OMAHA, NE — Less-expensive combination disease-modifying anti-rheumatic drugs (DMARDs) produced the same clinical benefits as much costlier biological treatment, according to a large VA study comparing the effectiveness of drug therapies for rheumatoid arthritis.
Results of the 48-week study, which was led by James O’Dell, MD, of the VA Nebraska-Western Iowa Health Care System and the University of Nebraska Medical Center, were published this summer in the New England Journal of Medicine.1
For the 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, marketed as Enbrel, is a tumor necrosis factors (TNF) antagonist or anti-TNF therapy, also known as a biological treatment.
“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 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 healthcare system.”
The double-blind study involved 353 patients at 16 VA medical centers, 12 rheumatoid arthritis investigational network sites and eight Canadian medical centers. Two groups were created from study subjects: one where patients were administered the triple therapy combination first, and the other where patients took methotrexate and etanercept first for 24 weeks.
Patients who didn’t respond to either therapy were switched to the other therapy halfway through, and, although patients in both groups who switched to the other therapy improved, their response was not significantly different between the two study groups.
In fact, both strategies resulted in significant and similar improvement over 48 weeks, meeting the final outcome goals. Furthermore, no significant differences in secondary outcomes were recorded, including radiographic progression, pain, health-related quality of life or, for the most part, adverse events associated with any of the medications.
O’Dell said the study was conducted because the cost of treating rheumatoid arthritis has increased significantly, primarily because of the increased use of biological therapies, noting it now is more expensive per patient than diabetes.
“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,” he pointed out.
Conventional medications also carry less risk of severe side effects than the biologics used in the study, according to O’Dell. Biologic therapy has been associated with increased risk of developing tuberculosis and other infections, as well as elevated chances of multiple sclerosislike 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,” O’Dell said.
- O’Dell JR, Mikuls TR, Taylor TH, Ahluwalia V, et. al. Therapies for active rheumatoid arthritis after methotrexate failure. N Engl J Med. 2013 Jul 25;369(4):307-18. doi: 10.1056/NEJMoa1303006. Epub 2013 Jun 11. PubMed PMID: 23755969.