No, that's not a typo: There actually has been a flurry of news surrounding lupus lately.
If that's surprising, it's because it's been half a century since a new treatment for lupus, an autoimmune disease that can affect various organs, has been developed and approved. Since then the disease, whose manifestations range from mild to deadly, has been managed with a mishmash of drugs, mostly steroids, nonsteroid anti-inflammatory drugs (NSAIDs) and even antimalarials, all devised to treat other diseases. In this respect lupus has long been something of a backwater. The disease affects 1.5 million Americans, 90 percent of them women.
But with the successful Phase III clinical trials of a drug called Benlysta this summer, the lupus scene has shifted. Benlysta, developed by the Rockville-based Human Genome Sciences and GlaxoSmithKline, showed promising results in keeping lupus disease activity at bay; it also appears to be safe. Further clinical trials are underway, with results expected in November. After that, the firms will seek FDA approval for the drug.
As with many autoimmune diseases, lupus is characterized by a baffling set of symptoms, some vague and others pronounced, ranging from fatigue and joint stiffness and pain to depression and a butterfly-shaped facial rash that covers the cheeks and bridge of the nose. More serious is the damage the disease can do to internal organs, particularly the kidneys, lungs and heart.
Just as multiple sclerosis, another autoimmune disease affecting some 400,000 Americans, was viewed largely as a hopeless disease until 1993 WHEN the FDA approved Betaseron, the first drug to treat underlying MS and not just its symptoms, lupus is quickly becoming viewed as a treatable disease, not just a manageable one. (There are now six FDA-approved drugs to treat MS, and many more are in the research pipeline.)
About two dozen lupus therapies are currently under investigation, according to the Lupus Foundation of America. Momentum is clearly underway.
But there's one hitch: the Lupus Foundation recently put the word out that drug researchers aren't finding enough subjects to take part in clinical trials. The Foundation directs potential participants to its clinical trials Web site for information about getting involved -- a major but often rewarding undertaking.
Posted by: jenrellis | September 14, 2009 2:51 PM | Report abuse
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