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The use of mitoxantrone (Novantrone) for the treatment of multiple sclerosis

Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology

From the Therapeutics and Technology Assessment Subcommittee, American Academy of Neurology, St. Paul, MN., The University of California, San Francisco is participating in a clinical trial of mitoxantrone in the treatment of primary progressive MS (PI: S. Zamvil). D.S.G. is a participating investigator (without salary) in that trial, which received $161,900 in appropriations from Immunex.

Address correspondence and reprint requests to TTA, American Academy of Neurology, 1080 Montreal Avenue, St. Paul, MN 55116; e-mail: nking{at}aan.com

Mitoxantrone is the first drug approved for the treatment of secondary progressive multiple sclerosis (SPMS) in the United States. This assessment considers use of mitoxantrone in the treatment of MS. Mitoxantrone probably reduces the clinical attack rate and reduces attack-related MRI outcomes in patients with relapsing MS (Type B recommendation). Also, mitoxantrone may have a beneficial effect on disease progression in patients with MS whose clinical condition is worsening (Type B recommendation). The potential for serious toxicity of mitoxantrone, however, must be taken into account when considering this therapy in individual patients. Moreover, because the potential clinical benefits on disease progression appear to be only modest, the results of the single phase III trial should be replicated in another (and hopefully much larger) clinical study before this agent is widely recommended for the treatment of patients with MS.

Received December 7, 2001. Accepted in final form September 3, 2003.

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