Evaluation of belimumab treatment in patients with systemic lupus erythematosus in a clinical practice setting: Results from a 24-month OBSErve study in Argentina.

OBJECTIVE: To describe clinical effectiveness of belimumab for systemic lupus erythematosus (SLE) in real-world practice in Argentina. METHODS: This retrospective, observational study analysed medical record data of patients with SLE treated with belimumab in 15 centres in Argentina. Primary endpoint: overall clinical response (assessed on a scale similar to the 6-point Physician Global Assessment) at months 6, 12, 18 and 24, all versus index (belimumab initiation). Secondary endpoints: improvement in disease activity (SELENA-SLEDAI), SLE manifestations, and corticosteroid dose change. RESULTS: Records for 81 patients (91% female) were analysed. Clinical improvements were reported for 95%, 95%, 98% and 100% patients at 6, 12, 18, and 24 months post index, respectively. Mean SELENA-SLEDAI score decreased from 11.21 at index to 4.76, 3.77, 3.86 and 2.17 at 6, 12, 18, and 24 months post index, respectively. Number of flares decreased from 1.05 at index to 0.21, 0.09, 0.22 and 0.30 at 6, 12, 18, and 24 months post index, respectively. Mean corticosteroid dose was 14.59 mg/day at index, and 6.45, 5.18, 5.17 and 4.78 mg/day at 6, 12, 18, and 24 months post index, respectively. CONCLUSIONS: Real-world patients with SLE treated with belimumab in Argentina demonstrated clinical improvements and reductions in corticosteroid dose.

Correction to: PANLAR consensus statement on biosimilars.

The two co-authors of the mentioned above article were incorrect. The correct are authors should have been "P. A. Beltrán" instead of "P. A. B. Roa" and "J. F. Diaz-Coto" instead of "L. Diaz Soto".

PANLAR consensus statement on biosimilars.

INTRODUCTION: Biologics have improved the treatment of rheumatic diseases, resulting in better outcomes. However, their high cost limits access for many patients in both North America and Latin America. Following patent expiration for biologicals, the availability of biosimilars, which typically are less expensive due to lower development costs, provides additional treatment options for patients with rheumatic diseases. The availability of biosimilars in North American and Latin American countries is evolving, with differing regulations and clinical indications. OBJECTIVE: The objective of the study was to present the consensus statement on biosimilars in rheumatology developed by Pan American League of Associations for Rheumatology (PANLAR). METHODS: Using a modified Delphi process approach, the following topics were addressed: regulation, efficacy and safety, extrapolation of indications, interchangeability, automatic substitution, pharmacovigilance, risk management, naming, traceability, registries, economic aspects, and biomimics. Consensus was achieved when there was agreement among 80% or more of the panel members. Three Delphi rounds were conducted to reach consensus. Questionnaires were sent electronically to panel members and comments about each question were solicited. RESULTS: Eight recommendations were formulated regarding regulation, pharmacovigilance, risk management, naming, traceability, registries, economic aspects, and biomimics. CONCLUSION: The recommendations highlighted that, after receiving regulatory approval, pharmacovigilance is a fundamental strategy to ensure safety of all medications. Registries should be employed to monitor use of biosimilars and to identify potential adverse effects. The price of biosimilars should be significantly lower than that of reference products to enhance patient access. Biomimics are not biosimilars and, if they are to be marketed, they must first be evaluated and approved according to established regulatory pathways for novel biopharmaceuticals. KEY POINTS: • Biologics have improved the treatment of rheumatic diseases. • Their high cost limits access for many patients in both North America and Latin America. • Biosimilars typically are less expensive, providing additional treatment options for patients with rheumatic diseases. • PANLAR presents its consensus on biosimilars in rheumatology.

The basal to total insulin ratio in outpatients with diabetes on basal-bolus regimen.

