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Objetivo: Actualizar los resultados del registro BIOBADASAR sobre seguridad, duración y causas de interrupción del tratamiento luego de 8 años de seguimiento. Métodos: BIOBADASAR es un registro de seguridad de terapias biológicas establecido por la Sociedad Argentina de Reumatología. Se presenta la descripción de BIOBADASAR 3.0, una cohorte compuesta por 53 centros de Argentina seguidos prospectivamente desde agosto de 2010 hasta enero de 2018. Resultados: Se registraron 4656 pacientes, 6234 tratamientos [3765 casos (terapia con biológicos) y 2469 controles (terapia no biológicos)]. Se interrumpió el tratamiento en el 44,6% en los casos vs. 27,9% en los controles. Causa principal de discontinuación fue por ineficacia (40% casos vs. 32% controles). Se presentaron 3154 eventos adversos (2230 en casos vs. 924 en controles), de los cuales el 13,6% fueron graves (9,8% en casos y 3,7% en controles). El evento adverso (EA) más frecuente en ambos grupos fueron las infecciones (43,56% en casos vs. 34,31% en los controles, RR: 3,42; IC 95%: 3,02-3,88), y de ellas las de vías aéreas superiores (14,5%). Las neoplasias se presentaron en 78 casos vs. 45 en controles (RR: 1,98; IC 95%: 1,37-2,86). Conclusiones: En este sexto reporte no se observan tendencias diferentes sobre seguridad, duración y causas de interrupción del tratamiento respecto a informes previos. Las infecciones fueron el principal EA y la ineficacia, seguido por EA y la pérdida de pacientes las principales causas de suspensión del tratamiento. El advenimiento de nuevos agentes biológicos y la necesidad de control en seguridad a largo plazo, fortalece el uso de este tipo de registro. Objective: Update the results of the BIOBADASAR registry on safety, duration and causes of treatment interruption after 8 years of follow-up. Methods: BIOBADASAR is a safety record of biological therapies established by the Argentine Society of Rheumatology. The description of BIOBADASAR 3.0 is presented, a cohort of 53 centers in Argentina followed prospectively from August 2010 to January 2018. Results: 4656 patients were registered, 6234 treatments [3765 cases (therapy with biologicals) and 2469 controls (non-biological therapy)]. Treatment was interrupted in 44.6% in cases vs. 27.9% in controls. Main cause of discontinuation was due to inefficiency (40% cases vs. 32% controls). There were 3154 adverse events (2230 in cases vs. 924 in controls), of which 13.6% were tombs (9.8% in cases and 3.7% in controls). The most frequent adverse event (AE) in both groups were infections (43.56% in cases vs. 34.31% in controls, RR: 3.42, 95% CI: 3.02-3.88), and the upper airway pathways (14.5%). Neoplasms were published in 78 cases versus 45 controls (RR: 1.98, 95% CI: 1.37-2.86). Conclusions: In this article, there are no different trends regarding safety, duration and causes of interruption of treatment compared to previous reports. Infections were the main causes of treatment discontinuation. The advent of new biological agents and the need for control over long-term security, strengthens the use of this type of registration.

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.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.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 was1 (E wave velocity decreased, A wave velocity increased) , and desaceleration time (DT) and isovolumic relaxation time (IRT) were prolonged. Ap-value0.05 was considered as significant.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 ratio1compared with the controls ( p00001). The mean IRT value was significantly longer than in controls ( 83,59 1 13,82 vs 74,41 i 15,14 p0.01). There was no correlation between the duration of illness and E/A ratio and IRT ( p=0.70, p=0.13).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.

Rheumatoid Arthritis (RA) is a chronic disease leading to functional impairment and early mortality. Treatment with disease-modifying antirheumatic drugs have shown to achieve disease remission and improves its evolution. The use of combined therapy should have a biological efficacy, no increased toxicity and have an acceptable dose interval. Also, it should begin its action quickly and be cost-effective.to assess the security of the combined treatment with Methotrexate (MTX) and Leflunomide (LF) in patients with Rheumatoid Arthritis (RA) and to evaluate whether the dose and route of MTX administration influence on the toxicity.Patients with RA who fulfilled ACR criteria and they attended to the Rheumatology Unit at Córdoba Hospital in the last 2 years were assessed. All the patients that received combined treatment with MTX in doses from 7.5 mg to 25 mg weekly orally (PO) or intramuscularly (i.m.) that started LF treatment in doses of 20 mg/day due to disease activity persistence were retrospectively assessed. Patients having at least 6 months of combined treatment were included. Data on treatment and adverse events were collected. They were evaluated at the beginning, at 6 and 12 months of treatment. The presence of adverse events as well as the stop of combined treatment was evaluated at 6 and 12 months of treatment. Adverse events in patients with oral and i.m. MTX treatment and in different doses were compared for the analyses. P0.05 was considered significant.62 patients with a mean age of 54 were included. 89% were female and had positive rheumatoid factor and 83% had radiological erosions. Eighty eight percent were in doses of 15 mg MTX, 4.9% with 10 mg and 25 mg at the beginning of LF treatment. Twenty four percent suffered from adverse events and 33% left the medication by 6 months. Among adverse events, 6 patients had diarrhea, 5 increased hepatic enzymes, 3 alopecia, 3 weight loss, and 2 had anemia and leucopenia. Eight patients stopped the medication in 6 months, but only 5 did because of adverse events. There was not significant statistical difference in adverse events between patients with different dose or routes of administration of MTX.The presence of adverse events in MTX and LF combined treatment was low and it developed during the first 6 months of treatment in our patients. The MTX route of administration and doses did not influence on the toxicity of the combined treatment with LF. The combined therapy seems to be a safe treatment option in RA patients.