“Days would go by when I couldn’t get out of bed. When I was better, I was constantly afraid because I didn’t know when the flares would strike again,” said Fitzgibbon. “My world was so narrow. Once I spent eight days on the couch, watching Turner Classic Movies. And no one could really understand what was wrong with me.”
Today, as far as she can tell, she’s a normal 54-year-old woman. “I walk three miles a day. I lift weights.”
The difference, says Fitzgibbon, is belimumab, or Benlysta, which won a Food and Drug Administration license this year as the first drug ever designed specifically to fight the symptoms and causes of lupus.
For Arthur Weinstein, chief of rheumatology at the Washington Hospital Center, Benlysta is a drug that squeaked through the FDA approval process with a great deal of uncertainty about its ultimate value. “I’m happy that the drug is approved, and I hope it will find a place,” he said. “Whether it will remains to be seen.”
Weinstein estimates that 10 to 20 percent of lupus patients might benefit from Benlysta, and he has no idea how much the drug will help that minority in the long run. Meanwhile, the drug is expected to cost about $35,000 for 12 monthly infusions.
In the studies that led to the drug’s approval, the percentage of patients who improved on Benlysta was only slightly higher than that of those who improved on a placebo. As a result, some rheumatologists are leery about the high cost of trying it.
“From the data, it doesn’t look like a great drug,” said John J. Cush, a rheumatologist in Dallas. “I’m not sure who will benefit from it.”
This is the dilemma facing those suffering from lupus. For the first time in 50 years, there is a possible remedy for their fearsome, unpredictable and terribly painful disease. But it might not work for them, and they may never even be offered the drug because of its high price tag.
Difficult to diagnose
Lupus is an autoimmune disease, a disorder in which the immune system, for mostly unknown reasons, turns on the body. It can attack any organ, from skin to bone to kidneys, heart and brain. More than 90 percent of the patients are women.
“It seemed like my symptoms changed constantly: One week it was my joints, then I got ulcers in my mouth, then rashes,” said Fitzgibbon. “It was like, ‘Okay, lupus, where are you going to hit me next?’ ”
According to the Lupus Foundation of America, 1.5 million Americans have lupus or related diseases. However, only about 325,000 people have been given that diagnosis by rheumatologists, who specialize in lupus because the disease almost always attacks a patient’s joints. The vagueness and difficulty of lupus diagnosis — there is no single blood test or symptom that defines the disease — explain the disparity. People with less severe symptoms don’t always see a rheumatologist.