OBJECTIVE: To evaluate the basal/total ratio of daily insulin dose (b/T) in outpatients with diabetes type 1 (DM1) and type 2 (DM2) on basal-bolus regimen, by investigating whether there is a relationship with HbA1c and episodes of hypoglycemia. METHODS: Multicentric, observational, cross-sectional study in Italy. Adult DM1 (n = 476) and DM2 (n = 541) outpatients, with eGFR >30 mL/min/1.73 m2, on a basal-bolus regimen for at least six months, were recruited from 31 Italian Diabetes services between March and September 2016. Clinicaltrials.govID: NCT03489031. RESULTS: Total daily insulin dose was significantly higher in DM2 patients (52.3 ± 22.5 vs. 46 ± 20.9 U/day), but this difference disappeared when insulin doses were normalized for body weight. The b/T ratio was lower than 0.50 in both groups: 0.46 ± 0.14 in DM1 and 0.43 ± 0.15 in DM2 patients (p = 0.0011). The b/T was significantly higher in the patients taking metformin in both groups, and significantly different according to the type of basal insulin (Degludec, 0.48 in DM1 and 0.44 in DM2; Glargine, 0.44 in DM1 and 0.43 in DM2; Detemir, 0.45 in DM1 and 0.39 in DM2). The b/T ratio was not correlated in either group to HbA1c or incidence of hypoglycemia (<40 mg/dL, or requiring caregiver intervention, in the last three months). In the multivariate analysis, metformin use and age were independent predictors of the b/T ratio in both DM1 and DM2 patients, while the type of basal insulin was an independent predictor only in DM1. CONCLUSION: The b/T ratio was independent of glycemic control and incidence of hypoglycemia.

Correction to: The basal to total insulin ratio in outpatients with diabetes on basal-bolus regimen.

[This corrects the article DOI: 10.1007/s40200-018-0358-2.].

Sex differences in food choices, adherence to dietary recommendations and plasma lipid profile in type 2 diabetes - The TOSCA.IT study.

BACKGROUND AND AIMS: Diabetic women have a more adverse plasma lipid profile than men. Sex differences in dietary habits may play a role, but are little investigated. The study evaluates the quality of diet, adherence to the nutritional recommendations of the Diabetes and Nutrition Study Group and their relation with plasma lipid in men and women with diabetes. METHODS AND RESULTS: We studied 2573 people, aged 50-75, enrolled in the TOSCA.IT study (clinicaltrials.gov; NCT00700856). Plasma lipids were measured centrally. Diet was assessed with a semi-quantitative food frequency questionnaire. Women had a more adverse plasma lipid profile than men. Women consumed significantly more legumes, vegetables, fruits, eggs, milk, vegetable oils, and added sugar, whereas men consumed more starchy foods, soft drinks and alcoholic beverages. This stands for a higher proportion (%) of energy intake from saturated fat and added sugar (12.0 ± 2.4 vs 11.5 ± 2.5 and 3.4 ± 3.2 vs 2.3 ± 3.2, P < 0.04), and a higher intake of fiber (11.2 ± 2.8 vs 10.4 ± 2.6 g/1000 Kcal/day) in women. Adherence to the recommendations for saturated fat and fiber consumption was associated with significantly lower LDL-cholesterol regardless of sex. Adherence to the recommendations for added sugars was associated with significantly lower triglycerides and higher HDL-cholesterol in men and women. CONCLUSIONS: Men and women with diabetes show significant differences in adherence to nutritional recommendations, but sex differences in plasma lipid profile are unlikely to be explained by nutritional factors. Adherence to the nutritional recommendations is associated with a better plasma lipid profile regardless of sex, thus reinforcing the importance of substituting saturated for unsaturated fat sources, increasing fiber and reducing added sugar intake.

Influence of dietary fat and carbohydrates proportions on plasma lipids, glucose control and low-grade inflammation in patients with type 2 diabetes-The TOSCA.IT Study.

