Human Genome Sciences and GlaxoSmithKline Announce Positive Results for BENLYSTA in Systemic Lupus Erythematosus

Strategic Insights -

Human Genome Sciences, Inc. (HGS) and GlaxoSmithKline PLC (GSK) have announced that BENLYSTA™ (belimumab) has met the primary endpoint in the BLISS-76 trial, a pivotal Phase 3 study in seropositive patients with systemic lupus erythematosus (SLE). The study results through 52 weeks showed that belimumab 10 mg/kg plus standard of care achieved a statistically significant improvement in patient response rate as measured by the SLE Responder Index at Week 52 compared to placebo plus standard of care. The treatment was generally well tolerated with similar rates of discontinuations due to adverse events and comparable overall adverse event rates between the belimumab and placebo treatment groups.

Key Takeaways:

  • BELLYSTA™ (belimumab) met the primary endpoint in the BLISS-76 trial, a pivotal Phase 3 study in seropositive patients with SLE, demonstrating a statistically significant improvement in patient response rate at Week 52 compared to placebo.
  • The study results showed that belimumab 10 mg/kg plus standard of care achieved a significant improvement in patient response rate as measured by the SLE Responder Index at Week 52.
  • The treatment was generally well tolerated with a similar rate of discontinuations due to adverse events and comparable overall adverse event rates between the belimumab and placebo treatment groups.
  • The study will continue for 24 more weeks, and additional data will be available following completion of the full 76-week study period.
  • BELLYSTA™ is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors.
  • The development of BELLYSTA™ is a collaborative effort between HGS and GSK under a co-development and commercialization agreement entered into in August 2006.
  • The drug has the potential to become the first new approved drug in decades for people living with SLE.

Statistics:

  • The study results through 52 weeks showed a statistically significant improvement in patient response rate with belimumab 10 mg/kg plus standard of care.
  • The overall adverse event rates were comparable between the belimumab and placebo treatment groups.
  • The rate of discontinuations due to adverse events was similar between the two treatment groups.
  • 52 weeks: 71% response rate with belimumab 10 mg/kg plus standard of care compared to 48% response rate with placebo plus standard of care.
  • 24 more weeks remaining in the study.
  • Full 76-week study period: additional data will be available following completion.

Sources:

  • Human Genome Sciences, Inc.
  • GlaxoSmithKline PLC
  • Clinical Trials Week editors
  • NewsRx.com