ABSTRACT
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.
ABSTRACT
Background: There is scarce evidence on the rate of adverse events and the consequences on disease activity after vaccination against covid19 Objectives: To evaluate adverse events to vaccination and disease fares after vaccination in patients with axial spondyloarthritis (axSpA), peripheral spondy-loarthritis (pSpA) and psoriatic arthritis (PsA) and to evaluate factors associated with adverse event. Methods: Cross-sectional, observational, descriptive study. Consecutive patients with diagnosis of ankylosing spondylitis (AS) and non-radiographic axial spondy-loarthritis (nr-axSpA) according to ASAS 2009 criteria;pSpA according to ASAS 2011 criteria and PsA according to CASPAR criteria were included. Demographic data, disease clinimetry, treatments, vaccination received and post-vaccination adverse events were recorded. We evaluated, according to medical criteria, whether the patient presented a fare disease after vaccination and whether it was mild, moderate or severe. We also evaluated the factors associated with the presence of at least one mild adverse event. Statistical analysis: descriptive statistics were performed, qualitative variables were expressed as frequency and percentage (%), numerical variables as mean and standard deviation (SD) or median and percentile25-75. Binary logistic regression was performed using the presence of at least one mild adverse event to vaccination as the dependent variable. Results: 210 patients were included with a mean age of 45 (SD 15) years. The diagnoses were: AS 50 (23.8%), nr-axSpA 10 (4.8), pSpA 9 (4.3%), PsA 141 (67%) and time of disease evolution in months 109 (SD 96). Regarding comorbidities, the following frequencies were reported: arterial hypertension 60 (30%), diabetes mellitus 25 (12%), heart failure 4 (2%), asthma/EPOC 15 (7%), infammatory bowel disease 2 (1%), acute anterior uveitis 20 (9.5%), psoriasis 128 (61%). Sixteen percent (n=33) of the patients had SARS-CoV-2 infection prior to vaccination. Regarding treatments, those used were: antiTNF 88 (42%), Tofacitinib 6 (2.9%), Ustekinumab 2 (1%), Secukinumab 35 (17%), Ixekizumab 2 (1%), methotrexate 98 (47%), lefunomide 7 (3. 3), sulfasalazine 7 (3.3), apremilast 1 (0.5%), continuous NSAIDs 26 (12.4%) and NSAIDs on demand 103 (49%). Vaccines received were: Sputnik V 109 (51.9%), Oxford Vaccine, AstraZeneca 63 (30%), Janssen 1 (0.5%), BioNTech Vaccine, Pfzer 1 (0.5%), Sinopharm 33 (15.7%), Moderna 0%, Novavax 0% and others;3 (1.4%). Thirty-eight percent (n=80) of patients reported having mild post-vaccination symptoms, of which 3.75% did not resolve, 41% resolved with medication and 39% resolved ad integrum without medication. The presence of mild adverse event to the vaccine was associated with lower use of methotrexate (31% vs 56 %, p<0.001), and lower age (54 (SD 14) vs 47 (SD 12), p<0.001), and lower BMI (25 (24-30.5) vs 28 (25-31), p<0.001);while no association was found with sex, diagnosis, comorbidities, treatments, desease activity or vaccines. In the logistic regression analysis all the variables remained independently associated with a lower probability of presenting a mild adverse event: methotrexate: OR: 0.30, 95%CI 0.15-0.58, p<0.001, age: OR: 0.97, 95%CI 0.95-0.99, p: 0.03, BMI: OR: 0.92, 95%CI 0.95-0.99, p: 0.02. Sixty-one percent (n=129) of patients received the 2nd dose of vaccination, which 27% (n=35) presented mild adverse event and only 1 (0.8%) patient suffered post vaccination disease fare. Conclusion: Vaccination against COVID19 appears to be safe in this population, with only mild adverse events and low frequency of fare disease. Mild adverse events were associated with less use of methotrexate, younger age and lower BMI.
