title: The effect of cladribine on T(1) 'black hole' changes in progressive MS.
abstract: We compared the changes of the volumes of T(1)-hypointense lesions seen on the magnetic resonance imaging scans of the brain from 159 progressive multiple sclerosis (MS) patients who were enrolled in a double-blind, placebo-controlled trial assessing the efficacy of two doses of cladribine. Although in patients treated with cladribine there was a tendency to have a lower increase of T(1)-hypointense lesion volumes than those treated with placebo, no statistically significant effect of cladribine on T(1)-hypointense lesion accumulation was found over the one-year double-blind phase. Furthermore, no significant treatment effect was also detected in a subset of 22 patients who received placebo during the double-blind phase of the study and cladribine during the subsequent one-year open-label phase. We conclude that cladribine does not have a major impact on the mechanisms leading to severe tissue destruction in progressive MS.
authors.affiliation: Neuroimaging Research Unit, Department of Neuroscience, Scientific Institute Ospedale San Raffaele, University of Milan, Milan, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Filippi
authors.forename: M
authors.initials: M
authors.lastname: Rovaris
authors.forename: G P
authors.initials: GP
authors.lastname: Rice
authors.forename: M P
authors.initials: MP
authors.lastname: Sormani
authors.forename: G
authors.initials: G
authors.lastname: Iannucci
authors.forename: L
authors.initials: L
authors.lastname: Giacomotti
authors.forename: G
authors.initials: G
authors.lastname: Comi
mesh_terms: D000704:Analysis of Variance; D001921:Brain / Q000473:pathology; D017338:Cladribine / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D008279:Magnetic Resonance Imaging; D020528:Multiple Sclerosis, Chronic Progressive / Q000188:drug therapy* / Q000473:pathology; D013997:Time Factors
chemical_list: D017338:Cladribine