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BackgroundComorbidities, particularly cardio-metabolic disorders, are highly prevalent in patients with psoriatic arthritis (PsA) and they were associated with an increased risk of atherosclerotic cardiovascular disease, which have been associated with higher morbidity and mortality. Whether PsA enhances the risk of SARS-CoV-2 infection or affects the disease outcome remains to be ascertained.ObjectivesTo describe the sociodemographic, clinical and treatment characteristics of patients with PsA with confirmed SARS-CoV-2 infection from the SAR-COVID registry and to identify the variables associated with poor COVID-19 outcomes, comparing them with those with rheumatoid arthritis (RA).MethodsCross-sectional observational study including patients ≥18 years old, with diagnosis of PsA (CASPAR criteria) and RA (ACR / EULAR 2010 criteria), who had confirmed SARS-CoV-2 infection (RT-PCR or serology) from the SAR-COVID registry. Recruitment period was between August 13, 2020 and July 31, 2021. Sociodemographic variables, comorbidities, and treatments were analyzed. To assess the severity of the infection, the ordinal scale of the National Institute of Allergy and Infectious Diseases (NIAID)1 was used, and it was considered that a patient met the primary outcome, if they presented criteria of categories 5 or higher on the severity scale. For this analysis, Chi2 test, Fisher’s test, Student’s test or Wilcoxon test, and binomial logistic regression using NIAID>=5 as dependent variable were performed.ResultsA total of 129 PsA patients and 808 with RA were included. Clinical characteristics are shown in Table 1. Regarding PsA treatment, 12.4% of PsA were receiving IL-17 inhibitors, 5.4% IL12-23 inhibitors, one patient apremilast and one abatacept. The frequency of NIAID≥5 was comparable between groups (PsA 19.5% vs RA 20.1%; p=0.976). (Figure 1).Table 1.Characteristics of patients with PsA and RA who presented COVID-19 in the SAR-COVID registry.Psoriatic arthritis (n=129)Rheumatoid arthritis (n=808)P valueTotal (n=937)Age (years), mean (SD)51.7 (12.7)53.1 (12.9)0.23952.9 (12.9)Female72 (55.8)684 (84.7)756 (80.7)Comorbidities65 (50.4)355 (43.9)0.203420 (44.8) Obesity (BMI ≥30)19 (15.2)102 (13.4)0.692121 (13.7) Morbid obesity (BMI ≥40)1 (0.8)10 (1.3)111 (1.25) Hypertension35 (28.5)205 (26.8)0.783240 (27.0) Diabetes16 (13.0)67 (8.8)0.18883 (9.39) Dyslipidemia24 (19.5)102 (13.5)0.106126 (14.4) Cardiovascular or cerebrovascular disease5 (11.4)32 (3.9)0.03337 (4.2)Two or more comorbidities55 (42.6)219 (27.1)274 (29.2)Current smoking4 (3.6)60 (8.4)0.7964 (7.7)High disease activity0 (0)29 (3.8)0.02729 (3.23)Glucocorticoids treatment5 (20.0)95 (60.1)100 (54.6)Conventional DMARDs47 (36.4)443 (54.8)490 (52.3)Biologic DMARDs60 (46.5)193 (23.9)253 (27.0)JAK inhibitors4 (3.10)72 (8.9)0.03876 (8.1)Full recovery of COVID-19105 (84.0)644 (81.7)0.127749 (82.0)COVID-19 complications16 (12.5)68 (8.7)0.22784 (9.2)Death due to COVID-191 (0.8)34 (4.3)0.07435 (3.8)Notes=values n (%) unless otherwise indicated; BMI: Body Mass Index; DMARDs: disease-modifying antirheumatic drugs; JAK inhibitors: Janus kinase inhibitors.PsA patients with NIAID≥5 in comparison with NIAIDConclusionAlthough PsA patients have a higher frequency of cardiovascular and metabolic comorbidities than those with RA, the COVID-19 severity was similar. Most of the patients had mild SARS-CoV-2 infection and a low death rate.References[1]Beigel JH, et al. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med. 2020 Nov 5;383(19):1813-1826.Disclosure of InterestsNone declared

BackgroundCurrently 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 inflammatory diseases (IMIDs) who have received a SARS-CoV-2 vaccine in order to assess their efficacy and safety in this population.ObjectivesTo assess SARS-CoV-2 vaccine efficacy and safety in patients with rheumatic and IMIDs.MethodsSAR-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 modification 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 documentedResultsA 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 spondyloarthritis (12.3%). Most of them were in remission (28.5%) and low disease activity (41.4%). At the time of vaccination, 21% were receiving glucocorticoid 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 first dose of the vaccine, the most of the patients (51.1%) received Gam-COVID-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 CoronaVac (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 first dose and 15.9% after the second. The flu-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 significantly lower incidence of AE in comparison with the other types of vaccines. (118.5 events/1000 doses, pRegarding efficacy, 63 events of SARS-CoV-2 infection were reported after vaccination, 19% occurred before 14 days post-vaccination, 57.1% after the first 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.ConclusionIn 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.