An experimental new drug, the first in a new class of drugs being evaluated for the treatment of rheumatoid arthritis, has been shown effective in significantly improving the signs and symptoms of disease and enhancing quality of life, according to a preliminary study by researchers at the University of Alabama at Birmingham (UAB). Details of the study are reported in the Nov. 13 issue of the New England Journal of Medicine.

November 12, 2003

BIRMINGHAM, AL — An experimental new drug, the first in a new class of drugs being evaluated for the treatment of rheumatoid arthritis, has been shown effective in significantly improving the signs and symptoms of disease and enhancing quality of life, according to a preliminary study by researchers at the University of Alabama at Birmingham (UAB). Details of the study are reported in the Nov. 13 issue of the New England Journal of Medicine.

Rheumatoid arthritis is a disease in which the body’s immune system attacks and destroys its own healthy cells and tissues, causing progressive joint damage and disability. An estimated 2.1 million adults in the United States have the disease, according the National Institutes of Health.

“Although current therapies are effective in slowing disease progression and reducing joint damage, only about 40 percent of patients improve by 50 percent or more,” said Dr. Larry Moreland, professor of medicine with UAB’s Division of Immunology and Rheumatology. “There is a real need for new therapies.”

The candidate drug being tested by Moreland’s research team is known as cytotoxic T-lymphocyte-associated antigen 4-IgG1 (CTLA4Ig). “It works by blocking one of at least two signals required to fully activate damage-causing T-cells,” Moreland said. “This is different from current therapies, which work by blocking the activity of a particular protein produced by cells called macrophages.”

The preliminary study enrolled 339 patients with rheumatoid arthritis. All patients continued to receive methotrexate, currently prescribed for treatment of rheumatoid arthritis, plus either a placebo, two milligrams of the test drug or 10 milligrams of the test drug. Patients were followed and evaluated over a period of six months.

The study found patients who received methotrexate and CTLA4Ig improved significantly more than patients who received methotrexate alone. “A far greater percentage of patients taking CTLA4Ig improved by 50 to 70 percent, especially patients who received 10 milligrams CTLA4Ig,” Moreland said. “They did much better overall but rated greater improvement particularly in physical health, pain, vitality and social function.”

The study opens the door for further testing of this and other therapies in this new class of drugs known as costimulation blockers. “Further research is needed, but we believe CTLA4Ig and similar such drugs will one day offer patients with rheumatoid arthritis an effective alternative to treatments currently on the market,” Moreland said.