Submitted by Armen Hareyan on Mar 9th, 2006
Multiple Sclerosis Drug
Cleveland Clinic-based research has found that a drug used to treat multiple sclerosis (MS), which was pulled off the market by its manufacturers a year ago because of safety concerns, is effective in treating patients with relapsing multiple sclerosis.
Researchers are reporting that when used in combination with the standard treatment of interferon beta-1a, natalizumab, the drug previously marketed under the brand name Tysabri, reduced the risk of a multiple sclerosis relapse by 55 percent. The combined treatment was also found to decrease the risk of a patient's disability progressing by 24 percent in two years.
"The results of our study show a significant improvement over the current standard therapy for patients with MS," said Richard Rudick, M.D., the study's lead investigator and Chairman of the Division of Clinical Research and Director of the Mellen Center for Multiple Sclerosis at Cleveland Clinic. "We noted a significant decrease in the number of relapses and new lesions among patients who were treated with both natalizumab and interferon beta-1a. More studies are needed to examine the long-term safety and benefit of the combined treatment."
The Safety and Efficacy of Natalizumab in Combination with Interferon Beta-1a in Patients with Relapsing Remitting Multiple Sclerosis (SENTINEL) trial aimed to determine if natalizumab was safe and effective when used alone or in combination with interferon beta-1a, the standard therapy. Preliminary studies had shown that both uses of the drug appeared to be safe and effective.
The SENTINEL study involved 1,171 patients who, despite receiving the standard treatment of interferon beta-1a, suffered at least one multiple sclerosis relapse in the 12 months prior to their enrollment in the trial. The patients were randomly assigned to receive interferon beta-1a in combination with natalizumab (589) or the interferon beta-1a alone (582). Results of the SENTINEL trial appear in the March 2 issue of the New England Journal of Medicine.
Natalizumab was approved under accelerated review by the U.S. Food and Drug Administration (FDA) in November 2004 after the initial one-year data from SENTINEL and another study, AFFIRM (Tysabri Safety and Efficacy in Relapsing-Remitting MS), showed significant benefits in treating MS patients.
Following the FDA's approval, researchers continued the trials to obtain and analyze two years of data. However natalizumab was taken off the market by its manufacturers in February 2005 after it was linked to a rare brain infection in three patients. The infection was fatal in two of the cases. As a result, clinical use of natalizumab and use in the research protocols was suspended pending a safety review and further review by FDA.
Last month the FDA allowed the makers of natalizumab to resume clinical trials in MS patients who had previously received the drug. An FDA panel is set to discuss the possibility of returning natalizumab to the market later this month.
Results for the AFFIRM trial and the safety review will also be published in the March 2 issue of the New England Journal of Medicine.
Source:
The Cleveland Clinic 