Nov. 6, 2002 -- Some rheumatoid arthritis sufferers don't get enough relief from methotrexate alone, which is the standard drug prescribed. A new study finds that they can safely take a second drug to get that pain relief.
The combination treatment -- methotrexate plus Arava -- has shown positive results in a preliminary study, reports lead researcher Joel M. Kremer, MD, at the Center for Rheumatology in Albany, N.Y.
His study, supported by Arava's manufacturer, Aventis Pharmaceuticals, appears in the Nov. 5 issue of Annals of Internal Medicine.
In the large study, researchers looked at the effects of these two drugs over a six-month period. The study involved 263 patients in 20 arthritis treatment clinics across the U.S. and Canada. Each participant was taking methotrexate and was then given either Arava or a placebo.
Compared to patients taking placebo, more than twice as many patients taking Arava had a significant improvement in symptoms -- fewer joint problems, less intense pain, and better ability to function.
However, about 90% of patients in both groups reported some side effects, including diarrhea, upper-respiratory tract infections, nausea, headache, rash, dizziness, and hair loss -- although diarrhea was the most common problem, affecting one-quarter of the patients.
One concern about giving patients both methotrexate and Arava is the potential for liver damage. In fact, people taking methotrexate alone have regular liver enzyme tests just to monitor this problem -- so very few have toxicity problems, notes Kremer.
His study shows that the combination can be used "effectively and safely with careful monitoring," says Kremer. It represents a logical alternative for people who don't get enough relief from methotrexate alone, he adds.