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Human Genome Sciences Reports Positive Long-Term Data for LymphoStat-B in Patients With Active Systemic Lupus Erythematosus
Date:6/12/2008

tained clinical effect in belimumab-treated patients from Week 52 to Week 160 includes:

-- An increase from 46% to 52% among serologically active patients based

on the combined response rate selected as the primary efficacy endpoint

of the Phase 3 trials (intention-to-treat analysis).

-- A decrease over time in the overall frequency of SLE disease flares,

and in the frequency of severe disease flares, in patients who remained

on belimumab through three years, as measured by the SELENA SLEDAI

flare index.

-- A greater proportion of patients in the belimumab group reduced their

prednisone dose from baseline compared with the placebo group in the

double-blind phase of the study, and this number continued to increase

through three years.

-- Reversion of autoantibody levels from positive to negative

(anti-dsDNA, anti-RNP, anti-Smith).

-- Stable reductions in immunoglobulins, with no increase in infections or

infectious events over time.

-- An increase in C3 and C4 complement among patients with low complement

at baseline.

About the Phase 2 Study of LymphoStat-B in SLE

The primary objectives of the Phase 2 study were to evaluate the efficacy and safety of belimumab (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 belimumab or placebo (1, 4 or 10 mg/kg) 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 o
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SOURCE Human Genome Sciences, Inc.
Copyright©2008 PR Newswire.
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