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BY OUR PHARMA CORRESPONDENT
18 September,2005: A researcher at the Stanford University School of Medicine says a new drug could offer pain relief and increased mobility to rheumatoid arthritis patients who have exhausted their other medical treatment options.
The study report published in the in the Sept. 15 issue of the New England Journal of Medicine suggest that a six-month, multicenter clinical trial with abatacept, marketed as Orencia, made by Bristol-Myers Squibb, found patients
with rheumatoid arthritis were more than twice as likely to have significant improvement with the new drug than with standard therapy.
The study was a phase-III trial, the final stage of human testing normally required by the U.S. Food and Drug Administration before it will consider approving a drug. Based on the results, an FDA advisory panel met on Sept. 6 and recommended the drug’s approval for the treatment of rheumatoid arthritis in cases in which standard therapy has failed.
Bristol-Myers Squibb sponsored the study. The lead author, Mark Genovese, MD, Stanford associate professor of medicine (immunology and rheumatology), is a paid consultant for the company.
Autoimmune diseases such as rheumatoid arthritis are characterized by an overactive immune system that turns its attack to body tissues instead of invading microbes. T cells are immune cells thought to play a major role in the development of rheumatoid arthritis. Abatacept is the first of a class of drugs, called co-stimulation blockers, that selectively impede one of the two signals needed to activate T cells.
Bristol-Myers Squibb is also testing the drug for use in lupus.
Rheumatoid arthritis is a disease of the joints that affects more than 2 million Americans. The disease is characterized by an infiltration of the joints with immune cells aimed against the cells lining the joint. The immune system attack causes pain, stiffness and swelling of the joints and can eventually lead to cartilage breakdown, bone loss and weakness of the joints. Without effective therapy, approximately 15 percent of patients will be crippled by their disfigured joints.
Nonsteroidal anti-inflammatory drugs can provide pain relief for rheumatoid arthritis but do not treat the underlying disease. Standard therapy currently includes other agents that suppress the immune system and can actually modify the course of disease. In addition, new medications that block the immune system’s response have become available in recent years. Still, many patients don’t benefit from these medications.
Bristol-Myers Squibb conferred with Genovese and others to design an international trial to test whether abatacept could benefit these rheumatoid arthritis sufferers who hadn’t responded to existing therapy. At 89 sites around the world, 258 of these patients received abatacept as an intravenous injection seven times over the course of the study, and 133 patients received a placebo. Neither the patients nor the physicians knew who received active drug.
BY OUR PHARMA CORRESPONDENT |
