Abetimus sodium (riquent) for the prevention of nephritic flares in patients with systemic lupus erythematosus.
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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ABSTRACT: No new therapy for systemic lupus erythematosus has been approved. In the last decade, the development of several novel compounds has been pursued for lupus, but so far nothing has been proven to be effective. This review discusses some of the reasons why it may be so difficult to demonstrate that a novel therapy is effective for this disease. These include the complexity of the disease itself; the lack of reliable outcome measures; our limited understanding of the pathogenesis of the disease; the propensity of lupus patients to have bad outcomes and to react to medicines in unusual ways; the heterogeneity of the patient population; the unpredictable course of disease in individual patients; and the lack of reliable biomarkers. Although some of the tested targeted compounds that are apparently based on strong preclinical and mechanistic data may indeed not be effective therapies for SLE, it is hard not to believe that among the various specific agents now being tested that at least some of them should downregulate the abnormal immunoregulation characteristic of SLE, and thus be clinically effective. We need to be persistent and imaginative in identifying these effective agents and proving their efficacy so that they may be widely used in our lupus populations.Journal of Autoimmunity 04/2009; 32(3-4):223-30. · 8.15 Impact Factor
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ABSTRACT: Glomerulonephritis is a common cause of chronic kidney disease and end stage renal failure. Current therapy relies on variably effective, nonspecific and toxic immunosuppression. Recent insights into underlying biology and disease pathogenesis in human glomerulonephritis combined with advances in the fields of inflammation and autoimmunity promise a cadre of novel targeted interventions. This review highlights the therapeutic potential of two antigens, alpha3 (IV)NC1 collagen and podocyte neutral endopeptidase, and two cell signaling and effector molecules, IgG Fc receptors and complement, judged to be particularly amenable to therapeutic manipulation in man. It is anticipated that continued dissection of pathogenesis in the diverse disorders that comprise the glomerulonephritides will provide the basis for individualized disease-specific therapy.Targets & therapy 10/2008; 2(3):531-45.
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ABSTRACT: Lupus nephritis is one of the most common and serious complications of systemic lupus erythematosus (SLE) in childhood affecting more than 80 % of patients. Treatment of this complication has undergone significant evolution in recent years. A series of randomized controlled trials has clarified the role of a variety of immunomodulating regimens including some novel biologic medications. This review touches on the major trials that have influenced practice and shaped current thinking about the treatment of proliferative lupus glomerulonephritis.Pediatric Nephrology 11/2012; · 2.94 Impact Factor