Belimumab (Benlysta): The First New Drug For Systemic Lupus Erythematosus Since 1955
Systemic Lupus Erythematosus (SLE) is a chronic, autoimmune disease that can affect organs and tissue throughout the body. Most frequently, it shows up in the skin, joints, blood and kidneys. According to the University of Maryland Medical Center, two types of immune cells,T-lymphocytes or T-cells and B-lymphocytes or B-cells, are involved in the cause of SLE. T-cells and B-cells secrete cytokines, proteins that carry signals to neighboring cells to coordinate the immune response of the body to a particular antigen. Scientists believe that in people with SLE, cytokines are overexpressed and this leads to hyperactivity of T-cells and B-cells. The overactive B-cells eventually produce abnormal antibodies that go beyond the usual scope of antibody recognition. Healthy tissues are mistakenly identified as invading organisms, and the overactive immune cells initiate an inflammatory response against the healthy tissues.
Information on Belimumab (Benlysta)
Belimumab was approved as a treatment for systemic lupus erythematosus (SLE) by the U.S. Food and Drug Administration in March 2011. It is in a class of drugs called monoclonal antibodies, and is administered by intravenous infusion. Belimumab is the first new treatment for SLE since 1955 when the FDA approved Plaquenil and corticosteroids. It works by blocking the binding of B-cell stimulator protein, a cytokine, to receptors on the B-cells. This has the effect of limiting the number of overactive B-cells that differentiate into plasma cells responsible for the production of harmful abnormal antibodies.
The efficacy of belimumab was demonstrated in a phase 3 clinical study of 867 patients with active systemic lupus erythematosus. The results of this study were published in the February 26, 2011, issue of "The Lancet." Patients were treated with standard corticosteroid therapy combined with once monthly i.v. infusion of belimumab over the course of one year, and evaluated primarily by improvements in their Systemic Lupus Erythematosus Responder Index (SRI), a method of assessing disease activity in SLE patients. Results of the study showed that patients taking belimumab with standard care had significantly higher SRI rates relative to those on standard care plus placebo. This means that there was a general decrease in disease activity in patients taking belimumab. In addition, a secondary criterion of efficacy was reduction in the use of the corticosteroid prednisone. When the results of this phase 3 study were analyzed with those of a second phase 3 trial, it was clear that a significantly greater number of patients on belimumab were able to reduce their use of prednisone relative to patients on placebo.
Generally speaking, belimumab has been relatively well tolerated in clinical trials.The most common side effects include infusion-site reactions, nausea, diarrhea, fever, sore throat, bronchitis, insomnia, pain in the extemities, depression and migraine. ln clinical trials, more deaths and serious infections occurred in patients taking belimumab relative to those on placebo. For this reason, physicians need to exercise caution in prescribing belimumab to patients with chronic infections. Patients who develop an infection while taking belimumab should seriously consider stopping treatment.
What Benlysta Means for Lupus R & D
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