Benlysta(belimumab) is an investigational human monoclonal antibody drug and the first in a new class of drugs called BLyS-specific inhibitors. These drugs prevent b-cell proliferation and development in to mature plasma cells with a resulting drop in antibody production. This mechanism of action is very well-suited to Lupus whose pathophysiology is widely thought to involve autoantibody formation. As of March 10, 2011, This agent is now approved for treatment of SLE. This was mainly based on a 52-week study, also known as BLISS-52, enrolled 865 patients in 13 countries outside North America and randomized active lupus patients to 10mg/kg active drug (Belimumab, also known as Benlysta), 1 mg/kg active drug, or placebo (not containing active drug) in addition to their standard lupus medications.
Patients had to fulfill the American College of Rheumatology lupus criteria, have active lupus, and remain on a stable treatment regimen (excluding other biologic therapies or cyclophosphamide) in order to be eligible for the trial. Patients with severe lupus kidney disease and lupus-related neurologic problems were excluded. The study medication was given intravenously (through the veins) two weeks apart for the first two doses, and then every four weeks. The study met primary end point and the the response rates were 57.6%, 51.7% and 43.6% for Benlysta 10mg/kg, 1 mg/kg, and placebo, respectively (the response rates were significantly better in the active drug arms). In addition to improvement in various clinical measurements of disease activity, patients were also able to reduce steroid dosages. Notably, the drug was tolerated well and the safety profile, including the infection rate, was comparable to the placebo arm. Another trial was similar and also excluded patients kidney and CNS involvement. African American patients and patients of African heritage participating in the two studies did not appear to respond to treatment with Benlysta. The studies lacked sufficient numbers to establish a definite conclusion. The most common side effects in the studies included nausea, diarrhea, and fever (pyrexia). Patients also commonly experienced infusion reactions, so pre-treatment with an antihistamine should be considered.
Again, a nice step forward towards treatment of LUPUS in general but Patients with Severe kidney disease were excluded. At this point, lets see what the renal community feels about this novel agent.
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