Seguridad de abatacept en pacientes con artritis reumatoidea / Safety of abatacept in patients with rheumatoid arthritis
Dal Pra, Fernando; Tamborenea, María N; Mysler, Eduardo; Velasco, Jorge; Berman, Alberto; Spindler, Alberto; Paz, Silvia; Papagno, María J; Velasco Zamora, José L; Citera, Gustavo.
Rev. argent. reumatol
; 23(4): 30-36, 2012. graf
Artigo
em Espanhol
| BINACIS | ID: bin-128101
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 ACR87) 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...(AU)
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.Statisticalanalysis:
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
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)...(AU)
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