The Medical Letter on Drugs and Therapeutics
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Belimumab (Benlysta) for Systemic Lupus Erythematosus

Belimumab (Benlysta – Human Genome Sciences/GlaxoSmithKline) has been approved by the FDA for treatment of adults with active, autoantibody-positive, systemic lupus erythematosus (SLE). It is the first biologic agent approved for SLE and the first drug of any kind to be approved for this disease in >50 years.

PHARMACOLOGY — Belimumab is a human IgG1λ monoclonal antibody that blocks the binding of soluble B-lymphocyte stimulator (BLyS, also known as B cell activating factor) to its receptors on B cells. BLyS levels are elevated in SLE and correlate with disease activity.1-3

CLINICAL STUDIES — In two clinical trials, BLISS-52 (52-week follow-up) and BLISS-76 (76-week follow-up), a total of 1684 patients with active SLE were randomized to receive, in addition to their current therapy, belimumab 1 mg/kg, 10 mg/kg or placebo IV at 0, 2 and 4 ... more      

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