RESUMO
Abatacept (ABA) es una proteína de fusión que inhibe la señal coestimulatoria del linfocito T y está indicado en pacientes con artritis reumatoidea (AR) y artritis crónica juvenil moderada a severa sin respuesta a metotrexato (MTX). ABA ha demostrado su eficacia y seguridad en numerosos estudios controlados, doble ciego, randomizados en poblaciones seleccionadas. La incidencia de eventos adversos en estos estudios oscila entre 80 y 400 por 100 pacientes año. El objetivo del presente estudio fue evaluar la seguridad de ABA en pacientes con AR no seleccionados de la vida real. Material y métodos: Se incluyeron en forma consecutiva todos los pacientes con AR (criterios ACR'87) de 4 centros de reumatología que hubieran recibido al menos 1 dosis de ABA. Se consignaron datos socio-demográficos, características clínicas de la enfermedad, número de infusiones, dosis, y medicación concomitante. Se evaluaron todos los eventos adversos y se determinó la severidad y causalidad. Se consideraron las causas de suspensión del tratamiento. Análisis estadístico: Se evaluó la incidencia de eventos adversos/100 pacientes año de tratamiento, las variables categóricas fueron comparadas por Chi cuadrado y las continuas por test de Student o ANOVA...
Abatacept (ABA) is a fusion protein that inhibits the T cell costimulatorysignal and is indicated in patients with moderate to severe RheumatoidArthritis (RA) and Juvenil Idiopathic Arthritis, not responding to methotrexate. ABA has demonstrated eficacy and security in severalcontrolled, double-blind, randomized studies in selected populations.The objective of the present study was to evaluate security of ABA in patients with RA in the real life. Material and Methods: Consecutive patients with RA (ACR´87 classification) from 4 rheumatology centers that received at least one infusion of ABA were included. Socio-demographic data, disease characteristics, number of infusions, dosis, and concomitant medicationswere registered. All Adverse Events (AE) were evaluated and severityand causality were determined. Causes of treatment discontinuationwas also considered.Statistical analysis: Incidence of AE per 100 patient-years was evaluated, categorical variables were compared by Chi2 and continuous variables by Student T-test or ANOVA. Results: 184 patients were included, 155 (84.2%) were female, median age was 56 years (IQR 48-64) and median duration of disease was 13 years (IQR 8-18). 94.7% of the patients were rheumatoidfactor-positive and 82% had erosive disease. 90% were treatedwith concomitant DMARDs, methotrexate being the most frequent(76.5%). In 67% of the patients ABA was the first biologic agent used, and 23% had previously received at least one anti-TNF. Median duration of treatment with ABA was 24 months (IQR 11-34) and median number of infusions was 23 (IQR 10-34). Incidence of all AE was 46.18 per 100 patient-years, being the more frequents: Infections (27.3 per 100 patient-years), and infusion reactions (8.6 per100 patient-years)...
