Mitoxantrone in the treatment of severe multiple sclerosis

Mitoxantrone is an anthracenedione antineoplastic agent that has recently b een shown to be effective in ameliorating disease activity in multiple scle rosis (MS) as indicated by clinical and MRI data. However, the role of mito xantrone in escalating treatment of patients with frequent and severe relap ses and with rapid progression of disability is less clear. In this retrosp ective analysis we report on 15 patients with severe relapsing-remitting (9 patients) and secondary progressive MS with superimposed exacerbations (6 patients) treated open-labeled with mitoxantrone in our Clinical Research G roup from July 1994 to October 1998. Eleven of these patients (73%) were tr eated with azathioprine, interferon-beta-1b or cyclophosphamide before. The patients received mitoxantrone over a period of at least 12 months (19 +/- 6 months) with a single dose of 10 mg/m(2) monthly far the first three mon ths. Thereafter, infusions were repeated every 3 months (total dose 141 mg +/- 45 mg). The annual relapse rate could be significantly reduced from 3,0 +/- 1,5 in the year before therapy to 0,5 +/- 0,5 during therapy. Nine pat ients (60%) were stabilised, while four patients (27%) showed an improvemen t of disability. The treatment was well tolerated with only minor side effe cts. These results although retrospectively obtained confirm previous trial s showing that mitoxantrone may be useful in MS patients with frequent and severe exacerbations and/or a rapidly progressive course of the disease who have had other immunomodulatory medication.