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Human Genome Sciences Reports Positive Long-Term Data for BENLYSTA(TM) (Formerly LymphoStat-B(R)) in Patients With Active Systemic Lupus Erythematosus
Date:6/11/2009

R 2009 showed that continued treatment with belimumab (BENLYSTA) is associated with sustained improvement or stabilization of SLE disease activity and with decreased frequency of SLE disease flares in serologically active patients through four years of treatment. The overall incidence of adverse events (in general and by system organ class), serious adverse events, infections, malignancies and laboratory abnormalities decreased or stabilized over time from Week 52 to Week 208.

The evidence of sustained clinical effect from Week 52 to Week 208 in serologically active patients who were treated with belimumab from initiation of the Phase 2 study includes:

  • An increase from 46% to 57% in the response rate selected as the primary efficacy endpoint of the Phase 3 trials (defined by an improvement in SELENA SLEDAI score of 4 points or greater, no BILAG worsening, and no worsening in Physician's Global Assessment; post hoc; intention-to-treat analysis).
  • A decrease from 62% to 16% in the overall frequency of SLE disease flares, and from 8% to 1% in the frequency of severe disease flares, as measured by the SELENA SLEDAI Flare Index.
  • A decrease from 23% to 5% in the frequency of patients experiencing one new BILAG A organ domain score (which would indicate a severe flare of lupus disease activity) or more than one new BILAG B organ domain score (which would indicate a moderate flare of disease activity).

The data presented at EULAR 2009 suggest that belimumab was generally well tolerated and may be safely administered long-term in patients with SLE. By Week 208, overall belimumab exposure was 1192 patient years. The incidence rates per 100 patients in all adverse event categories, including serious adverse events, overall adverse events, and serious infections, were similar for belimumab and placebo during the 52-week double-blind period, a
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SOURCE Human Genome Sciences, Inc.
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