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1.
Arthritis Care Res (Hoboken) ; 76(1): 120-130, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37605835

RESUMO

OBJECTIVE: The objective of this study was to assess the SARS-CoV-2-specific humoral and T cell response after a two-dose regimen of SARS-CoV-2 vaccine in patients with rheumatoid arthritis (RA). METHODS: In this observational study, patients with RA who are ≥18 years of age and vaccinated for SARS-CoV-2 according to the Argentine National Health Ministry's vaccination strategy were included. Anti-SARS-CoV-2 immunoglobulin G (IgG) antibodies (ELISA-COVIDAR test), neutralizing activity (cytotoxicity in VERO cells), and specific T cell response (IFN-γ ELISpot Assay) were assessed after the first and second dose. RESULTS: A total of 120 patients with RA were included. Mostly, homologous regimens were used, including Gam-COVID-Vac (27.5%), ChAdOx1 (24.2%), and BBIBP-CorV (22.5%). The most frequent combination was Gam-COVID-Vac/mRNA-1273 (21.7%). After the second dose, 81.7% presented with anti-SARS-CoV-2 antibodies, 70.0% presented with neutralizing activity, and 65.3% presented with specific T cell response. The use of BBIBP-CorV and treatment with abatacept (ABA) and rituximab (RTX) were associated with undetectable antibodies and no neutralizing activity after two doses. BBIBP-CorV was also associated with the absence of T cell response. The total incidence of adverse events was 357.1 events per 1,000 doses, significantly lower with BBIBP-CorV (166.7 events per 1,000 doses, P < 0.02). CONCLUSION: In this RA cohort vaccinated with homologous and heterologous regimens against COVID-19, 2 out of 10 patients did not develop anti-SARS-CoV-2 IgG, 70% presented with neutralizing activity, and 65% presented with specific T cell response. The use of BBIBP-CorV was associated with deficient humoral and cellular response, whereas treatment with ABA and RTX resulted in an impaired anti-SARS-CoV-2 IgG formation and neutralizing activity.


Assuntos
Artrite Reumatoide , COVID-19 , Chlorocebus aethiops , Animais , Humanos , Vacinas contra COVID-19 , SARS-CoV-2 , Células Vero , COVID-19/prevenção & controle , Linfócitos T , Artrite Reumatoide/tratamento farmacológico , Abatacepte , Rituximab , Vacinação , Anticorpos Antivirais , Imunoglobulina G
2.
Arthritis Care Res (Hoboken) ; 76(2): 274-287, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37643903

RESUMO

OBJECTIVE: Approximately one third of individuals worldwide have not received a COVID-19 vaccine. Although studies have investigated risk factors linked to severe COVID-19 among unvaccinated people with rheumatic diseases (RDs), we know less about whether these factors changed as the pandemic progressed. We aimed to identify risk factors associated with severe COVID-19 in unvaccinated individuals in different pandemic epochs corresponding to major variants of concern. METHODS: Patients with RDs and COVID-19 were entered into the COVID-19 Global Rheumatology Alliance Registry between March 2020 and June 2022. An ordinal logistic regression model (not hospitalized, hospitalized, and death) was used with date of COVID-19 diagnosis, age, sex, race and/or ethnicity, comorbidities, RD activity, medications, and the human development index (HDI) as covariates. The main analysis included all unvaccinated patients across COVID-19 pandemic epochs; subanalyses stratified patients according to RD types. RESULTS: Among 19,256 unvaccinated people with RDs and COVID-19, those who were older, male, had more comorbidities, used glucocorticoids, had higher disease activity, or lived in lower HDI regions had worse outcomes across epochs. For those with rheumatoid arthritis, sulfasalazine and B-cell-depleting therapy were associated with worse outcomes, and tumor necrosis factor inhibitors were associated with improved outcomes. In those with connective tissue disease or vasculitis, B-cell-depleting therapy was associated with worse outcomes. CONCLUSION: Risk factors for severe COVID-19 outcomes were similar throughout pandemic epochs in unvaccinated people with RDs. Ongoing efforts, including vaccination, are needed to reduce COVID-19 severity in this population, particularly in those with medical and social vulnerabilities identified in this study.


Assuntos
COVID-19 , Doenças Reumáticas , Reumatologia , Humanos , Masculino , Pandemias , Vacinas contra COVID-19/uso terapêutico , Teste para COVID-19 , COVID-19/epidemiologia , Doenças Reumáticas/diagnóstico , Doenças Reumáticas/tratamento farmacológico , Doenças Reumáticas/epidemiologia , Fatores de Risco , Sistema de Registros
4.
J Clin Rheumatol ; 30(1): e9-e17, 2024 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-37936271

RESUMO

OBJECTIVE: To describe characteristics of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in patients with rheumatic immune-mediated inflammatory diseases (IMIDs) from Argentina, Mexico and Brazil, and to assess factors associated with mortality in this population. METHODS: Data from 3 national registries, SAR-COVID (Argentina), CMR-COVID (Mexico), and ReumaCoV-Brasil (Brazil), were combined. Adult patients with IMIDs and SARS-CoV-2 infection were recruited. Sociodemographic data, comorbidities, IMID clinical characteristics and treatment, and SARS-CoV-2 infection presentation and outcomes were recorded. RESULTS: A total of 4827 individuals were included: 2542 (52.7%) from SAR-COVID, 1167 (24.2%) from CMR-COVID, and 1118 (23.1%) from ReumaCoV-Brasil. Overall, 82.1% were female with a mean age of 49.7 (SD, 14.3) years; 22.7% of the patients were hospitalized, and 5.3% died because of COVID-19 (coronavirus disease 2019). Argentina and Brazil had both 4% of mortality and Mexico 9.4%. In the multivariable analysis, older age (≥60 years; odds ratio [OR], 7.4; 95% confidence interval [CI], 4.6-12.4), male sex (OR, 1.5; 95% CI, 1.1-2.1), living in Mexico (OR, 3.0; 95% CI, 2.0-4.4), comorbidity count (1 comorbidity: OR, 1.5; 95% CI, 1.0-2.1), diagnosis of connective tissue disease or vasculitis (OR, 1.8; 95% CI, 1.3-2.4), and other diseases (OR, 2.6; 95% CI, 1.6-4.1) compared with inflammatory joint disease, high disease activity (OR, 4.2; 95% CI, 2.5-7.0), and treatment with glucocorticoids (OR, 1.9; 95% CI, 1.4-2.5) or rituximab (OR, 4.2; 95% CI, 2.7-6.6) were associated with mortality. CONCLUSIONS: Mortality in patients with IMIDs was particularly high in Mexicans. Ethnic, environmental, societal factors, and different COVID-19 mitigation measures adopted have probably influenced these results.


