Reduction in circulating dsDNA antibody titer after administration of LJP 394

Abstract

Objective: To examine the safety and immunological effects, in patients with systemic lupus erythematosus (SLE), of LJP 394, a novel B cell toleragen designed to lower dsDNA antibodies.

Methods: Four women with stable SLE were given a 100 mg infusion of LJP 394 and were followed for 4 weeks. Routine safety variables were measured, as well as anti-dsDNA, circulating immune complexes, complement, and complement split products.

Results: Anti-dsDNA titers were promptly lowered. At 4 weeks postinfusion, 2 patients' titers remained below baseline and 2 returned to pretreatment levels. Transient increases in some complement split products were noted; however, no adverse clinical events occurred during or immediately after infusion.

Conclusion: LJP 394 successfully and safely lowered anti-dsDNA in 4 patients with SLE. Immune complex formation and rapid elimination is the most likely explanation for the observed findings.