PURPOSE: The optimal macronutrient composition of the diet for the management of type 2 diabetes is debated, particularly with regard to the ideal proportion of fat and carbohydrates. The aim of the study was to explore the association of different proportions of fat and carbohydrates of the diet-within the ranges recommended by different guidelines-with metabolic risk factors. METHODS: We studied 1785 people with type 2 diabetes, aged 50-75, enrolled in the TOSCA.IT Study. Dietary habits were assessed using a validated food-frequency questionnaire (EPIC). Anthropometry, fasting lipids, HbA1c and C-reactive protein (CRP) were measured. RESULTS: Increasing fat intake from <25 to ≥35 % is associated with a significant increase in LDL-cholesterol, triglycerides, HbA1c and CRP (p < 0.05). Increasing carbohydrates intake from <45 to ≥60 % is associated with significantly lower triglycerides, HbA1c and CRP (p < 0.05). A fiber intake ≥15 g/1000 kcal is associated with a better plasma lipids profile and lower HbA1c and CRP than lower fiber consumption. A consumption of added sugars of ≥10 % of the energy intake is associated with a more adverse plasma lipids profile and higher CRP than lower intake. CONCLUSIONS: In people with type 2 diabetes, variations in the proportion of fat and carbohydrates of the diet, within the relatively narrow ranges recommended by different nutritional guidelines, significantly impact on the metabolic profile and markers of low-grade inflammation. The data support the potential for reducing the intake of fat and added sugars, preferring complex, slowly absorbable, carbohydrates.

Evolución y factores pronósticos en pacientes lúpicos con admisión en unidad de terapia intensiva / Evolution and prognostic factors in patients with lupus admitted to intensive care unit

El objetivo de este estudio fue evaluar las causas de ingreso y la mortalidad de pacientes con LES admitidos en Unidad de Terapia Intensiva (UTI), e identificar factores de riesgo asociados con mortalidad así comola utilidad de la escala de APACHE II como factor de pronóstico. Se estudiaron retrospectivamente pacientes con diagnóstico de LES acorde al ACR 1997, ingresados en UTI del Hospital Córdoba des de junio de 2008 a marzo del 2011. Se analizaron datos demográficos, características de la enfermedad, causas de admisión, escala de APACHEII en las primeras 24 hs de internación, tratamiento realizado, días de internación y mortalidad. Valores de p <0,05 fueron considerados estadísticamente significativos. Se incluyeron 23 pacientes con edad promedio de 31 años, 87,5% de sexo femenino. Las principales causas de ingreso fueron la actividad lúpica e infección en 52,1%. El promedio de días de internación fue de 12. Los tratamientos recibidos más frecuentes fueron: antibióticos 93,8%, pulsos de esteroides 62,5%, ARM e inmunosupresores 56,3%, respectivamente. Ninguno se correlacionó conmortalidad. La mortalidad fue de un 21,7% principalmente causada por la combinación de actividad lúpica con infección. El scoreAPACHE II no tuvo asociación estadísticamente significativa con lamortalidad. Conclusión: La tasa de mortalidad en los pacientes lúpicos admitidosen UTI fue elevada. Sería importante desarrollar instrumentos más certeros de pronóstico en pacientes lúpicos que ingresen a UTI.

Objective: To study the causes of admission and mortality in lupus patients admitted to Intensive Care Unit (ICU) and to identify risk factors associated with mortality.We retrospectivel y studied patients with SLE diagnosis with ACRCriteria who were admitted to ICU of Córdoba hospital from June2008 to March 2011. We analyzed demographic data (age, gender, socioeconomic status by Graffar scale), duration of disease, treatment, disease activity by ECLAM score, organic damage by SLICC, causes of ICU admission, APACHE II score in the first 24 hours of hospitalization, days in ICU and mortality. P value <0.05 was considered statistically significant.23 patients were included with a mean age of 31 years, 87.5% female and 81.3% with good socioeconomic status. The duration of SLE beforeICU admission was 53 months, 37.5% had no treatment at admission.The main reasons for admission were lupus activity and infection in 52.1% of the patients. The average days of ICU hospitalization was12. The most frequent treatments used were steroid pulses (62.5%), ARM, immunosuppressive treatment (56.3%), and antibiotics 93.8%. Treatments received were not correlated with mortality. Mortality was21.7% and the most frequent cause was the combination of lupus activity with infection. The APACHE II score was not statistically significant association with mortality. Conclusion: The mortality rate in lupus patients admitted to ICU remains high despite of treatment.

