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Abstract
Background: Lupus nephritis, one of the most severe and therapeutically challenging manifestations of systemic lupus erythematosus (SLE), has been the target of drug development by La Jolla Pharmaceutical Company. Abetimus sodium, an example of the La Jolla Pharmaceutical Company's Tolerance Technology® is an intravenously administered tetrameric oligonucleotide conjugate that safely reduces antidouble-stranded DNA (anti-dsDNA) antibodies. Given the importance of anti-dsDNA antibodies in the pathogenesis of lupus nephritis, the Phase II and III trials were designed to evaluate whether treatment with abetimus sodium could prolong the time to renal flare in cohorts of patients at high risk of nephritic flares. Objective and methods: The available data regarding abetimus were reviewed and the current status of the drug's development program is reported. Conclusions: Animal studies have demonstrated the ability of abetimus to reduce the titers of anti-dsDNA antibodies as well as of antidsDNA antibody-secreting cells. Administration of abetimus to patients with SLE has uniformly been associated with reductions in circulating anti-dsDNA antibodies. However, two pivotal trials with large numbers of lupus nephritis patients failed to demonstrate statistically signi ficant prolongations in time to renal flare. An event-driven randomized placebo-controlled trial was abruptly terminated in February 2009 after an interim data safety monitoring board determined that achievement of a successful study outcome was futile.