Assuntos
COVID-19 , Doenças Reumáticas , Adulto , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , SARS-CoV-2 , México/epidemiologia , América Latina , Argentina/epidemiologia , Brasil/epidemiologia , Doenças Reumáticas/epidemiologia , Agentes de Imunomodulação
5.
Rev. argent. reumatolg. (En línea) ; 34(1): 3-15, ene. 2023. tab
Artigo em Espanhol | BINACIS, LILACS | ID: biblio-1449435

RESUMO

Introducción: conocer la seguridad de las drogas actualmente disponibles para el tratamiento de las enfermedades reumáticas es muy importante al momento de tomar decisiones terapéuticas objetivas e individualizadas en la consulta médica diaria. Asimismo, datos de la vida real amplían el conocimiento revelado por los ensayos clínicos. Objetivos: describir los eventos adversos (EA) reportados, estimar su frecuencia e identificar los factores relacionados con su desarrollo. Materiales y métodos: se utilizaron datos BIOBADASAR, un registro voluntario y prospectivo de seguimiento de EA de tratamientos biológicos y sintéticos dirigidos en pacientes con enfermedades reumáticas inmunomediadas. Los pacientes son seguidos hasta la muerte, pérdida de seguimiento o retiro del consentimiento informado. Para este análisis se extrajeron datos recopilados hasta el 31 de enero de 2023. Resultados: se incluyó un total de 6253 pacientes, los cuales aportaron 9533 ciclos de tratamiento, incluyendo 3647 (38,3%) ciclos sin drogas modificadoras de la enfermedad biológicas y sintéticas dirigidas (DME-b/sd) y 5886 (61,7%) con DME-b/sd. Dentro de estos últimos, los más utilizados fueron los inhibidores de TNF y abatacept. Se reportaron 5890 EA en un total de 2701 tratamientos (844 y 1857 sin y con DME-b/sd, respectivamente), con una incidencia de 53,9 eventos cada 1000 pacientes/año (IC 95% 51,9-55,9). La misma fue mayor en los ciclos con DME-b/sd (71,1 eventos cada 1000 pacientes/año, IC 95% 70,7-77,5 versus 33,7, IC 95% 31,5-36,1; p<0,001). Las infecciones, particularmente las de la vía aérea superior, fueron los EA más frecuentes en ambos grupos. El 10,9% fue serio y el 1,1% provocó la muerte del paciente. El 18,7% de los ciclos con DME-b/sd fue discontinuado a causa de un EA significativamente mayor a lo reportado en el otro grupo (11,5%; p<0,001). En el análisis ajustado, las DME-b/sd se asociaron a mayor riesgo de presentar al menos un EA (HR 1,82, IC 95% 1,64-1,96). De igual manera, la mayor edad, el mayor tiempo de evolución, el antecedente de enfermedad pulmonar obstructiva crónica, el diagnóstico de lupus eritematoso sistémico y el uso de corticoides se asociaron a mayor riesgo de EA. Conclusiones: la incidencia de EA fue significativamente superior durante los ciclos de tratamientos que incluían DME-b/sd.


Introduction: knowing the efficacy and safety of the drugs currently available for the treatment of rheumatic diseases is very important when making objective and individualized therapeutic decisions in daily medical consultation. Likewise, real-life data extends the knowledge revealed by clinical trials. Objectives: to describe the reported adverse events (AEs), estimate their frequency and identify factors associated to them. Materials and methods: BIOBADASAR data were used, which is a voluntary, prospective follow-up registry of AEs of biological and synthetic treatments in patients with immune-mediated rheumatic diseases. Patients are followed until death, loss of followup, or withdrawal of informed consent. To carry out this analysis, the data collected up to January 31, 2023 was extracted. Results: a total of 6253 patients were included, who contributed with 9533 treatment periods, including 3647 (38.3%) periods without b/ts-DMARDs and 5886 (61.7%) with b/ts-DMARDs. Among the latter, the most used were TNF inhibitors and abatacept. A total of 5890 AEs were reported in a total of 2701 treatments (844 and 1857 without and with b/ts-DMARDs, respectively), with an incidence of 53.9 events per 1000 patients/ year (95% CI 51.9-55.9). It was higher during the periods with b/ts-DMARDs (71.1 events per 1000 patients/year, 95% CI 70.7-77.5 vs 33.7, 95% CI 31.5-36.1, p<0.001). Infections, particularly those of the upper respiratory tract, were the most frequent AEs in both groups. 10.9% were severe and 1.1% were associated with the death of the patient. 18.7% of the periods with b/ts-DMARDs were discontinued due to an AE, significantly higher than that reported in the other group (11.5%; p<0.001). In the adjusted analysis, b/ts-DMARDs were associated with a higher risk of presenting at least one AE (HR 1.82, 95% CI 1.64-1.96). Similarly, older age, longer evolution time, history of chronic obstructive pulmonary disease, diagnosis of systemic lupus erythematosus, and use of corticosteroids were associated with a higher risk of AE. Conclusions: the incidence of AEs was significantly higher during those treatment periods that included DME-b/sd.


Assuntos
Terapia Biológica , Terapia de Alvo Molecular , Medicamentos Sintéticos
6.
J Clin Rheumatol ; 29(2): 68-77, 2023 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-36454054

RESUMO

BACKGROUND/OBJECTIVE: This study describes the impact of immunomodulatory and/or immunosuppressive (IM/IS) drugs in the outcomes of COVID-19 infection in a cohort of patients with immune-mediated inflammatory diseases (IMIDs). METHODS: Adult patients with IMIDs with a confirmed SARS-CoV-2 infection were included. Data were reported by the treating physician between August 13, 2020 and July 31, 2021. Sociodemographic data, comorbidities, and DMARDs, as well as clinical characteristics, complications, and treatment of the SARS-CoV-2 infection, were recorded. Descriptive analysis and multivariable logistic regression models were carried out. RESULTS: A total of 1672 patients with IMIDs were included, of whom 1402 were treated with IM/IS drugs. The most frequent diseases were rheumatoid arthritis (47.7%) and systemic lupus erythematosus (18.4%). COVID-19 symptoms were present in 95.2% of the patients. A total of 461 (27.6%) patients were hospitalized, 8.2% were admitted to the intensive care unit, and 4.4% died due to COVID-19.Patients without IM/IS treatment used glucocorticoids less frequently but at higher doses, had higher levels of disease activity, were significantly older, were more frequently hospitalized, admitted to the intensive care unit, and died due to COVID-19. After adjusting for these factors, treatment with IM/IS drugs was not associated with a worse COVID-19 outcome (World Health Organization-Ordinal Scale ≥5) (odds ratio, 1.24; 95% confidence interval, 0.73-2.06). CONCLUSIONS: SAR-COVID is the first multicenter Argentine registry collecting data from patients with rheumatic diseases and SARS-CoV-2 infection. After adjusting for relevant covariates, treatment with IM/IS drugs was not associated with severe COVID-19 in patients with IMIDs. STUDY REGISTRATION: This study has been registered in ClinicalTrials.gov under the number NCT04568421.


