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.
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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.
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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.
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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.
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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. .
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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.