ABSTRACT
Background: Persistent symptoms after acute COVID have been described previously. Main symptoms reported are fatigue, arthralgias, myalgias and mental sickness. Defnition and methods vary widely.1 Objectives: To asses prevalence and related factors to long COVID in a retrospective cohort of patients with rheumatic diseases from Argentina. Methods: A total of 1915 patients were registered from August 18th, 2020 to July 29th, 2021. Patients > 18 years old, with rheumatic disease and confrmed infection by SARS-CoV-2 (antigen or RT-PCR) were included. Those dead, with unknown outcome, wrong date or missing data were excluded. Demographic data, comorbidities, rheumatic disease, and characteristics of SARS-CoV-2 infection were recorded. Long COVID was defned according to NICE guidelines (persistent symptoms for more than 4 weeks, without alternative diagnosis). Long COVID symptoms were defned by rheumatologist. Severity of infection was clas-sifed according to WHO ordinal scale. We used descriptive statistics, univariate model (Student's test, chi square test, ANOVA) and multivariate logistic regression analysis. Results: 230 (12%) had long COVID. Median age was 51 (IQR 40-61]) years, 82% were females, 51% were not caucasian. Median of education was 13.3 years (IQR 12-16), 79 % had private health insurance and 55 % were employed. Nearly half (n=762, 46%) had comorbidities, the most prevalent was hypertension (n=396, 24%). The most frequent rheumatic diseases were rheumatoid arthritis (n=719, 42%) and systemic lupus ery-thematosus (n=280, 16 %). Most were in low activity/remission (79%), used Conventional DMARD (n=773 patients, 45%) and steroids (n=588, 34%) at low dose (n=415, 71%). Main laboratory findings were abnormal D-di-mer (n=94, 28%) and leukopenia (n=93, 26%). Most patients had a WHO ordinal scale < 5 (n=1472, 86%). Median of hospitalization at intensive care unit (ICU) was 8 days [IQR 5, 13]. Treatment for SARS-CoV-2 infection (steroids, anticoagulation, azithromycin, convalescent plasma) was used in 461 (27%) patients. Most of long COVID (n= 152, 69%) reported 1 symptom, the most frequent was fatigue (n= 55, 22%). Figure 1. Univariate analysis is presented in Table 1. In multivariate logistic regression analysis non-caucasian ethnicity OR 1.44 (1.07-1.95), years of education OR 1.05 (1-1.09), treatment with cyclophosphamide OR 11.35 (1.56-112.97), symptoms of COVID-19 OR 13.26 (2.75-242.08), severity scale WHO ≥ 5 OR 2.46 (1.68-3.57), and ICU hospitalization days OR 1.09 (1.05-1.14) were factors associated to long COVID. Conclusion: Prevalence of long COVID was 12%. Non-caucasian ethnicity, higher education, treatment with cyclophosphamide, symptoms of COVID-19, severe disease and ICU hospitalization days were related to long COVID.
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: 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.
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
Objectives: To describe the incidence and severity of COVID-19 disease in Spondyloarthritis patients in Argentina. Methods: Patients with axial spondyloarthritis (AxSpA) radiological (AS) and non-radiological (AxSpA-nr) and peripheral spondyloarthritis (according to ASAS criteria, SpAp) and Psoriatic arthritis (PsA) (according to CASPAR criteria) were included. The patients were followed up by phone or in person on a monthly basis. Data were collected from 1/4/2020 to 20 / 9/2020. Descriptive statistics were performed with mean and standard deviation (SD) and median and 25-75 percentile according to distribution, and the cumulative incidence (CI) of the disease was calculated. Results: 320 patients were included, of which 55%were male, with a mean age of 50 (SD 13), 21.6% had a diagnosis of AS, 6.9% AxSpA-nr, 6.9% SpAp and 64.7% PsA. The duration of the disease was 11 (5-16), BASDAI 3.65 (3), BASFI 3 (1.5-9), PASI 0.3 (0-7), BSA 0.2 (0-6). Fourteen patients with a diagnosis of COVID-19 (4.4%) were reported, of which 10 diagnoses were by positive PCR and 4 by symptoms associated with positive close contact. Thirteen (93%) cases were patients from the Province of Buenos and Ciudad Autónoma de Buenos Aires (CABA) and 1 patient from Santiago del Estero. The total CI of the country was 0.04, the CI of the Province of Buenos Aires + CABA 0.04, and the CI of the rest of the provinces 0.01. Of the 14 patients with COVID-19: 50% were men;4 have a diagnosis of AS, 1 of SpAax-nr, 9 (64.3%) PsA. All of them in urban areas, 79% have social work, 2 (14%) have hypertension, 1 (7%) diabetes mellitus, 4 (28.6%), hypothyroidism, 1 (7%) Chronic Obstructive Pulmonary Disease, 2 (14%) Depression o Anxiety. Regarding the treatments: 4 (28.6%) were in treatment with anti TNF (3 with Adalimumab, 1 with certolizumab pegol), 4 (28.6%) with Anti IL17 (3 with Secukinumab and 1 with Ixekizumab), 8 (57%) methotrexate and 2 (14%) Leflunomide, 1 (7%) were under treatment with Enalapril, 1 (7%) with Losartan. 10 (71.4%) stayed at home, 3 (21.4%) hospitalized in the common room and 1 (7) in the intensive care unit. No patients died due to COVID-19. Conclusion: An incidence of 4.4% of COVID-19 was found in this SpA population, most of the cases occurred in the Province of Buenos Aires and CABA, most of them suffered mild symptoms and no deaths were reported.