Assuntos
Artrite Reumatoide , COVID-19 , Adulto , Humanos , COVID-19/complicações , SARS-CoV-2 , Agentes de Imunomodulação , Artrite Reumatoide/tratamento farmacológico , Imunossupressores/uso terapêutico , Sistema de Registros
7.
Clin Rheumatol ; 42(2): 563-578, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36201124

RESUMO

BACKGROUND/OBJECTIVE: This study aims to describe the course and to identify poor prognostic factors of SARS-CoV-2 infection in patients with rheumatic diseases. METHODS: Patients ≥ 18 years of age, with a rheumatic disease, who had confirmed SARS-CoV-2 infection were consecutively included by major rheumatology centers from Argentina, in the national, observational SAR-COVID registry between August 13, 2020 and July 31, 2021. Hospitalization, oxygen requirement, and death were considered poor COVID-19 outcomes. RESULTS: A total of 1915 patients were included. The most frequent rheumatic diseases were rheumatoid arthritis (42%) and systemic lupus erythematosus (16%). Comorbidities were reported in half of them (48%). Symptoms were reported by 95% of the patients, 28% were hospitalized, 8% were admitted to the intensive care unit (ICU), and 4% died due to COVID-19. During hospitalization, 9% required non-invasive mechanical ventilation (NIMV) or high flow oxygen devices and 17% invasive mechanical ventilation (IMV). In multivariate analysis models, using poor COVID-19 outcomes as dependent variables, older age, male gender, higher disease activity, treatment with glucocorticoids or rituximab, and the presence of at least one comorbidity and a greater number of them were associated with worse prognosis. In addition, patients with public health insurance and Mestizos were more likely to require hospitalization. CONCLUSIONS: In addition to the known poor prognostic factors, in this cohort of patients with rheumatic diseases, high disease activity, and treatment with glucocorticoids and rituximab were associated with worse COVID-19 outcomes. Furthermore, patients with public health insurance and Mestizos were 44% and 39% more likely to be hospitalized, respectively. STUDY REGISTRATION: This study has been registered in ClinicalTrials.gov under the number NCT04568421. Key Points • High disease activity, and treatment with glucocorticoids and rituximab were associated with poor COVID-19 outcome in patients with rheumatic diseases. • Some socioeconomic factors related to social inequality, including non-Caucasian ethnicity and public health insurance, were associated with hospitalization due to COVID-19.


Assuntos
COVID-19 , Doenças Reumáticas , Feminino , Humanos , Masculino , COVID-19/complicações , Glucocorticoides/uso terapêutico , Hospitalização , Sistema de Registros , Doenças Reumáticas/complicações , Doenças Reumáticas/epidemiologia , Doenças Reumáticas/tratamento farmacológico , Rituximab/uso terapêutico , SARS-CoV-2 , Adolescente , Adulto , Estudos Observacionais como Assunto
8.
Rheumatology (Oxford) ; 62(4): 1621-1626, 2023 04 03.
Artigo em Inglês | MEDLINE | ID: mdl-36124987

RESUMO

OBJECTIVE: To describe obstetric outcomes based on COVID-19 vaccination status, in women with rheumatic and musculoskeletal diseases (RMDs) who developed COVID-19 during pregnancy. METHODS: Data regarding pregnant women entered into the COVID-19 Global Rheumatology Alliance registry from 24 March 2020-25 February 2022 were analysed. Obstetric outcomes were stratified by number of COVID-19 vaccine doses received prior to COVID-19 infection in pregnancy. Descriptive differences between groups were tested using the chi-squared or Fisher's exact test. RESULTS: There were 73 pregnancies in 73 women with RMD and COVID-19. Overall, 24.7% (18) of pregnancies were ongoing, while of the 55 completed pregnancies, 90.9% (50) of pregnancies resulted in livebirths. At the time of COVID-19 diagnosis, 60.3% (n = 44) of women were unvaccinated, 4.1% (n = 3) had received one vaccine dose while 35.6% (n = 26) had two or more doses. Although 83.6% (n = 61) of women required no treatment for COVID-19, 20.5% (n = 15) required hospital admission. COVID-19 resulted in delivery in 6.8% (n = 3) of unvaccinated women and 3.8% (n = 1) of fully vaccinated women. There was a greater number of preterm births (PTB) in unvaccinated women compared with fully vaccinated 29.5% (n = 13) vs 18.2% (n = 2). CONCLUSIONS: In this descriptive study, unvaccinated pregnant women with RMD and COVID-19 had a greater number of PTB compared with those fully vaccinated against COVID-19. Additionally, the need for COVID-19 pharmacological treatment was uncommon in pregnant women with RMD regardless of vaccination status. These results support active promotion of COVID-19 vaccination in women with RMD who are pregnant or planning a pregnancy.


Assuntos
COVID-19 , Nascimento Prematuro , Doenças Reumáticas , Gravidez , Recém-Nascido , Feminino , Humanos , Vacinas contra COVID-19 , COVID-19/epidemiologia , COVID-19/prevenção & controle , Teste para COVID-19 , Doenças Reumáticas/tratamento farmacológico , Vacinação
9.
J Rheumatol ; 49(12): 1385-1389, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36182107

RESUMO

OBJECTIVE: The aim of this study was to assess the immune response after a third dose of SARS-CoV-2 vaccine in patients with rheumatoid arthritis (RA) with undetectable antibody titers after the primary regimen of 2 doses. METHODS: Patients with RA with no seroconversion after 2 doses of SARS-CoV-2 vaccine and who received a third dose of either an mRNA or vector-based vaccine were included. Anti-SARS-CoV-2 IgG antibodies, neutralizing activity, and T cell responses were assessed after the third dose. RESULTS: A total of 21 nonresponder patients were included. At the time of vaccination, 29% were receiving glucocorticoids and 85% biologic disease-modifying antirheumatic drugs (including 6 taking abatacept [ABA] and 4 taking rituximab [RTX]). The majority (95%) received the BNT162b2 vaccine and only one of them received the ChAdOx1 nCoV-19 vaccine. After the third dose, 91% of the patients presented detectable anti-SARS-CoV-2 IgG and 76% showed neutralizing activity. Compared to other treatments, ABA and RTX were associated with the absence of neutralizing activity in 4 out of 5 (80%) patients and lower titers of neutralizing antibodies (median 3, IQR 0-20 vs 8, IQR 4-128; P = 0.20). Specific T cell response was detected in 41% of all patients after the second dose, increasing to 71% after the third dose. The use of ABA was associated with a lower frequency of T cell response (33% vs 87%, P = 0.03). CONCLUSION: In this RA cohort, 91% of patients who failed to seroconvert after 2 doses of SARS-CoV-2 vaccine presented detectable anti-SARS-CoV-2 IgG after a third dose. The use of ABA was associated with a lower frequency of specific T cell response.


Assuntos
Artrite Reumatoide , COVID-19 , Vacinas , Humanos , Vacinas contra COVID-19 , ChAdOx1 nCoV-19 , Vacina BNT162 , COVID-19/prevenção & controle , SARS-CoV-2 , Artrite Reumatoide/tratamento farmacológico , Abatacepte , Imunoglobulina G , Vacinação , Rituximab , Anticorpos Antivirais , Imunidade
10.
Rev. argent. reumatolg. (En línea) ; 33(4): 188-198, oct. 2022. tab, graf
Artigo em Espanhol | LILACS, BINACIS | ID: biblio-1449423

