In a major advance that could revolutionize the treatment of lupus, the Food and Drug Administration (FDA) has approved Benlysta (belimumab), the first new therapy specifically designed for the disease in 56 years. It’s also a scientific milestone, as the first approved drug derived from genomics (the study of genes and their functions).
“I can’t emphasize enough our joy that there is finally a breakthrough because we desperately need new treatments,” says Margaret Dowd, president of the Lupus Research Institute. “Some of the therapies we’re using now, such as steroids, can be more toxic than the disease. For severe cases, doctors also had to use cancer drugs to suppress immune system activity, causing tremendous difficulties and suffering for patients.”
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Lupus is a chronic autoimmune disease in which the body attacks its own organs and tissues. Common symptoms and complications include joint pain and swelling, kidney damage, blood clots, fevers, sun sensitivity and a “butterfly” rash across the cheeks and nose. According to the Lupus Foundation, the disease affects 1.5 million Americans, 90 percent of them women. Lupus typically strikes people who are between the ages of 15 and 44. Among the celebrities reportedly affected by lupus are musician Seal and Lady Gaga, who has tested “borderline positive” for the disease, but announced that she doesn’t have any symptoms.
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Developed by Human Genome Sciences, Inc. and GlaxoSmithKline PLC, Benlysta blocks a protein called BLyS (B-lymphocyte stimulator), found at elevated levels in people with lupus, rheumatoid arthritis and other autoimmune diseases. BLyS is thought to contribute to production of autoantibodies (antibodies that attack and destroy healthy tissue as if it were an alien invader).
The FDA approval was based on results of two clinical trials in which patients either received standard medications alone (the control group) or standard treatments plus Benlysta, says Mary Anne Dooley, MD, MPH, associate professor, University of North Carolina at Chapel Hill and member, Lupus Foundation of America, Medical-Scientific Advisory Board. “During the trial, patients with mild to moderate active lupus were able to change their usual medications, add new ones, or alter dosages to better control their disease. Benlysta still showed a significant benefit even though the patients’ disease was also being actively managed with standard treatments. This is very impressive data.”
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However, Benlysta is not a cure for lupus and wasn’t effective for some patients in the trial. The best candidates for the new treatment, says Dr. Dooley, are people with moderate active lupus. The drug is given once a month by IV infusion. Since many specialists who treat lupus already have infusion equipment in their office to treat other disorders, such as rheumatoid arthritis, Dr. Dooley anticipates that the drug will be widely available and likely to be covered, at least partially, by insurance. The most common side effects include nausea, diarrhea and fever.
What makes the approval particularly exciting, adds Dr. Dooley, is that it comes after 15 years of clinical trials to look for a lupus treatment yielded disappointing results.
“Not only is Benlysta a tremendous breakthrough for people whose disease is not adequately controlled by other treatments, but it could open the floodgate for more discoveries. Before Benlysta’s approval, the fear was that with so many trials with negative outcomes, pharmaceutical companies would give up looking for the new treatments that people with lupus desperately need. This approval has reenergized the lupus community to continue doing new research that might lead to even better new therapies.”
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