Factors predictive of severe thrombocytopenia and its impact on poor outcomes in Latin American patients with systemic lupus erythematosus: Data from a multiethnic Latin American cohort.

OBJECTIVE: To examine the predictors of the occurrence of severe thrombocytopenia and its impact on damage accrual and mortality in SLE patients. METHODS: Factors associated with time to severe thrombocytopenia (platelet count ≤20,000/mm3) occurring from the onset of SLE symptoms were assessed by Cox proportional hazards regressions. The association of severe thrombocytopenia with mortality was evaluated by logistic regression analyses while its impact on damage was by negative binomial regression. RESULTS: Of 1,217 patients, 33 (2.7%) developed severe thrombocytopenia over a mean (SD) follow-up time of 5.9 (3.6) years. The median time from the onset of SLE symptoms to severe thrombocytopenia occurrence was 22 months (IQR 8.7-62.0). Mestizo (60.6%) was the predominant ethnic group, followed by Caucasian (27.3%), while African Latin American exhibited the lowest frequency (12.1%). By multivariable analysis, Mestizo ethnicity (HR 2.67, 95% CI 1.12-6.37, p = 0.027), and autoimmune hemolytic anemia (AIHA) at baseline (HR 3.99; 95% CI 1.05-15.19, p = 0.042) were associated with a shorter time to the occurrence of severe thrombocytopenia while middle/high socioeconomic status (HR 0.23; 95% CI 0.08-0.69, p = 0.008) was associated with a longer time. Severe thrombocytopenia contributed neither to damage nor to mortality. CONCLUSIONS: Severe thrombocytopenia occurs during the early course of SLE. Mestizo ethnicity and AIHA at baseline emerged as independent predictors of a shorter time to severe thrombocytopenia occurrence while a middle/high socioeconomic status seems to be protective against its occurrence. Damage and mortality did not seem to be impacted by the occurrence of severe thrombocytopenia.

Predictors of first hospitalization due to disease activity and infections in systemic lupus erythematosus patients.

OBJECTIVES: To identify the predictive factors of first hospitalization and associated variables to the main causes of hospitalizations in lupus patients from a Latin American cohort. METHODS: The first hospitalization after entry into the cohort during these patients' follow-up due to either lupus disease activity and/or infection was examined. Clinical and therapeutic variables were those occurring prior to the first hospitalization. Descriptive statistical tests, multivariable logistic, and Cox regression models were performed. RESULTS: 1341 individuals were included in this analysis; 1200 (89.5%) were women. Their median and interquartile range (IQR) age at diagnosis were 27 (20-37) years and their median and IQR follow up time were 27.5 (4.7-62.2) months. A total of 456 (34.0%) patients were hospitalized; 344 (75.4%), 85 (18.6%) and 27 (5.9%) for disease activity, infections, or both, respectively. The predictors of the first hospitalization regardless of its cause were: medium (HR 2.03(1.27-3.24); p = 0.0028) and low (HR 2.42(1.55-3.79); p < 0.0001) socioeconomic status, serosal (HR 1.32(1.07-1.62); p = 0.0074) and renal (HR 1.50(1.23-1.82); p < 0.0001) involvement. Antimalarial (AM) use (HR 0.61(0.50-0.74); p < 0.0001) and achieving remission (HR 0.80(0.65-0.97); p = 0.0300) were negative predictors. CONCLUSIONS: The first hospitalization was associated with worse socioeconomic status and serosal and renal involvement. Conversely, AM use and achieving remission were associated with a lower risk of hospitalizations.

Predictors of severe hemolytic anemia and its impact on major outcomes in systemic lupus erythematosus: Data from a multiethnic Latin American cohort.

