Clinical Trial Results Encouraging

Encouraging results were reported from the ongoing analysis of the data from LJP's Phase II/III clinical trial of Riquent™, previously referred to as LJP 394. The study was designed to determine if Riquent treatment could reduce the number of renal flares in lupus patients with a history of renal disease, measured as an increase in the time to renal flare. Renal flares are life-threatening episodes of severe inflammation which damage the kidneys of lupus patients. The study was also designed to determine if Riquent therapy could reduce the need for treatments with high doses of corticosteroids and/or cyclophosphamide.

Conducted over an 18-month period at 51 sites in North America and Europe, the double-blind, placebo-controlled trial studied more than 200 lupus patients, half of whom were treated with Riquent. As we have previously reported, the trial was ended in 1999 before its scheduled completion, as a result of an interim analysis conducted by our former corporate partner.

Reduction in Renal Flares

Among patients whose antibodies exhibited high-affinity binding to Riquent, time to renal flare was delayed in the drug-treated group in a statistically significant manner when compared to the placebo-treated group. In the high-affinity group, there was only one-third the number of renal flares in drug-treated patients when compared to placebo-treated patients. Specifically, only seven drug-treated high-affinity patients had flares, compared to 21 placebo-treated high-affinity patients.

Patients who began the trial with impaired renal function and who had lost about half of their renal function (serum creatinine >1.5 mg/dL) also experienced fewer renal flares when given Riquent. None of the patients with impaired renal function and high-affinity antibodies who received Riquent experienced a flare, compared to 60% of the placebo-treated high-affinity patients. These data suggest that the drug could prove most beneficial for those patients who most need it. Lupus patients with impaired renal function have an urgent need for better therapy. They experience irreversible morbidity and have a high risk of end-stage renal disease, long-term dialysis and/or kidney transplants.

Reduction in Immunosuppressive Treatments

The reduction in renal flares suggests a significant potential therapeutic benefit, since renal flares lead to the use of highly toxic drugs. Among the 42 patients who had renal flares, 83% received high-dose corticosteroids and/or cyclophosphamide, 45% received cyclophosphamide and 48% required hospitalization. These results confirm the seriousness of a lupus renal flare.

Lupus patients face an increased risk of treatment with immunosuppressive therapy. Among high-affinity patients, time to treatment with high-dose corticosteroids and/or cyclophosphamide was significantly delayed in the drug-treated group versus the placebo-treated group. In the Phase II/III trial, there were fewer than half as many treatments with high-dose corticosteroids and/or cyclophosphamide in the high-affinity drug-treated patients (13) as compared to the high-affinity placebo-treated group (34).

For all patients, time to treatment with high-dose corticosteroids and/or cyclophosphamide was also significantly delayed. There were 23 treatments with high-dose corticosteroids and/or cyclophosphamide in the drug-treated group compared to 39 treatments in the placebo-treated group.

Terms of Use & Privacy Policy
Copyright © 2008, La Jolla Pharmaceutical Company