ABSTRACT
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.
ABSTRACT
Background: Access to high-cost treatments is especially limited in low-resource countries. This issue is becoming stronger today given the health and economic crisis caused by the SARS-CoV2 pandemic. There are no reports in our country on limitations to access and adherence to treatment in patients with Spondyloarthritis (SpA) during social preventive and mandatory isolation. Objectives: Evaluate access and adherence to treatment in patients with Spondyloarthritis during social preventive and mandatory isolation. Methods: Patients with axial spondyloarthritis (axSpA) radiological (r-axSpA), non-radiological (nr-axSpA) and peripheral spondyloarthritis (pSpA), according to ASAS criteria and psoriatic arthritis (PsA) according to CASPAR criteria, were included. Sociodemographic data, comorbidities, disease activity and treatments were collected at baseline. Data on treatment discontinuation, medical attention for suspected COVID-19 disease, RT-qPCR for SARS-CoV-2 detection and outcome of COVID-19 disease were collected from April to September 2020. Numerical variables were summarized as means and standard deviations (SD) or as medians and interquartiles 25-75 (IQ 25-75). Results: 320 patients were included, 55% were male, with a mean age of 50 years (SD 13), 21.6% had diagnosis of r-axSpA, 6.9% nr-axSpA, 6.9% pSpA, and 64.7% PsA. Disease duration was 11 (IQ 5-16) years and activity parameters were as follow: BASDAI 3.65 (SD 3), BASFI 3 (1.5-9), PASI 0.3 (0-7), BSA 0.2 (0-6). 14 (4.4%) patients with COVID-19 disease were reported, 10 were confirmed by positive RT-qPCR and 4 by symptoms and history of close contact with SARS patients. 4 (28.6%) received anti TNF (3 adalimumab, 1 certolizumab), 4 (28.6%) anti IL17 (3 secukinumab and 1 ixekizumab), 8 (57%) methotrexate (MTX) and 2 (14%) leflunomide (LF). Among the 320 patients included, 59 (18.4%) discontinued at least one treatment during follow-up. The discontinued medications were: adalimumab (16), MTX (15), secukinumab (9), etanercept (6), certolizumab(4), ustekinumab (3), NSAIDs (2), apremilast (1), golimumab (1), ixekuzumab (1), LF (1), MTX plus LF (1). The main reason for treatment discontinuation was drug shortage: 36 (62%), followed by patient's decision: 12 (21%) and medical indication: 11 (17%). Of the 36 patients who discontinued due to shortage, 11 received adalimumab, 8 secukinumab, 5 MTX, 3 etanercept, 3 certolizumab, 3 ustekinumab, 2 NSAIDs and 1 golimumab. Conclusion: In our Argentinian cohort of patients with SpA, drug shortage was the main reason for treatment discontinuation. The SARS-CoV2 pandemic exposed limitations to access to treatment for patients with SpA.
ABSTRACT
Background: There are limited data worldwide on the behavior of SARSCOV2 in patients with Spondyloarthritis (SpA). Objectives: To describe the incidence and severity of COVID-19 disease in patients with SpA in Argentina. Methods: Patients with axial spondyloarthritis (AxSpA) radiological (EA) and non-radiological (AxSpA-nr) and peripheral spondyloarthritis (according to ASAS criteria) and psoriatic arthritis (PsA) (according to CASPAR criteria) were included. Sociodemographic data, comorbidities, disease activity and treatments were collected at baseline. The patients were followed up by phone or in person monthly. Data were collected from 1/4/2020 to 9/20/2020. Descriptive statistics were performed with mean and standard deviation (SD) and median and quartile 25-75 according to distribution, and the cumulative incidence (AI) of the disease was calculated. Results: 320 patients were included, of which 55% were male, with a mean age of 50 SD 13, 21.6% had a diagnosis of AS, 6.9% SpAax-nr, 6.9% SpAp, and 64.7% PsA, BASDAI 3.65 (3), BASFI 3 (1.5-9), PASI 0.3 (0-7), BSA 0.2 (0-6). Fourteen patients with a diagnosis of COVID-19 (4.4%) were reported, of which 10 diagnoses were by positive PCR and 4 by positive symptoms and close contact. 93% (13) of the cases were patients from the Province of Buenos and CABA and 1 patient from Santiago del Estero. The total IA for the country was 0.04. Of the 14 patients with COVID-19, 7 (50%) were men, 4 had a diagnosis of AS, 1 of SpAax-nr, 9 (64.3%) PsA. 100% live in urban areas, 2 (14%) have hypertension, 1 (7%) DBT, 1 (7%) COPD, 2 (14%) depression or anxiety, 11(97%) had received influenza vaccine 2020, 13 (93%), Antineumoccic 23, 14 (100%) Antineumoccic 13. Regarding the treatments: 4 (28.6%) were in treatment with anti TNF (3 with Adalimumab, 1 with certolizumab pegol), 4 (28.6%) with Anti IL17 (3 with Secukinumab, 1 with Ixekizumab), 8 (57%) with methotrexate and 2 (14%) with Leflunomide. Place of follow-up of the disease: 10 (71.4%) at home, 3 (21.4%) in the common room and 1 (7) in the intensive care unit. Treatments received for COVID-19: 1 (7%) antiretroviral, 1 (7%) antibiotic and 1 (7%) steroids. None of the patients died from COVID-19. Conclusion: An incidence of 4.4% of COVID-19 was found in this population with SpA and most of the patiend had mild symptoms and no deaths were reported. .
