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Pharmaceutical industry

Belimumab Meets Primary Endpoint in Phase 3 Trials for Systemic Lupus Erythematosus

Strategic Insights

— 1 min read

Human Genome Sciences, Inc. (NASDAQ:HGSI) and GlaxoSmithKline PLC (GSK) announced that BENLYSTA, formerly known as LymphoStat-B, has achieved the primary endpoint in the BLISS-52 pivotal Phase 3 trial for patients with serologically active systemic lupus erythematosus (SLE). The results of the placebo-controlled study showed a clinically and statistically significant improvement in patient response rate at Week 52 when belimumab was added to standard care, compared to standard care alone. The study demonstrated that belimumab was generally well-tolerated, with adverse event rates comparable between the belimumab and placebo groups. The success of this trial marks a significant step forward in the treatment of SLE, a chronic and debilitating disease that affects an estimated five million people worldwide.

Key Takeaways:

  • Belimumab, marketed as BENLYSTA, has demonstrated a clinically and statistically significant improvement in patient response rate at Week 52 in the BLISS-52 Phase 3 trial for patients with serologically active SLE.
  • The study results showed that belimumab plus standard care achieved an improvement of 43.6% in the SRI-4 response rate, compared to 36.2% for standard care alone.
  • Belimumab was generally well-tolerated in the study, with adverse event rates comparable between the belimumab and placebo groups.
  • The success of the BLISS-52 trial marks a significant advancement in the treatment of SLE, a disease that has not seen the approval of a new drug in over 50 years.
  • Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors.
  • HGS and GSK plan to submit marketing applications to regulatory authorities in the United States, Europe, and other regions in the first half of 2010, pending positive results from the second Phase 3 trial.

Statistics:

  • 43.6% SRI-4 response rate with belimumab plus standard care
  • 36.2% SRI-4 response rate with standard care alone
  • Estimated 5 million people worldwide affected by SLE
  • Over 50 years since a new drug for lupus was approved by regulatory authorities

Sources:

  • "Human Genome Sciences, Inc. and GlaxoSmithKline Announce Positive Results From BLISS-52 Pivotal Phase 3 Trial of BENLYSTA in Patients with SLE," September 2009.
  • "Lupus: Understanding the Chronic and Debilitating Disease," Lupus Research Alliance.
  • "BENLYSTA: A New Treatment Option for Systemic Lupus Erythematosus," HGS and GSK press release, August 2006.

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