Detection and molecular characterization of Egyptian isolates of grapevine viruses.

Selected commercial and/or local vineyards and nurseries in three different governorates of Egypt (Alexandria, El-Beheira and El-Menofia) were surveyed for symptoms indicative of infection by grapevine viruses. Leaf samples from red-fruited and white-fruited Vitis vinefera were tested for grapevine leafroll associated viruses (GLRaV-1, GLRaV-2, and GLRaV-3), grapevine viruses A and B (GVA, GVB), grapevine rupestris stem pitting virus (GRSPaV), grapevine fanleaf virus (GFLV), and grapevine fleck virus (GFKV) from early April to late October 2010. Incidence of these viruses was assessed by RT-PCR in 60 different samples. Selected amplicons were sequenced. While GVA was the most wide spread (30%), GLRaV-1, GVB, GFLV, and GFKV were not detected during the survey. However, GVA, GLRaV-2, GLRaV-3, and GRSPaV were detected in the form of single infection or in mixed infections of 2 to 4 viruses. Phylogenetic analysis was performed on all Egyptian isolates of GLRaV-2 (4), GLRaV-3 (7), GVA (3), and GRSPaV (6). GRSPaV was detected for the first time in Egypt. Phylogenetic analysis provided insights into the evolutionary relationship between the reported Egyptian isolates and other previously reported isolates.

Uso de rituximab en lupus eritematoso sistémico / Use of rituximab in systemic lupus erythematosus

Objetivos: Evaluar la evolución en el transcurso de dos años en pacientes con Lupus Eritematoso Sistémico (LES) refractarios al tratamiento inmunosupresor convencional, que recibieron Rituximab (RTX). Pacientes y métodos: Se estudiaron retrospectivamente 14 pacientes con diagnóstico de LES que recibieron tratamiento con RTX, atendidos en los servicios de Reumatología del Hospital Córdoba, Sanatorio Allende y Hospital Italiano de la ciudad de Córdoba, desde el año 2006. Se recabaron datos demográficos, diagnósticos, motivos de indicación de RTX, tasas de respuestas y eventos adversos. La dosis del mismo fue de 1 gramo día 1 y 15, luego cada 6 meses. Todos los pacientes habían recibido tratamiento con inmunosupresores: 12 ciclofosfamida, azatioprina, micofenolato mofetil y esteroides y 2 azatioprina y micofenolato mofetil. La actividad de la enfermedad fue medida por SELENA SLEDAI basalmente, a los 6, 12 y 24 meses postratamiento. El daño acumulado fue medido por SLICC solo basalmente. En los pacientes con nefropatía según clasificación ISN/RPS 2003, se analizó la proteinuria basal, a los 6, 12 y 24 meses, sedimento urinario y función renal medida por clearance de creatinina. Un valor de p <0,05 fue considerada significativa. Resultados: El número total de pacientes incluidos con diagnóstico de LES fue de 14, de los cuales 12 eran de sexo femenino (85,7%) y 2 de sexo masculino (14,3%). La edad promedio fue de 33,64 ± 10,33 años. Del total de pacientes, 9 presentaban compromiso renal, 3 compromiso hematológico (anemia hemolítica autoinmune, leucopenia, (trombocitopenia), 1 compromiso pulmonar (neumonitis lúpica aguda) y 1 artritis refractaria. De los pacientes con nefropatía, la clase histológica más frecuente fue la clase IV (proliferativa difusa) 77,8% (IC 95% 44,4-100%)

