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news.Belimumab significantly reduced SLE disease activity, disease flare rates and fatigue in the BLISS-52 study
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Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) have presented results from BLISS-52, the first of two pivotal phase 3 trials of belimumab in seropositive patients with systemic lupus erythematosus (SLE).
The data, which were presented at the 73rd Annual Scientific Meeting of the American College of Rheumatology (ACR) in Philadelphia, demonstrated that, in BLISS-52, belimumab plus standard of care achieved a clinically and significant improvement in patient response rate as measured by the SLE Responder Index at Week 52, compared with placebo plus standard of care.
Reportedly, in the study among 865 patients randomised and treated, belimumab met its primary efficacy endpoint by achieving a superior SLE patient response rate at Week 52 vs. placebo. A significant improvement was shown in patient response rate for belimumab plus standard of care vs. placebo plus standard of care, 57.6% for 10mg/kg belimumab, 51.4% for 1mg/kg belimumab, and 43.6% for placebo.
The company has said that the results from BLISS-76, the second phase 3 trial of belimumab, are expected to be announced on November 2, 2009. Assuming the results from BLISS-76 are positive, HGS and GSK plan to submit marketing applications in the first half of 2010.
David Stump, executive vice president of research and development at HGS, said: “The BLISS-52 phase 3 results presented at ACR demonstrated that the efficacy of treatment with belimumab plus standard of care was superior to that of placebo plus standard of care. These data were statistically significant and were strongly supported across multiple measures of clinical effect and multiple time-points. Of note, a greater percentage of patients receiving belimumab were able to reduce their use of steroids.”
Carlo Russo, senior vice president of biopharm development at GSK, said: “We have been pleased by the consistency of benefit demonstrated by belimumab in the BLISS-52 study, and we hope to confirm these results in the second phase 3 study which is to report shortly. We very much hope that we will be able to deliver a new option for the treatment of this debilitating disease.”