title: Mitoxantrone treatment in patients with early relapsing-remitting multiple sclerosis.
abstract: We investigated the clinical and MRI effects of mitoxantrone (MITOX) administered to 45 patients during the first five years of highly active relapsing-remitting multiple sclerosis. Differences occurring between the end of treatment and follow-up (clinical mean: 3.6 years; brain MR: 1.8 years) with respect to baseline variables (EDSS, annualized relapse rate, active T2 lesions, new T1 lesions and number of Gd-enhancing lesions) were analysed using parametric and non-parametric tests. One patient developed leukemia four months after the end of the treatment; no other serious adverse events occurred during treatment and the follow-up period. A clinically relevant reduction in the annualized relapse rate ( P < 0.0001 at end of treatment and P < 0.0001 at follow-up) and improvement in the EDSS (P < 0.0001 at end of treatment and P = 0.0005 at follow-up) was found. At the end of treatment, 53% of patients experienced no increase in active T2 lesions, while 73% showed no increase in the number of new T1 lesions. At follow-up, 41 out of 45 (91%) patients showed a stable MRI pattern and were active-scan free. Despite potential serious adverse events, MITOX may be considered an option in selected patients with very active early MS.
authors.affiliation: Centro Sclerosi Multipla, Dipartimento di. Scienze Cardiovascolari e Neurologiche, University of Cagliari, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Cocco
authors.forename: P
authors.initials: P
authors.lastname: Marchi
authors.forename: C
authors.initials: C
authors.lastname: Sardu
authors.forename: P
authors.initials: P
authors.lastname: Russo
authors.forename: A
authors.initials: A
authors.lastname: Paolillo
authors.forename: Mg
authors.initials: M
authors.lastname: Mascia
authors.forename: M
authors.initials: M
authors.lastname: Solla
authors.forename: J
authors.initials: J
authors.lastname: Frau
authors.forename: L
authors.initials: L
authors.lastname: Lorefice
authors.forename: S
authors.initials: S
authors.lastname: Massole
authors.forename: G
authors.initials: G
authors.lastname: Floris
authors.forename: Mg
authors.initials: M
authors.lastname: Marrosu
mesh_terms: D000293:Adolescent; D000328:Adult; D017668:Age of Onset; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000627:therapeutic use*; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D008942:Mitoxantrone