Lupus

by Food and Drug Administration (FDA)

Arletha Manlove, 41, of Kansas City, Mo., first noticed feeling different after having her first child. She experienced unusual fatigue, but thought maybe it was the adjustment of taking care of a new baby.

Everything was a struggle, she says. "It was a chore to take a shower and a chore to get dressed." She also had unexplained fevers, recurrent upper respiratory infections, and swelling and aching in her hands. "I would wake up in the morning with swollen fingers, and by the time I got dressed, the swelling would go down."

She had six miscarriages in five years and repeated bouts of uterine pain. "I had been to gynecologists, psychiatrists, psychologists, and general practitioners," she says. "I started to think maybe they were right; maybe it was all in my head."

After a devastating miscarriage in the second trimester of pregnancy, Manlove's uterine pain became even worse and her other symptoms continued. At her mother's urging, she agreed to try one more doctor, a fertility specialist. He diagnosed her with both endometriosis and lupus in 1990 and referred her to a rheumatologist, a doctor who has additional training in diagnosing and treating arthritis and other diseases of the joints, muscles, and bones.

Manlove recalls feeling better right away after taking a combination of three medicines: prednisone, Imuran (azathioprine), and Plaquenil (hydroxychloroquine). "I remember thinking: 'I'm back! This is what it's like to feel good,'" she says. "But then the side effects kicked in. I had horrible mood swings, and within a very short time, I went from 121 pounds to 200 pounds."

Under close monitoring from her doctor, Manlove went on to have a successful pregnancy and had a second child 12 years ago. She says she's learned that good communication between patients and doctors is essential for coping with chronic illness. "I was very good about letting him know about side effects and asking questions, and we have been able to cut back on some of the medications over time," she says. She's also made important lifestyle changes. "You can't expect your doctor to give you a pill and then everything will be OK," she adds.

Lupus experts recommend that people with lupus have regular medical appointments and take their medication as prescribed. Other recommendations include sunscreen use and limiting sun exposure to prevent flares, regular exercise to improve joint flexibility and muscle strength, good eating habits, and plenty of rest.

"I've learned to stop when I need to, and sometimes I take three short naps in a day," says Manlove, who works full time and is active with the Lupus Foundation of America (LFA) as a support group facilitator. A chronic illness can take a toll on family and friends, too, so it's important to seek out support.

"My husband believes me when I say I feel bad," she says. "Without his support, the stress of this journey would have been much harder. Not everyone is so lucky."

The body's natural defenses, called the immune system, protect us from viruses, bacteria, and other foreign invaders. But in people with systemic lupus erythematosus (SLE), the immune system can't tell the difference between foreign substances and the healthy cells and tissues.

"Instead of fighting infection, the immune system attacks 'self,' the person's normal tissues," says Michelle Petri, M.D., a professor of medicine and director of the Lupus Center at The Johns Hopkins University School of Medicine in Baltimore. Immune complexes then build up in the tissues, causing inflammation, tissue injury, and pain. "SLE can affect any organ system," Petri says, "but especially causes skin rashes after sun exposure, swollen joints, and kidney disease."

SLE, also commonly called lupus, is a chronic autoimmune disease that affects 1.5 million to 2 million Americans, according to the LFA. Nine out of 10 people who have it are women, and it mostly affects women of childbearing age, those between ages 15 and 44. But men, children younger than 15, and older people also get lupus. People of any race or ethnicity can develop lupus, but blacks, Hispanics, Asians, and American Indians are at increased risk.

There is no cure for lupus, but, in most cases, the disease can be managed. Because of better detection and early treatment, between 80 percent and 90 percent of people with lupus can look forward to a normal lifespan, according to the LFA.

"Although the overall outlook has improved, it is a disease that must be monitored very carefully," says David Isenberg, M.D., academic director of rheumatology at University College London. "It has a major effect on quality of lives, and a smaller, but significant, number of people still die from it."

Maribel Ramirez, 43, was diagnosed with lupus in 1989 and started a support group in the Houston area in 1995 for Spanish speakers who have the disease. "I see people dying, and it's very difficult," she says. "We are desperate for better treatments." Ramirez has suffered damage to her lungs, kidneys, and heart. In 1994, she had a stroke due to vasculitis, a condition in which blood vessels become inflamed. "I worry about the disease and all the medications that I've been taking for so long," she says.

There are effective drugs that decrease inflammation and suppress the immune system in people with lupus, but these drugs also can lead to damaging side effects. Doctors and patients have to weigh carefully the benefits and risks of treatment. Isenberg likens treating patients with lupus to putting them on a fence between two fields.

"One side represents the effects of the disease, and the other represents the side effects of treatment," he says. For example, people with lupus are at increased risk for developing hardening of the arteries that can cause a heart attack or stroke. The risk is due partly to having lupus and partly to taking corticosteroids, which decrease inflammation caused by the disease.

Another challenge, says Petri, is that there are no treatments for two common complaints of lupus patients — fatigue and memory loss. Ramirez says she once had to pull off the freeway and call a friend for help because she was lost, even though she was very close to home.

Researchers are looking for lupus treatments that are safer and more targeted, but the uniqueness of the disease poses challenges for drug development. The exact cause of lupus is unknown. The disease varies in intensity. And the symptoms are wide-ranging, sometimes involving multiple organs. Symptoms also tend to come and go, with active periods, called flares, and quiet periods when the disease is in remission.

In March 2005, the Food and Drug Administration released a draft guidance for industry on testing drugs for lupus in clinical trials. The guidance includes a general discussion of outcomes and measurements of disease activity, as well as claims that the agency may be willing to approve if they are supported by substantial evidence. "This guidance is an important step in stimulating new drug development for lupus treatment," says Acting FDA Commissioner Dr. Lester M. Crawford. "We are intensely interested in this area."

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