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Pharmaceutical industry

Belimumab Demonstrates Clinically and Statistically Significant Improvement in Patient Response Rate in Phase 3 Study

Strategic Insights

— 2 min read

In a significant breakthrough for the treatment of systemic lupus erythematosus (SLE), Human Genome Sciences, Inc. (HGS) and GlaxoSmithKline PLC (GSK) announced the full presentation of results from BLISS-52, the first of two pivotal Phase 3 trials of BENLYSTA (belimumab) in seropositive patients with SLE. The data, presented at the 73rd Annual Scientific Meeting of the American College of Rheumatology (ACR), demonstrate that belimumab plus standard of care achieved a clinically and statistically significant improvement in patient response rate as measured by the SLE Responder Index at Week 52, compared with placebo plus standard of care.

The study results show that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups. The efficacy of treatment with BENLYSTA plus standard of care was superior to that of placebo plus standard of care, with a statistically significant improvement in patient response rate. Furthermore, a greater percentage of patients receiving BENLYSTA were able to reduce their use of steroids.

Key Takeaways:

  • Belimumab (BENLYSTA) plus standard of care achieved a clinically and statistically significant improvement in patient response rate as measured by the SLE Responder Index at Week 52, compared with placebo plus standard of care.
  • The study results show that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups.
  • The efficacy of treatment with BENLYSTA plus standard of care was superior to that of placebo plus standard of care.
  • A greater percentage of patients receiving BENLYSTA were able to reduce their use of steroids.
  • The improvement in patient response rate was generally consistent across subgroups.
  • A dose response trend was observed, with a greater rate of patient response in the 10 mg/kg belimumab dose group.
  • Belimumab met its primary efficacy endpoint by achieving a superior SLE patient response rate at Week 52 vs. placebo.
  • Among 865 patients randomized and treated, belimumab achieved a patient response rate of 57.6% for 10 mg/kg belimumab, 51.4% for 1 mg/kg belimumab, and 43.6% for placebo (p=0.0006 and p=0.013 for 10 mg/kg and 1 mg/kg belimumab, respectively).

Statistics:

  • 865 patients were randomized and treated in the study
  • Belimumab achieved a patient response rate of 57.6% for 10 mg/kg belimumab, 51.4% for 1 mg/kg belimumab, and 43.6% for placebo
  • The improvement in patient response rate was statistically significant, with p-values of 0.0006 and 0.013 for 10 mg/kg and 1 mg/kg belimumab, respectively
  • A dose response trend was observed, with a greater rate of patient response in the 10 mg/kg belimumab dose group

Sources:

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

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