Acta Neurol Belg 2001 Dec;101(4):210-6
van de Wyngaert FA, Beguin C, D'Hooghe MB, Dooms G, Lissoir F, Carton H, Sindic CJ.
Department of Neurology, Cliniques Saint-Luc, Universite Catholique de Louvain, Brussels, Belgium.
A double-blind clinical trial of mitoxantrone versus methylprednisolone was performed in 49 patients with relapsing, secondary multiple sclerosis.
Patients were randomized to receive 13 infusions of mitoxantrone 12 mg/m2 (n = 28), or 13 infusions of 1 g of methylprednisolone (n = 21), over 32 months.
Twenty-four patients completed the trial. There were no statistical differences between the two groups of patients at study entry.
A significant improvement in the Expanded Disability Scale Score (EDSS) was observed in the mitoxantrone group after one year of treatment (p < 0.0022).
The total number of relapses, the mean number of relapses/patient/year, and the total number of gadolinium-enhanced lesions on bi-annual MRI scans were significantly decreased in the mitoxantrone group throughout the study period.
Nausea, vomiting, and alopecia were more frequent in the mitoxantrone-treated patients.
Mitoxantrone has a role in the treatment of MS patients with frequent exacerbations and rapid disease progression.