Study: Prograf Effective and Safe as Stand-Alone Therapy for Rheumatoid Arthritis

Prograf, a drug normally used to prevent rejection of organ transplants, appears to be effective in improving the function of rheumatoid arthritis patients, according to a study reported in the December issue of Arthritis and Rheumatism.

University of Arizona researchers evaluated the effectiveness and safety of Prograf (tacrolimus) as a stand-alone therapy to treat the signs and symptoms of rheumatoid arthritis.

The six-month study involved 464 rheumatoid arthritis patients who either received a two-milligram or three milligram dose of tacrolimus once a day or a placebo.

The primary endpoint was a 20 percent clinical improvement according to the American College of Rheumatology criteria or ACR20. Only 10.2 percent of those taking the placebo achieved this level of improvement, compared to 18.8 percent of the patients taking the two-milligram and 26.8 percent of the patients taking the three-milligram dose of tacrolimus.

On the safety side, the researchers found levels of serum creatinine, which indicates kidney function, to be within normal range throughout the trial in about 90 percent of the tacrolimus patients.

Arthritis & Rheumatism 2003 Dec;48(12):3328-37