HGS PRESENTS POSITIVE 76-WEEK RESULTS FROM LUPUS TRIAL

Human Genome Sciences (HGS) has announced that the 76-week results of a Phase II clinical trial demonstrate that LymphoStat-B (belimumab) reduced disease activity in patients with serologically active systemic lupus erythematosus (SLE), exhibited durable biological activity and appeared to be safe and well-tolerated. In the LymphoStat-B treatment groups, the percentage of serologically active SLE patients who achieved the combined response rate selected as the primary efficacy endpoint for Phase III trials, increased from 46 percent at week 52 to 56 percent at week 76, with no increase in infections or infectious events observed over time.

The results were presented at the Annual Meeting of the American College of Rheumatology.

The Phase II study was designed as a randomized, double-blind, placebo-controlled, dose-ranging superiority trial to evaluate the safety, tolerability and efficacy of LymphoStat-B plus standard of care versus placebo plus standard of care. A total of 449 patients with active SLE were randomized to receive one of three different doses of LymphoStat-B or placebo (1, 4 or 10 mg/kg) administered intravenously over a 52-week treatment period, in addition to standard-of-care therapy. Serologically active patients accounted for 72 percent of the total Phase II study population. Eighty-six percent of the patients were receiving background prednisone therapy, either alone or in combination. At week 52, patients were offered the opportunity to participate in an optional 24-week extension phase.

In June HGS presented the 52-week data. The 52-week results demonstrated that LymphoStat-B significantly reduced disease activity in patients with serologically active SLE, exhibited clinically relevant biological activity and appeared safe and well-tolerated.

The data presented recently demonstrate that LymphoStat-B continued to reduce the signs and symptoms of SLE disease activity throughout the 24-week extension phase of the study, demonstrated durable biological activity at week 76 and appeared safe and well-tolerated, with frequency and severity of adverse events similar to placebo and with no increase at higher doses.