Benlysta approved: Which lupus patients will benefit?
Lady Gaga is perhaps the most famous Lupus patient. Will Benlysta help her?
/ MARK RALSTON(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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Next, some poor person on here stated here that "Benlysta takes with it lives". I don't think that is a fair statement. Of course, all drugs have side effects, even aspirin. This person also was involved in several drug trials with few good effects and horrible side effects, which is no doubt unfortunate. However, to me it is frightening to make such a drastic claim about a drug without sharing insight to the contrary. Especially when there could be someone reading this who's considering Benlysta, who has had no benefits from the standard therapies and could greatly benefit from this drug, as I have.
I started on Benlysta in the drug trial phase, prior to it having FDA approval, therefore I know a little about drug trials. I researched long and hard before joining this trial. Deciding to become a guinea pig is not an easy choice. I was very, very sick at the time. I had nearly all the symptoms on the list of criteria used to diagnose lupus. However, I'd spent a long time on many of the "old drugs" used to treat lupus, with awful side effect and was not experiencing much relief. After consulting with my Rheumatologist I decided to enter the study. The way my doctor explained it to me, Benlysta is a disease modifier. In other words, Benlysta has the ability to effect actual change in my disease activity, on a cellular level. All those other drugs I'd been taking could only ever treat the symptoms, not the disease itself. I'd taken Prednisone, Imuran, and Plaquinil and was on 12 different drugs at the same time. Like I said, I was extremely ill and was ready to try nearly anything. After I started Benlysta relief began to come. Relief was not swift, in fact it was a rather slow process, but I continued on the therapy and I kept getting better. Flash ahead to today and I'm doing well. I'm one of the fortunate lupus patients that Benlysta has helped. While I'm not cured, I am feeling much stronger and have been able to avoid any major flares and have not had to be hospitalized, as I was then. I'm on very few other medications and have not been on prednisone for 5 years. I still have lupus, with all it's aches & pains, good days & bad days. But now I truly feel that I'm controlling lupus instead of lupus controlling me. Additionally, I've yet to suffer any side effects from Benlysta. I am not claiming this drug is a cure all. I'm also not saying anyone will have the response to Benlysta that I've had. I am saying that it should be considered by any SLE patient who has not responded well to traditional therapies, and to do your research and consult with a good rheumatologist. Like the FDA and drug trial finding state, this drug does not benefit everyone with lupus, but no one knows who could be one of the lucky ones it helps.
Lastly, someone on here stated you "should try to avoid medications" and that lupus is "deemed terminal". Wrong again. Complications from lupus can kill, but lupus is not an automatic death sentence. What you should do is educate yourself about SLE, work closely with your rheumatologist, take your medication without fail, and use all resources available to fight this disease. Not doing so is what could be deemed terminal. Best wishes to you!
NO ONE HAS THE SAME LUPUS or related problems - so to "I hate to tell you..." I am going to stay positive and believe that my children will be healthy and happy.
On the good news front simple vitamin D supplementation shows vast benefit for almost all lupus patients, and it's practically free.
Look up the research and follow through.