RESUMO

Introducción: el lupus eritematoso sistémico (LES) es una enfermedad sistémica que se ha asociado a mayor severidad con la infección por SARS-CoV-2. Particularmente la alta actividad de la enfermedad y algunos inmunosupresores se han vinculado a peores desenlaces. Objetivos: describir las características por SARS-CoV-2 en pacientes con LES en Argentina del registro SAR-COVID y establecer los factores asociados a peor desenlace de la misma. Materiales y métodos: estudio observacional. Se incluyeron pacientes con diagnóstico de LES con infección confirmada por SARS-CoV-2 (RT-PCR y/o serología positiva) del registro SAR-COVID. Los datos se recolectaron desde agosto de 2020 hasta marzo de 2022. El desenlace de la infección se midió mediante la escala ordinal de la Organización Mundial de la Salud (EO-OMS). Se definió COVID-19 severo con un valor EO-OMS ≥5. Análisis descriptivo, test T de Student, test de Mann Whitney U, ANOVA, chi2 y Fisher. Regresión logística múltiple. Resultados: se incluyeron 399 pacientes, el 93% de sexo femenino, con una edad media de 40,9 años (DE 12,2). El 39,6% tenía al menos una comorbilidad. Al momento de la infección, el 54,9% recibía glucocorticoides, el 30,8% inmunosupresores y el 3,3% agentes biológicos. La infección por SARS-CoV-2 fue leve en la mayoría de los casos, mientras que un 4,6% tuvo curso severo y/o falleció. Estos últimos presentaban comorbilidades, usaban glucocorticoides y tenían síndrome antifosfolipídico (SAF) con mayor frecuencia y mayor actividad de la enfermedad al momento de la infección. En el análisis multivariado, la hipertensión arterial, el diagnóstico de SAF y el uso de glucocorticoides se asociaron a hospitalización severa y/o muerte por COVID-19 (EO-OMS ≥5). Conclusiones: en esta cohorte de pacientes con LES con infección por SARS-CoV-2 confirmada, la mayoría cursó de manera sintomática, un 22,1% fue hospitalizado y un 5% requirió ventilación mecánica. La mortalidad fue cercana al 3%. El diagnóstico de SAF, tener hipertensión arterial y el uso de glucocorticoides se asociaron significativamente con COVID-19 severo.


Introduction: systemic lupus erythematosus (SLE) is a systemic disease that has been associated with greater severity with SARS-CoV-2 infection. Particularly high disease activity and some immunosuppressants have been linked to worse outcomes. Objectives: to describe the characteristics due to SARS-CoV-2 in patients with SLE in Argentina from the SAR-COVID registry and to establish the factors associated with a worse outcome of the same. Materials and methods: observational study. Patients diagnosed with SLE with confirmed SARS-CoV-2 infection (RT-PCR and/or positive serology) from the SAR-COVID registry were included. Data was collected from August 2020 to March 2022. The outcome of the infection was measured using the World Health Organization - ordinal scale (WHO-OS). Severe COVID-19 was defined as an WHO-OS value ≥5. Descriptive analysis, Student's T test, Mann Whitney U, ANOVA, chi2 and Fisher. Multiple logistic regression. Results: a total of 399 patients were included, 93% female, with a mean age of 40.9 years (SD 12.2), 39.6% had at least one comorbidity. At the time of infection, 54.9% were receiving glucocorticoids, 30.8% immunosuppressants, and 3.3% biological agents. SARS-CoV-2 infection was mild in most cases, while 4.6% had a severe course and/or died. The latter had comorbidities, used glucocorticoids and had antiphospholipid syndrome (APS) more frequently and higher disease activity at the time of infection. In the multivariate analysis, high blood pressure, the diagnosis of APS, and the use of glucocorticoids were associated with severe hospitalization and/or death from COVID-19 (WHO-EO ≥5). Conclusions: in this cohort of SLE patients with confirmed SARS-CoV-2 infection, most had a symptomatic course, 22.1% were hospitalized, and 5% required mechanical ventilation. Mortality was close to 3%. The diagnosis of APS, having high blood pressure, and the use of glucocorticoids were significantly associated with severe COVID-19.


Assuntos
Pandemias
11.
Rev. argent. reumatolg. (En línea) ; 33(4): 205-214, oct. 2022. tab, graf
Artigo em Espanhol | LILACS, BINACIS | ID: biblio-1449425

RESUMO

Introducción: los pacientes con artritis psoriásica (APs) presentan más comorbilidades. Las guías del Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) establecen lineamientos para los tratamientos de acuerdo a ellas. Objetivos: describir la prevalencia de comorbilidades en pacientes con APs según el Rheumatic Disease Comorbidity Index (RDCI), analizar el efecto sobre la enfermedad y estudiar la adherencia a las guías GRAPPA. Materiales y métodos: estudio observacional. Se incluyeron pacientes con APs de la cohorte RAPSODIA. Se reportaron características sociodemográficas y clínicas. Las comorbilidades se valoraron por RDCI. Se estudiaron variables asociadas a RDCI ≥1 mediante análisis multivariado. Se analizó el cumplimiento de las recomendaciones de tratamiento en relación a las comorbilidades según las guías GRAPPA. Resultados: se incluyeron 170 pacientes. El 67,6% presentó al menos una comorbilidad (RDCI ≥1); estos eran de mayor edad (X 57,3±12,7 años vs. 48,2±13,2 años; p<0,0001), presentaban más sobrepeso u obesidad (84,3% vs. 67,3%; p=0,011) y peor calidad de vida (PsAQoL X 7,6±6,6 vs. 5,2±6; p=0,025). El análisis multivariado evidenció asociación de la edad y el uso de antiinflamatorios no esteroideos (AINEs) con RDCI ≥1. Contrariamente a las recomendaciones de GRAPPA, el 70% de los pacientes con cardiopatía utilizaba AINEs, y la mitad de aquellos con enfermedades hepáticas o renales tomaba AINEs o metotrexato. Conclusiones: la prevalencia de comorbilidades en los pacientes con APs es alta. En algunos casos no se cumplían las recomendaciones de tratamiento en relación a las comorbilidades.


Introduction: comorbidities are common in patients with psoriatic arthritis (PsA). The GRAPPA (Group for Research and Assessment of Psoriasis and Psoriatic Arthritis) guidelines strengthen the choice of treatments according to them. Objetives: to describe the prevalence of comorbidities in patients with psoriatic arthritis according to Rheumatic Disease Comorbidity Index (RDCI) and to analyze the influence of them on disease activity, functional capacity and quality life and to assess adherence to GRAPPA 2015 treatment recommendations according to the presence of comorbidities. Materials and methods: adult patients with PsA (CASPAR criteria) from the RAPSODIA cohort were included. Sociodemographic and clinical characteristics, disease activity and current treatment were recorded. Comorbidities were assessed by the RDCI. Variables associated with RDCI≥1 were studied by multivariate analysis. Adherence to treatment recommendations in relation to the reported comorbidities was analyzed according to the 2015 GRAPPA guidelines. Results: a total of 170 patients were included. Patients with RDCI ≥1 were reported by 67.6%. These patients were older (57±13 years vs 48±13 years, p<0.0001), had a higher frequency of overweight or obesity (84.3% vs 67.3%, p=0.011), and had a poorer quality of life (PsAQoL 7.6±6.6 vs 5.2±6, p=0.025). The multivariate analysis showed an association between age and the use of NSAIDs with RDCI≥1. Contrary to GRAPPA recommendations, 70% of patients with heart disease were using NSAIDs. Moreover, about half of those with hepatic or kidney disease took NSAIDs or methotrexate. Conclusions: most patients with PsA presented at least one comorbidity. GRAPPA recommendations were not followed in a considerable number of patients.

