AAN: Oral FTY720 Effective in Multiple Sclerosis
Three years of treatment associated with sustained low annualized relapse rates
WEDNESDAY, April 16 (HealthDay News) -- In patients with relapsing multiple sclerosis, three years of treatment with oral FTY720 significantly reduces relapse rates and inflammatory activity, according to research presented this week at the annual meeting of the American Academy of Neurology in Chicago.
Giancarlo Comi, M.D., Scientific Institute H. San Raffaele, Milan, Italy, and colleagues conducted a six-month study in which 281 patients were randomly assigned to receive FTY720 at dosages of 1.25 mg or 5 mg, or placebo. Then they conducted a 30-month extension including 250 patients in which the placebo patients were re-randomized to receive FTY720 at dosages of 1.25 mg or 5 mg and the previously medicated patients stayed on the same dosage. At 18-24 months, they switched all the 5 mg patients to 1.25 mg. A total of 173 patients completed the entire 36-month study.
The researchers found that patients receiving FTY720 for 36 months had sustained low annualized relapse rates of 0.20 for those on dosages of FTY720 at 1.25 mg and 0.21 for those whose dosages were switched from 5 mg to 1.25 mg. They also found that 68 percent and 73 percent of these two groups were relapse-free at month 36.
"The inflammatory activity on MRI remained low with 89 percent of patients free of Gadolinium-enhanced lesions at month 36 (versus 84 percent at month 24) and 75 percent free of new/newly enlarging T2 lesions since month 24," the researchers write. "In patients treated for up to 36 months, most frequently reported adverse events were nasopharyngitis, influenza, headache and fatigue."
This study was supported by Novartis Pharma AG.