Article

Abetimus sodium (riquent) for the prevention of nephritic flares in patients with systemic lupus erythematosus.

New York University School of Medicine, New York, NY, USA.
Rheumatic Disease Clinics of North America (impact factor: 3.02). 03/2006; 32(1):149-56, x. DOI:10.1016/j.rdc.2005.11.001 pp.149-56, x
Source: PubMed

ABSTRACT Abetimus sodium has been under development for the treatment of systemic lupus erythematosus since the early 1990s. Because its administration results in the selective reduction of circulating double-stranded DNA antibodies, La Jolla Pharmaceutical Company has focused on the agent's ability to prolong time to nephritic flare. Fourteen trials have been initiated since 1994, but the two pivotal registration trials failed to meet primary end points. The US Food and Drug Administration issued a letter in October 2004 that stated abetimus sodium was "approvable" pending the successful completion of a trial demonstrating clinical benefit. The fate of this agent lies in the ability of the company to successfully complete a phase III study.

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    Article: Tratamiento de la nefritis lúpica
    L. Silva Fernández, José Luis Andréu Sánchez, Ellen M. Ginzler
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    ABSTRACT: La nefritis lúpica es una causa importante de morbilidad y mortalidad en los pacientes con lupus eritematoso sistémico. El tratamiento convencional de inducción de remisión en la nefritis lúpica grave se basa en la utilización de ciclofosfamida intravenosa mensual. Datos recientes han puesto de manifiesto que se consigue mantener la remisión de la nefritis lúpica con azatioprina o micofenolato, con un menor número de efectos secundarios que con la administración trimestral de ciclofosfamida intravenosa. En los últimos años se han publicado ensayos clínicos controlados y aleatorizados que plantean nuevas modalidades terapéuticas en la inducción de remisión en nefritis lúpica, como la utilización de pautas menos agresivas de ciclofosfamida intravenosa o el uso de micofenolato mofetilo. Son necesarios más estudios para establecer el tratamiento óptimo de los pacientes con nefritis lúpica grave.
    Reumatología clínica, ISSN 1699-258X, Vol. 4, Nº. 4, 2008, pags. 140-151.
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Keywords

Abetimus sodium
 
administration results
 
agent's ability
 
approvable
 
clinical benefit
 
double-stranded DNA antibodies
 
Drug Administration
 
La Jolla Pharmaceutical Company
 
nephritic flare
 
primary end points
 
selective reduction
 
stated abetimus sodium
 
systemic lupus erythematosus
 
two pivotal registration trials
 

Richard Furie