12.
ACR Open Rheumatol ; 4(10): 872-882, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-35869686

RESUMO

OBJECTIVE: Some patients with rheumatic diseases might be at higher risk for coronavirus disease 2019 (COVID-19) acute respiratory distress syndrome (ARDS). We aimed to develop a prediction model for COVID-19 ARDS in this population and to create a simple risk score calculator for use in clinical settings. METHODS: Data were derived from the COVID-19 Global Rheumatology Alliance Registry from March 24, 2020, to May 12, 2021. Seven machine learning classifiers were trained on ARDS outcomes using 83 variables obtained at COVID-19 diagnosis. Predictive performance was assessed in a US test set and was validated in patients from four countries with independent registries using area under the curve (AUC), accuracy, sensitivity, and specificity. A simple risk score calculator was developed using a regression model incorporating the most influential predictors from the best performing classifier. RESULTS: The study included 8633 patients from 74 countries, of whom 523 (6%) had ARDS. Gradient boosting had the highest mean AUC (0.78; 95% confidence interval [CI]: 0.67-0.88) and was considered the top performing classifier. Ten predictors were identified as key risk factors and were included in a regression model. The regression model that predicted ARDS with 71% (95% CI: 61%-83%) sensitivity in the test set, and with sensitivities ranging from 61% to 80% in countries with independent registries, was used to develop the risk score calculator. CONCLUSION: We were able to predict ARDS with good sensitivity using information readily available at COVID-19 diagnosis. The proposed risk score calculator has the potential to guide risk stratification for treatments, such as monoclonal antibodies, that have potential to reduce COVID-19 disease progression.

13.
Clin Rheumatol ; 41(10): 3199-3209, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-35760939

RESUMO

BACKGROUND/OBJECTIVE: To evaluate the efficacy and safety of SARS-CoV-2 vaccine in patients with rheumatic and immune-mediated inflammatory diseases (IMIDs) in Argentina: the SAR-CoVAC registry. METHODS: SAR-CoVAC is a national, multicenter, and observational registry. Adult patients with rheumatic or IMIDs vaccinated for SARS-CoV-2 were consecutively included between June 1 and September 17, 2021. Sociodemographic data, comorbidities, underlying rheumatic or IMIDs, treatments received, their modification prior to vaccination, and history of SARS-CoV-2 infection were recorded. In addition, date and place of vaccination, type of vaccine applied, scheme, adverse events (AE), disease flares, and new immune-mediated manifestations related to the vaccine were analyzed. 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%) or 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 (DMARD), and 5.4% JAK inhibitors. In total, 16.9% had SARS-CoV-2 infection before the first vaccine dose. Most patients (51.1%) received Gam-COVID-Vac as the first vaccine dose, followed by ChAdOx1 nCoV-19 (32.8%) and BBIBP-CorV (14.5%). Half of them (48.8%) were fully vaccinated with 2 doses; 12.5% received combined schemes, being the most frequent Gam-COVID-Vac/mRAN-1273. The median time between doses was 51 days (IQR 53). After the first dose, 25.9% of the patients reported at least one AE and 15.9% after the second, being flu-like syndrome and local hypersensitivity the most frequent manifestations. There was one case of anaphylaxis. Regarding efficacy, 63 events of SARS-CoV-2 infection were reported after vaccination, 19% occurred during the first 14 days post-vaccination, 57.1% after the first dose, and 23.8% after the second. Most cases (85.9%) were asymptomatic or mild and 2 died due to COVID-19. CONCLUSIONS: In this national cohort of patients, the most common vaccines used were Gam-COVID-Vac and ChAdOx1 nCoV-19. A quarter of the patients presented an AE and 5.1% presented SARS-CoV-2 infection after vaccination, in most cases mild. STUDY REGISTRATION: This study has been registered in ClinicalTrials.gov under the number: NCT04845997. Key Points • This study shows real-world data about efficacy and safety of SARS-CoV-2 vaccination in patients with rheumatic and immune-mediated inflammatory diseases. Interestingly, different types of vaccines were used including vector-based, mRNA, and inactivated vaccines, and mixed regimens were enabled. • A quarter of the patients presented an adverse event. The incidence of adverse events was significantly higher in those receiving mRAN-1273 and ChAdOx1 nCoV-19. • In this cohort, 5.1% presented SARS-CoV-2 infection after vaccination, in most cases mild.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Adulto , Idoso , Antirreumáticos/uso terapêutico , Argentina/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , ChAdOx1 nCoV-19 , Feminino , Glucocorticoides , Humanos , Inibidores de Janus Quinases , Masculino , Metotrexato , Pessoa de Meia-Idade , Dados Preliminares , RNA Mensageiro , Sistema de Registros , SARS-CoV-2 , Vacinação , Vacinas de Produtos Inativados
14.
Rev. argent. reumatolg. (En línea) ; 33(2): 67-75, abr. - jun. 2022. ilus
Artigo em Espanhol | LILACS, BINACIS | ID: biblio-1393386

RESUMO

Introducción: en el contexto de la pandemia por SARS-CoV-2, la Sociedad Argentina de Reumatología (SAR) organizó su congreso "híbrido" (presencial y virtual), en diciembre de 2021, en concordancia con la condición epidemiológica. El objetivo principal de este trabajo fue describir la frecuencia de nuevos casos de infección luego de asistir al Congreso y la opinión de los médicos sobre los aspectos de bioseguridad del evento, y como objetivo secundario, analizar las características de los asistentes durante la pandemia por SARS-CoV-2. Materiales y métodos: estudio transversal a través de una encuesta online, autoadministrada y anónima. Se encuestaron a los concurrentes (médicos y no médicos) al Congreso (presencial o virtual). La primera encuesta fue al momento de la inscripción y la segunda luego de 14 días de culminado, solo para los médicos. Se realizó un análisis descriptivo de los resultados. Resultados: 1.322 individuos se inscribieron al Congreso; 1.039 (98,9%) eran médicos. 1.051 (79,5%) completaron la primera encuesta y 501 (48,2%) contestaron la segunda. Mientras 428 (85,4%) asistieron presencialmente, la virtualidad la eligieron aquellos con más años de ejercicio (p=0,023), con comorbilidades (p=0,03) y quienes tuvieron una internación previa por SARS-CoV-2 (p=0,05). Del total, 1.028 (97,8%) estaban vacunados. El 84,6% tuvo una opinión favorable sobre la modalidad "híbrida". Cinco (1,2%) presentaron síntomas de infección por SARS-CoV-2 y tres (0,7%) tuvieron confirmación diagnóstica. Conclusiones: cinco personas registraron la infección sintomática después del evento. Las medidas de bioseguridad tomadas fueron las aconsejadas por el Ministerio de Salud de la Nación y la opinión de los médicos sobre las mismas fueron favorables.


Introduction: in the context of the pandemic due to SARS-CoV-2, the Argentine Society of Rhematology organized its "hybrid" congress (face-to-face and virtual), on December 2021, in accordance with the epidemiological condition. The main objective of this work was to describe the frequency of new cases of infection after attending the Congress and the opinion of doctors on the biosafety aspects of the event, and as a secondary objective, to analyze the characteristics of those attending the Congress during the pandemic. by SARS-CoV-2. Materials and methods: cross-sectional study, through an online, self-administered and anonymous survey. The attendees (physician and non- physician) to the congress (face-to-face or virtual) were surveyed. The first survey was at the time of registration and the second after 14 days of finish, only for physicians. A descriptive analysis of the results was performed. Results: 1,322 subjects registered for Congress; 1,039 (98.9%) were physicians. 1,051 (79.5%) completed the first survey and 501 (48.2%) answered the second. While 428 (85.4%) attended in person, virtuality was chosen by those with more years of practice (p=0.023), with comorbidities (p=0.03) and those who had a previous hospitalization for SARS-CoV-2 (p =0.05). Of the total, 1,028 (97.8%) were vaccinated. 84.6% had a favorable opinion about the "hybrid" modality. Five (1.2%) presented symptoms of SARS-CoV-2 infection and three (0.7%) had diagnostic confirmation. Conclusions: five subjects had symptoms and three confirmed infections. The biosafety measures taken were those recommended by the Ministry of Health and the opinion of the colleagues about them was favorable.