OBJECTIVE: To determine the predictors of the occurrence of severe autoimmune hemolytic anemia (AIHA) and its impact on damage accrual and mortality in SLE patients. METHODS: Factors associated with time to severe AIHA (hemoglobin level ≤7 g/dL) occurring from the onset of SLE symptoms were examined by Cox proportional hazards regressions. The association of severe AIHA with mortality was examined by logistic regression analyses while its impact on damage was by negative binomial regression. RESULTS: Of 1,349 patients, 49 (3.6%) developed severe AIHA over a mean (SD) follow-up time of 5.4 (3.8) years. The median time from the first clinical manifestation to severe AIHA was 111 days (IQR 43-450). By multivariable analysis, male sex (HR 2.26, 95% CI 1.02-4.75, p = 0.044), and higher disease activity at diagnosis (HR 1.04, 95% CI 1.01-1.08, p = 0.025) were associated with a shorter time to severe AIHA occurrence. Of the SLEDAI descriptors, only hematologic (leukopenia and/or thrombocytopenia) showed a certain trend toward significance in the multivariable analysis (HR 2.36, 95% CI 0.91-6.13, p = 0.0772). Severe AIHA contributed neither to damage nor to mortality. CONCLUSIONS: Severe AIHA occurs during the early course of SLE. Male sex and higher disease activity at diagnosis emerged as independent predictors of a shorter time to severe AIHA occurrence. Although not statistically significant, hematological abnormalities at SLE diagnosis could predict the occurrence of severe AIHA in a shorter time. Damage and mortality did not seem to be impacted by the occurrence of severe AIHA.

A longitudinal multiethnic study of biomarkers in systemic lupus erythematosus: Launching the GLADEL 2.0 Study Group.

Introduction: After more than 20 years of sustained work, the Latin American Group for the Study of Lupus (GLADEL) has made a significant number of contributions to the field of lupus, not only in the differential role that race/ethnicity plays in its course and outcome but also in several other studies including the beneficial effects of using antimalarials in lupus patients and the development of consensus guidelines for the treatment of lupus in our region. Methods: A new generation of "Lupus Investigators" in more than 40 centers throughout Latin America has been constituted in order to continue the legacy of the investigators of the original cohort and to launch a novel study of serum and urinary biomarkers in patients with systemic lupus erythematosus. Results: So far, we have recruited 807 patients and 631 controls from 42 Latin-American centers including 339 patients with SLE without renal involvement, 202 patients with SLE with prevalent but inactive renal disease, 176 patients with prevalent and active renal disease and 90 patients with incident lupus nephritis. Conclusions: The different methodological aspects of the GLADEL 2.0 cohort are discussed in this manuscript, including the challenges and difficulties of conducting such an ambitious project.

Applying the 2019 European Alliance of Associations for Rheumatology/American College of Rheumatology Lupus Criteria to Patients From the LUMINA Cohort: Results From the Multiethnic, Multicenter US Cohort.

OBJECTIVE: To evaluate the performance of the 2019 European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) criteria for systemic lupus erythematosus (SLE) in terms of earlier SLE classification in comparison to the ACR or the Systemic Lupus International Collaborating Clinics (SLICC) criteria. METHODS: Patients from a multiethnic, multicenter cohort, the Lupus in Minorities: Nature versus Nurture cohort, where SLE was defined using the 1982/1997 ACR criteria were included. Demographic, clinical, and immunologic criteria were compared among the 2019 EULAR/ACR and the 1982/1997 ACR and the 2012 SLICC timing categories. RESULTS: The 2019 EULAR/ACR criteria allowed an earlier SLE classification in 13.3% of patients (mean 0.66 years) and 15.3% of patients (mean 0.63 years) compared to the 1982/1997 ACR and the 2012 SLICC criteria, respectively. Patients accruing the 2019 EULAR/ACR criteria later than the 1982/1997 ACR criteria had a lower disease activity, were less likely to have positivity to anti-double-stranded DNA and anti-Sm, as well as lupus nephritis classes II or V; they were more likely to have mucocutaneous manifestations, serositis, leukopenia, and antiphospholipid antibodies positivity. These differences were less pronounced when compared to the 2012 SLICC criteria CONCLUSION: The 2019 EULAR/ACR criteria classified SLE patients earlier than the 2 other criteria sets in real-life clinical practice scenarios in a relatively small proportion of the patients. However, these criteria could allow earlier classification of a subset of patients with a more severe disease.

