ABSTRACT
BackgroundPatients with rheumatic diseases may present more severe SARS-CoV-2 infection compared to the general population. However, in some studies, hospitalization and mortality due COVID-19 were lower in patients with axial spondyloarthritis (axSpA) compared to other rheumatic diseases.ObjectivesTo assess the severity of SARS-CoV-2 infection in patients with axSpA from the SAR-COVID registry, comparing them with patients with rheumatoid arthritis (RA), and to determine the factors associated with poor outcomes and death.MethodsPatients ≥18 years old from the SAR-COVID national registry with diagnosis of AxSpA (ASAS criteria 2009) and RA (ACR/EULAR criteria 2010) who had confirmed SARS-CoV-2 infection (RT-PCR or positive serology), recruited from August 2020 to June 2022 were included. Sociodemographic and clinical data, comorbidities, treatments and outcomes of the infection were collected. Infection severity was assessed using the WHO-ordinal scale (WHO-OS)[1]: ambulatory [1], mild hospitalizations (2.3 y 4), severe hospitalizations (5.6 y 7) and death [8].Statistical analysisDescriptive statistics. Chi[2] or Fischer test and Student T or Mann-Whitney as appropriate. Poisson generalized linear model.ResultsA total of 1226 patients were included, 59 (4.8%) with axSpA and 1167 (95.2%) with RA. RA patients were significantly older, more frequently female, and had a longer disease duration. More than a third of the patients were in remission. 43.9 % presented comorbidities, arterial hypertension being the most frequent. At the time of SARS-Cov-2 diagnosis, patients with RA used glucocorticoids and conventional DMARDs more frequently than those with axSpA, while 74.6% of the latter were under treatment with biological DMARDs being anti-TNF the most used (61%).94.9 % of the patients in both groups reported symptoms related to SARS-CoV-2 infection. Although the differences were not significant, patients with RA presented more frequently cough, dyspnea, and gastrointestinal symptoms, while those with axSpA reported more frequently odynophagia, anosmia, and dysgeusia. During the SARS-CoV-2 infection, 6.8% and 23.5% of the patients with axSpA and RA were hospitalized, respectively. All of the patients with axSpA were admitted to the general ward, while 26.6% of those with RA to intensive care units. No patient with axSpA had complications or severe COVID-19 (WHO-OS>=5) or died as a result of the infection while mortality in the RA group was 3.3% (Figure 1).In the multivariate analysis adjusted to poor prognosis factors, no association was found between the diagnosis of axSpA and severity of SARS-CoV-2 infection assessed with the WHO-OS (OR -0.18, IC 95%(-0.38, 0.01, p=0.074).ConclusionPatients with EspAax did not present complications from SARS-CoV-2 infections and none of them died due COVID-19.Reference[1]World Health Organization coronavirus disease (COVID-19) Therapeutic Trial Synopsis Draft 2020.Figure 1.Outcomes and severity of SARS-CoV-2 infection in patients with axSpA and RA.[Figure omitted. See PDF]Acknowledgements:NIL.Disclosure of InterestsAndrea Bravo 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 influenced 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., Tatiana Barbich 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 influenced 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., Carolina 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 influenced the development of the project, data collection, analysis, interpretati n, or writing the report. They do not have access to the information collected in the database., Gustavo Citera 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 influenced 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., Emilce Edith Schneeberger 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 influenced 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., Rosana Quintana 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 influenced 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., Cecilia Pisoni 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 influenced 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., Mariana Pera 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 influenced 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., Edson Velozo 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 influenced 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., Dora Aida Pereira 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 influenced 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., Paula Alba 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 influenced 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., Juan A Albiero 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 influenced 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., Jaime Villafañe 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 influenced 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., Hernan Maldonado Ficco 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 influenced 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., Veronica Sa io 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 influenced 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., Santiago Eduardo Aguero 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 influenced 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., Romina Rojas Tessel 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 influenced 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., Maria Isabel Quaglia 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 influenced 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., María Soledad Gálvez Elkin 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 influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access tothe information collected in the database., Gisela Paola Pendon 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 influenced 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., Carolina Aeschlimann 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 influenced 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., Gustavo Fabian Rodriguez Gil 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 influenced 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., Malena Viola 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 influenced 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., Cecilia Romeo 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 influenced 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., Carla Maldini 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 influenced 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., Silvana Mariela Conti Grant/research support from: SAR-COVID is a multi-sponsor re istry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced 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., Rosana Gallo 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 influenced 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., Leticia Ibañez Zurlo 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 influenced 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., Maria Natalia Tamborenea 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 influenced 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., Susana Isabel Pineda Vidal 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 influenced 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., Debora Guaglianone 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 influenced 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., Jonatan Marcos Mareco 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 influenced 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., Cecilia Goizueta 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 influenced 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., Elisa Novatti 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 influenced 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., Fernanda Guzzanti 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 influenced 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., Gimena Gómez 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 influenced 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., Karen Roberts Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of t em participated or influenced 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., Guillermo Pons-Estel 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 influenced 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.