Assuntos
COVID-19 , Reumatologia , Congresso
15.
Rheumatol Int ; 42(8): 1331-1339, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-34420067

RESUMO

Rheumatoid arthritis (RA) was significantly associated with increased overall risk of periodontitis, both chronic, inflammatory pathologies leading to connective tissue breakdown and bone destruction. To identify clinical and/or serological variables routinely evaluated during follow-up of people with RA which are associated with the severity of their periodontal disease. An observational, cross-sectional study was carried out, which included RA patients according to ACR/EULAR 2010 criteria having chronic periodontal disease. RA clinical parameters (disease duration, erythrocyte sedimentation rate, serum C-reactive protein, disease activity (DAS28) and rheumatoid factor, presence of bone erosions and rheumatic nodules) and also corticosteroid therapy were considered. Periodontitis was evaluated according to the American Academy of Periodontology (1999) and chronic periodontitis was assessed by full mouth periapical radiographic examination, periodontal probing depth, clinical attachment level and bleeding index. A total of 110 subjects with RA and chronic periodontitis were included. The female/male relation was 5.1, and no significant differences between genres were found in rheumatic or oral variables. RA patients with longer disease duration, higher disease activity and with rheumatic nodules had significantly greater periodontitis severity. Multivariate analysis confirmed that severe periodontitis was associated with DAS283 4.1 (OR 51.4, CI 95% 9.4-281.5) and the presence of rheumatic nodules (OR 6.4, CI 95% 1.3-31.6). Disease activity and rheumatic nodules were strongly associated with severe periodontitis. Based on these findings it would be desirable to include interdisciplinary management at an early stage of RA to ensure comprehensive treatment of both pathologies.


Assuntos
Artrite Reumatoide , Periodontite Crônica , Nódulo Reumático , Artrite Reumatoide/complicações , Artrite Reumatoide/tratamento farmacológico , Periodontite Crônica/complicações , Periodontite Crônica/terapia , Estudos Transversais , Feminino , Humanos , Masculino , Nódulo Reumático/complicações , Fator Reumatoide
16.
Rev. argent. reumatolg. (En línea) ; 32(4): 2-11, dic. 2021. ilus, tab
Artigo em Espanhol | LILACS, BINACIS | ID: biblio-1376438

RESUMO

Introducción: la artritis reumatoidea (AR) y los tratamientos indicados para su manejo pueden afectar la respuesta a la vacuna para SARS-CoV-2. Sin embargo, aún no se cuenta con datos locales. Objetivos: evaluar la respuesta humoral de la vacuna para SARS-CoV-2 y su seguridad en esta población. Materiales y métodos: estudio observacional. Se incluyeron pacientes ≥18 años, con AR ACR/EULAR 2010 que recibieron la vacunación para SARS-CoV-2. Detección de IgG anti-proteína S (kit COVIDAR). Resultados: se incluyeron 120 pacientes con AR. El 24,4% recibió tratamiento con glucocorticoides, 50,9% drogas biológicas y 13,3% inhibidores de JAK (janus kinases). El 6% había tenido infección por SARS-CoV-2 previamente. La vacuna más utilizada en la primera dosis fue Sputnik V (52,9%). El 25% recibió esquemas heterólogos. Luego de la primera dosis, el 59% presentó una prueba no reactiva o indeterminada, y un 18% luego de la segunda dosis. La aplicación de esquemas homólogos de vacuna Sinopharm (63,6% vs 13,3%, p<0,0001), y el uso de abatacept (27,3% vs 5,1%, p=0,005) y rituximab (18,2% vs 0%, p=0,001) al momento de la vacunación se asociaron a un resultado no reactivo o indeterminado. Conclusiones: similar a lo reportado en otras poblaciones internacionales, en esta cohorte, dos de cada 10 pacientes no desarrollaron anticuerpos. Una menor respuesta se asoció con la vacuna Sinopharm y al tratamiento con abatacept y rituximab.


Introduction: rheumatoid arthritis (RA) and its treatments can affect the response to the SARS-CoV-2 vaccine. However, we still do not have local data. Objectives: to evaluate the humoral response of the SARS-CoV-2 vaccine and its safety in this population. Materials and methods: observational study. Patients ≥18 years of age, with RA ACR/EULAR 2010 who had received vaccination for SARS-CoV-2 were included. Detection of anti-protein S IgG (COVIDAR Kit). Results: a total of 120 patients with RA were included. A quarter was receiving glucocorticoids, 50.9% biological drugs and 13.3% JAK inhibitors (janus kinases). Only 6% had a history SARS-CoV-2 infection. The most used vaccine was Sputnik V (52.9%) and 25% received mixed regimenes. After the first dose, 59% had a non-reactive or indeterminate test, and after the second, 18% were still having this result. The application of homologous Sinopharm vaccine regimen (63.6% vs 13.3%, p<0.0001) and the use of abatacept (27.3% vs 5.1%, p=0.005) and rituximab (18.2% vs 0%, p=0.001) at vaccination was associated with a non-reactive or indeterminate result. Conclusions: similar to other international populations, in this cohort, two out of 10 patients did not develop antibodies. A lower response was associated with the Sinopharm vaccine and treatment with abatacept and rituximab.


Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Artrite Reumatoide/imunologia , Imunidade Humoral , Vacinas contra COVID-19/imunologia , Estudos Longitudinais , Vacinas contra COVID-19/efeitos adversos , COVID-19/imunologia , COVID-19/prevenção & controle , Eficácia de Vacinas
17.
JAMA Netw Open ; 4(10): e2129639, 2021 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-34661663

