In the large U.S. Department of Veterans Affairs cooperative blinded study that compared the effectiveness of drug therapies for rheumatoid arthritis, Dr. O'Dell and his fellow 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.
In a 48-week study, researchers compared the strategy of first starting oral, "triple therapy" DMARDS, methotrexate, sulfasalazine and hydroxychloroquine, to that of first starting one DMARD (methotrexate) plus etanercept. Etanercept is part of a class of injectable drugs called tumor necrosis factors (TNF) antagonist or anti-TNF therapy, also known as biologics.
"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 The Nebraska Medical Center. 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.
Results, now on the New England Journal of Medicine's web page, will also appear in the July 25 print edition.