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. 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, pTotal incidence of EA was 182.5 events/10 00 doses, it was significantly lower for BBIBP-CorV (105.9 events/1000 dosis, pPatients with AE were younger [mean 55 years (SD 14) vs 59 years (SD 14), p 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

BackgroundAdvances in rheumatology and new therapeutic options have certainly impacted patient survival, changing the age range, from youth to seniors. The differences between the age groups could influence the evolution of the disease and the adverse events (AEs) related to the treatments. There are few real-world data on the safety and efficacy of treatments in different age groups.ObjectivesTo evaluate the frequency of AEs and the survival of treatments according to the age in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS).MethodsRetrospective, observational, multicenter study of real-life data of patients included in the BIOBADASAR 3.0 registry; exposed and not exposed to original biological treatments (b-DMARDs), biosimilars, targeted synthetic drugs (ts-DMARDs). The unexposed group received treatment with conventional disease-modifying drugs (cDMARDs). A Kaplan-Meier and Log Rank Test analysis was performed to study AEs-free survival and treatment in different age groups (young people 65). Factors related to treatment survival were evaluated using Cox regression models.Results5,297 patients were included, 80.3% female, mean age 43.7 years (SD 15.6) and median disease progression 14.3 [IQR 11.5]. RA 4658 (87.9%); APs 490 (9.25%) and EA 149 (2.8%). The main reason for treatment discontinuation was ineffectiveness, in 624 patients in the exposed group and in 53 (2.5%) patients in control group, followed by the presence of AEs in 352 (11.2%) and 83 (3.9%), respectively (p=0.001).A mean Charlson Score of 0.268 (SD 0.6) in the exposed group and 0.306 (SD 0.7) in the control group (p=0.095). Median EAs-free survival in the exposed group was 12.5 years [IQR 16.6] while in controls was 28 years [IQR 11], p0.017). The exposed group presented a median treatment survival in years of 11.25 years [IQR: 10] in young people; 12.5 years [IQR: 4.7] in young adults, 7.5 years [IQR: 12.1] in mature adults and 4.5 years [IQR: 1.14] in old adults (p>0.0001). Considering only the first line of treatment, a median survival of 11.5 years [IQR: 10] was evidenced in the age group 65 years old (p>0.004). (Figure 1). Considering the second line of treatment, the differences between the groups were not statistically significant (p=0.57). In the multivariate regression model for patients with RA, the factors with the greatest impact on treatment survival were female sex (HR 1.3, 95% CI 1.2-1.4), old age (HR 1.01, 95% CI 1.008-1.01), treatment with steroids (HR 1.19, 95% CI1.1-1.2) and longer disease duration (HR 1.01, 95% CI1.01 – 1.02).ConclusionIn the present study we were able to demonstrate a greater occurrence of AEs in old adults and mature adults compared to young people and young adults. Conversely, survival for b-DMARDs and ts-DMARDs were greater in youth and young adults. In patients with RA, female sex, corticosteroid therapy, old aged and longer disease duration were associated with treatment discontinuation.References[1]Souto A, et al. Rate of discontinuation and drug survival of biologic therapies in rheumatoid arthritis: a systematic review and meta-analysis of drug registries and health care databases. Rheumatology (Oxford). 2016;55(3):523–34.[2]Ray D, et al. Immune senescence, epigenetics and autoimmunity. Clin Immunol. 2018 Nov;196:59-63. doi: 10.1016/j.clim.2018.04.002. Epub 2018 Apr 11.[3]Vela P, et al. Influence of age on the occurrence of adverse events in rheumatic patients at the onset of biological treatment: data from the BIOBADASER III register. Arthritis Res Ther. 2020 Jun 15;22(1):143. doi: 10.1186/s13075-020-02231-x.Disclosure of InterestsNone declared