Posted on November 12, 2001 at 12:30 p.m.
BIRMINGHAM, AL — A multi-center, international pilot study of two new drugs to treat patients with rheumatoid arthritis has found the drugs to be safe and effective in treating the disease. Dr. Larry Moreland, professor of medicine with the Division of Clinical Immunology and Rheumatology at the University of Alabama at Birmingham (UAB), will present findings during the American College of Rheumatology’s Annual Scientific Meeting, November 11-15, in San Francisco, California.
“We found the drugs to be safe and we saw significant improvements in a large percentage of patients who participated in the study,” says Moreland. “This trial lays the groundwork for further studies to more fully investigate whether the drugs are safe and effective when given long term.”
Rheumatoid arthritis, which affects 2.1 million Americans, primarily women, is an autoimmune disease in which the body’s immune system attacks healthy joint tissue causing inflammation and damage. Symptoms include joint swelling, stiffness and pain.
The drugs, CTLA4Ig and LEA29Y, developed by Bristol-Myers Squibb, work differently than drugs currently on the market to treat rheumatoid arthritis. “Current therapies inhibit the production of certain proteins which regulate immune response,” says Moreland. “These drugs target a different part of the immune system, working to inhibit the activation of damage-causing T-cells.”
The short-term study involved 214 patients with recurring disease who received four infusions of either a placebo or one of the drugs, in the absence of any other therapy, over a period of 57 days. The trial tested three doses of the drugs and found that all doses were generally well tolerated by patients. The study also showed that a majority of patients met ACR20 criteria — guidelines established by the American College of Rheumatology to measure improvement — indicating patients improved 20 percent.
The drugs may one day offer patients an alternative treatment. “This is just the first step,” says Moreland, “but findings are promising.”