Comparación de máscaras laríngeas (I-gel Fastrach) para realización de intubación endotraqueal guiada con broncofibroscopio flexible / Comparison of I-gel Fastrach laryngeal masks in conducting flexible bronchofiberscope-guided

GOALS: Determine the success rate of guided intubation with a flexible bronchofibroscope (BFC) through supraglottic devices: I-gel or Fastrach, establish the degree of fibroscopic visualization and determine the insertion time of the laryngeal mask airway (LMA) and endotracheal intubation. METHODS: Experimental, prospective, comparative and randomized study of 60 ASA I-II-III patients, older than 18 years, undergoing elective surgeries that required general anesthesia and endotracheal intubation. After anesthetic induction, the assigned LMA was placed and intubation with BFC was performed through it. Both the success of laryngeal mask insertion and intubation were recorded, as well as the time (in seconds) equired for these procedures. The vision of the laryngeal structures was classified according to the Brimacombe Scale. RESULTS: The groups analyzed presented similar general characteristics. Insertion time of he LMA was significantly lower with I-gel than Fastrach (median 12 s vs 16 s. Respectively, p = 0.001). Also, in the intubation time BFC guided through the laryngeal mask, differences in favor of I-gel were found, with a median of 72 s. vs 89 s. (p = 0.001). Regarding the degree of glottic visualization with BFC, no statistically significant differences were found between both groups.CONCLUSIONS: Although both devices had the highest success rate (both in their placement and in intubation through them), with I-gel the intubation was performed quicker.

OBJETIVOS: Determinar la tasa de éxito de intubación guiada con broncofibroscopio flexible (BFC) a través de los dispositivos supraglóticos: I-gel o Fastrach, establecer el grado de visualización fibroscópica y determinar el tiempo de inserción de la máscara laríngea y de intubación endotraqueal. MATERIALES Y MÉTODOS: Estudio experimental, prospectivo, comparativo y aleatorizado de 60 pacientes ASA I- II ­III, mayores de 18 años, sometidos a cirugías electivas que requerían anestesia general e intubación endotraqueal. Luego de la inducción anestésica, se procedió a colocar la máscara laríngea asignada y se realizó la intubación con BFC a través de la misma. Tanto el éxito de inserción de máscara laríngea como de intubación fueron registrados, así como el tiempo (en segundos) requerido para dichos procedimientos. La visión de las estructuras laríngeas fue clasificada de acuerdo a Escala de Brimacombe. RESULTADOS: Los grupos analizados presentaron características generales similares. El tiempo de inserción de la ML fue significativamente menor con I-gel que con Fastrach (medianas: 12 s. vs 16 s. respectivamente, p = 0,001). También en el tiempo de intubación guiada con BFC a través de la máscara laríngea, se encontraron diferencias en favor de I-gel, con una mediana de 72 s. vs 89 s. (p = 0,001). Respecto al grado de visualización glótica con BFC, no se encontraron diferencias estadísticamente significativas entre ambos grupos. CONCLUSIONES: Aunque ambos dispositivos tuvieron la máxima tasa de éxito (tanto en su colocación como en la intubación a través de ellos), con I-gel se realizó la intubación de manera más rápida.

Predictors of renal damage in systemic lupus erythematous patients: data from a multiethnic, multinational Latin American lupus cohort (GLADEL).

