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La Jolla Pharmaceutical Announces Positive Interim Antibody Results,From Riquent Lupus Phase 3 Trial

Furthermore," said Jill Buyon, M.D., Professor of Medicine at New York University School of Medicine, "these are highly encouraging data which should attract attention from the lupus community since a reduction in antibodies to dsDNA is a biomarker we associate with clinical improvement."

Dose Dependent Antibody Reduction

The analyses assessed the impact of treatment with Riquent on reducing antibodies to dsDNA in 101 patients by measuring the percent of antibody reduction from baseline compared with placebo following weekly treatment with 100 mg, 300 mg or 900 mg of Riquent or placebo. All demographics and baseline characteristics were comparable across dosing groups and there were 16 to 30 patients per treatment group.

Following eight weeks of treatment, the median percent reduction in antibodies to dsDNA for Riquent-treated patients compared with placebo-treated patients was 36% (100 mg), 48% (300 mg), and 66% (900 mg). Antibody reduction for each dose group was significantly better than placebo. Approximately three times as many patients treated with 900 mg of Riquent (38%) had at least a 50% or greater antibody reduction at week 8 compared with patients treated with 100 mg (13%). Patients reached their maximum reduction after four weeks of treatment at which time separation between doses was also seen.

Consistent Antibody Reductions

Published data from earlier La Jolla studies indicated that maintaining antibody reductions over time in individual patients was associated with a significantly reduced renal flare rate. The current data indicate that the higher the Riquent dose, the greater the consistency of response and the greater the magnitude of this response. While more than twice as many 900 mg-treated patients (58%) as 100 mg-treated patients (25%) had a consistent 20% reduction, six times as many 900 mg-treated patients (39%) had a consistent 40% reduction, compared with 100 mg-treated patients (6%). Twice as many patient
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