-- 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
-- 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
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
|SOURCE Human Genome Sciences, Inc.|
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