Wednesday, 21 May 2014

Gilenya slows down brain shred

Barkhof F, de Jong R, Sfikas N, de Vera A, Francis G, Cohen J; on behalf of the TRANSFORMS study group. The influence of patient demographics, disease characteristics and treatment on brain volume loss in Trial Assessing Injectable Interferon vs FTY720 Oral in Relapsing-Remitting Multiple Sclerosis (TRANSFORMS), a phase 3 study of fingolimod in multiple sclerosis.Mult Scler. 2014 May. [Epub ahead of print]

BACKGROUND:Patients with multiple sclerosis (MS) lose brain volume (BV) faster than healthy individuals.
OBJECTIVE:Our purpose was to examine the effect of treatment on BV loss in patient subgroups, establish correlations between baseline normalized BV (NBV) and baseline disease parameters, to identify variables predictive of baseline NBV and on-study percentage BV change (PBVC), and to establish correlations between on-study PBVC and on-study efficacy outcomes.
METHODS: Patients received fingolimod 0.5 mg or 1.25 mg, or intramuscular (IM) interferon β-1a (IFNβ-1a) for 12 months. The effect of treatment on PBVC was examined in patient demographic, disease and magnetic resonance imaging (MRI) characteristic subgroups. Pearson's correlation analyses and a stepwise linear regression model were used to identify variables predictive of NBV and PBVC.
RESULTS: Fingolimod reduced BV loss over 12 months versus IFNβ-1a IM in all patient subgroups assessed, including individuals with or without gadolinium (Gd)-enhancing lesions at baseline. Baseline T1 hypointense lesion volume had the strongest correlation with baseline NBV. Baseline Gd-enhancing T1 lesion count was most predictive of change in PBVC over 12 months.
CONCLUSIONS: Our results improve understanding of the contributions of different baseline demographic, clinical and MRI characteristics to NBV, including factors that may be predictive of future BV loss.
People receiving Gilenya did better than people taking a beta interferon and  they showed less loss of brain over a twelve month assessment period. We have been saying for some time now that if you can inhibit the damaging immune response, you can slow down the effects of brain shred and this is a further example of this. T1 lesions (black holes) were a better predictor of whether brains will shrink or not.

CoI: None ProfG multiple

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