The drug laquinimod reduced the number of relapses for people with multiple sclerosis (MS), in a large, long-term Phase III clinical study that will be presented as late-breaking research at the 63rd Annual Meeting of the American Academy of Neurology, April 9–16, 2011, in Honolulu.
The study involved 1,106 people with relapsing-remitting MS in 24 countries. The participants received either a once-daily oral dose of 0.6 milligrams of laquinimod or a matching placebo for two years. Eighty percent of those taking laquinimod and 77 percent of those taking the placebo finished the two-year study.
Patients treated with laquinimod experienced a statistically significant reduction of 23 percent in annual relapse rate, compared to patients treated with a placebo. Additionally, there was a reduction of 36 percent in disability progression, as well as a 33 percent reduction in brain atrophy for those people treated with laquinimod.
“These exciting results confirm that laquinimod has a significant impact on progression of disability and disease activity, while maintaining a high safety profile,” said lead author Giancarlo Comi, MD, director of the Department of Neurology and Institute of Experimental Neurology at the Scientific Institute and University Vita-Salute San Raffaele in Milan, Italy. “This may be attributed to the novel mechanism of action of laquinimod, which effectively and safely addressed both the acute inflammatory activity and the accumulation of irreversible tissue damage. This suggests a substantial future role for laquinimod in the treatment of MS.”
Laquinimod was safe and well tolerated. Overall frequencies of adverse events were low and comparable to those observed in the placebo group. “The incidence of liver enzyme elevation was higher in laquinimod treated patients,” said Comi. “However, these elevations were temporary, reversible and did not lead to any signs of liver problems.”
The study was supported by Teva Pharmaceuticals.
The American Academy of Neurology, an association of more than 22,500 neurologists and neuroscience professionals, is dedicated to promoting the highest quality patient-centered neurologic care. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as Alzheimer’s disease, stroke, migraine, multiple sclerosis, brain injury, epilepsy and Parkinson’s disease. For more information about the American Academy of Neurology and its upcoming Annual Meeting, visit http://www.aan.com.
Dr. Comi is available for advance interviews. Please contact Rachel Seroka, [email protected], to schedule an advance interview.
To access non-late-breaking abstracts to be presented at the 2011 AAN Annual Meeting, visit http://www.aan.com/go/am11/science. Late-breaking abstracts will not be posted online in advance of the meeting and are embargoed until the date and time of presentation at the AAN Annual Meeting in Honolulu or unless otherwise noted by the Academy’s Media and Public Relations Department.