Benlysta (belimumab) was approved on March 9, 2011 by the FDA for the treatment of active, autoantibody-positive lupus in patients who are receiving standard therapy including corticosteroids,antimalarials, immunosuppressives, and NSAIDs (nonsteroidal anti-inflammatory drugs). Benlysta is administered as an intravenous infusion (through an I.V.). It is the first drug designed to target B-lymphocyte stimulator (BLyS) protein. This action should decrease the number of abnormal B cells which are thought to be problematic in lupus.
It’s fair to say, the approval of Benlysta has been watched and anticipated by lupus patients and anyone with an interest in lupus. It has been 56 years since a new drug was approved for lupus. Plaquenil and corticosteroids were approved for lupus back in 1955.
Two clinical trials involving 1,684 lupus patients concluded that Benlysta was safe and effective. The studies randomly assigned patients with active lupus to receive Benlysta along with standard lupus therapy, or placebo along with standard therapy. Patients receiving Benlysta and standard therapy had less disease activity than the placebo group. African Americans did not seem to respond well to Benlysta in the studies. Further studies are needed so researchers can formulate a conclusion regarding African Americans and Benlysta. For more Benlysta information, check out the FDA news about the approval.
It is still early to say who should receive this treatment and how. Is it going to be used for the most severe cases or for anyone with active SLE? We are awaiting this medication eagerly in the UAE and will be posting here as soon as it becomes available.