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New lupus drug offers hope to millions

May 6, 2011 12:00:00 AM PDT
One-point-five million Americans and 5 million people worldwide are living with lupus right now. Lupus has no known causes or cures. Now there's new hope. The Food and Drug Administration just approved the first new lupus drug in 50 years.

Finally there's a bit of good news in the long search for a viable treatment.

Lupus is an autoimmune disease in which the body's immune system attacks healthy, normal tissue. It mainly strikes women ages 15 to 44, and women of color are two to three times more likely to develop the disease.

From wiring to check cashing, solving money troubles and managing her team, being a manager of a bank is always challenging and never boring for Diane Salemi. Imagine keeping all of this straight while fighting a debilitating disease.

"That's where it came. The pain where you had to get up and down from your desk or walk up or down the stairs," said Salemi.

Doctors diagnosed her with the most common form of lupus, called systemic lupus erythematosus.

"Lupus can be mild. Lupus can be moderate, but if it really attacks you severely, it can be fatal," said Dr. Robert S. Katz, a rheumatologist and professor of medicine at Rush University Medical Center in Chicago.

Lupus can be painful. Sufferers have overactive immune systems, which are misdirected and can attack their organs, including the skin, muscles, kidneys, lungs, brain and joints. Treatment includes various forms of steroids and immunosuppressive medications. They're often administered orally and can have awful side effects.

"As you can see, I do have the butterfly rash," said Salemi. "Methotrexate causes you to lose your hair, and it's like a cancer drug, and it does evil things to the inside of your body."

Seeking alternatives, Salemi was one of the first to take a new drug called Benlysta (generic name: belimumab). It's administered intravenously monthly. Doctors say it may be less toxic than some of the other drugs, and side effects are less severe. The reason? Doctors believe it's because it's made biologically by live antibodies that don't suppress the immune system.

Doctors actually use animals like mice and inject a specific human protein into it. The mouse then makes more of the proteins. Those proteins are removed, purified, copied and then injected into lupus patients.

"It's good to have a new, completely different type of medication that may suppress one protein in the immune system but not everything, and so it's a new age," said Katz.

But doctors say Benlysta isn't for all types of lupus and hasn't worked for African-Americans in the clinical trial. And it's expensive, about $35,000 a year.

But even with these limitations, Lupus Foundation officials say Benlysta offers a lot of hope.

"We think it's going to bring a lot of attention to lupus, and that means a lot to us because we are constantly trying to bring awareness to lupus," said Charles Brummell, Lupus Foundation of America, Illinois chapter president.

"I think it's a potentially exciting time where there might be significant breakthroughs," said Katz.

Breakthroughs that some people have already experienced.

"Benlysta has helped me as far as my fatigue. I have less fatigue now. I have more energy and absolutely no side effects from the drug," said Salemi.

Which means besides her career, she can enjoy everything that life has to offer when her work day is done.


Lupus is an autoimmune disease in which the body's immune system cannot distinguish threats from healthy, normal tissue such as organs. The body's immune system sends autoantibodies that attack the healthy tissue, causing inflammation and pain in many parts of the body.

Lupus is a chronic disease, which means it lasts for more than six weeks (lupus often lasts for several years). It generally follows a pattern of flares and remissions: symptoms will be pronounced for a while, then get better, and then worsen again.

While people of both genders and all ages, races and ethnic groups can develop lupus, it mainly strikes women ages 15-44, and women of color are two- to three-times more likely to develop the disease.

An estimated 1.5 million people in the U.S. suffer from lupus, with 16,000 new cases being diagnosed every year. While lupus is not contagious (you cannot catch lupus from someone who already has it), the exact cause of the disease is unknown. Doctors believe the cause of lupus is linked to genetics. Though genes may be the underlying cause of lupus, an environmental trigger is necessary for the symptoms to surface.

Common environmental triggers are exposure to sunlight or ultraviolet rays from fluorescent light bulbs, taking certain prescription drugs, an injury, an illness, or even extra stress. (SOURCE: http://www.lupus.org)

THE NEW TREATMENT: The FDA recently approved Benlysta (generic name belimumab) for the treatment of lupus, making Benlysta the first new lupus drug in 50 years. While it is by no means a miracle drug (only 30 percent of people in clinical trials found it helped their lupus symptoms), doctors hope it will allow patients with lupus to take lower steroid doses and still see less lupus activity. In clinical studies, one of the main benefits of Benlysta was the relief it provided for the skin rashes and mouth and nose ulcers that are symptoms of lupus. Benlysta is a man-made antibody. Due to the high cost of producing biological treatments, Benlysta is quite expensive. However, healthcare organizations might cover the treatment. (SOURCE: http://lupus.webmd.com)