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OBJECTIVES: Data about hydroxychloroquine (HCQ) levels during pregnancy are sparse. We assessed HCQ whole blood levels at first trimester of pregnancy as a potential predictor of maternal and obstetric/fetal outcomes in patients with systemic lupus erythematosus (SLE). METHODS: We included pregnant SLE patients enrolled in the prospective GR2 study receiving HCQ, with at least one available first-trimester whole-blood HCQ assay. We evaluated several cut-offs for HCQ whole blood levels, including ≤200 ng/ml for severe non-adherence. Primary outcomes were maternal flares during the second and third trimesters of pregnancy, and adverse pregnancy outcomes (APOs: fetal/neonatal death, placental insufficiency with preterm delivery, and small-for-gestational-age neonates). RESULTS: We included 174 patients (median age: 32.1 years, IQR 28.8-35.2). Thirty (17.2%) patients had flares, 4 (2.3%) being severe. APOs occurred in 28 patients (16.1%). There were no significant differences in APOs by HCQ level for either those with subtherapeutic HCQ levels (≤500 ng/ml vs >500 ng/ml: 23.5% vs 14.3%, p = 0.19) or those with non-adherent HCQ levels (≤200 ng/ml vs >200 ng/ml: 20.0% vs 15.7%, p = 0.71). Similarly, the overall rate of maternal flares did not differ significantly by HCQ level cut-off, but patients with subtherapeutic (HCQ ≤500 ng/ml: 8.8% vs 0.7%, p = 0.02) and non-adherent HCQ levels (≤200 ng/ml: 13.3% vs 1.3%, p = 0.04) had significantly more severe flares. CONCLUSION: In this large prospective study of pregnant SLE patients, first-trimester subtherapeutic (≤500 ng/ml) and severe non-adherent (≤200 ng/ml) HCQ levels were associated with severe maternal flares, but not with APOs. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02450396.
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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.
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COVID-19 , Nacimiento Prematuro , Enfermedades Reumáticas , Embarazo , Recién Nacido , Femenino , Humanos , Vacunas contra la COVID-19 , COVID-19/epidemiología , COVID-19/prevención & control , Prueba de COVID-19 , Enfermedades Reumáticas/tratamiento farmacológico , VacunaciónRESUMEN
OBJECTIVE: The aim is to analyze health care resource utilization (HCRU) of patients with lupus (SLE) from a health management organization (HMO) in Buenos Aires, Argentina, compared with matched controls and comparing periods of flare, low disease activity, and remission. METHODS: This is a retrospective observational study including all SLE incident cases (ACR 1997/SLICC 2012 criteria) between 2000 and 2020 and 5 matched controls. Clinical data and HCRU (medical and nonmedical consultations, lab and imaging tests performed, emergency room visits, hospitalizations, and drugs prescribed) were obtained from administrative databases and electronic medical records. For each patient with SLE, an activity state was determined in every month of follow-up: flare (BILAG A or 2 BILAG B); low disease activity (LLDAS); remission (DORIS definition); or intermediate activity (not fulfilling any of previous). Incidence rates for each HCRU item and incidence rate ratios between SLE and control patients were and between remission and flare periods were calculated. Multivariate negative binomial logistic regression analyses were performed for identification of variables associated with major resource use. RESULTS: A total of 62 SLE and 310 control patients were included, 88.7% were women, the median age at diagnosis was 46 years, and were followed for more than 8 years. Patients with SLE contributed with 537.2 patient-years (CI 95% 461.1-613.3) and controls with 2761.9 patient-years (CI 95% 2600.9-2922.8). HCRU in patients with SLE was significantly higher than in controls in all items, even in remission periods. Patients with SLE remained 74.4% of the time in remission, 12.1% in LLDAS, 12.2% in intermediate activity, and 1.3% in flare (there were 64 flares in 36 patients). HCRU was significantly higher during flare periods compared with remission periods. Number of flares was independently associated with emergency department consultations, lab tests and X-ray performed, number of drugs prescribed, and hospitalizations. CONCLUSION: Significantly more HCRU was observed in patients with SLE in flare compared to remission periods.