AIM: A decrease in proteinuria has been considered protective from renal damage in lupus nephritis (LN), but a cut-off point has yet to be established. The aim of this study was to identify the predictors of renal damage in patients with LN and to determine the best cut-off point for a decrease in proteinuria. METHODS: We included patients with LN defined clinically or histologically. Possible predictors of renal damage at the time of LN diagnosis were examined: proteinuria, low complement, anti-double-stranded DNA antibodies, red cell casts, creatinine level, hypertension, renal activity (assessed by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)), prednisone dose, immunosuppressive drugs and antimalarial use. Sociodemographic variables were included at baseline. Proteinuria was assessed at baseline and at 12 months, to determine if early response (proteinuria <0.8 g/day within 12 months since LN diagnosis) is protective of renal damage occurrence. Renal damage was defined as an increase of one or more points in the renal domain of The Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index (SDI). Cox regression models using a backward selection method were performed. RESULTS: Five hundred and two patients with systemic lupus erythematosus patients were included; 120 patients (23.9%) accrued renal damage during their follow-up. Early response to treatment (HR=0.58), antimalarial use (HR=0.54) and a high SES (HR=0.25) were protective of renal damage occurrence, whereas male gender (HR=1.83), hypertension (HR=1.86) and the renal component of the SLEDAI (HR=2.02) were risk factors for its occurrence. CONCLUSIONS: Early response, antimalarial use and high SES were protective of renal damage, while male gender, hypertension and higher renal activity were risk factors for its occurrence in patients with LN.

Applying the 2019 EULAR/ACR lupus criteria to patients from an established cohort: a Latin American perspective.

OBJECTIVE: To evaluate the performance of the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) systemic lupus erythematosus (SLE) criteria in terms of earlier patients' classification in comparison to the 1982/1997 ACR or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria. MATERIALS AND METHODS: Patients from a Latin America, multiethnic, multicentre cohort, where SLE was defined using the physicians' diagnosis, were included. To calculate the sensitivity of the 2019 EULAR/ACR criteria, the 1982/1997 ACR criteria were considered the gold standard. Additionally, comparison of the 1982/1997 ACR criteria and the 2012 SLICC criteria with the 2019 EULAR/ACR criteria was performed. RESULTS: The sensitivity of the 2019 EULAR/ACR criteria when compared with the 1982/1997 ACR criteria as the gold standard was 91.3%. This new set of criteria allowed an earlier SLE patient classification in 7.4% (mean 0.67 years) and 0.6% (mean 1.47 years) than the 1982/1997 ACR and the 2012 SLICC criteria, respectively. Patients accruing the 2019 EULAR/ACR earlier than the 1982/1997 ACR criteria were more likely to have high anti-dsDNA titres; those accruing them later were less likely to have mucocutaneous and joint manifestations; this was not observed when comparing them with the 2012 SLICC criteria. CONCLUSIONS: The 2019 EULAR/ACR criteria classified earlier only a small proportion of Latin America patients than with the two other criteria sets in real-life clinical practice scenarios. Further studies in different patient populations are needed before these new criteria are adopted worldwide.

Course of serological tests in treated subjects with chronic Trypanosoma cruzi infection: A systematic review and meta-analysis of individual participant data.

OBJECTIVE: To determine the course of serological tests in subjects with chronic Trypanosoma cruzi infection treated with anti-trypanosomal drugs. METHODS: A systematic review and meta-analysis was conducted using individual participant data. Survival analysis and the Cox proportional hazards regression model with random effects to adjust for covariates were applied. The protocol was registered in the PROSPERO database (http://www.crd.york.ac.uk/PROSPERO; CRD42012002162). RESULTS: A total of 27 studies (1296 subjects) conducted in eight countries were included. The risk of bias was low for all domains in 17 studies (63.0%). Nine hundred and thirteen subjects were assessed (149 seroreversion events, 83.7% censored data) for enzyme-linked immunosorbent assay (ELISA), 670 subjects (134 events, 80.0% censored) for indirect immunofluorescence assay (IIF), and 548 subjects (99 events, 82.0% censored) for indirect hemagglutination assay (IHA). A higher probability of seroreversion was observed within a shorter time span in subjects aged 1-19 years compared to adults. The chance of seroreversion also varied according to the country where the infection might have been acquired. For instance, the pooled adjusted hazard ratio between children/adolescents and adults for the IIF test was 1.54 (95% confidence interval 0.64-3.71) for certain countries of South America (Argentina, Bolivia, Chile, and Paraguay) and 9.37 (95% confidence interval 3.44-25.50) for Brazil. CONCLUSIONS: The disappearance of anti-T. cruzi antibodies was demonstrated along the course of follow-up. An interaction between age at treatment and country setting was found.