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  • 1
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 81, No. Suppl 1 ( 2022-06), p. 953.1-953
    Abstract: High disease activity, treatment with glucocorticoids (GC) and rituximab (RTX), have been related to worse outcomes of COVID-19. Objectives To assess the clinical characteristics and severity of the SARS-CoV-2 infection in patients with rheumatoid arthritis (RA) included in the SAR-COVID registry and to identify factors associated with poor outcomes. Methods SAR-COVID is a national, longitudinal and observational registry. Patients of ≥18 years old, with diagnosis of RA (ACR-EULAR criteria 2010) who had confirmed SARS-CoV-2 infection (RT-PCR or positive serology) were included between 13-8-20 and 31-7-21. Sociodemographic and clinical data, comorbidities, disease activity and treatment at the moment of the SARS-CoV-2 infection were collected. Additionally, infection symptoms, complications, medical interventions and treatments for COVID-19 were registered. Infection severity was assessed using the WHO-ordinal scale (WHO-OS) 1 . A cut-off value of ≥5 identified patients with severe COVID-19 and those who died. Statistical analysis : Descriptive statistics. Chi 2 or Fischer test, Student T test or Mann-Whitney and Kruskal Wallis or ANOVA, as appropriate. Multiple logistic regression model. Results A total of 801 patients were included, with a mean age of 53.1 ± 12.9 years, most of them were female (84.5%) and the median ( m ) disease duration was 8 years (IQR 4-14). One third were in remission and 46.4% had comorbidities, being the most frequent, hypertension (26.9 %), dyslipidemia (13.5 %), obesity (13.4 %) and diabetes (8.9%). Moreover, 3.2% had interstitial lung disease (ILD) associated with RA. At SARS-CoV-2 diagnosis, 42.5% were receiving glucocorticoids (GC), 73.9% conventional (c) disease modifying antirheumatic drugs (DMARD), 24% biologic (b) DMARD and 9.1% targeted synthetic (ts) DMARD. Among bDMARD, the most frequently used were TNF inhibitors (17%), followed by abatacept (2.8%), IL-6 inhibitors (2.4%) and rituximab (RTX) (2.1%). During the SARS-CoV-2 infection, 95.8% had symptoms, 27% required hospitalization, 7.9% presented complications and 4.4% died due to COVID-19. Severe disease and death (WHO-OS≥5) was present in 7.5% of the patients. They were older (62.9±12.5 vs 52.2±12.7, p 〈 0.001), and they had more frequently ILD (18.5% vs 2%, p 〈 0.001), comorbidities (82.5% vs 43.7%, p 〈 0.001), ≥2 comorbidities (60.3% vs 25.8%, p 〈 0.001), treatment with GC (61% vs 40.7%, p=0.04) and RTX (8.3% vs 1.6%, p=0.007). Conversely, the use of cDMARD and TNF inhibitors was more frequent in patients with WHO-OS 〈 5, nevertheless this difference was not significant. Disease activity was comparable between groups. In multivariable analysis, older age, the presence of diabetes, ILD, the use of GC and RTX were significantly associated with WHO-OS≥5 (Figure 1). Furthermore, older age (65.7±10.8 vs 52.4±12.8, p 〈 0.001), the presence of comorbidities (87.9% vs 44.7%, p 〈 0.001), chronic obstructive pulmonary disease (21.9% vs 5.2%, p=0.002), diabetes (30.3% vs 7.9%, p 〈 0.001), hypertension (57.6% vs 25.6%, p 〈 0.001), cardiovascular disease (15.6% vs 3.2%, p=0.005), cancer (9.1% vs 1.3%, p=0.001), ILD (23.3% vs 2.4%, p 〈 0.001) and the use of GC (61.8% vs 41.4%, p=0.02) were associated with mortality. Older age [OR 1.1 IC95% 1.06-1.13] and the use of GC 5-10 mg/day [OR 4.6 IC95% 1.8-11.6] remained significantly associated with death due to COVID-19. Figure 1. Factors associated with severe disease and death due to COVID-19 (WHO-OS≥5) in patients with rheumatoid arthritis. Multivariable analysis. (ref.: reference; PDN: prednisone; OR: odds ratio; CI: confidence interval) Conclusion Treatment with RTX and GC, as well as older age, the presence of diabetes and ILD were associated with poor COVID-19 outcomes in this national cohort of patients with RA. Older patients and those taking GC had a higher mortality rate. References [1]World Health Organization coronavirus disease (COVID-19) Therapeutic Trial Synopsis Draft 2020. Disclosure of Interests None declared
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
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    Language: English
    Publisher: BMJ
    Publication Date: 2022
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  • 2
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 81, No. Suppl 1 ( 2022-06), p. 1665.2-1666
    Abstract: 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 inflammatory 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 modification 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 spondyloarthritis (12.3%). Most of them were in remission (28.5%) and low disease activity (41.4%). At the time of vaccination, 21% were receiving glucocorticoid 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 first dose of the vaccine, the most of the patients (51.1%) received Gam-COVID-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 CoronaVac (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 first dose and 15.9% after the second. The flu-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 significantly 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 first 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. Disclosure of Interests None declared