ABSTRACT
Background: High disease activity, treatment with glucocorticoids (GC) and rituximab (RTX), have been related to worse outcomes of COVID-19. Objectives: To assess the clinical characteristics and severity of the SARS-CoV-2 infection in patients with rheumatoid arthritis (RA) included in the SAR-COVID registry and to identify factors associated with poor outcomes. Methods: SAR-COVID is a national, longitudinal and observational registry. Patients of ≥18 years old, with diagnosis of RA (ACR-EULAR criteria 2010) who had confrmed SARS-CoV-2 infection (RT-PCR or positive serology) were included between 13-8-20 and 31-7-21. Sociodemographic and clinical data, comorbidities, disease activity and treatment at the moment of the SARS-CoV-2 infection were collected. Additionally, infection symptoms, complications, medical interventions and treatments for COVID-19 were registered. Infection severity was assessed using the WHO-ordinal scale (WHO-OS)1. A cut-off value of ≥5 identifed patients with severe COVID-19 and those who died. Statistical analysis: Descriptive statistics. Chi2 or Fischer test, Student T test or Mann-Whitney and Kruskal Wallis or ANOVA, as appropriate. Multiple logistic regression model. Results: A total of 801 patients were included, with a mean age of 53.1 ± 12.9 years, most of them were female (84.5%) and the median (m) disease duration was 8 years (IQR 4-14). One third were in remission and 46.4% had comor-bidities, being the most frequent, hypertension (26.9 %), dyslipidemia (13.5 %), obesity (13.4 %) and diabetes (8.9%). Moreover, 3.2% had interstitial lung disease (ILD) associated with RA. At SARS-CoV-2 diagnosis, 42.5% were receiving glucocorticoids (GC), 73.9% conventional (c) disease modifying antirheumatic drugs (DMARD), 24% biologic (b) DMARD and 9.1% targeted synthetic (ts) DMARD. Among bDMARD, the most frequently used were TNF inhibitors (17%), followed by abatacept (2.8%), IL-6 inhibitors (2.4%) and rituximab (RTX) (2.1%). During the SARS-CoV-2 infection, 95.8% had symptoms, 27% required hospital-ization, 7.9% presented complications and 4.4% died due to COVID-19. Severe disease and death (WHO-OS≥5) was present in 7.5% of the patients. They were older (62.9±12.5 vs 52.2±12.7, p<0.001), and they had more frequently ILD (18.5% vs 2%, p<0.001), comorbidities (82.5% vs 43.7%, p<0.001), ≥2 comor-bidities (60.3% vs 25.8%, p<0.001), treatment with GC (61% vs 40.7%, p=0.04) and RTX (8.3% vs 1.6%, p=0.007). Conversely, the use of cDMARD and TNF inhibitors was more frequent in patients with WHO-OS<5, nevertheless this difference was not signifcant. Disease activity was comparable between groups. In multivariable analysis, older age, the presence of diabetes, ILD, the use of GC and RTX were signifcantly associated with WHO-OS≥5 (Figure 1). Furthermore, older age (65.7±10.8 vs 52.4±12.8, p<0.001), the presence of comor-bidities (87.9% vs 44.7%, p<0.001), chronic obstructive pulmonary disease (21.9% vs 5.2%, p=0.002), diabetes (30.3% vs 7.9%, p<0.001), hypertension (57.6% vs 25.6%, p<0.001), cardiovascular disease (15.6% vs 3.2%, p=0.005), cancer (9.1% vs 1.3%, p=0.001), ILD (23.3% vs 2.4%, p<0.001) and the use of GC (61.8% vs 41.4%, p=0.02) were associated with mortality. Older age [OR 1.1 IC95% 1.06-1.13] and the use of GC 5-10 mg/day [OR 4.6 IC95% 1.8-11.6] remained signifcantly associated with death due to COVID-19. Conclusion: Treatment with RTX and GC, as well as older age, the presence of diabetes and ILD were associated with poor COVID-19 outcomes in this national cohort of patients with RA. Older patients and those taking GC had a higher mortality rate.
