EFFECT OF LJP 394 ON SLE PATIENTS WITH IMPAIRED RENAL FUNCTION

Matthew D Linnik, Robert G. Bagin and the 90-05 Investigator Consortium
La Jolla Pharmaceutical Co., San Diego, CA, USA.

Introduction: 230 SLE patients were enrolled in a double-blind, placebo-controlled trial (90-05 trial) to determine if LJP 394 reduces time to renal flare in these patients. The current analysis assessed the clinical course of a subgroup of patients from the 90-05 trial with the greatest impairment of renal function at baseline as defined by baseline serum creatinine levels.

Methods: Patients with antibodies to dsDNA and a history of lupus renal disease received intermittent dosing with LJP 394 or PBO for 60 weeks. Patients with active renal disease or serum creatinine > 2.5 mg/dl were excluded from the trial. This analysis assessed renal outcome in patients who entered the trial with serum creatinine > 1.5 mg/dl.

Results: Serum creatinine values > 1.5 mg/dl at study entry were recorded in 17/114 (14.9%) LJP 394 patients and 11/116 (9.5%) PBO patients. Nine of 28 patients (32%) in this subgroup recorded a renal flare during the 90-05 trial compared with 42/230 patients (18%) in the entire cohort of patients in the trial. Renal flares were recorded in 3/17 (18%) LJP 394 patients and 6/11 (55%) PBO patients in the subgroup analysis. When all available pretreatment serum samples were analyzed for affinity to drug, 10/10 placebo patients and 11/16 LJP 394 patients had high-affinity antibodies to drug. No renal flares were observed in the high-affinity, drug-treated subgroup.

Conclusion: LJP 394 may provide clinical benefit to SLE patients with impaired renal function and elevated serum creatinine levels.

Presented at
The 6th International Lupus Conference
Barcelona, Spain
March 24-28, 2001