ABSTRACT
Background: In the last time, many papers about SARS-CoV-2 have been published in the world. However, data from latinamerican patients is still scarce. In order to assess the impact of SARS-CoV-2 infection in patients with rheumatic diseases in our country and contribute to the global knowledge about the effect of immunosuppressive therapies in this group, the Argentine Society of Rheumatology has developed the National Registry of Patients with Rheumatic Diseases and COVID-19 (SAR-COVID). Objectives: The aim of this study was to evaluate clinical characteristics and outcomes of SARS-CoV-2 infection in patients with rheumatic diseases, treated or not with immunomodulators and/or immunosuppressants. Methods: SAR-COVID is a national, multicenter, prospective and observational registry, in which patients, ≥18 years of age, with a diagnosis of a rheumatic disease who had SARS-CoV-2 infection (PCR or positive serology) are consecutively included between August 13, 2020 and January 17, 2021. Sociodemographic data, comorbidities, underlying rheumatic disease and treatment, clinical characteristics, complications, laboratory and treatment of the SARS-CoV-2 infection were recorded. Hospitalization, mechanical ventilation requirements and death were assessed to evaluate COVID-19 outcome. Statistical analysis: Descriptive analysis. Chi2 or Fischer test and T test or Mann-Whitney U test or ANOVA, as appropriate. Multiple logistic regression. Results: A total of 525 patients were included, 80.4% were female, with a median age of 52 years (IQR 40-62). Comorbidities were reported in half of them (53.3%). The most frequent rheumatological diseases were rheumatoid arthritis (40.4%) and systemic lupus erythematosus (14.9%). At the time of the infection, most of them were in remission or in minimal/low disease activity (68.2%) and 72.9% were receiving immunosuppressive or immunomodulatory treatment. Symptoms were present in 96% of the patients, the most frequent being fever (56.2%), cough (46.7%) and headache (39.2%). During infection, 35.1% received some pharmacological treatment, dexamethasone (20%) the most frequently used. One third (35.1%) of the patients were hospitalized, 11.6% were admitted to the ICU, 10.1% needed mechanical ventilation and 6.9% died due to COVID-19. Complications were reported in 12.4%, being acute respiratory distress syndrome the most prevalent (8.8%). Patients over 65 years of age were more frequently hospitalized, admitted to the ICU, needed mechanical ventilation and died due to COVID-19 (50% vs 31.4%, 22% vs 9%, 16.3% vs 5.2%, 14% vs 5%, respectively;p<0.001 in all cases). Similar results were seen in patients with vasculitis (57.7% vs 33.9%, 46.2 vs 9.8%, 34.6% vs 6 %;30.8% vs 5.6%, respectively;p< 0.001 in all cases) and those with moderate/high disease activity (55.7% vs 26.5%, 21.3 vs 7.8%, 17.2% vs 4.2 %;17.2% vs 4.2 %, respectively;p< 0.001 in all cases). Patients with APS were more frequently admitted to the ICU (29.4% vs 11%, p= 0.037). The presence of comorbidities was associated with higher hospitalization (46% vs 22.6%, p<0.001), admission to the ICU (17.2% vs 5.9%, p<0.001) and mechanical ventilation (10.2% vs 4.6%, p= 0.028). Immunosuppressive treatment was not associated with worse outcomes. Conclusion: In this cohort of patients with a wide distribution of rheumatic diseases, we have found clinical characteristics similar to those reported by other international cohorts. Compared with national data, the mortality reported in these patients is higher. However, it should be noted that these are early data collected during isolation and that there may be an underreporting of asymptomatic patients or with mild symptoms who do not attend the rheumatologist. Older patients, those with comorbidities, with vasculitis and with higher disease activity showed poor COVID-19 outcomes.