RESUMO

Importance: Although tumor necrosis factor (TNF) inhibitors are widely prescribed globally because of their ability to ameliorate shared immune pathways across immune-mediated inflammatory diseases (IMIDs), the impact of COVID-19 among individuals with IMIDs who are receiving TNF inhibitors remains insufficiently understood. Objective: To examine the association between the receipt of TNF inhibitor monotherapy and the risk of COVID-19-associated hospitalization or death compared with other commonly prescribed immunomodulatory treatment regimens among adult patients with IMIDs. Design, Setting, and Participants: This cohort study was a pooled analysis of data from 3 international COVID-19 registries comprising individuals with rheumatic diseases, inflammatory bowel disease, and psoriasis from March 12, 2020, to February 1, 2021. Clinicians directly reported COVID-19 outcomes as well as demographic and clinical characteristics of individuals with IMIDs and confirmed or suspected COVID-19 using online data entry portals. Adults (age ≥18 years) with a diagnosis of inflammatory arthritis, inflammatory bowel disease, or psoriasis were included. Exposures: Treatment exposure categories included TNF inhibitor monotherapy (reference treatment), TNF inhibitors in combination with methotrexate therapy, TNF inhibitors in combination with azathioprine/6-mercaptopurine therapy, methotrexate monotherapy, azathioprine/6-mercaptopurine monotherapy, and Janus kinase (Jak) inhibitor monotherapy. Main Outcomes and Measures: The main outcome was COVID-19-associated hospitalization or death. Registry-level analyses and a pooled analysis of data across the 3 registries were conducted using multilevel multivariable logistic regression models, adjusting for demographic and clinical characteristics and accounting for country, calendar month, and registry-level correlations. Results: A total of 6077 patients from 74 countries were included in the analyses; of those, 3215 individuals (52.9%) were from Europe, 3563 individuals (58.6%) were female, and the mean (SD) age was 48.8 (16.5) years. The most common IMID diagnoses were rheumatoid arthritis (2146 patients [35.3%]) and Crohn disease (1537 patients [25.3%]). A total of 1297 patients (21.3%) were hospitalized, and 189 patients (3.1%) died. In the pooled analysis, compared with patients who received TNF inhibitor monotherapy, higher odds of hospitalization or death were observed among those who received a TNF inhibitor in combination with azathioprine/6-mercaptopurine therapy (odds ratio [OR], 1.74; 95% CI, 1.17-2.58; P = .006), azathioprine/6-mercaptopurine monotherapy (OR, 1.84; 95% CI, 1.30-2.61; P = .001), methotrexate monotherapy (OR, 2.00; 95% CI, 1.57-2.56; P < .001), and Jak inhibitor monotherapy (OR, 1.82; 95% CI, 1.21-2.73; P = .004) but not among those who received a TNF inhibitor in combination with methotrexate therapy (OR, 1.18; 95% CI, 0.85-1.63; P = .33). Similar findings were obtained in analyses that accounted for potential reporting bias and sensitivity analyses that excluded patients with a COVID-19 diagnosis based on symptoms alone. Conclusions and Relevance: In this cohort study, TNF inhibitor monotherapy was associated with a lower risk of adverse COVID-19 outcomes compared with other commonly prescribed immunomodulatory treatment regimens among individuals with IMIDs.


Assuntos
Artrite Reumatoide/tratamento farmacológico , COVID-19/mortalidade , Doenças Inflamatórias Intestinais/tratamento farmacológico , Psoríase/tratamento farmacológico , Inibidores do Fator de Necrose Tumoral/uso terapêutico , Adulto , Artrite Reumatoide/epidemiologia , Comorbidade , Quimioterapia Combinada/efeitos adversos , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Doenças Inflamatórias Intestinais/epidemiologia , Masculino , Pessoa de Meia-Idade , Pandemias , Psoríase/epidemiologia , Sistema de Registros , Estudos Retrospectivos , SARS-CoV-2
18.
Rev. argent. reumatolg. (En línea) ; 32(2): 26-32, jun. 2021. ilus, tab
Artigo em Espanhol | LILACS, BINACIS | ID: biblio-1365489

RESUMO

Objetivos: Golimumab ha sido aprobado para el tratamiento de pacientes con artritis reumatoidea (AR), artritis psoriásica (APs) y espondiloartritis axial. Sin embargo, los datos provenientes de nuestra región son escasos. El objetivo de este estudio fue evaluar la eficacia, seguridad y sobrevida acumulada de golimumab en pacientes de la vida real con AR, APs y espondilitis anquilosante (EA) de diferentes centros de Argentina. Material y métodos: Se llevó a cabo un estudio longitudinal, en el que se incluyeron pacientes consecutivos mayores de 18 años con diagnóstico de AR (criterios ACR/EULAR 2010), APs (criterios CASPAR) y Espax (criterios ASAS 2009), que hayan iniciado tratamiento con golimumab de acuerdo a la indicación médica. Se obtuvieron los datos por revisión de historias clínicas. Se consignaron características sociodemográficas, clínicas, comorbilidades y tratamientos previos. Con respecto al golimumab, se registraron fecha de inicio, vía de administración y tratamientos concomitantes. Se determinó la actividad de la enfermedad mediante DAS28 en el caso de la AR, por DAPSA y MDA para APs y por BASDAI en el caso de Espax. Se consignó la presencia de eventos adversos (EA). En el caso de suspensión del tratamiento, se identificaron la fecha y motivo del mismo. Los pacientes fueron seguidos hasta la suspensión del golimumab, pérdida de seguimiento, muerte, o finalización del estudio (30 de noviembre de 2020). Resultados: Se incluyeron 182 pacientes, 116 con diagnóstico de AR, 30 con APs y 36 con Espax. La mayoría de ellos (70.9%) eran mujeres con una edad mediana (m) de 55 años (RIC 43.8-64) y una duración de la enfermedad m de 7 años (RIC 4-12.7) al inicio del tratamiento. El 34.6% de los mismos habían recibido al menos una droga modificadora de la enfermedad (DME) biológica (-b) o sintética dirigida (-sd) previamente. El seguimiento total fue de 318.1 pacientes/año. El tratamiento con golimumab mostró mejoría clínica en los tres grupos de pacientes. La incidencia de eventos adversos fue de 6.6 por 100 pacientes/año, siendo las infecciones las más frecuentes. Durante el seguimiento, 50 pacientes (27.5%) suspendieron golimumab, la causa más frecuente fue el fracaso del tratamiento (68%), seguida de la falta de cobertura (16%) y el desarrollo de eventos adversos (10%). La persistencia de golimumab fue del 76% y 68% a los 12 y 24 meses, respectivamente. Se registró una sobrevida de 50.2 meses (IC 95% 44.4-55.9). Los pacientes que habían recibido tratamiento previo con DME-b y/o -sd mostraron una menor sobrevida (HR 2.4, IC 95% 1.3-4.4). Conclusiones: El tratamiento con golimumab en pacientes de la vida real en Argentina ha demostrado una buena eficacia y seguridad. La sobrevida del fármaco fue de más de 4 años y casi el 80% seguía usando golimumab después de un año. El tratamiento previo con otros DME-b o -sd se asoció con una menor sobrevida al tratamiento.


Objectives: Golimumab is approved for patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis. However, data from our region are scarce. The aim of this study was to evaluate the efficacy, safety, and cumulative survival of golimumab in real-life patients with RA, PsA and axial spondyloarthritis (axSpa) from different rheumatology centers in Argentina. Material and methods: We performed a longitudinal study of consecutive adults with RA (ACR/EULAR 2010 criteria), PsA (CASPAR criteria) and axSpa (ASAS 2009 criteria), who have started treatment with golimumab according to medical indication. Data was obtained by review of medical records. Sociodemographic and clinical data, musculoskeletal manifestations, comorbidities and previous treatments were recorded. In reference to golimumab treatment, start date, route of administration and concomitant treatments were identified. Disease activity was assessed using DAS28 for RA patients, DAPSA and MDA for PsA and BASDAI for axSpa. The presence of adverse events was recorded. If golimumab was stopped, date and cause was documented. Patients were followed up until golimumab discontinuation, loss of follow-up, death, or study completion (November 30, 2020). Results: In total 182 patients were included, 116 with a diagnosis of RA, 30 with PsA and 36 with axSpa. Most of them (70.9%) were female with a median (m) age of 55 years (IQR 43.8-64) and m disease duration of 7 years (IQR 4-12.7) at treatment initiation. Al least one prior biological (-b) and/or targeted synthetic (-ts) disease modifying antirheumatic drug (DMARD) was received by 63 patients (34.6%). Total follow-up was 318.1 patients/year. Golimumab treatment showed clinical improvement in all three groups of patients. The incidence of AE was 6.6 per 100 patients/year, being infections the most frequents ones. During follow-up, 50 patients (27.5%) discontinued golimumab, the most frequent cause was treatment failure (68%), followed by lack of health insurance (16%) and adverse events (10%). Golimumab persistence was 76% and 68% at 12 and 24 months, respectively. Treatment survival was 50.2 months (95% CI 44.4-55.9). Patients who had received prior treatment with b- or ts-DMARDs showed lower survival (HR 2.41, 95% CI 1.3-4.4). Conclusions: Golimumab treatment in real life patients in Argentina has shown good efficacy and safety. Drug survival was over 4 years and almost 80% were still using golimumab after one year. Prior treatment with other b- or ts-DMARDs was associated with lower treatment survival.


