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Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Erythematosus
Date:7/19/2009

primary efficacy endpoint of superiority versus placebo at Week 52. A clinically and statistically significant improvement was shown in patient response rate for belimumab plus standard of care, vs. placebo plus standard of care: 57.6% for 10 mg/kg belimumab, 51.7% for 1 mg/kg belimumab, and 43.6% for placebo (p=0.0006 and p=0.011 for 10 mg/kg and 1 mg/kg belimumab, respectively vs. placebo). Patient response was defined by an improvement in SELENA SLEDAI score of 4 points or greater, no clinically significant BILAG worsening, and no clinically significant worsening in Physician's Global Assessment. Results for each individual component of the patient response rate were consistent with the overall improvement shown for the primary endpoint. -- Results for prespecified major secondary efficacy endpoints were: -- A significantly greater percentage of patients receiving belimumab achieved a reduction in SELENA SLEDAI score of at least 4 points by Week 52, with 58.3% for 10 mg/kg belimumab, 53.% for 1 mg/kg belimumab, and 46.0% for placebo (p=0.0024 and p=0.019 for 10 mg/kg and 1 mg/kg belimumab, respectively vs. placebo). -- Improvement in Physician's Global Assessment (PGA) at Week 24 was greatest in the belimumab 10 mg/kg treatment group versus placebo (p=0.0003 for 10 mg/kg and p=0.27 for 1 mg/kg belimumab, respectively) with improvement observed within 4-8 weeks. -- A higher percentage of patients in both belimumab treatment groups, versus placebo, had their average prednisone dose reduced by at least 25% from baseline to 7.5 mg per day or less during the last 12 weeks of study (p=0.053 for 10 mg/kg and p=0.025 for 1 mg/kg belimum
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SOURCE Human Genome Sciences, Inc.
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