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Benlysta: first targeted lupus treatment 01 November 2011, 9:14am Benlysta (belimumab) is licensed as add-on therapy in patients with autoantibody-positive systemic lupus erythematosus (SLE) who have high disease activity despite standard treatment. Benlysta must be administered in hospital 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 Benlysta Summary of Product Characteristics, July 2011. Furie R et al. Arthritis Rheum 2011, Accepted article; DOI: 10.1002/art.30613. Navarra SV et al. Lancet 2011; 377: 721–31. View Benlysta drug record Further information: GlaxoSmithKline