By MEREDITH GOAD, Blethen Maine Newspapers Inc.
Lois Winter had just been diagnosed with rheumatoid arthritis when, only a week later, she had her first flare.
Until then, she had experienced trouble only with sore, achy feet. Now her knees and shoulders were bothering her, and her fingers hurt. She found herself literally crawling around on the floor of her living room.
"I said, 'What in the world is going on here?' " Winter recalls. "It was just really strange and scary. These things called joints that you don't even pay attention to can go haywire."
Winter tried traditional arthritis medications for several months, but she only seemed to be getting worse. Then her doctor put her on Enbrel, one of the revolutionary new arthritis drugs that not only soothes the pain of the disease but also slows its progression, fundamentally modifying the course of the illness. It worked for Winter, who now says her life is "nearly back to normal."
"I suppose for me there would have been only one worse thing than getting diagnosed with rheumatoid arthritis," she says, "and that would have been to get it five years earlier."
The introduction of new drugs to fight arthritis "is something that hasn't occurred for a decade or more," notes Dr. John H. Klippel, medical director of the Arthritis Foundation and clinical director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases in Bethesda, Md.
During just the past year, at least three new drugs have come on the market, and more are in the pipeline. While one class of new drugs may offer more hype than hope, the others are considered major advances that are helping people wracked by the disease see significant and sometimes dramatic improvements in their quality of life. Rheumatoid sufferers
Arthritis, the leading cause of disability in people over 15, affects 14 percent of the population of Maine. Osteoarthritis is the most common form of the disease, and the number of cases is expected to swell significantly as Baby Boomers grow older.
Almost 2,000 Mainers, most of them women, have rheumatoid arthritis. An autoimmune disease, it is one of the most serious and disabling forms of the illness.
Two of the new drugs, Enbrel and Arava, fight only rheumatoid arthritis. A new class of drugs known as COX-2 inhibitors, which include Celebrex and Vioxx, can be used to relieve osteoarthritis as well.
Enbrel and Avara are "smart drugs" that leave most of the immune system untouched while targeting the portion that causes the uncontrolled inflammation that is characteristic of rheumatoid arthri- tis.
Enbrel, approved earlier this year, is a genetically engineered drug that is taken in twice-weekly injections. It specifically targets a protein that plays an important role in the early stages of inflammation, "soaking it up" like a sponge. Arava is a pill that targets white blood cells.
Traditional medications for rheumatoid arthritis sometimes have serious side effects, so patients who use them have to be monitored closely. Although the jury is still out on the long-term safety of Enbrel and Arava, both new medications have good track records so far, says Dr. Charles Radis, one of five physicians at Rheumatology Associates in Portland who enrolled patients in clinical trials for the new drugs.
People who respond well to the drugs may go completely into remission and not have any signs of their disease.
"When they're working at their best, they seem to stop progression," Radis said. "When they're not working quite as well as we'd like, we think they slow progression."
Over the next few years researchers will be building on the success of these drugs, fine-tuning their suppression of the immune system.
"I think this is just the beginning," Klippel said.
Another new drug, Celebrex, is the first in a new class of medications called COX-2 inhibitors. These so-called "super aspirins" counter pain and inflammation without the stomach ulcers and other side effects of traditional drugs.
Doctors wrote so many prescriptions for Celebrex after it hit the market that it became more popular than Viagra. But Radis, who considers the drug a bit overhyped, points out that it is no more effective in terms of pain relief than traditional anti-inflammatories — and it is more expensive.
Doctors emphasize that while the new drugs are impressive, there still is no cure for arthritis.
"None of them really get to the root, which is what causes rheumatoid arthritis and how do you shut it off permanently?" Radis says. "They're not Nobel Prize kind of medications . . . but I think they're very important new medicines."
Lois Winter, a wildlife biologist with the U.S. Fish and Wildlife Service, is one of the lucky ones who caught her disease early and has been able to use the new drugs to slow its progression.
Winter was an active, outdoor-loving 43-year-old when she was diagnosed with rheumatoid arthritis in January 1997. The troubles began with her feet: She felt like she was walking on broomsticks, and even started hobbling occasionally.
