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Real-Life Mitoxantrone (Novantrone) Study Confirms Efficacy, Safety With Known Risk of Malignancy: Presented at ECTRIMS By Bruce Sylvester THESSALONIKI, GREECE -- October 3, 2005 -- A real-life, postapproval study of mitoxantrone (Novantrone) confirms the drug's efficacy as well as the associated risk of secondary malignancy in patients with aggressive relapsing multiple sclerosis (MS) who have failed first-line treatment. Researchers presented these findings here on September 30th at the 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Mitoxantrone is used for patients with aggressive relapsing MS who have shown increasing disability and who do not respond to first-line disease-modifying agents (interferon beta or glatiramer acetate). Class I evidence shows the drug is effective at 12 mg/m2 every 3 months, the dose approved by the US Food and Drug Administration. However, physicians use various dosing regimens and have reported varying degrees of therapeutic efficacy. "Clear descriptive studies attesting to the safety and efficacy of the approved [mitoxantrone] regimen in a typical MS clinical setting would be reassuring," the authors noted in explaining the goal of the study. "The goal of this study was to look at real-life experience in how patients are tolerating mitoxantrone treatment for severe MS, and also to look at its effectiveness in a real clinical setting after marketing approval," said investigator and presenter Heather MacLean, MD, neurologist and assistant professor, University of Ottawa, Ottawa Hospital, Ottawa, Ontario, Canada. Eligibility for the study included failure of a first-line disease-modifying agent for either severe relapsing-remitting MS with step-wise deterioration or secondary progressive MS with continued attacks and disability progression. Most subjects received 12 mg/m2 every 3 months to a maximum cumulative dose of 120 mg/m2. Some subjects received a more aggressive protocol of 8 mg/m2 monthly for 3 months, which was then repeated every 3 months to the maximum cumulative dose of 120 mg/m2. The researchers collected data on 81 subjects, who were followed for a mean of 3 years. Of the total, 78% had the secondary progressive form, 22% had relapsing-remitting MS, and 64% were women. Mean age at baseline was 42 years, mean duration of disease was 14.4 years, and mean baseline score on the Expanded Disability Status Scale (EDSS) was 5.5. The researchers found that 54% of patients remained stable with no significant EDSS change from baseline. They also found that 21% were significantly improved, with a decrease in EDSS of 1 point in patients with a baseline score of 0-5.5 and a 0.5-point decrease in patients with baseline score of 6.0 or higher. Significant worsening of disease was observed in 25% of subjects. There was 1 serious adverse event, secondary malignancy. "But this is a known risk with this agent, so it has to be taken into consideration when use of this treatment is considered for severe cases of MS," Dr. MacLean said. [Presentation title: Mitoxantrone in Severe Relapsing MS: A Phase IV Experience in 81 Patients Attests to its Safety and Efficacy. Poster 646] E-mail this page to a friend or colleague! To print, use this version