Weisman M H, Bluestein H G, Berner C M, de Haan H A
Division of Rheumatic Diseases, School of Medicine, University of California, San Diego, USA.
J Rheumatol. 1997 Feb;24(2):314-8.
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.
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.
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.
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.
研究新型B细胞耐受原LJP 394对系统性红斑狼疮（SLE）患者的安全性和免疫效应，该耐受原旨在降低双链DNA抗体水平。
对4名病情稳定的SLE女性患者静脉输注100mg LJP 394，并随访4周。检测常规安全性变量以及抗双链DNA、循环免疫复合物、补体和补体裂解产物。
抗双链DNA滴度迅速降低。输注后4周，2名患者的滴度仍低于基线水平，2名患者恢复到治疗前水平。观察到一些补体裂解产物短暂升高；然而，输注期间或输注后即刻未发生不良临床事件。
LJP 394成功且安全地降低了4名SLE患者的抗双链DNA水平。免疫复合物形成和快速清除是观察到的结果的最可能解释。