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Lupus Eritematoso Sistémico , Humanos , Femenino , Masculino , Argentina/epidemiología , Lupus Eritematoso Sistémico/epidemiología , Estudios Retrospectivos , Aceptación de la Atención de Salud , Índice de Severidad de la EnfermedadRESUMEN
OBJECTIVE: The aim of this study was to evaluate prognostic factors associated with advanced chronic kidney disease (ACKD) in a cohort of patients with ANCA-associated vasculitis and renal involvement. METHODS: Observational retrospective study. We included patients with biopsy-proven ANCA glomerulonephritis (GN) diagnosed between 2001 and 2016, with at least 1-year follow-up. Data were recorded at diagnosis, end of induction, after 12 months of treatment, and at the end of follow-up. We analysed clinical-analytical data and renal histopathology, as well as treatments, dialysis requirement, relapses and death. Univariate analysis was performed to identify factors associated with long-term ACKD (eGFR < 30 ml/min). Multivariate analysis using an alternative outcome (eGFR at the end of follow-up) was performed. Diagnostic accuracy for ACKD of each predictor variable was compared using AUC of ROC curves. RESULTS: Sixty patients were included: 17 GPA, 14 MPA, 5 EGPA, and 24 RLV. Forty-six patients were women (76.7%). Mean age at diagnosis was 67.8 years (SD 13.1), and median follow-up time was 4.2 years (IQR 2.2-6.8). At the end of follow-up, 12 patients (20.0%) had an eGFR < 30 ml/min. Univariate analysis showed a statistically significant association of ACKD with sclerotic class biopsy (OR 7.17, 95% CI 1.34-38.31), 12-month proteinuria (OR 5.16, 95% CI 1.16-22.87), and creatinine at diagnosis (OR 1.24, 95% CI 1.02-1.52), end of induction (OR 15.40, 95% CI 2.41-98.28), and after 12 months (OR 19.25, 95% CI 2.75-134.92). In the multivariate analysis, eGFR at baseline (< 0.001), after 6 months (< 0.001) and 12 months of treatment (< 0.001), remained statistically associated with eGFR at the end of follow-up. The best diagnostic accuracy in ROC curves was shown by serum creatinine at the end of induction treatment (AUC 0.93) and after 12 months (AUC 0.94). CONCLUSION: In this cohort of patients with ANCA GN, creatinine and eGFR at baseline and after 6 and 12 months of treatment were the best predictors of ACKD at the end of follow-up.
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Vasculitis Asociada a Anticuerpos Citoplasmáticos Antineutrófilos , Glomerulonefritis , Insuficiencia Renal Crónica , Humanos , Femenino , Anciano , Masculino , Anticuerpos Anticitoplasma de Neutrófilos , Pronóstico , Estudios Retrospectivos , Creatinina , Glomerulonefritis/complicaciones , Insuficiencia Renal Crónica/complicacionesRESUMEN
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.
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Artritis Reumatoide , COVID-19 , Adulto , Humanos , COVID-19/complicaciones , SARS-CoV-2 , Agentes Inmunomoduladores , Artritis Reumatoide/tratamiento farmacológico , Inmunosupresores/uso terapéutico , Sistema de RegistrosRESUMEN
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.
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COVID-19 , Enfermedades Reumáticas , Femenino , Humanos , Masculino , COVID-19/complicaciones , Glucocorticoides/uso terapéutico , Hospitalización , Sistema de Registros , Enfermedades Reumáticas/complicaciones , Enfermedades Reumáticas/epidemiología , Enfermedades Reumáticas/tratamiento farmacológico , Rituximab/uso terapéutico , SARS-CoV-2 , Adolescente , Adulto , Estudios Observacionales como AsuntoRESUMEN
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.
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Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory disease occasionally associated with severe extra-articular manifestations, mostly in cases of longstanding highly active disease. We report the case of a 56 year-old woman diagnosed with active RA at the age of 40. After 5 years of high activity, her arthritis subsides spontaneously during pregnancy despite the lack of treatment with disease-modifying anti-rheumatic drugs. She remains without articular symptoms for 7 years, and then she develops a Felty's syndrome requiring steroid treatment and splenectomy. Following steroid withdrawal she develops pericarditis with massive serohematic pericardial effusion, still in absence of articular activity, and responds to immunosuppressive therapy and colchicine. We emphasize the unusual spontaneous and sustained joint remission without specific treatment, and the development of severe extra-articular manifestations of RA in absence of concomitant articular activity, as well as the importance of controlling inflammation.