Benlysta: first targeted lupus treatment

PHARMACOLOGY
Belimumab is a monoclonal antibody specific for the soluble human B lymphocyte stimulator protein, BLyS. It inhibits the differentiation of B cells into antibody-producing plasma cells.¹

CLINICAL STUDIES
Two pivotal randomised trials showed that the addition of belimumab to standard care improves control of disease activity in SLE.

BLISS-76 and BLISS-52 enrolled seropositive SLE patients (n=819 and n=865, respectively). In addition to standard treatment, patients received belimumab 10mg/kg or 1mg/kg or placebo by intravenous infusion on days 0, 14 and 28, and every 28 days thereafter.^2,3

In both studies, response rates at week 52 (as determined by the SLE Responder Index) were significantly higher in patients treated with the 10mg/kg dose of belimumab than in patients who received placebo. In a pooled analysis of the two studies, the combined response rate was 51% for belimumab 10mg/kg compared with 39% for placebo (p<0.0001).^2,3

Belimumab was well tolerated in both studies, with rates of adverse events similar to placebo.^2,3

REFERENCES

1. Benlysta Summary of Product Characteristics, July 2011.
2. Furie R et al. Arthritis Rheum 2011, Accepted article; DOI: 10.1002/art.30613.
3. Navarra SV et al. Lancet 2011; 377: 721–31.

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Further information: GlaxoSmithKline