Objective: To evaluate the clinical response of RTX in refractory toother immunosuppressive drugs SLE patients. Patients and Methods: We retrospectively studied SLE patients who were treated with rituximab (RTX) at Rheumatology Units of Córdoba Hospital, Italiano Hospital and Sanatorium Allende in Córdoba city, since 2006. We studied demographic data, indication to RTX therapy, response, and adverse events. The disease activity was measured by SLEDAI and ECLAM and organ damage by SLICC at baseline andat 6, 12 and 24 months post-treatment. Patients with SLE and renal disease were analyzed baseline proteinuria, urinary sediment, renal function was measured by creatinine clearance. p <0.05 was considered statistically significant. Results:The number of patients was 14, 85.7% female with meanage of 33.64 ± 10.33 years old. 9 patients had renal involvement, 3 haematological, 1 lung involvement and severe arthritis. The basal SLEDAI was 15.93 ± 9.05, and 5.86 ± 5.57 and 2.8 ± 3.29 1 at 6and 24 months respectively (p <0,001).The level of proteinuria decreased from the baseline to 6, 12, 24 months (p=0.011), (p=0.028),(p=0.018). The main adverse reactions were infections in 3 patients(cutaneous infection, oral candidiasis, and pneumonia) and infusionsreactions in 2 cases. Conclusion: RTX could be a therapeutic option in SLE patients re-fractory to other immunosuppressive treatment.

Uso de rituximab en lupus eritematoso sistémico / Use of rituximab in systemic lupus erythematosus

Objetivos: Evaluar la evolución en el transcurso de dos años en pacientes con Lupus Eritematoso Sistémico (LES) refractarios al tratamiento inmunosupresor convencional, que recibieron Rituximab (RTX). Pacientes y métodos: Se estudiaron retrospectivamente 14 pacientes con diagnóstico de LES que recibieron tratamiento con RTX, atendidos en los servicios de Reumatología del Hospital Córdoba, Sanatorio Allende y Hospital Italiano de la ciudad de Córdoba, desde el año 2006. Se recabaron datos demográficos, diagnósticos, motivos de indicación de RTX, tasas de respuestas y eventos adversos. La dosis del mismo fue de 1 gramo día 1 y 15, luego cada 6 meses. Todos los pacientes habían recibido tratamiento con inmunosupresores: 12 ciclofosfamida, azatioprina, micofenolato mofetil y esteroides y 2 azatioprina y micofenolato mofetil. La actividad de la enfermedad fue medida por SELENA SLEDAI basalmente, a los 6, 12 y 24 meses postratamiento. El daño acumulado fue medido por SLICC solo basalmente. En los pacientes con nefropatía según clasificación ISN/RPS 2003, se analizó la proteinuria basal, a los 6, 12 y 24 meses, sedimento urinario y función renal medida por clearance de creatinina. Un valor de p <0,05 fue considerada significativa. Resultados: El número total de pacientes incluidos con diagnóstico de LES fue de 14, de los cuales 12 eran de sexo femenino (85,7%) y 2 de sexo masculino (14,3%). La edad promedio fue de 33,64 ± 10,33 años. Del total de pacientes, 9 presentaban compromiso renal, 3 compromiso hematológico (anemia hemolítica autoinmune, leucopenia, (trombocitopenia), 1 compromiso pulmonar (neumonitis lúpica aguda) y 1 artritis refractaria. De los pacientes con nefropatía, la clase histológica más frecuente fue la clase IV (proliferativa difusa) 77,8% (IC 95% 44,4-100%)

