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As the following article shows there's drastic side effects with other MS drugs. (Rebif)
Risk of Leukemia With Mitoxantrone in Multiple Sclerosis Patients May Be Higher Than Previously Thought
Elsevier Global Medical News. 2009 Apr 30, J Evans
SEATTLE (EGMN) - The immunosuppressive drug mitoxantrone might be associated with a threefold higher risk for acute myeloid leukemia than has been previously reported in patients with multiple sclerosis, according to a multicenter retrospective study of nearly 3,000 patients.
The study found that acute myeloid leukemia (AML) occurred in 21 (0.74%) of 2,854 Italian patients with various types of multiple sclerosis, a higher incidence than in previous smaller studies that have reported an incidence in the range of 0.07%-0.25%.
The patients who developed AML received a significantly greater number of mitoxantrone (Novantrone) administrations and a greater cumulative dose of the drug than did those who did not develop leukemia, Dr. Vittorio Martinelli reported April 30 at a poster session at the annual meeting of the American Academy of Neurology.
Mitoxantrone is approved by the Food and Drug Administration for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis; it is not indicated for treating patients with primary-progressive MS.
In an interview, Dr. Martinelli advised that clinicians should discuss the risk of mitoxantrone against the risk of worsening multiple sclerosis with every patient who is a candidate for treatment with the drug.
Patients who have already been treated with mitoxantrone "must be followed carefully and must undergo prolonged monitoring of their blood cell count," for at least 5 years - the longest time after treatment in which a patient developed leukemia in this study - although the necessary length of such monitoring is unknown, said Dr. Martinelli of the department of neurology at Scientific Institute H San Raffaele, Milan, Italy.
All the patients had received at least one cycle of mitoxantrone and underwent follow-up for at least 1 year (mean of 46 months). Leukemia was diagnosed in the patients a mean of 37 months after the therapy began and a mean of 18 months after it ended. The patients had a mean age of 44 years and had relapsing-remitting (41%), primary progressive (8%) and secondary progressive (51%) MS.
Patients who developed leukemia received more cycles of mitoxantrone than those who did not develop the malignancy (8.6 cycles vs. 7.2 cycles, respectively) and also received a higher cumulative dose (82.4 mg/m² vs. 62.9 mg/m²).
Because the drug is associated with cardiotoxicity at high cumulative doses, clinicians normally limit the lifetime total dose of mitoxantrone to about 8-12 treatment cycles during a 2- to 3-year period.
Eight (38%) of the 21 patients who developed leukemia died. "This rate is not very different from the mortality of patients with leukemia in the literature," Dr. Martinelli said.
He noted that a study from EMD Serono, the manufacturer of mitoxantrone, that was reported at the Americas Committee for Treatment and Research in Multiple Sclerosis conference in Montreal last year found 36% mortality in 39 patients with leukemia who had been reported to the company. EMD Serono's prospective, open-label cohort study of 509 patients who have taken mitoxantrone, called RENEW, should help to gather further information about the risks of mitoxantrone, he said.
The data in Dr. Martinelli and his colleagues' study are current through February of this year, but the researchers will continue to collect data through the end of May.
Dr. Martinelli and some of his coinvestigators disclosed receiving personal compensation for being a speaker, consultant, or advisory board member for Merck Serono, which operates as EMD Serono in the United States.
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