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    You are here : Home » MS Research News » Drugs » Betaseron® (Betaferon®)

    Betaseron® (Betaferon®)

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    Relationship between early clinical characteristics and long term disability outcomes

    Betaferon16 year cohort study (follow-up) of the pivotal interferon β-1b trial in multiple sclerosis

    Abstract
    Background Evaluating the long term benefit of therapy in multiple sclerosis (MS) is challenging. Although randomised controlled trials (RCTs) demonstrate therapeutic benefits on short term outcomes, the relationship between these outcomes and late disability is not established.

    Methods In a patient cohort from the pivotal interferon β-1b trial, the value of clinical and MRI measures were analysed, both at baseline and during the RCT, for predicting long term physical and cognitive outcome.

    Results Baseline disability correlated with both physical (R2=0.22; p<0.0001) and cognitive (R2=0.12; p<0.0001) outcome after 16 years. Accrual of disability during the RCT (R2=0.12; p<0.0001) and annualised relapse rates during the trial correlated with physical outcome (R2=0.12; p<0.0001) but not with cognition. In contrast, baseline MRI measures of atrophy and lesion burden correlated with cognitive (R2=0.21; p<0.0001), but not with physical, outcome. Accumulation of plaque burden measured by MRI did not correlate with late physical disability or with cognitive outcome.

    Multivariate regression analysis using stepwise elimination demonstrated that baseline variables contributed independently to predicting long term outcomes while trial outcome variables contributed little. Overall, and considerably dependent on baseline measures, the models developed by this method accounted for approximately half of the variance in long term cognitive and disability outcome.

    Conclusions Although on-trial change in some short term clinical measures correlated with long term physical and disability outcomes, the proportion of the variance explained by single commonly employed on-study variables was often small or undetectable. Better correlations were observed for several baseline measures, suggesting that long term outcome in MS may be largely determined early in the disease course.

    Full article

    Source: Journal of Neurology Neurosurgery and Psychiatry Copyright © 2012 by the BMJ Publishing Group Ltd (17/02/12)

    Benefit seen with interferon lasts into progressive MS

    InterferonPatients with primary progressive multiple sclerosis (PPMS) who took interferon-beta-1b for two years in a randomized trial continued to show improvement relative five years later, Spanish researchers said.

    Although the patients received no further interferon treatment after the randomized trial ended, those who had taken the drug during the study had both better scores for functional outcomes and better MRI evaluations at follow-up than those who had been treated with placebo, according to Xavier Montalban, PhD, of Autonomous University of Barcelona, and colleagues.

    In addition, the study suggested that interferon-treated patients with better than average benefit during the trial showed less disability progression when they went off the drug, they wrote in the November issue of Archives of Neurology.

    That finding, Montalban and colleagues said, "provides some evidence that immunomodulation could be explored still further in the search for an effective treatment for PPMS."

    There is currently no established treatment for PPMS. The clinical symptoms are similar to those of the more common relapsing-remitting form of the disease (RRMS), but PPMS has been less responsive to treatments effective against RRMS.

    Two-year results from the 73-patient randomized trial, published in 2009, indicated that interferon-beta-1b did not significantly delay disability progression as measured with EDSS scores, but the drug did show some benefit in certain functional outcomes and MRI variables.

    Montalban and colleagues followed participants for another five years. The current report includes data on functional outcomes for 59 of the original patients and MRI variables for 50, about equally divided between the interferon and placebo groups.

    At the five-year evaluation, the interferon-treated patients still showed no improvement in EDSS-scored disability progression relative to the placebo group.

    But interferon treatment was associated with significantly better performance on a test of manual dexterity and another involving cognitive ability, the latter being part the Brief Repeatable Battery of Neuropsychological Tests:

    Nine-hole peg test score: interferon 0.32; placebo -0.90 (P=0.02)
    Word list generation: interferon 19.0; placebo 11.5 (P<0.001)
    There were also weak trends favoring the interferon group for other functional evaluations, including scores on the Sickness Impact Profile, tests of spatial recall, and symbol digit manipulation.

    MRI variables also trended toward better numbers for the patients who had received interferon. Mean T1 and T2 lesion volumes at the five-year follow-up were about 40% lower in the interferon-treated patients, although large variations among patients kept the differences from reaching statistical significance.

    One significant difference was in brain atrophy tracked since the study began. The brain parenchymal fraction declined by 1.78% in the interferon group versus 3.16% in the placebo-treated patients (P=0.004).

    Montalban and colleagues also reported a significant correlation between MRI results during the two-year treatment phase and changes in EDSS disability scores after the trial ended (r=0.36, P=0.004.)

    The researchers stopped short of endorsing interferon-beta-1b treatment for PPMS patients, since the randomized trial results were not particularly impressive.

    Instead, they suggested that treatments altering immune activity should be investigated further in the disorder, despite the disappointing findings of earlier trials with various forms of interferon as well as rituximab (Rituxan) and glatiramer acetate (Copaxone).

    Limitations of the current study included the lack of data on some patients and the absence of gadolinium-enhanced MRI scans.

    Montalban and colleagues also noted that patients who dropped out of the study were "probably the most disabled ones."

    The study was funded by Bayer Schering's Spanish affiliate.

    Study authors reported serving as consultants or speakers for Serono, sanofi, Novartis, Teva, Biogen Idec, Bayer Schering, Almirall, Lilly, and Bracco, as well as receiving research support from several of these companies.

    Full Article - "Interferon beta-1b for the treatment of primary progressive multiple sclerosis: five-year clinical trial follow-up" Arch Neurol 2011; 68: 1421-27.

    Source: MedPage Today © 2011 Everyday Health, Inc. (16/11/11)

    © Multiple Sclerosis Resource Centre (MSRC)

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