ABSTRACT
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. However in our country, adenovirus and inactivated vaccines, as well as heterologous schemes are frequently used. Objectives: To 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. Methods: Adult patients with RD who have been vaccinated for SARS-CoV-2 were consecutively included between June 1st and December 21st, 2021. Con-frmed SARS-CoV-2 infection (RT-PCR o serology) was reported by the treated physician. Infection after an incomplete scheme was defned when the event was diagnosed at least 14 days after frst dose;and after a complete scheme when it occurred > 14 days after second dose. Homologous scheme is defned 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 defne unfavorable infection outcome. Descriptive statics, Chi2 test, Fischer test, T test and ANOVA were used. Results: A 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% methotrex-ate, 27% bDMARDs and 6% JAK inhibitors. A total of 11 (16%) patients had SARS-CoV-2 infection <14 days after the frst 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 signifcant 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 comorbid-ities [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 signifcance. Conclusion: In 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.
ABSTRACT
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.
ABSTRACT
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.
ABSTRACT
Background: Comorbidities, 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. Objectives: To describe the sociodemographic, clinical and treatment characteristics of patients with PsA with confrmed 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). Methods: Cross-sectional observational study including patients ≥18 years old, with diagnosis of PsA (CASPAR criteria) and RA (ACR/EULAR 2010 criteria), who had confrmed 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. Results: A 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). PsA patients with NIAID≥5 in comparison with NIAID<5 were older (58.6±11.4 vs 50±12.5;p=0.002), had more frequently hypertension (52.2% vs 23%;p=0.011) and dyslipidemia (39.1% vs 15%;p=0.017). In the multivariate analysis, age (OR 1.06;95% CI 1.02-1.11) was associated with a worse outcome of the COVID-19 (NIAID≥5) in patients with PsA, while those who received methotrexate (OR 0.34;95% CI 0.11-0.92) and biological DMARDs (OR 0.28;95% CI 0.09-0.78) had a better outcome. Conclusion: Although 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.
ABSTRACT
Background: SARS CoV-2 infection has recently burst onto the global scene, and the knowledge of the course of this infection in patients with rheumatic diseases receiving immunomodulatory treatment is still insufficient. The Argentine Society of Rheumatology (SAR) designed a national registry called SAR-COVID in order to get to assess our reality. Objectives: To identify the particular characteristics of patients with rheumatic diseases and COVID-19 in Argentina (SAR-COVID Registry), and to compare them with the data reported at the Latin American and Global level (Global International Alliance Rheum-COVID Registry). Methods: A national, multicenter, prospective 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 serology, were included between August 13, 2020 and January 17, 2021. Demographic data, underlying rheumatic disease (activity of the disease, current treatment), comorbidities, clinical-laboratory characteristics of the SARS-CoV-2 infection, as well as received treatments (pharmacological, oxygen therapy / ventilatory support) and outcomes (hospitalization, mortality) were recorded. The characteristics of the included patients 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, according to the type of variable. Results: Four hundred sixty-five patients from Argentina, 74 patients from Latin America and 583 from the rest of the world were included, mostly women (79.6%, 73% and 71% respectively), with a mean age of 50.2 (SD 15.3), 53.5 (DE 15.6) and 55.8 (15.5), years respectively. The most frequent rheumatic diseases in the three groups were rheumatoid arthritis (43.9%, 35%, and 39%) and systemic lupus erythematosus (16.1%, 22%, and 14%) (Table 1). In Argentina, fewer patients received specific pharmacological treatment for COVID-19 (40.9%, 68% and 43% respectively, p <0.0001), and there was a lower requirement of NIMV / IMV (Non-Invasive Mechanical Ventilation/Invasive Mechanical Ventilation) than in the rest of Latin America and the world (10.5% vs 31% vs 13%, p <0.0001). Hospitalization was lower in Argentina than in the rest of Latin America (37.4% vs 61% p 0.0002) and of the world (37.4% vs 45% p 0.0123), and mortality was numerically lower in Argentina, but without statistically significant differences between the three groups (6.9%, 12% and 11%;p 0.6311). Most of the patients, (86.9%) did not present any complications in Argentina, with a statistically significant difference with the rest of the groups (62% and 77%, p <0.0001) (Graph 1). Conclusion: The patients with rheumatic diseases and SARS-CoV-2 infection reported in this argentinian registry received less specific pharmacological treatment for COVID-19, presented fewer complications and required less ventilatory support, than those reported in the Latinoamerican and Global registry. However, no statistically significant differences were observed in terms of mortality.