New drug may hold promise for lupus sufferers

For the first time in a half-century, a new drug appears to offer hope to sufferers of lupus, the chronic, autoimmune disease that plagues an estimated 2 million people, mostly women, in the United States.

Benlysta, a drug developed by Human Genome Sciences and GlaxoSmithKline, showed positive results in clinical trials that wrapped up last year.

The drug works by inhibiting the biological activity of the B-lymphocyte stimulator, which is believed to contribute to the production of autoantibodies that attack and destroy the body's healthy tissues.

"It's a major step forward," says Dr. Gary Gilkeson, a professor at the Medical University of South Carolina's Division of Rheumatology & Immunology who subspecializes in lupus and conducted a trial in Charleston.

Gilkeson says the drug companies are preparing to present the paperwork to the Food and

Drug Administration this spring and that the FDA recognizes the importance of expediting its approval. Benlysta could make it on the market as early as next winter.

So far, the only relief for lupus sufferers has been treatments or drugs not specifically developed for lupus, such as chemotherapy or steroids, to tamp down symptoms of lupus, which include sore joints, skin rashes and fatigue. But those treatments also carried the heavy price of side effects.

Benlysta's arrival comes at the same time many insurance companies are starting to withdraw coverage of off-label drugs and treatments.

Sandra Raymond, CEO of the Lupus Foundation, called the success of Benlysta "groundbreaking news" for those who suffer from lupus.

She says another benefit is that Benlysta could lead to more, even more effective drugs, for the treatment of the disease.

"I hasten to say that lupus is different from patient to patient and that one drug may not fit all," says Raymond. "We need an arsenal of treatments, and what these two companies have shown is that it (a drug for lupus) can be done. Until now, companies have shied away from lupus because it was a complex disease."

She adds that drug companies also were reluctant because the prevalence of lupus is somewhat unknown.

While the estimates are 2 million in the United States, the Centers for Disease Control and Prevention is conducting a prevalence study that is expected to be completed by 2012. Raymond thinks the estimate may be higher.

Charleston resident Evola Gardner is among the locals who have suffered from lupus. She was diagnosed in 1989 and was part of the MUSC trial.

"I've had some bad times," says the 63-year-old downtown resident. "Lupus is a painful disease. My joints were sore and I got so tired."

In the two years since taking Benlysta, she's gone from being in a wheelchair to a walker and now just uses a cane.

Her joints aren't aching anymore, her blood pressure has gone down. She also has stopped taking an expensive, off-label drug. In fact, she said she feels so good that she's returned to cooking big meals, hosting 18 people at Thanksgiving and 15 at Christmas, which is an endurance feat itself.

"I'm back in the kitchen. I've always loved to cook," she says, adding she's known for her seafood quiche and macaroni and cheese. "When people found out I was feeling better, a lot more wanted to come for dinner."

Facts about lupus

--Lupus is also a disease of flares (the symptoms worsen and you feel ill) and remissions (the symptoms improve and you feel better). Lupus can range from mild to life-threatening and should always be treated by a doctor. With good medical care, most people with lupus can lead full lives.

--Lupus is not contagious, not even through sexual contact. You cannot "catch" lupus from someone or "give" lupus to someone.

--Lupus is not like or related to cancer or HIV/AIDs.

--Lupus strikes mostly women of childbearing age (15-44). However, men, children and teenagers develop lupus, too.

--Women of color are two to three times more likely to develop lupus, though people of all races and ethnic groups can develop lupus.

--More than 16,000 new cases of lupus are reported annually across the country.

--No gene or group of genes has been proven to cause lupus, though study findings strongly suggest that genes are involved.

--While a person's genes may increase the chance that he or she will develop lupus, it takes some kind of environmental trigger to set off the illness or to bring on a flare. Examples include ultraviolet rays from the sun or fluorescent light bulbs, drugs that make a person more sensitive to the sun (such a tetracycline), penicillin and other antibiotic drugs, infections and viral illnesses, exhaustion and emotional stress.

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