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Objectives: Patients with immune-mediated diseases achieve lower seroconversion rates to COVID19 vaccines compared to healthy controls. The aim of this study was to assess the SARS-CoV-2-specific humoral and T-cell responses after a two-dose regimen of SARS-CoV-2 vaccine in patients with rheumatoid arthritis (RA). Method(s): Observational study. Patients with RA, >=18 years of age, who were vaccinated according to the Argentine National Health Ministry's vaccination strategy were included. Anti-SARS-CoV-2 IgG antibodies, neutralizing activity and specific T-cell responses were assessed after the first and second doses. Result(s): A total of 120 RA patients were included. Mostly, homologous regimens were used, including Gam-COVID-Vac (27.5%), ChAdOx1 (24.2%), BBIBP-CorV (22.5%) and BNT162b2 (0.8%), while the most frequent combination of vaccines was Gam-COVID-Vac/mRNA-1273 (21.7%). After the second dose 81.7% presented anti-SARS-CoV-2 antibodies, 70.0% neutralizing activity and 65.3% specific T-cell response. The use of BBIBP-CorV, treatment with abatacept (ABA) and rituximab (RTX) were associated with undetectable antibodies and no neutralizing activity after two doses of vaccine. BBIBP-CorV was also associated with the absence of T-cell response. The total incidence of adverse events was 357.1 events/1000 doses: significantly lower with BBIBP-CorV (166.7 events/1000 doses, p alpha 0.02). Conclusion(s): In this cohort of patients with RA who received 2 doses of COVID-19 vaccine, according to the Argentine strategic vaccination planwhich included homologous and heterologous regimens, two of ten did not develop IgG anti-SARS-CoV-2, 70% presented neutralizing activity and 65% specific T-cell response. The use of BBIBP-CorV was associated with deficient humoral and cellular response, while treatment with ABA and RTXaffected the development of IgG anti-SARS-CoV-2 and neutralizing activity.
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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: Vaccination for COVID-19 is an essential tool to fght the pandemic. Evidence suggests that patients with immune mediated infammatory diseases (IMIDs) have less response. The application of a booster shot is a strategy that has been implemented in this population, however there is scarce information about its efficacy. Objectives: To assess the humoral and cellular immune response after a third dose of SARS-CoV-2 vaccine in patients with rheumatoid arthritis (RA) with undetectable antibodies titles after primary regimen of two doses. Methods: Observational study. Patients with RA (ACR/EULAR 2010 criteria) from two rheumatology centers, ≥18 years old, with no seroconversion after two doses of SARS-CoV-2 vaccine, who received a third dose of either mRNA or vector-based vaccines (BNT162b2 or ChAdOx1 nCoV-19) were included. Anti-SARS-CoV-2 IgG antibodies, neutralising activity and T cell responses were assessed between 21 and 40 days after the third dose. Sociodemographic data, comorbid-ities, treatment, vaccine applied and the presence of adverse events (AE) were recorded. Statistical analysis: descriptive analysis. Chi2 or Fischer test and T test. Results: A total of 21 non-responder patients were included, all of them females with a mean age of 63.7 years (SD 11,6) and mean disease duration of 15.8 years (SD 8). Most of them (81%) reported comorbidities, being the most frequent arterial hypertension, obesity and dyslipidemia. At vaccination time, 6 (28.6%) were receiving glucocorticoids, 3 of them ≥10 mg/day, 17 c-DMARDs (methotrexate 57.1%) and 18 (85.1%) b-DMARDs, 6 abatacept (ABT) and 4 rituximab (RTX). Regarding the primary vaccination regimen, 13 (61.9%) received two doses of BBIBP-CorV, 3 (14.3%) Gam-COVID-Vac, 3 (14.3%) ChAdOx1 nCoV-19 and 2 (9.5%) a mix regimen of Gam-COVID-Vac/mRNA-1273. The majority (95.2%) received BNT162b2 vaccine and only one of them ChAdOx1 nCoV-19, with a mean time between the second and third dose of 151,4 days (SD 46,4). After the third dose, 90.5% of the patients presented detectable anti-SARS-CoV-2 IgG and 76.2% presented neutralizing activity. The median of neutralizing antibodies titers was 1/12 (IQR 1/7-1/48). Both patients who did not present detectable antibodies were obese, recieved BBIBP-CorV during the primary regimen and BNT162b2 as the third dose, one of them was taking methotrexate and ABT and the other one RTX. Compared to other treatments, ABT and RTX was associated with no neutralizing activity in 4 (80%) patients and lower titers of neutralizing antibodies [median 1/3 (IQR 0-1/20) vs median 1/8 (IQR 1/4-1/128), p=0.197]. A T-cell response was present in 41.2% of all patients after the second dose, increasing to 75% after the third dose. The use of ABT was associated with a lower frequency of T-cell response (80% vs 20%, p=0.014). Sixteen (76.1%) patients reported at least one AE, 66.7% injection site reaction and 25% fu-like syndrome. Conclusion: In this RA cohort who failed to seroconvert after two doses of SARS-CoV-2 vaccine, 90.5% presented detectable anti-SARS-CoV-2 IgG and 75% T-cell responce after a third dose. The use of ABT was associated with a lower frequency of T-cell response. This data highlights the importance of a third vaccine in this group of patients.
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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. 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.
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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.