New Arthritis Drug Beats Placebo In Phase III Trial

Main Category: Arthritis / Rheumatology
Also Included In: Clinical Trials / Drug Trials
Article Date: 21 Jun 2006 - 14:00 PDT

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In a randomized trial involving 652 patients with active chronic rheumatoid arthritis (RA) despite treatment, the drug abatacept reduced disease activity, improved physical function and slowed joint damage when compared with placebo (Article, p. 865).

Those receiving abatacept also had more serious infections (2.5 percent vs. 0.9 percent) and infusion reactions.

During the trial, participants continued taking methotrexate, a drug used to aggressively treat RA. The one-year study was limited to patients with established RA (mean duration of about nine years) and who had an inadequate response to methotrexate.

An editorial writer notes that the trial, a so-called "registration trial" needed for FDA approval, compares a new drug to a placebo (sugar pill) rather than to the best alternative drug, which is what would be most useful to practicing clinicians (Editorial, p. 933). The writer also says that practicing clinicians will have to monitor patients receiving abatacept carefully until the drug's safety profile becomes clearer with longer time on treatment.

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Tip sheet, Annals of Internal Medicine, April 2006

Contact: Susan Anderson
American College of Physicians

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