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Mitoxantrone - What is the evidence that it works in MS?

In 1997, a French study reported results of a short-term randomised controlled trial in 40 people with very active multiple sclerosis (MS), with dramatic suppression of MRI measured disease activity and clinical relapses (4).

More recently, a German placebo controlled randomised trial of mitoxantrone in 194 patients with worsening relapsing-remitting or secondary progressive MS (people with secondary progressive MS in this trial were still able to walk at the start of the study) concluded that mitoxantrone was generally well tolerated and reduced the progression of disability and relapses (5). There were no drug-related serious adverse events.

Summarising the data from all of these trials; a person with relapsing MS can expect the frequency of relapses to be reduced by up to 80% whilst undergoing treatment with mitoxantrone. Although this reduction is clearly greater than with drugs like beta interferon or Copaxone, it should be remembered that treatment involves a greater risk of side-effects.

For people with secondary progressive MS, who remain mobile, around two thirds can expect their condition to remain stable during two years on treatment.