Rheumatoid Arthritis Drug May Improve Function
Experimental Drug Orencia May Help Relieve RA Symptoms, Study Shows
Sept. 14, 2005 -- The experimental rheumatoid arthritis drug Orencia is safe and effective, researchers report in The New England Journal of Medicine.
The researchers show that Orencia offered pain relief and increased movement in arthritis patients who had exhausted other treatment options.
"This drug works where others haven't," researcher Mark Genovese, MD, says in a news release. He is the associate chief of the immunology and rheumatology division at Stanford's medical school and an associate professor of medicine at Stanford.
Several of the study's researchers, including Genovese, have served as employees or paid consultants for Orencia's maker, Bristol-Myers Squibb. The study was sponsored in part by Bristol-Myers Squibb. The company is a WebMD sponsor.
An FDA advisory panel recently recommended Orencia for approval. The FDA often follows the advice of its advisory panels but isn't required to do so.
The study was reviewed by the FDA advisory panel, states the news release.
First in a New Class of Drugs
Orencia is the first in a new class of drugs, note Genovese and colleagues.
In rheumatoid arthritis, the body's immune system attacks cells in joints. That can cause pain, stiffness, and swelling of the joints. Over time, it can lead to cartilage breakdown, bone loss, joint weakness, and disability.
The immune system is targeted by several current rheumatoid arthritis drugs. Those drugs work and have helped many people. But some patients don't respond to those drugs, note Genovese and colleagues.
Orencia also focuses on the immune system. It blocks a signal from the immune system's T-cells, which are needed to activate many of the cells of the immune system and play an important role in the development of rheumatoid arthritis.
Genovese's study included 322 rheumatoid arthritis patients who hadn't responded to other rheumatoid arthritis drugs.
The patients were assigned to take Orencia or a fake medication (placebo) for six months. No one knew which treatment the patients got.
The patients' rheumatoid arthritis symptoms and physical function were rated in before-and-after surveys.
After six months, half of the patients who received Orencia had at least a 20% improvement in their rheumatoid arthritis symptoms, compared with one in five of those receiving the fake drug, the study shows.
In addition, nearly half of the Orencia group had a "clinically meaningful improvement in physical function," the researchers write.
"For many of these patients, it means a significant increase in their ability to function," says Genovese in the news release.
Both groups had similar rates of side effects, which were mostly mild to moderate, write the researchers.
However, infections were more frequent in the Orencia group. Most of those cases were mild or moderate in intensity, including bronchitis and upper respiratory tract infections, the study shows.
"It's a fine line between trying to modulate the immune system and suppressing it to an extent that you are at an increased risk for infections," says Genovese.
"Any time you modulate the immune system, you are at a potential risk," he continues. "You just have to carefully weigh the risks and the benefits."
"In the next few years we are going to get an increasing sense of who the best patients are for this therapy and even whether patients with other autoimmune diseases might benefit," says Genovese.