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AAN: Multiple Sclerosis Drugs Show Harm, Benefit

Last Updated: April 30, 2009.

 

Mitoxantrone linked to high incidence of leukemia; combo treatment to fewer relapses

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In multiple sclerosis, mitoxantrone treatment is associated with a higher-than-expected risk of leukemia, but combined treatment with methylprednisolone and interferon-beta 1a is associated with more beneficial effects on disease activity than interferon alone, according to two studies presented at the annual meeting of the American Academy of Neurology, held April 25 to May 2 in Seattle, and a study published online April 30 in The Lancet Neurology.

THURSDAY, April 30 (HealthDay News) -- In multiple sclerosis, mitoxantrone treatment is associated with a higher-than-expected risk of leukemia, but combined treatment with methylprednisolone and interferon-beta 1a is associated with more beneficial effects on disease activity than interferon alone, according to two studies presented at the annual meeting of the American Academy of Neurology, held April 25 to May 2 in Seattle, and a study published online April 30 in The Lancet Neurology.

In one study, Vittorio Martinelli, M.D., of the University Vita-Salute in Milan, Italy, and colleagues analyzed data on 2,854 patients who were treated with mitoxantrone, including 21 who developed leukemia. They found that the 0.74 percent incidence of leukemia was significantly higher than previously reported incidences of 0.07 to 0.25 percent.

In a second study, Mads Ravnborg, M.D., of the Danish Multiple Sclerosis Research Center at Copenhagen University Hospital in Denmark, and colleagues randomly assigned 341 patients to receive methylprednisolone and interferon-beta 1a or interferon-beta 1a and placebo. After three years, they found that the combination-treatment group had 38 percent fewer relapses than the interferon-only group. A similar study, published in The Lancet Neurology, analyzed 130 patients who had relapsed despite interferon treatment and who were given add-on treatment with either methylprednisolone or placebo for 96 weeks. This group of researchers found that add-on methylprednisolone reduced the relapse rate by 62 percent.

"The potential risk of acute leukemia should be carefully considered against the potential benefits of mitoxantrone treatment on every single patient," Martinelli and colleagues conclude. "Moreover, all multiple sclerosis patients treated with mitoxantrone must undergo a prolonged and careful hematological follow-up."

The second study was supported by Biogen-Idec. The Lancet Neurology study was supported by Merck Serono.

Abstracts-AAN
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More Information-Ravnborg
Abstract-The Lancet Neurology
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