Assuntos
Artrite Reumatoide , Sobrevida , Fator de Necrose Tumoral alfa , Espondilartrite
19.
Ann Rheum Dis ; 80(9): 1137-1146, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34049860

RESUMO

OBJECTIVE: To investigate baseline use of biologic or targeted synthetic (b/ts) disease-modifying antirheumatic drugs (DMARDs) and COVID-19 outcomes in rheumatoid arthritis (RA). METHODS: We analysed the COVID-19 Global Rheumatology Alliance physician registry (from 24 March 2020 to 12 April 2021). We investigated b/tsDMARD use for RA at the clinical onset of COVID-19 (baseline): abatacept (ABA), rituximab (RTX), Janus kinase inhibitors (JAKi), interleukin 6 inhibitors (IL-6i) or tumour necrosis factor inhibitors (TNFi, reference group). The ordinal COVID-19 severity outcome was (1) no hospitalisation, (2) hospitalisation without oxygen, (3) hospitalisation with oxygen/ventilation or (4) death. We used ordinal logistic regression to estimate the OR (odds of being one level higher on the ordinal outcome) for each drug class compared with TNFi, adjusting for potential baseline confounders. RESULTS: Of 2869 people with RA (mean age 56.7 years, 80.8% female) on b/tsDMARD at the onset of COVID-19, there were 237 on ABA, 364 on RTX, 317 on IL-6i, 563 on JAKi and 1388 on TNFi. Overall, 613 (21%) were hospitalised and 157 (5.5%) died. RTX (OR 4.15, 95% CI 3.16 to 5.44) and JAKi (OR 2.06, 95% CI 1.60 to 2.65) were each associated with worse COVID-19 severity compared with TNFi. There were no associations between ABA or IL6i and COVID-19 severity. CONCLUSIONS: People with RA treated with RTX or JAKi had worse COVID-19 severity than those on TNFi. The strong association of RTX and JAKi use with poor COVID-19 outcomes highlights prioritisation of risk mitigation strategies for these people.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/complicações , Artrite Reumatoide/tratamento farmacológico , COVID-19/complicações , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , SARS-CoV-2 , Índice de Gravidade de Doença
20.
Rev. argent. reumatolg. (En línea) ; 32(1): 7-15, mar. 2021. ilus, tab
Artigo em Espanhol | LILACS, BINACIS | ID: biblio-1279753

RESUMO

Con el fin de evaluar el impacto de la infección por SARS-CoV-2 en pacientes con enfermedades reumáticas, la Sociedad Argentina de Reumatología desarrolló el Registro Nacional de Pacientes con Enfermedades Reumáticas y COVID-19 (SAR-COVID). El objetivo del presente trabajo fue evaluar las características sociodemográficas y clínicas de los pacientes con enfermedades reumáticas e infección por SARS-CoV-2 incluidos en el registro SAR-COVID y describir las complicaciones y desenlaces de la COVID-19 en esta población. Material y métodos: SAR-COVID es un registro nacional, multicéntrico y observacional, en el cual se incluyen de manera consecutiva pacientes ≥18 años de edad, con diagnóstico de alguna enfermedad reumática que hayan cursado infección por SARS-CoV-2. Se consignan datos sociodemográficos, comorbilidades, enfermedad reumática y su tratamiento, características clínicas, laboratorio, complicaciones y tratamientos de la infección por SARS-CoV-2. Resultados: Se incluyeron 525 pacientes, con una edad media de 51.3 años (DE 15.2). Las enfermedades reumatológicas más frecuentes fueron artritis reumatoidea (40.4%), lupus eritematoso sistémico (14.9%) y espondiloartritis (8.2%). El 72.9% recibía tratamiento inmunosupresor o inmunomodulador al momento del inicio de la infección y 36.9% glucocorticoides. En la mayoría de los casos, el diagnóstico de infección por SARS-CoV-2 se llevó a cabo mediante RT-PCR (95%), 39.4% en la consulta externa, 32.2% en el departamento de urgencias, y 14.7% durante la hospitalización. La mayoría de los pacientes presentaron síntomas, siendo los más frecuentes fiebre (56.2%), tos (46.7%) y cefalea (39.2%). Durante la infección, 35.1% requirieron hospitalización y 11.6% en unidad de cuidados intensivos. El 75.1% se recuperó completamente, 8.4% presentó secuelas y 6.9% murieron a causa de COVID-19. Conclusión: En este primer reporte del registro SAR-COVID encontramos una amplia distribución de enfermedades reumáticas. La mayoría de los pacientes tuvieron una buena evolución de la infección, sin embargo un 7% falleció como consecuencia de la misma, datos comparables a los reportados por otros registros latinoamericanos con poblaciones similares.


In order to assess the impact of SARS-CoV-2 infection in patients with rheumatic diseases, the Argentine Society of Rheumatology has developed the National Registry of Patients with Rheumatic Diseases and COVID-19 (SAR-COVID). The aim of this study was to evaluate the sociodemographic and clinical characteristics of patients with rheumatic diseases and SARS-CoV-2 infection included in the SAR-COVID registry and to describe the complications and outcomes of COVID-19 in this population. Methods: SAR-COVID is a national, multicenter and observational registry, in which patients ≥18 years of age, with a diagnosis of a rheumatic disease who had SARS-CoV-2 infection are consecutively included. Sociodemographic data, comorbidities, underlying rheumatic disease and treatment, clinical characteristics, complications, laboratory and treatment of the SARS-CoV-2 infection were recorded. Results: A total of 525 patients were included, with a mean age of 51.3 years (SD 15.2). The most frequent rheumatic diseases were rheumatoid arthritis (40.4%), systemic lupus erythematous (14.9%) and spondyloarthritis (8.2%). At the time of the infection, 72.9% were receiving immunosuppressive or immunomodulatory treatment and 36.9% glucocorticoids. Most of the patients were diagnosed using RT-PCR (95%), at outpatient consultation (39.4%), at the emergency room (32.2%) or during hospitalization (14.7%). 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% were hospitalized, 11.6% were admitted to the ICU and 6.9% died due to COVID-19. Most of them (75.1%) recovered completely. Conclusions: In this first report of the SAR-COVID registry we found a wide distribution of rheumatic diseases. Most of the patients had a good evolution of the infection, however 7% died as a result of it, comparable to other Latin American registries with similar populations.


Assuntos
Humanos , Artrite Reumatoide , Reumatologia , Doenças Reumáticas , Infecções por Coronavirus , Betacoronavirus
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