April 4, 2003
By Jill Stein
Mitoxantrone, an anti-neoplastic agent, may prevent disease progression in primary progressive multiple sclerosis (PPMS), say researchers.
Dr. Marc Coustans and colleagues at the Multiple Sclerosis Clinic in Rennes, France, conducted an open-label study in which 64 clinically definite PPMS patients were treated with mitoxantrone 20 mg intravenously, either monthly for 6 months, or every 3 months for up to 24 months. The mean cumulative dose of mitoxantrone was 65 mg/m2. The data were presented here at the 55th Annual Meeting of the American Academy of Neurology
The mean disease duration prior to mitoxantrone treatment was 6.8 years, and the mean Kurtzke Expanded Disability Status Scale (EDSS) at the start of treatment was 5.6. EDSS was performed every six months before treatment and for two years after the start of treatment.
During the year before the start of mitoxantrone treatment, 44% of patients had a 1-point worsening in their EDSS, and 56% had no change in their EDSS rate; the mean EDSS increased from 5 to 5.6.
At the start of mitoxantrone treatment, 38% had an EDSS between 3 and 5, and 48% had an EDSS between 5.5 and 6.5. During two years of treatment, the mean EDSS remained stable at 5.6.
From baseline to the first year, 19% of patients had a 1-point worsening in their EDSS, while 24% had an improvement. Between the first and second year, 25% of patients deteriorated, and 5% improved. Between baseline and the second year, 34% deteriorated and 24% had a one-point improvement in their EDSS.
Of the 29 patients whose baseline EDSS was less than 6, none of the 16 patients in the monthly treatment group had a 1-point worsening of their EDSS at one year compared with 4 of 13 patients treated every three months.
Overall, the results demonstrate that mitoxantrone favorably alters disease progression, and warrant the launch of a phase III trial in PPMS patients, especially those with an EDSS less than 6, Dr. Coustans said.
Last year, the same group reported that induction treatment with mitoxantrone plus methylprednisolone helps prevent relapses in patients with worsening relapsing-remitting MS for at least four years.
Multiple sclerosis is the most common cause of neurologic disability in young patients.
[Study title: Clinical Impact of Mitoxantrone in 64 Primary Progressive
Multiple Sclerosis. Abstract: S31.002]
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