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Human Genome Sciences Reports That a Phase 2 Study of LymphoStat-B,Showed Significant Reductions in Disease Activity in Patients with,Active Systemic Lupus Erythematosus

olerated. Frequency and severity of adverse events were similar to placebo, with no increase at higher doses. Among the Phase 2 study findings was a significantly improved response rate among serologically active patients at Week 52, 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 no worsening in Physician's Global Assessment (46% for LymphoStat-B versus 29% for placebo, p<0.01). This combination of measures is the primary efficacy endpoint in the Phase 3 clinical trials.

The data presented at EULAR 2007 demonstrated 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 clinical and biological activity at Week 76, and appeared safe and well tolerated, with no increase in frequency and or severity of adverse events. The evidence of continuing improvement from Week 52 to Week 76 includes:

    -- An increase from 46% to 56% among serologically active patients in the

       patient response rate selected as the primary efficacy endpoint of the

       Phase 3 trials.


    -- An increase from 29% to 38% in the reduction in SLE disease activity

       among serologically active patients, as measured by SELENA SLEDAI.


    -- An increase from 33% to 41% in the reduction in SLE disease activity

       among serologically active patients, as measured by the Physician's

       Global Assessment.


    -- An increase in the mean improvement in health-related quality of life

       from 3.0 points to 3.4 points among serologically active patients, as

       measured by the SF-36 Physical Component Summary score.


    -- A durable reduction in anti-dsDNA autoantibodies (at least 50% or

       negative) among patients who were positive for anti-dsDNA at baseline

       (30% at Week 52; 34% at Week 76).


    -- Durable or increased reductions from Week 52 t
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