Objective: To evaluate the clinical response of RTX in refractory toother immunosuppressive drugs SLE patients. Patients and Methods: We retrospectively studied SLE patients who were treated with rituximab (RTX) at Rheumatology Units of Córdoba Hospital, Italiano Hospital and Sanatorium Allende in Córdoba city, since 2006. We studied demographic data, indication to RTX therapy, response, and adverse events. The disease activity was measured by SLEDAI and ECLAM and organ damage by SLICC at baseline andat 6, 12 and 24 months post-treatment. Patients with SLE and renal disease were analyzed baseline proteinuria, urinary sediment, renal function was measured by creatinine clearance. p <0.05 was considered statistically significant. Results:The number of patients was 14, 85.7% female with meanage of 33.64 ± 10.33 years old. 9 patients had renal involvement, 3 haematological, 1 lung involvement and severe arthritis. The basal SLEDAI was 15.93 ± 9.05, and 5.86 ± 5.57 and 2.8 ± 3.29 1 at 6and 24 months respectively (p <0,001).The level of proteinuria decreased from the baseline to 6, 12, 24 months (p=0.011), (p=0.028),(p=0.018). The main adverse reactions were infections in 3 patients(cutaneous infection, oral candidiasis, and pneumonia) and infusionsreactions in 2 cases. Conclusion: RTX could be a therapeutic option in SLE patients re-fractory to other immunosuppressive treatment.(AU)

Monoterapia biológica en pacientes con artritis reumatoidea en Argentina / Biological monotherapy in patients with rheumatoid arthritis in Argentina

Introducción: La utilización de agentes biológicos para el tratamiento de la Artritis Reumatoidea (AR) es habitualmente usada en aquellos pacientes con enfermedad activa que no hayan respondido al tratamiento con drogas modificadoras de la Artritis Reumatoidea convencionales (DMARD, por sus siglas en inglés) o que hayan presentado intolerancia a las mismas. Al estado actual de la evidencia, la terapia combinada de agentes biológicos más un DMARD convencional (principalmente metotrexato) constituye el estándar de tratamiento. Sin embargo existen algunos escenarios como la intolerancia, la falta de adherencia y la aparición de eventos adversos a las DMARDs convencionales donde la monoterapia biológica emerge como una opción terapéutica válida. Según los distintos registros a nivel internacional, la frecuencia de utilización de agentes biológicos en monoterapia oscila entre 12 a 39%. Debido a la ausencia de estos datos a nivel local decidimos realizar este estudio para conocer el porcentaje de pacientes que se encuentran en monoterapia biológica y analizar las causas que llevaron a este tipo de tratamiento. Materiales y métodos: Estudio de tipo corte transversal donde se invitó a participar a diferentes centros reumatológicos distribuidos a lo largo de Argentina. Cada centro revisó las historias clínicas de los últimos 30 a 50 pacientes consecutivos vistos con AR, mayores de 18 años, que habían presentado inadecuada respuesta al tratamiento con DMARDs y que estaban bajo tratamiento biológico. Se completaba una ficha por cada paciente incluido, registrando datos demográficos, de la enfermedad y tratamientos previos. Resultados: Se incluyeron 32 centros y se evaluaron 1148 historias clínicas de pacientes con AR durante el mes de octubre y noviembre del 2012. Un 21,4% (246) de los pacientes al momento del estudio se encontraba bajo tratamiento biológico en monoterapia...

Introduction: The use of biological agents for the treatment of rheumatoid arthritis (RA) is commonly used in patients with active disease who have not responded to treatment with conventional rheumatoid arthritis-modifying drugs (DMARDs) or Who have presented intolerance to them. At the present state of evidence, combined therapy of biological agents plus conventional DMARD (mainly methotrexate) is the standard of treatment. However, there are some scenarios such as intolerance, lack of adherence and the appearance of adverse events to conventional DMARDs where biological monotherapy emerges as a valid therapeutic option. According to different international registries, the frequency of use of biological agents in monotherapy ranges from 12 to 39%. Due to the absence of these data at the local level we decided to carry out this study to know the percentage of patients who are in biological monotherapy and to analyze the causes that led to this type of treatment. Materials and methods: A cross-sectional study where different rheumatologic centers throughout Argentina were invited to participate. Each center reviewed the medical records of the last 30 to 50 consecutive patients seen with RA, older than 18 years, who had inadequate response to treatment with DMARDs and who were under biological treatment. One card was completed for each patient included, recording demographic, disease and previous treatment data. Results: Thirty-two centers were included and 1148 clinical records of patients with RA were evaluated during October and November 2012. A total of 244 patients (246) at the time of the study were under monotherapy...

