LJP-394 (abetimus) is an anti-anti-ds-DNA B-cell toleragen consisting of four synthetic double-stranded oligodeoxyribonucleotides. Toleragens have been shown to suppress antibody synthesis by targeted B cells. They cross-link B-cell surface antibodies without providing the second T-cell activating signal, thereby making the B cells unresponsive. The consequence is a down-regulation of anti-ds-DNA antibody, an autoantibody presumed to be a causative factor in lupus nephritis. Therefore, a double-blind placebo-controlled study including 230 SLE patients with a history of renal disease has been performed (Alacron-Segovia et al. 2000, Furie et al. 2001, McNeely et al. 2001). Although the initial evaluation of the results indicated no efficacy in the improvement of renal disease, upon a second analysis it appeared that LJP-394 provided clinical benefit only in those patients with high levels of anti-ds-DNA antibodies. Moreover, the compound was well tolerated with a low risk for serious side effects (Wallace 2001b).

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