Rituximab
DANCER Study shows RA drug rituximab is safe and well-tolerated
By European Society for Human Reproduction and Embryology
Jun 9, 2005, 13:26

In the biggest study of its kind, researchers have shown that the drug rituximab, used to treat rheumatoid arthritis (RA) is safe and effective. The results were presented for the first time today (Thursday 9 June), at the Annual European Congress of Rheumatology, EULAR 2005, in Vienna.

Professor Paul Emery from the University of Leeds in the UK led the DANCER study (Double blind placebo controlled dose ranging study), designed to confirm the efficacy of rituximab for the treatment of patients with active RA who have failed to improve on one or more disease modifying anti-rheumatic drugs (DMARDs). Rituximab targets a specific type of immune cell and helps to control inflammation and pain.

The DANCER study involved 465 men and women who had had arthritis for about 10 years. It examined the relative efficacy of two different dose levels of rituximab, as well as the role of anti-inflammatory drugs, glucocorticoids (steroids), in the treatment programme.

Speaking at the Vienna congress, Professor Emery said, "The results of the study's 24 week-analysis showed that both doses of rituximab were highly effective, and significantly better than a placebo. It seems that that the higher of the two doses produced the best effects."

An intravenous infusion of glucocorticoids alone before the treatment began was compared with a pre-infusion plus a short oral course. Either way, the steroids did not enhance the efficacy of rituximab. "Our analyses demonstrate that rituximab is safe and well-tolerated, consistent with that seen previously in studies of rituximab, in patients with RA," Professor Emery said.



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