Primer reporte de eventos adversos de tratamientos biológicos en Argentina. Informe de Registro BIOBADASAR / First report of adverse events for biologic treatments in Argentine. BIOBADASAR Register

Introducción: En la actualidad existe gran cantidad de pacientes sometidos a tratamiento con agentes biológicos en enfermedades reumatológicas y se desconocen los efectos adversos predominantes, así como la eficacia y tasa de discontinuación de nuestros pacientes en dichos tratamientos. Objetivo: Comunicar los primeros resultados de BIOBADASAR, Registro Argentino de Acontecimientos Adversos ocasionados por el Uso de Agentes Biológicos en Reumatología. Métodos: Participan del registro 56 centros de Reumatología de Argentina. Se requiere el ingreso de un paciente no tratado con agentes biológicos por cada paciente expuesto ingresado en el registro. Datosdesde el 1 de agosto de 2010 hasta 1 abril 2011. Las variables categóricasse calcularon con chi cuadrado y las continuas con T student. Se calcularon porcentajes de incidencia y por persona/año. Resultados: Se incorporaron 966 pacientes (1132 tratamientos). Mujeres 763 (79%) y hombres 203 (21%). La edad media fue 52 años (3-88); 543 pacientes (56%) fueron tratados con agentes biológicos (casos) y 423 (44%) fueron no tratados con agentes biológicos (controles). 786 pacientes tenían artritis reumatoidea (81,4%) y 79 artritis psoriásica (8,2%), entre otros diagnósticos. La media de tiempo de evolución de enfermedad fue 11 años para los casos y 8,25 años para los controles. El fármaco biológico más utilizado fue el etanercept con 348 tratamientos (50%) y una supervivencia al tratamiento en años cuya media fue 2,90 seguido por el adalimumab con 158 tratamientos (22,7%) y una supervivencia al tratamiento en años cuya media fue 2,15. La causa más frecuente de interrupción de tratamiento en los casos fue ineficacia (42,1%) seguido por eventos adversos (32%).

Clinical guidelines for the management of acute viral infections in patients with systemic lupus erythematosus.

In recent decades, many research groups have focused on the role of viral infections in the etiopathogenesis of systemic lupus erythematosus (SLE), the so-called "viral hypothesis". The main candidates are herpes viruses such as Epstein-Barr virus (EBV) and cytomegalovirus (CMV), which have a high seroprevalence in the general population. However, a viral causal agent of SLE has not yet been discovered, although many interesting clinical findings on the complex interactions between viruses and SLE have been made. This review analyzes 88 cases of acute viral infections in adult patients with SLE and identifies situations in which viral infections influenced the diagnosis, prognosis or treatment of SLE. We also propose clinical guidelines for the management of these infections in patients with SLE.

[Ventricular diastolic dysfunction in rheumatoid arthritis]. / Disfunciondiastólica ventricular izquierda en la artritis reumatoidea.