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
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    Language: English
    Publisher: BMJ
    Publication Date: 2022
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  • 3
    In: Naunyn-Schmiedeberg's Archives of Pharmacology, Springer Science and Business Media LLC, Vol. 394, No. 3 ( 2021-03), p. 437-446
    Type of Medium: Online Resource
    ISSN: 0028-1298 , 1432-1912
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 1462940-9
    SSG: 15,3
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  • 4
  • 5
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 81, No. Suppl 1 ( 2022-06), p. 929.1-929
    Abstract: 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 flares 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 defined 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-flu syndrome was the most frequent (11%), followed by injection site reaction (7%). They were significantly more frequent after the first 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 flares reported, 17 (68%) cases of arthritis. Among patients with two doses, those with heterologous 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 significantly 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 inflammatory 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) Figure 1. Variables associated with the development of AE. Multivariate logistic regression model Conclusion The incidence of AE was 1825 events/1000 doses, were significantly higher for mRAN-1273 and ChAdOx1 nCov-19 and lower for BBIBP-CorV. Most common AE was pseudo-flu syndrome. Female sex, being younger, higher education level, ChAdOx1 nCov-19 and mRAN-1273 vaccines, the use of methotrexate and antimalarials were related of EA in patients with RD. References [1]Sattui SE et al. Early experience of COVID-19 vaccination in adults with systemic rheumatic diseases: results from the COVID-19 Global Rheumatology Alliance Vaccine Survey. RMD Open 2021;7. Disclosure of Interests None declared
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
    RVK:
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 1481557-6
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  • 6
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 79, No. Suppl 1 ( 2020-06), p. 750-751
    Abstract: The questionnaire “Assessment of Spondyloarthritis international Society Health Index” (ASAS HI) was developed to measure functionality and health status in patients with spondyloarthritis (SpA) 1 . Objectives: To describe the state of health measured by ASAS HI in Argentinian patients with SpA and to evaluate factors associated with poor health. Methods: Analytical, cross sectional, multicenter study. Patients with SpA according to ASAS criteria were consecutively included from 15 Argentinian centers. Statistical analysis: frequencies and percentages (%), mean and standard deviation (SD) or median and interquartile range (IQR). Bivariate analysis and logistic regression were performed to evaluate the factors associated with poor health status (ASAS HI 〉 or equal to 12). Correlation with other parameters was evaluated by Spearman correlation. Results: We included 274 patients with a mean age 49 (SD 14) years, median disease duration 60 month (IQR 24-135), 155 (56.6%) of patients are male, 47% (n:129) axial SpA and 52.9 (n:145) peripheral SpA. One hundred and nine patients (43.4%) presented good health status, 117 (42.7%) had moderate state of health and 38 (13.9%) had poor health. In the bivariate analyses patients with ASAS health index greater than or equal to 12 (poor status), were older [54 (11) vs 48 (14), p: 0.01], had higher disease duration [11(IQR 57-192) vs 60 (IQR 24-120), p: 0.02] , more hypertension [20 (52.6%) vs 67 (28.4%), p:0.004], more diabetes mellitus [10 (26.3%) vs 22(9.3%), p: 0.006] , depression [6 (15.8%) vs 10 (4.2%), p:0.013], anxiety [8 (21%) vs (22 (9.3%),p:0.046] , less years of education [9.8 (SD 3.5) vs 13 (SD 10), p:0.001], higher ASQol [12.6 (SD 4.6) vs 5.7 (SD4), p 〈 0.001], BASFI [7(SD2) vs 4(SD6), p: 0.001] , DAS28 [4.71 (SD3.2) vs 2.8 (SD1),p: 〈 0.001]. In the multivariate analyses the following variables were independently associated with poor health status: duration of disease, ASQol and DAS28. ASAS HI showed positive correlation with the following parameters: BASDAI (r:0.67, p 〈 0.001), HAQ (r:0.54, p 〈 0.001), ASDAS (r:0.67, p 〈 0.001), ASQol (r:0.80, p 〈 0.001), BASFI (r:0.72, p 〈 0.001) and DAS28 (0.56, p 〈 0.001). Conclusion: Poor health status is associated with disease activity, poor quality of life and functional activity. ASAS HI has a good correlation with other parameters to evaluate SpA, reinforcing the construct validity of this new tool. References: [1]Kiltz U, et al . Ann Rheum Dis 2018; 0 :1–7. Disclosure of Interests: None declared
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
    RVK:
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 1481557-6
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  • 7
    In: JAMA Otolaryngology–Head & Neck Surgery, American Medical Association (AMA), Vol. 143, No. 10 ( 2017-10-01), p. 975-
    Type of Medium: Online Resource
    ISSN: 2168-6181
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2017
