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Interferon ?-1b and glatiramer acetate effects on permanent black hole evolution.

ABSTRACT: To compare interferon ?-1b (IFN?-1b) and glatiramer acetate (GA) on new lesion (NL) (gadolinium-enhancing, new T2) evolution into permanent black holes (PBH)--a marker of irreversible tissue damage--in patients with relapsing-remitting multiple sclerosis (RRMS).BEYOND was a large, phase III, clinical trial comparing IFN?-1b 250 ?g, IFN?-1b 500 ?g, and GA (2:2:1). Patient scans were reexamined post hoc for PBH in a rater-blinded manner. Two predefined coprimary endpoints compared IFN?-1b 250 ?g with GA: first, number of PBH per patient at year 2 evolving from year 1 NL, then proportion of year 1 NL evolving into PBH at year 2. IFN?-1b 500 ?g and GA were compared in an exploratory fashion.Approximately 90% (1,957/2,244) of patients had NL at year 1 with follow-up at year 2. Mean numbers of PBH per patient at year 2 evolving from year 1 NL were lower for IFN?-1b 250 ?g than GA (0.30 vs 0.43; p = 0.0451). The proportion of NL evolving into PBH was similar (IFN?-1b 250 ?g vs GA: 21.6% vs 23.5%; p > 0.20). For IFN?-1b 500 ?g, both the mean PBH number per patient at year 2 evolving from year 1 NL (0.26 vs 0.43; p = 0.0037) and proportion of NL evolving into PBH (16.3% vs 23.5%; p = 0.0409) were lower relative to GA.IFN?-1b affected PBH development to a similar or better extent than GA. IFN?-1b favorably influences an MRI outcome indicative of permanent tissue destruction in the brains of patients with multiple sclerosis.This study provides Class III evidence that IFN?-1b is associated with a reduction in MRI PBH formation and evolution compared with GA between years 1 and 2 of treatment.

SUBMITTER: Filippi M

PROVIDER: S-EPMC3068007 | biostudies-other | 2011 Apr

REPOSITORIES: biostudies-other

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Interferon β-1b and glatiramer acetate effects on permanent black hole evolution.

Filippi M M Rocca M A MA Camesasca F F Cook S S O'Connor P P Arnason B G W BG Kappos L L Goodin D D Jeffery D D Hartung H-P HP Comi G G Wolinsky J S JS Bogumil T T Pohl C C Beckmann K K Sandbrink R R Croze E E Brown C C Desimone T M TM Arnold D L DL Cutter G G Knappertz V V

Neurology 20110401 14

<h4>Objective</h4>To compare interferon β-1b (IFNβ-1b) and glatiramer acetate (GA) on new lesion (NL) (gadolinium-enhancing, new T2) evolution into permanent black holes (PBH)--a marker of irreversible tissue damage--in patients with relapsing-remitting multiple sclerosis (RRMS).<h4>Methods</h4>BEYOND was a large, phase III, clinical trial comparing IFNβ-1b 250 μg, IFNβ-1b 500 μg, and GA (2:2:1). Patient scans were reexamined post hoc for PBH in a rater-blinded manner. Two predefined coprimary e ...[more]

PMID: 21464426

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Project description:Background: Glatiramer acetate (GA) is a well-established treatment option for patients with clinically isolated syndrome and relapsing-remitting multiple sclerosis (MS) with few side effects. The double transgenic mouse model spontaneous opticospinal encephalomyelitis (OSE), based on recombinant myelin oligodendrocyte glycoprotein35-55 reactive T and B cells, mimicks features of chronic inflammation and degeneration in MS and related disorders. Here, we investigated the effects of prophylactic GA treatment on the clinical course, histological alterations and peripheral immune cells in OSE. Objective: To investigate the effects of prophylactic glatiramer acetate (GA) treatment in a mouse model of spontaneous opticospinal encephalomyelitis (OSE). Methods: OSE mice with a postnatal age of 21 to 28 days without signs of encephalomyelitis were treated once daily either with 150 µg GA or vehicle intraperitoneally (i. p.). The animals were scored daily regarding clinical signs and weight. The animals were sacrificed after 30 days of treatment or after having reached a score of 7.0 due to animal care guidelines. We performed immunohistochemistry of spinal cord sections and flow cytometry analysis of immune cells. Results: Preventive treatment with 150 µg GA i. p. once daily significantly reduced clinical disease progression with a mean score of 3.9 ± 1.0 compared to 6.2 ± 0.7 in control animals (p < 0.01) after 30 d in accordance with positive effects on weight (p < 0.001). The immunohistochemistry showed that general inflammation, demyelination or CD11c+ dendritic cell infiltration did not differ. There was, however, a modest reduction of the Iba1+ area (p < 0.05) and F4/80+ area upon GA treatment (p < 0.05). The immune cell composition of secondary lymphoid organs showed a trend towards an upregulation of regulatory T cells, which lacked significance. Conclusions: Preventive treatment with GA reduces disease progression in OSE in line with modest effects on microglia/macrophages. Due to the lack of established prophylactic treatment options for chronic autoimmune diseases with a high risk of disability, our study could provide valuable indications for translational medicine.

Dataset Information

Interferon ?-1b and glatiramer acetate effects on permanent black hole evolution.

Publications

Interferon β-1b and glatiramer acetate effects on permanent black hole evolution.

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