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. In our country, adenovirus-vector, inactivated and heterologous scheme vaccines are frequently used.ObjectivesTo 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 flares after vaccination.MethodsAdult 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 defined 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.ResultsA 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-flu syndrome was the most frequent (11%), followed by injection site reaction (7%). They were significantly more frequent after the first 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 flares reported, 17 (68%) cases of arthritis. Among patients with two doses, those with heterologous 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 significantly 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 inflammatory 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)Figure 1.Variables associated with the development of AE. Multivariate logistic regression modelConclusionThe incidence of AE was 1825 events/1000 doses, were significantly higher for mRAN-1273 and ChAdOx1 nCov-19 and lower for BBIBP-CorV. Most common AE was pseudo-flu syndrome. Female sex, being younger, higher education level, ChAdOx1 nCov-19 and mRAN-1273 vaccines, the use of methotrexate and antimalarials were related of EA in patients with RD.References[1]Sattui SE et al. Early experience of COVID-19 vaccination in adults with systemic rheumatic diseases: results from the COVID-19 Global Rheumatology Alliance Vaccine Survey. RMD Open 2021;7.Disclosure of InterestsNone declared

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