Editor's Note: This is the third story in a five-part series about clinical research at the University of Nebraska Medical Center. To learn more what clinical research is and the role it plays at UNMC, read the introduction to this series.
OMAHA - The doctor who pioneered the most popular treatment for rheumatoid arthritis is at it again, using genetic analysis to find even better therapies customized to individual patients.
The University of Nebraska Medical Center's Dr. Jim O'Dell in 1996 published a landmark study in The New England Journal of Medicine showing a three-drug combination was more effective at treating rheumatoid arthritis than single drugs or two-drug combinations in use at the time. Now, he's testing new therapies using genetic samples taken from hundreds of participants in his many clinical studies.
O'Dell's aim: Know from the start which drug combination will work for a particular patient, instead of letting the debilitating disease march through a patient's body for as long as a year while doctors try different treatment approaches.
Rheumatoid arthritis is a disease where the body's joints deteriorate, causing pain and disability. It afflicts more than 2 million Americans.
The future of rheumatoid arthritis treatment is to stop giving patients the drug combination that works in 70 percent of people like them, and start giving them the combination that works in 95 percent of similar people, said O'Dell, who directs the five-state Rheumatoid Arthritis Investigational Network. Ideally, the chance of harmful side effects would be very low -- like 2 percent.
Existing therapies, as greatly improved as they are, work slowly. Doctors need at least 3 to 4 months each to see whether one's working -- meanwhile, damage could be spreading from the small joints of the hand to the large joints of the elbows and knees. A painful but bearable inconvenience that might be stopped at the hands could be allowed to proceed throughout the body, causing partial or total disability.
"If I have to utilize a year in finding out the proper course, then that patient's going to be paying for that 10 years later," O'Dell said.
O'Dell's key to quickly determining the right treatment is his database of data and genetic material from the people who have participated in his arthritis-drug studies.
"What Jim O'Dell has is the best sample population in the world," said the director of clinical studies who works with him, Geoff Thiele.
O'Dell has data on patients before and after treatment with a variety of drugs; people who responded and didn't respond to certain treatments; and on people who were in control groups and received a placebo rather than the drug or drugs being tested. With all this information in hand, he can look at 20 different factors in the blood that can influence whether a person gets rheumatoid arthritis. This gets down into some tiny, tiny minutiae. For example, O'Dell has discovered how to treat the small number of people who get a certain trait they could only have inherited if both their parents had it. People have to have a certain subset of a feature on their cells, out of many possibilities, to be susceptible to this kind of rheumatoid arthritis. But there's an advantage: O'Dell has already found the drug combination that works best for them, so they don't have to try a bunch of approaches before hitting the right one.
Thiele and his assistants work in the laboratory on genetic samples from the people who have participated in O'Dell's studies. That way, when they come up with a theory that a certain treatment strategy worked because of traits unique to some people in the study, they can test the samples to see whether those traits are indeed present.
Barb Counihan, diagnosed with rheumatoid arthritis in 1979, is somewhat of a walking history of arthritis care. She received injections of gold (that's right, the metal) for 14 years, then took the steroid prednisone, then methotrexate and aspirin, and finally O'Dell's three-drug combination. She's been participating in O'Dell's clinical studies since 1995.
Counihan, an accountant at KMTV in Omaha, said she's grateful that world-class treatment for her arthritis can be found a short trip across town.
"Terrifically, immensely grateful for that," she said. "You don’t have to travel to another major city to get care."
She's also glad that while she's getting the best treatment for herself, her body's reaction to the drugs is helping doctors understand how similar people will fare.
"I'm excited that I can be a part of that study, and help patients in the future," she said.
O'Dell's next step is to compile a national database of rheumatoid arthritis patients, to put together on a large scale what he's done on a small scale. The larger the sample size, the more accurate the results. He's working now to get a National Institutes of Health grant for the effort.
"I could go and take 500 patients who responded to one treatment, 500 who didn't, and see if there's a common genetic trait," O'Dell said.
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This story originally appeared in Nebraska StatePaper on July 25, 2001.
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