disease activity or remission, 19% were taking steroids, 39% methotrexate, 27% bDMARDs and 6% JAK inhibitors.A total of 11 (16%) patients had SARS-CoV-2 infection <14 days after the first vaccine dose, 39 (58%) after an incomplete scheme and 17 (25 %) following a complete one. In the incomplete scheme group, 59% received Gam-COVID-Vac, 31% ChAdOx1 nCov-19 and 10% BBIBP-CorV; and in patients with complete scheme 47%, 24% and 29%, respectively. No event was reported after a complete heterologous scheme. No significant differences regarding sociodemoghraphic characteristics, RD, disease treatment, type of vaccine and regimen was found between in those with infection and those without it.After vaccination only 8 (12%) of the patients who got infected had an unfavorable course, 88% of them following an incomplete scheme (5 received Gam-COVID-Vac, 1 ChAdOx1 nCov-19 and 1 BBIBP-CorV) and one subject after a complete homologous Gam-COVID-Vac scheme. Having an unfavorable outcome of SARS-CoV-2 infection was associated to: male gender [63% vs 24%, p=0.036], older age [mean 70 years (SD 7) vs 55 years (SD 15), p=0.005], being Caucasian [100% vs 54%, p=0.018], higher education [mean 17 years (SD 4) vs 12 years (SD 4), p=0.010], the presence of comorbidities [100% vs 39%, p=0.001, having pulmonary disease [37% vs 5%, p=0.019], dyslipidemia [63% vs 17%, p=0.011] and arterial hypertension [63% vs 24%, p=0.036], RD, treatments, disease activity and types of vaccines received were comparable between groups.When comparing patients with and without vaccination prior SARS-CoV-2 infection, those who received at least one dose of vaccine had less frequently severe COVID-19 (12% vs 24%, p=0.067) and presented lower mortality due to COVID-19 (3% vs 6%, p=0.498). However these differences did not reach statistical significance.ConclusionIn the SAR-CoVAC registry 5% of the patients had SARS-CoV-2 infection after vaccination, most of them mild and 25% after a complete scheme. Any vaccine was associated with severe COVID-19. When comparing with non-vaccinated patients, those with at least one dose, had less frequently severe disease and died due COVID-19.Disclosure of InterestsNone declared

BackgroundIn Argentina we have witnessed two COVID 19 waves between 2020 and 2021. The first 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 first wave, patient with rheumatic diseases showed a higher frequency of hospitalization and mortality (4% vs 0.26%) when compared to the general population1; at that time, however, vaccination was not yet available.ObjectivesTo compare sociodemographic and disease characteristics, course and outcomes of SARS-CoV-2 infection in patients with immune-mediated/autoinflammatory diseases (IMADs) during the first and second waves in Argentina.MethodsSAR-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 confirmed SARS-CoV-2 infection (RT-PCR or positive serology) were consecutively included since August 2020. For the purpose of this report, only patients with IMADs who had SARS-CoV-2 infection during the first wave (defined 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.ResultsA total of 1777 patients were included, 1342 from the first 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-demographic features, disease diagnosis, disease activity, the use of glucocorticoids ≥ 10 mg/day and the immunosuppressive drugs (Table 1 below). Patients infected during the first 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 first 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 immunosuppressive 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).Table 1.Variable (% or Mean – SD)First wave(n=1342)Second wave(n=435)p ValueFemale gender81800.7Age (years)51.0 (14.5)50.0 (13.3)0.2Disease diagnosis Rheumatoid arthritis46461 Ankylosing spondylitis10110.8 Systemic lupus erythematosus171850.9 Systemic Scleroderma551 Sjögren´s syndrome650.7 Inflammatory myopathies330.5 Vasculitis430.4Disease activity High430.5Use of immune modulatorsDMARDcs53560.2DMARDts460.1DMARDb82821Use of glucocorticoids ≥10 mg12120.9Comorbidities49410.004ConclusionThe 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 findings 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.References[1]Isnardi CA et al. Epidemiology and outcomes of patients with rheumatic diseases and SARS-COV-2 infection: data from the argentinean SAR-COVID Registry. Ann Rheum Dis, 2021, suppl 1, 887.Disclosure of InterestsNone declared