To view the EULAR poster presentation reporting results of the Phase 2 long-term continuation study of BENLYSTA through four years, click here.
About the Phase 2 Study of BENLYSTA in SLE
The primary objectives of the Phase 2 study were to evaluate the efficacy and safety of belimumab (BENLYSTA) 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 belimumab (1, 4 or 10 mg/kg) or placebo administered intravenously over a 52-week treatment period, in addition to standard-of-care therapy. At the end of 52 weeks, 345 patients chose to participate in an optional 24-week extension phase of the study, during which all patients received belimumab. At Week 76, 296 patients chose to remain on belimumab treatment in an open-label long-term continuation phase of the Phase 2 trial, in which all patients are receiving 10 mg/kg belimumab. As of June 1, 2009, 213 patients remained on belimumab treatment in the continuation study.
In June 2006, HGS reported the 52-week results of the Phase 2 trial, which demonstrated that belimumab significantly reduced disease activity versus placebo in patients with serologically active SLE across multiple clinical measures, exhibited clinically relevant biological activity, and appeared generally safe and well tolerated. Frequency and severity of adverse events were similar to placebo. Among the findings at Week 52 was a significantly improved response rate among serologically active patients, as defined by an improvement in SELENA SLEDAI score of 4 points or greater, no new BILAG A flare and no more than one new BILAG B flare, and n
|SOURCE Human Genome Sciences, Inc.|
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