THESSALONIKI, GREECE -- October 3, 2005 -- Glatiramer acetate (Copaxone) treatment of children with multiple sclerosis is safe, with a safety profile similar to that found among adults, researchers reported here on September 29th at the 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

"Children get multiple sclerosis, and we found in this study children can be treated with multiple sclerosis in the same way adults can be treated," said lead investigator Lauren Krupp, MD, professor of neurology and director, National Pediatric Multiple Sclerosis Center, State University of New York Medical Center, Stony Brook, New York, United States. "We found that they can be treated equally safely with Copaxone, or glatiramer acetate."

The investigators conducted a retrospective chart review of 16 girls and 11 boys with a mean age of 12.2 years at onset of relapsing remitting multiple sclerosis (RRMS) who were diagnosed at or before age 18 years. They included subjects from 5 North American sites.

Subjects received off-label treatment with glatiramer acetate 20 mg/day, injected subcutaneously daily for a mean of 20.0 months (range, 2.0-60.0 months). Patients started glatiramer acetate treatment at mean age of 14.1 years and at a mean of 13.2 months postdiagnosis.

Sixty-four adverse events were reported among 17 patients. Less than 6% of reported adverse events resulted in temporary or permanent discontinuation of therapy after a mean of 14.8 months on glatiramer acetate.

Most frequently reported adverse events were comparable to the adult data, and they included injection site reactions in 8 patients (23.4%), skin reactions in 2 patients (12.5%), bronchitis in 4 patients (6.3%), and dyspnea in 3 patients (4.7%).

There was no evidence of abnormal laboratory values or vital signs.

"In summary," the authors wrote in their abstract, "[glatiramer acetate] was extremely well tolerated."

The researchers calculated the annual relapse rate for the patients who had at least 12 and 24 months of pre- and posttreatment data. They observed a 56% decrease in the frequency of relapse in the first 12 months and a 58% decrease in relapse frequency was seen for the smaller subset in the patients for whom 24-months posttreatment data was available.

Dr. Krupp concluded, "This medication, which is safe in adults, is equally safe in children. The clinical implication is that it's safe, so use it."


[Presentation title: Safety and Tolerability of Copaxone(R) in Paediatric Patients With Relapsing-Remitting Multiple Sclerosis. Poster 332]