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  • 8
    Online Resource
    Online Resource
    FapUNIFESP (SciELO) ; 2006
    In:  Brazilian Journal of Chemical Engineering Vol. 23, No. 4 ( 2006-12), p. 525-530
    In: Brazilian Journal of Chemical Engineering, FapUNIFESP (SciELO), Vol. 23, No. 4 ( 2006-12), p. 525-530
    Type of Medium: Online Resource
    ISSN: 0104-6632
    Language: Unknown
    Publisher: FapUNIFESP (SciELO)
    Publication Date: 2006
    detail.hit.zdb_id: 2028754-9
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  • 9
    Online Resource
    Online Resource
    Elsevier BV ; 2008
    In:  Bone Vol. 43, No. 6 ( 2008-12), p. S131-
    In: Bone, Elsevier BV, Vol. 43, No. 6 ( 2008-12), p. S131-
    Type of Medium: Online Resource
    ISSN: 8756-3282
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2008
    detail.hit.zdb_id: 1496324-3
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  • 10
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 81, No. Suppl 1 ( 2022-06), p. 602-603
    Abstract: The use of biological and targeted synthetic drugs has changed the outcomes of rheumatic diseases. The information on efficacy and safety provided by randomized controlled clinical trials does not always reflect the conditions of patients in real life. Data obtained from prospective registries, over extended periods and with real-world evidence, is a great contribution to the pharmacovigilance of these drugs. Objectives The aim of this study is to describe adverse events (AE) and survival of treatments of patients included in the Argentine Registry of Adverse Events of Biological Therapies and Target Synthetic Drugs (BIOBADASAR 3.0). Methods Observational, prospective and multicenter study of ten years of follow-up in patients with rheumatic diseases treated with original biological drugs, biosimilars or original and generic targeted synthetic therapies in Argentine. Those patients who received biological therapies were considered exposed while non-exposed patients represent the control group. All patients were evaluated at least once a year and whenever they experienced an AE or a change in treatment. Survival of treatments was evaluated by Kaplan Meier curves and the comparison between them was made by Log Rank Test analysis. Results A total of 6010 patients were included and 8810 treatment periods from 56 centers. 79.7% were female, mean age of 43.7 (SD 15.6) years. The most frequently reported rheumatological disease was rheumatoid arthritis (RA) (77.5%), followed by psoriatic arthritis (PsA) (8.2%), systemic lupus erythematosus (SLE) (3.1%), juvenile idiopathic arthritis (JIA) (2.6%) and ankylosing spondylitis (AS) (2.5%). The b-DMARD use frequencies were etanercept in 32.2%, followed by adalimumab in 18.7%, abatacept in 9.7%, certolizumab pegol in 8.7%, tofacitinib in 7.9%, rituximab in 7.3% and tocilizumab in 5.5%. The frequency of AE was 11.7% in the exposed group and 4.9% in controls (p=0.001). Infections were present in 41% in the exposed group vs 34% in controls (p 〈 0.001). AE-free survival was 23 years [IQR: 18.2] in controls vs 10 years [IQR: 8.8] ) in the exposed group p 〈 0.0001). In the multivariate regression model, age (HR: 1.005, 95% CI 1.001-1.009) and corticosteroid treatment (HR: 1.18, 95% CI 1.05-1.34) were associated with a higher risk of AE in exposed patients. Treatment survival was 15 years [IQR: 28] in unexposed group vs 4.7 years [IQR: 10] in exposed patients (p 〈 0.0001). In the multivariate analysis, female sex (HR 1.1, 95% CI 1.09-1.2), older age (HR 1.0, 95% CI: 1.010-1.014), corticosteroid treatment (HR 1.16, 95% CI 1.09-1.2), the diagnosis of systemic lupus erythematosus (HR1.547, CI95%1.3-1.8) and disease duration (HR1.01, CI95%1.008-1.015) were associated with a higher risk of treatment discontinuation while the diagnosis of rheumatoid arthritis (HR 0.83 CI95% 0.75-0.93) was associated with a lower risk of suspension. Conclusion We found that the use of steroids and elderly patients are still being associated with a higher risk of presenting an AE and treatment discontinuing. This could be related to the fact that the use of steroids is frequently associated with active disease or severe conditions. Exposed patients have a lower AE-free survival and a lower treatment survival. This could be since unexposed patients have a longer follow-up time and a longer duration of their disease. This data from real-world Latin American patients of ten years of follow-up are extremely useful for monitoring and pharmacovigilance of biological therapies in patients with rheumatic diseases. References [1]De la Vega M, et al. The importance of rheumatology biologic registries in Latin America. Rheumatol Int. 2013;33(4):827-35. Rocha FA. Latin-American challenges and opportunities in rheumatology. Arthritis Res Ther. 2017;19(1):29. [2]Prior-Español A, et al. Clinical factors associated with discontinuation of ts/bDMARDs in rheumatic patients from the BIOBADASER III registry. Sci Rep. 2021 May 27;11(1):11091. doi: 10.1038/s41598-021-90442-w. PMID: 34045525; PMCID: PMC8159943. Disclosure of Interests None declared
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
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    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 1481557-6
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