Show simple item record

dc.contributor.authorRadue, Ernst-Wilhelm
dc.contributor.authorO'Connor, Paul
dc.contributor.authorPolman, Chris H
dc.contributor.authorHohlfeld, Reinhard
dc.contributor.authorCalabresi, Peter
dc.contributor.authorSelmaj, Krystof
dc.contributor.authorMueller-Lenke, Nicole
dc.contributor.authorAgoropoulou, Catherine
dc.contributor.authorHoldbrook, Frederick
dc.contributor.authorde Vera, Ana
dc.contributor.authorZhang-Auberson, Lixin
dc.contributor.authorFrancis, Gordon
dc.contributor.authorBurtin, Pascale
dc.contributor.authorKappos, Ludwig
dc.date.accessioned2017-05-03T14:21:03Z
dc.date.available2017-05-03T14:21:03Z
dc.date.issued2012
dc.date.modified2013-09-17T22:53:29Z
dc.identifier.issn0003-9942
dc.identifier.doi10.1001/archneurol.2012.1051
dc.identifier.urihttp://hdl.handle.net/10072/53152
dc.description.abstractObjective To assess the impact of fingolimod (FTY720) therapy on magnetic resonance imaging measures of inflammatory activity and tissue damage in patients participating in a 2-year, placebo-controlled, phase 3 study. Design Patients with active relapsing-remitting multiple sclerosis were randomized to receive fingolimod, 0.5 mg; fingolimod, 1.25 mg; or placebo for 2 years. Standardized magnetic resonance imaging scans were obtained at months 0, 6, 12, and 24 and centrally evaluated for number and volume of T1 gadolinium-enhancing, T2 hyperintense, and T1 hypointense lesions and for percentage of brain volume change. Findings were compared across subgroups by treatment and baseline characteristics. Setting Worldwide, multicenter clinical trial. Patients Patients were part of the fingolimod FTY720 Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis (FREEDOMS) clinical trial for relapsing-remitting multiple sclerosis (N = 1272). Main Outcome Measures We measured the effect of therapy on acute inflammatory activity, burden of disease, and irreversible loss of brain volume. Results Fingolimod therapy resulted in rapid and sustained reductions in inflammatory lesion activity as assessed by gadolinium-enhancing and new/newly enlarged T2 lesions after 6, 12, and 24 months of therapy (P < .001, all comparisons vs placebo). Changes in T2 hyperintense and T1 hypointense lesion volume also significantly favored fingolimod (P < .05, all comparisons). Fingolimod, 0.5 mg (licensed dose), significantly reduced brain volume loss during months 0 to 6, 0 to 12, 12 to 24, and 0 to 24 (P < .05, all comparisons) vs placebo, and subgroup analyses confirmed these effects over 2 years irrespective of the presence/absence of gadolinium-enhancing lesions, T2 lesion load, previous treatment status, or level of disability. Conclusion These results, coupled with the significant reductions in relapse rates and disability progression reported previously, support the positive impact on long-term disease evolution.
dc.description.peerreviewedYes
dc.description.publicationstatusYes
dc.languageEnglish
dc.language.isoeng
dc.publisherAmerican Medical Association
dc.publisher.placeUnited States
dc.relation.ispartofstudentpublicationN
dc.relation.ispartofpagefrom1259
dc.relation.ispartofpageto1269
dc.relation.ispartofissue10
dc.relation.ispartofjournalArchives of Neurology
dc.relation.ispartofvolume69
dc.rights.retentionY
dc.subject.fieldofresearchClinical sciences
dc.subject.fieldofresearchNeurosciences
dc.subject.fieldofresearchCognitive and computational psychology
dc.subject.fieldofresearchcode3202
dc.subject.fieldofresearchcode3209
dc.subject.fieldofresearchcode5204
dc.titleImpact of fingolimod therapy on magnetic resonance imaging outcomes in patients with multiple sclerosis
dc.typeJournal article
dc.type.descriptionC1 - Articles
dc.type.codeC - Journal Articles
gro.date.issued2012
gro.hasfulltextNo Full Text
gro.griffith.authorBeran, Roy G.


Files in this item

FilesSizeFormatView

There are no files associated with this item.

This item appears in the following Collection(s)

  • Journal articles
    Contains articles published by Griffith authors in scholarly journals.

Show simple item record