CHICAGO—Glatiramer acetate can be used in the treatment of patients with clinically isolated syndrome to safely delay the progression to multiple sclerosis (MS), according to the results of a randomized, double-blind, placebo-controlled study presented at the 60th Annual Meeting of the American Academy of Neurology. Giancarlo Comi, MD, and Massimo Filippi, MD, reported that glatiramer acetate reduced the risk of conversion to clinically definite MS by 45%.
“The aim of the [Study to Evaluate the Effect of Early Glatiramer Acetate Treatment in Delaying the Conversion to CDMS in Subjects Presenting With a Clinically Isolated Syndrome (PreCISe)] is to evaluate the effect of treatment if given at the onset of the disease,” said Dr. Comi, Professor of Neurology and Chairman of the Department of Neurology at Vita-Salute San Raffaele University in Milan. A total of 481 patients who presented with their first clinical event and had at least two T2-weighted lesions 6 mm or larger in diameter were randomized to receive 20 mg/day of glatiramer acetate subcutaneously or placebo (mean time from first event to randomization, 74 days). Participants in the entire study group had a mean age of 31 and were not disabled (mean Expanded Disability Status Scale score, 1.0), and the majority used corticosteroids to treat their first attack.
Safety and Efficacy of Glatiramer Acetate
By the interim analysis, 2.4 years after the beginning of the study, only one quarter of the patients in the glatiramer acetate arm had converted to clinically definite MS (ie, they had a second attack), a significantly smaller proportion than those who were given placebo (43%). In addition, reported Dr. Comi, those who converted did so about one year later than the patients in the placebo arm. The 25th percentile of time to clinically definite MS was 722 days in the glatiramer acetate arm, 115% longer than the 336 days to conversion in the placebo arm.
Disease activity was also monitored with MRI every three months, and treatment appeared to have a beneficial effect. Dr. Comi’s group observed a significant reduction in new T2 lesions with glatiramer acetate, as well as a significant drop in the number of gadolinium-enhancing lesions seen at the last MRI scans before the conversion.
There were no unexpected safety concerns, reported the researchers. “Glatiramer acetate was well tolerated, with 16% overall withdrawals to the time of the interim analysis, and had a safety profile similar to that observed in relapsing-remitting MS,” they said.
Long-Term Benefits?
Dr. Comi added that as a result of the interim analysis, it was recommended that all participants who were randomized to receive placebo be offered glatiramer acetate and continue to be followed up via the original protocol. There was also a two-year extension planned “to understand if positive results of the early phase will [persist as] beneficial consequences of the long term,” he said.
—Jessica Dziedzic