"For a while I just dismissed it as, well, I guess this is just one of those things that start happening in middle age," she said.
But soon even one of her favorite pastimes hiking became more painful than pleasurable. Hiking with friends in Baxter State Park about four months before her diagnosis, she noticed that the pain in her feet was getting worse.
"Every time we stopped, I just had to tear my boots off and rub my feet," she said. "The bottoms of them and my toes were just hurting so much, and I couldn't understand why." Diagnosis shocks her
She went to a foot doctor, who noticed swelling and other problems in both of her feet and suspected arthritis. He sent her off for blood tests, and the test for rheumatoid factor came back positive.
The diagnosis came as a big shock to Winter. She started having visions of herself as an old woman with crooked fingers in a wheelchair, and that was not how she had envisioned her future.
"I think one of the first things I said was, 'Wait a second, I'm supposed to be hiking Katahdin when I'm 70,' " she said. "This isn't part of the game plan."
Radis, who is her rheumatologist, helped her to see that that picture floating around in her head wasn't necessarily her prognosis.
Over the past decade or so, says Klippel of the Arthritis Foundation, there's been a shift in the way rhematoid arthritis is treated. It used to be that physicians would start with milder medicines and gradually add on more as the disease grew worse. But now they hit the disease early, and hit it hard.
"Drugs are used much, much earlier in the course of the disease as a way of trying to reverse it and prevent chronic arthritis," Klippel said. But even with the advent of disease-modifying drugs like Enbrel and Arava, newly diagnosed patients are not likely to be started on them right away. That's because the downside of the newcomers is their cost. Arava costs almost $3,000 a year, according to the Arthritis Foundation, while Enbrel comes with a whopping price tag of almost $12,000 per year.
The drug companies that make them have started hardship programs for people who can't pay for them. But even among the insured, Enbrel is so pricey that insurers are setting guidelines for who can have it. In most cases, patients must have failed on other drugs before they can give Enbrel a try.
"We fight to get them on these medicines, with some insurance companies much less than others," Radis said. "But often it requires letters; it requires phone calls."
Klippel says he hopes the cost will come down once other comparable drugs come on the market and there's more competition. But he points out that even $12,000 a year is a bargain compared with the long-term cost of disability and caring for a chronic disease like arthritis.
"And what you can't place a dollar amount on is the emotional cost of the disease, what it does to a mother who's trying to raise kids," he said. "If a drug or combinations of drugs introduced early can impact that, that's the way that one needs to be thinking about the cost issue here. Twelve thousand dollars a year may be a minuscule amount to pay for what's going to be thousands and thousands of dollars that are going to be lost over the lifetime of the patient because of the disease."
Lois Winter started out on an antibiotic that seems to have some beneficial effect for people in the early stages of rheumatoid arthritis, but it didn't seem to help. Then she switched to methotrexate, one of the most common drugs prescribed for the disease.
"I was still achy, my joints were bugging me, and I wasn't getting any better," Winter said. "In fact, I was getting a little worse." Felt like I was 70 or 80'
On the outside, she was still fairly functional. Hiking and other hallmarks of her active lifestyle, however, had lost their allure.
"There were times when I'd startle myself when I'd look in the mirror and I'd see this relatively young, healthy-looking person looking at me, and I felt like I was 70 or 80 years old inside," she said. "It was very odd."
She worried about how quickly the disease would progress, and said a silent thanks that she had good insurance.
Winter noticed a difference within days of taking Enbrel. Today, a little less than a year after starting the drug, her life is almost back to normal. She notices a slight crook in one of her fingers, and she had to have surgery on one of her wrists, but she hasn't had any more flares. She swims, works out at the gym and goes hiking again.
"For me the biggest challenge is to remember to take my drug the right days," she said, "because I'm feeling so good I forget I have it."
She is not cured because there is no cure yet for arthritis. But a sense of hope has taken the place of those nightmarish visions of disability she had when she was first diagnosed.
"There clearly is life after rheumatoid arthritis," she said, "especially with these new drug therapies."
