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: 2.1). 03/2006; 32(1):149-56, x. DOI: 10.1016/j.rdc.2005.11.001
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.

  • Source
    [Show abstract] [Hide abstract]
    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. 07/2008;
  • [Show abstract] [Hide abstract]
    ABSTRACT: Rapid advances in understanding the immunopathogenesis of systemic lupus erythematosus (SLE) have yielded an unprecedented era of discovery of new targets with therapeutic potential. Recent clinical trials have also shed light on the optimal utility of several traditional therapies used in our SLE armamentarium.
    Bailli&egrave re s Best Practice and Research in Clinical Rheumatology 01/2008; 21(6):971-87. · 3.55 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Lupus nephritis is a relevant source of morbidity and mortality in patients with systemic lupus erythematosus. The standard therapy of remission induction in severe lupus nephritis is based on the use of monthly intravenous cyclophosphamide. Recent data have established that the maintenance of remission in lupus nephritis can be achieved with azathioprine or mycophenolate mofetil, with less adverse effects than quarterly intravenous cyclophosphamide. In recent years, a number of controlled randomized clinical trials have been published, opening new therapeutic options in the induction of remission in lupus nephritis, such as less aggressive regimens of intravenous cyclophosphamide or mycophenolate mofetil. Further studies are needed for establishing the optimal therapy of lupus nephritis patients.
    Reumatología Clínica 07/2008; 4(4):140-51.