Study: Prograf Effective for Difficult-to-Treat Rheumatoid Arthritis Patients

A drug that helps prevent rejection of transplanted organs may also be an effective therapy for difficult-to-treat rheumatoid arthritis.

The drug, Prograf (tacrolimus), is now mainly used to prevent the rejection of liver and other organ ransplants.

According to a study reported in the February issue of the Journal of Rheumatology, a team of Japanese researchers found tacrolimus effective in treating rheumatoid arthritis of patients who have failed to achieve good results with disease modifying antirheumatic drugs,

Researchers at Kitasato University School of Medicine in Japan evaluated the effectiveness and safety of tacrolimus in 212 such rheumatoid arthritis patients who were given either 1.5 milligrams or three milligrams a day of tacrolimus or a placebo.

The participants were allowed to continue taking prednisolone and/or one nonsteroidal antiinflammatory drug (NSAID) during the study.

About 48 percent of the patients receiving the higher dose of tacrolimus had a 20 percent improvement in the signs and symptoms of their rheumatoid arthritis as measured by American College of Rheumatology response scores, compared to 25 percent of the lower-dose tacrolimus group and 14 percent of the placebo group.

There were no significant differences between the tacrolimus groups and placebo group in the incidence of adverse events. The main adverse events in the tacrolimus groups, especially in the three-milligram group, were renal function abnormalities and gastrointestinal symptoms, according to the study.

The researchers said their findings "strongly suggest the usefulness" of tacrolimus for the treatment of such difficult-to-treat rheumatoid arthritis patients, noting that the optimal dosage appears to be three milligrams a day in terms of effectiveness and safety.

Other sources: Journal of Rheumatology 2004 Feb;31(2):243-51