UNLABELLED: Rheumatoid arthritis ( RA) is a chronic and systemic articular inflammatory disease, often associated with cardiac manifestations. However, cardiac involvement in RA is not always symptomatic. Previous studies reported high mortality rates for RA and that it was dependent on concurrent heart dis-ease. Myocardial infarction and inflammation have been reported in about 2% of the patients in autopsy studies. The earliest deterioration in cardiac disease is in diastolic function. OBJECTIVE: the aim of this study is to evaluate the ventricular diastolic dysfunction in patients with RA and its relation with the duration of the disease. PATIENTS AND METHODS: Thirty-two RA patients who attended the rheumatology unit at Hospital Cordoba during 2004 participated in this study. A control group was formed by thirty two healthy adults of matched sex and age. RA was diagnosed according to 1987 ACR criteria. None of them had diabetes mellitus, systemic hypertension, chronic lung disease, congenital cardiac malformation, coronary artery disease, arrhytmia or valvular heart disease. Two-dimensional, M-mode, pulsed and color Doppler echocardiography were performed on all these subjects by the same examiner. Diastolic dysfunction was defined when the E/A ratio was <1 (E wave velocity decreased, A wave velocity increased) , and desaceleration time (DT) and isovolumic relaxation time (IRT) were prolonged. Ap-value < 0.05 was considered as significant. RESULTS: The mean ages were 48,38 11,08 for patients and 46,81 9,96 for the control group.There were no significant differences between age, sex, heart rate, and systolic and diastolic blood pressure between RA patients and controls. Higher proportion of RA patients had E/A ratio < 1compared with the controls ( p<00001). The mean IRT value was significantly longer than in controls ( 83,59 1 13,82 vs 74,41 i 15,14 p<0.01). There was no correlation between the duration of illness and E/A ratio and IRT ( p=0.70, p=0.13). CONCLUSION: Diastolic function was impaired in patients with RA. There was no relation between some of the parameters of ventricular diastolic function and disease duration. These findings suggest a subclinical myocardial involvement in RA patients.

First Report of Strawberry vein banding virus on Strawberry in Italy.

In the summers of 2007 and 2008, diseased strawberry plants (Fragaria x ananassa Duch.) were observed in production fields in Ferrara and Forlì-Cesena districts (Emilia-Romagna Region) in northern Italy. Plants exhibited poor growth, leaf chlorosis, decline, and reduced fruit production. Older leaves sometimes displayed a premature purplish discoloration, while the younger leaves appeared chlorotic and were reduced in size with a marked yellow edge. Symptom severity was dependent on the cultivar and growing conditions. Sixty-one leaf samples were collected from diseased plants from production fields and cultivar collections. Each sample was tested by grafting on Fragaria vesca (clone 'UC4 and UC5') and F. virginiana (clone 'UC10' and 'UC11'). Forty-five days after indexing different symptoms, characteristic of viral diseases, appeared on indicator plants. In particular, 24 samples showed Strawberry vein banding virus (SVBV)-like symptoms with chlorotic streaks along and on both sides of the main leaf veins of UC5, UC10, and UC11 indicator plants. Molecular methods were also used to better investigate the causal agent. Nucleic acids were extracted from young leaves of field and indicator plants by the cetyltrimethylammoniumbromide method (1). PCR analyses were performed with primer pair SVBVdeta/SVBVdetb as previously described to specifically amplify a product of 423 bp (2). SVBV was detected on all symptomatic indicator plants and corresponding field samples as well as on the positive control sample (supplied by J. D. Postman, National Clonal Germplasm Repository, Corvallis, OR and I. E. Tzanetakis, Oregon State University, Corvallis). No amplicons were detected from nucleic acids extracted from symptomless strawberry plants. PCR products, amplified from four Italian SVBV isolates, were cloned and sequenced and represent part of ORF IV of the SVBV genome that codes for the coat protein (CP). Italian SVBV isolates were more similar to the U.S. isolates than to the Chinese isolates (Genbank Accession Nos. AY862389, AY955374, X97304, AY605662, AY605663, and AY605664), showing 93 and 86% nt sequence identity, respectively. Strawberry vein banding disease has been reported previously in Italy in 1986 (3), but to our knowledge, this is the first finding of SVBV on strawberry field plants in Italy. SVBV was listed as a quarantine pest by the European and Mediterranean Plant Protection Organization (OEPP/EPPO) in 1978, but its spread has been increasing within European countries. Further studies should be done to ensure that strawberry propagating material is free of known viruses including SVBV. References: (1) N. Boonham et al. J. Virol. Methods 101:37, 48, 2000. (2) J. R. Thompson et al. J. Virol. Methods 111:85, 93, 2003. (3) A. Pisi. EPPO Bull. 16:353, 358, 1986.