Benlysta approved: Which lupus patients will benefit?
(CBS/AP) WASHINGTON - In the fight against lupus, there's good news and bad and unfortunately it depends on who you are.
On Wednesday, the FDA approved Benlysta, the first new medication for lupus in 50 years. But the drug doesn't distribute its benefits equally. It works in only 35 percent of patients, isn't effective for those with the deadliest form of the disease and didn't show positive results for African Americans.
But for those it does help with pain and flareups, there is a sense of relief.
"It's given me my life back,"says Janice Fitzgibbon of McLean, Virginia, who was so crushed by pain that she couldn't take her dog for a walk or drive her children to school. She has been taking Benlysta for two years as part of the drug's clinical trial program.
Lupus causes fibrous tissue and inflammation of internal organs, skin rashes and joint pain. Most of Benlysta's benefit came from relieving muscle inflammation versus organ problems, as measured on a comprehensive checklist of lupus symptoms.
The disease occurs when the body's protector cells, known as antibodies, stop differentiating between foreign invaders, like bacteria, and healthy cells. The cause of this malfunction is not understood.
Unfortunately, there is no cure for the estimated 1.5 million Americans, mostly women, who suffer from it.
But in many cases, the symptoms can be treated with steroids, and non-steroidal anti-inflammatory drugs like aspirin and ibuprofen. Extreme cases are sometimes treated with immunosuppressive drugs. All current treatments have significant side effects and doctors are always walking a tight rope between symptoms and the side effects. In that regard, Benlysta is no different.
Of the FDA panel that recommended the drug for approval, some "expressed concern about whether the 'somewhat marginal' effectiveness of the drug outweighs the potential increased risk of death, infection, and psychiatric effects, including suicide, associated with its use," reported WebMD.
But that's not everyone's story.
"There's no one-size-fits-all for lupus and I'm just extremely fortunate that my lupus is mild and is helped by Benlysta," says Fitzgibbon.
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