In a large U.S. Department of Veterans Affairs cooperative blinded study that compared the effectiveness of drug therapies for rheumatoid arthritis, researchers found that the use of less-expensive combination disease-modifying anti-rheumatic drugs (DMARDs) produced the same clinical benefits as much more-expensive biological treatment.
The study’s primary author, James O’Dell, M.D., is chief of the VA Nebraska-Western Iowa Health Care System’s Omaha medical center and the University of Nebraska Medical Center divisions of rheumatology and immunology.
In a 48 week study, researchers compared the strategy of first starting oral, “triple therapy” disease modifying anti-rheumatic drugs (DMARDS), methotrexate, sulfasalazine and hydroxychloroquine, to that of first starting one DMARD (methotrexate) plus etanercept. Etanercept (brand name Enbrel) is part of a class of injectable drugs called tumor necrosis factors (TNF) antagonist or anti-TNF therapy, also known as biologics.
Results are being published at the New England Journal of Medicine’s web page at http://www.NEJM.org June 11 and will later appear in its July 25 print edition.
“Before the study, there was a general belief that biologics have significantly more potency, but this study has proven that not to be the case in this patient population,” said Dr. O’Dell. “The study shows when conventional therapy is used before biologics, there should be a significant cost-savings not only to patients, but to the health care system.”
The study included 353 patients at 16 VA medical centers, 12 rheumatoid arthritis investigational network sites and eight Canadian medical centers, which included the Omaha VA Medical Center and UNMC. The double-blind study is one where neither the patients nor their physicians knew which regimen they were receiving.
Patients were divided into two groups: one took the triple therapy combination first, while the other took methotrexate and etanercept first for 24 weeks. Patients who didn’t respond to either therapy were switched to the other therapy at 24 weeks for the last 24 weeks of the study. Patients in both groups who switched to the other therapy improved, but the response after switching was not significantly different between the two study groups.
The final study outcome was that both strategies resulted in significant and similar improvement over 48 weeks. In addition there were no significant differences in secondary outcomes including radiographic progression, pain, health-related quality of life or for the most part adverse events associated with any of the medications.
Rheumatoid arthritis is a chronic disease that causes pain, stiffness, swelling and limitation in the motion and function of multiple joints. Though joints are the principal body parts affected, inflammation can develop in other organs as well.
Dr. O’Dell said that one of the main reasons for the study is that the cost of treating rheumatoid arthritis has increased significantly and is now more expensive per patient than diabetes, primarily because of the increase use of biological therapies.
“We are looking for the safest and most-effective medications. The study shows that patients who start on the conventional combination therapy do just as well as people who start on a much-more expensive therapy,” Dr. O’Dell said.
In addition to being less-expensive, conventional medications present less-severe side effects than the biologics used in the study. Biologic therapy is associated with risks of infections, including tuberculosis. They also have been associated with an increased risk of multiple sclerosis-like symptoms and lymphoma.
“When I see my patients, I know I have a lot of different treatment options to offer them. Twenty years ago that wasn’t the case. Prognosis for patients newly diagnosed with rheumatoid arthritis is excellent if therapy is started early,” Dr. O’Dell said.
This research trial was supported by the Cooperative Studies Program of the U.S. Department of Veterans Affairs Office of Research and Development, Canadian Institutes for Health Research and National Institute for Health-ARRA interagency agreements.
This study is one of about 155 research studies conducted at the Omaha VA medical center in areas that include rheumatology, substance-abuse, diabetes, and pulmonary disease. The VA research program is unique because it focuses on medical issues that affect Veterans.
About VA Nebraska-Western Iowa Health Care System
The VA Nebraska-Western Iowa Health Care System’s mission is to honor America’s Veterans by providing exceptional health care that improves their health and well-being. VA NWIHCS employees serve more than 161,000 Veterans in Nebraska, western Iowa and portions of Kansas and Missouri. The system includes a tertiary medical center in Omaha and a Community Living Center in Grand Island, Neb. Community-based outpatient clinics are located in Lincoln, Grand Island, North Platte, Norfolk, and Bellevue, Neb., and Shenandoah, Iowa; and a contract outreach clinic in O’Neill, Neb. For more information, visit http://www.nebraska.va.gov
For further information, contact:
Will Ackerman — Public Affairs Officer, VA Nebraska-Western Iowa Health Care System
Office: (402) 995-4719; Cell: (402) 332-6780
E-mail: William.Ackerman@va.gov
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