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During the past two years we have witness a tremendous worldwide health crisis imposed by the coronavirus disease (COVID-19). This situation led to the urgent development and implementation of vaccines in an attempt to decrease not only the SARS-CoV-2 transmissibility but also the severe forms of COVID-19. Although these vaccines were approved based on an adequate benefit-risk ratio, at the moment of their implementation in 2021 we did not have sub-studies in special populations;patients with systemic lupus erythematosus (SLE) among them. We describe two cases of lupus nephritis flare following the immunization against SARS-CoV-2 with the first component of Sputnik V and Sinopharm. Both patients were in complete remission on maintenance therapy with mycophenolate and without glucocorticoids. The flare presented with an increased protein/creatinine ratio in urine and positive anti-DNA antibodies without other relevant accompanying findings. After treatment with prednisone (20 y 10 mg/day in case 1 and 2, respectively) and an increased dose of mycophenolate (from 1.5 g/day to 2.0 g/dayand 1.08 to 1.44 g/dia of sodic mycophenolate in case 1 y 2, respectively) both patients regained renal remission. These cases are of relevance as they introduce a possible association between the different anti-SARS-CoV-2 vaccine platforms and SLE flares;at the same time to suggest the need for close control in the post vaccination period in this population of patients.
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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: 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.
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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.
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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.
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Background: The pivotal BNT162b2 trials included only ∼60 vaccine recipients, all with well controlled HIV, and there is a need to gather more information on vaccine safety and immunogenicity in diverse populations. This prospective study evaluated solicited and unsolicited adverse events (AEs) and anti-S and anti-NC serological profiles in a diverse cohort of people with HIV undergoing BNT162b2 vaccination (2 doses 3 weeks apart). Methods: Participants completed structured questionnaires modelled on the BNT162b2 trials (FDA submission, Nov 2020) to report solicited and unsolicited AEs in the 7 days after each vaccine dose, indicating severity and duration. Serum samples collected prior to dose-1 (T0) and 3-6 weeks after dose-2 (T1) underwent qualitative anti-NC and quantitative anti-S testing by Elecsys®. Factors associated with T1 anti-S titres were explored in linear regression models including all available parameters. Results: Overall, 259 adults received dose-1 (26% female, 77% white, 44% MSM, 44% history of advanced disease, 31% ≥1 comorbidity, 10% HIV RNA >50 cps/ml [median 122 cps], 7% prior COVID-19 diagnosis, 15% anti-NC positive;median age 48 years, ART duration 7 years, nadir/current CD4 count 225/708 cells/mm3, CD4:CD8 ratio 0.8);257 received dose-2. Local AEs were more common after dose-1 than dose-2 (70% vs. 62%, p=0.015), whereas systemic AEs increased with dose-2 (50% vs 60%;p=0.006) (Fig 1a-c);22% experienced moderate-severe systemic AEs after dose-2. Unsolicited AEs (mainly nausea and light-headedness) were reported by 7% after dose-1 and 9% after dose-2. Among 206 participants with T1 samples, 205 (99%) had measurable anti-S (>0.8 U/ml). Anti-S levels were significantly lower at CD4 counts <200 cells/mm3 (Fig 1d). In adjusted regression analyses, factors associated with anti-S titres comprised anti-NC positivity (fold-change 7.39;95% CI 3.92-13.91;p<0.01), HIV viraemia (FC 0.24;0.11-0.50;p<0.01), reporting moderate-severe systemic AEs after dose-2 (FC 1.77;1.03-3.04;p=0.04) and either the CD4 count (FC 1.01;1.00-1.01;p=0.04) or CD4:CD8 ratio (FC 1.05;1.00-1.10;p=0.05). Conclusion: In this cohort with HIV, AE patterns after vaccination were similar to those seen in the pivotal BNT162b2 trials and most AEs were mild and short-lived. Whilst prior exposure to SARS-CoV-2 predicted higher anti-S responses, CD4 counts <200 cells/mm3 and low-level viraemia predicted reduced anti-S responses, thus identifying a subset potentially vulnerable to reduced vaccine efficacy.
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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.