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Annals of the Rheumatic Diseases ; 81:972, 2022.
Article in English | EMBASE | ID: covidwho-2009145


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.

Annals of the Rheumatic Diseases ; 81:1665-1666, 2022.
Article in English | EMBASE | ID: covidwho-2008843


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.

Annals of the Rheumatic Diseases ; 81:929, 2022.
Article in English | EMBASE | ID: covidwho-2008840


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.