Results of the national study, which set out to define the strategy for treatment of patients with early onset rheumatoid arthritis, have important cost and safety considerations for patients.
In the study, 28 percent of patients were treated successfully with methotrexate as an initial therapy — a drug that is lower in cost and has fewer side effects compared with other treatments for rheumatoid arthritis.
“This study validates the conservative strategy of methotrexate alone as a first therapy,” said James O’Dell, M.D., co-author of the study and chief of the University of Nebraska Medical Center Division of Rheumatology and Immunology. “We found patients on methotrexate alone did well compared to those who received aggressive therapy upfront. After two years in the study, they had no damage and there were no long-term consequences for them being treated with methotrexate alone.”
Dr. O’Dell, who also holds an appointment at the Omaha VA, presented results of the study in Chicago at the American College of Rheumatology’s (ACR) annual scientific meeting this week. He also was elected president of the ACR at the meeting.
The study is part of the Treatment of Early Aggressive Rheumatoid Arthritis (TEAR). Of 755 patients in the 26-state study, 377 started out on methotrexate alone and did not need to be stepped up to another treatment. Other step-up treatments were a “combination” or “triple therapy” of methotrexate, sulfasalazine and hydroxychloroquine, or a biologic treatment of methotrexate plus etanercept.
>Researchers say the study is important because many health professionals believe recently diagnosed patients whose factors indicate they may have a poor prognosis should be started with more aggressive therapy. Poor prognosis includes more damage to joints, more disability, and greater likelihood of having joint replacements.
Dr. O’Dell said the strategy of starting patients with methotrexate only, or even using “triple therapy” initially, could potentially keep a half to a third of patients off methotrexate plus etanercept (biologic therapy). He said more comparative effectiveness studies are needed, particularly when they have profound economic consequences for patients.
“The cost savings are dramatic and could range from less than $100 a month up to $1,500 a month,” Dr. O’Dell said. “If we just look at this area in rheumatoid arthritis, this could cut the pharmacy budget by 50 percent for the overall treatment of the disease. There will still be patients that need to be on the more expensive therapy, but that number of patients will be smaller and in the later course of the disease.”
Rheumatoid arthritis, which affects an estimated 2.5 million Americans, is a chronic disease that causes pain, stiffness, swelling and limitation in the motion and function of multiple joints. The disease also can bring on strokes and heart attacks.
Disclosure of interests statement: Dr. O’Dell was involved in the development of the triple therapy. Co-investigators received grant support from various companies including Pfizer, Abbott, Roche, Genentech, Centocor, and Amgen.
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