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BMC Neurology
Published in: BMC Neurology 1/2017

Open Access 01-12-2017 | Research article

Peginterferon beta-1a improves MRI measures and increases the proportion of patients with no evidence of disease activity in relapsing-remitting multiple sclerosis: 2-year results from the ADVANCE randomized controlled trial

Authors: Douglas L. Arnold, Peter A. Calabresi, Bernd C. Kieseier, Shifang Liu, Xiaojun You, Damian Fiore, Serena Hung

Published in: BMC Neurology | Issue 1/2017

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Abstract

Background

Subcutaneous peginterferon beta-1a has previously been shown to reduce the number of T2-hyperintense and gadolinium-enhancing (Gd+) lesions over 2 years in patients with relapsing-remitting multiple sclerosis (RRMS), and to reduce T1-hypointense lesion formation and the proportion of patients showing evidence of disease activity, based on both clinical and radiological measures, compared with placebo over 1 year of treatment. The objectives of the current analyses were to evaluate T1 lesions and other magnetic resonance imaging (MRI) measures, including whole brain volume and magnetization transfer ratio (MTR) of normal appearing brain tissue (NABT), and the proportions of patients with no evidence of disease activity (NEDA), over 2 years.

Methods

Patients enrolled in the ADVANCE study received continuous peginterferon beta-1a every 2 or 4 weeks for 2 years, or delayed treatment (placebo in Year 1; peginterferon beta-1a every 2 or 4 weeks in Year 2). MRI scans were performed at baseline and Weeks 24, 48, and 96. Proportions of patients with NEDA were calculated based on radiological criteria (absence of Gd + and new/newly-enlarging T2 lesions) and clinical criteria (no relapse or confirmed disability progression) separately and overall.

Results

Peginterferon beta-1a every 2 weeks significantly reduced the number and volume of T1-hypointense lesions compared with delayed treatment over 2 years. Changes in whole brain volume and MTR of NABT were suggestive of pseudoatrophy during the first 6 months of peginterferon beta-1a treatment, which subsequently began to resolve. Significantly more patients in the peginterferon beta-1a every 2 weeks group compared with the delayed treatment group met MRI-NEDA criteria (41% vs 21%; odds ratio [OR] 2.56; p < 0.0001), clinical-NEDA criteria (71% vs 57%; OR 1.90; p < 0.0001) and achieved overall-NEDA (37% vs 16%; OR 3.09; p < 0.0001).

Conclusion

Peginterferon beta-1a provides significant improvements in MRI measures and offers patients a good chance of remaining free from evidence of MRI, clinical and overall disease activity over a sustained 2-year period.

Trial registration

ClinicalTrials.gov: NCT00906399; Registered on: May 20, 2009.
Appendix
Available only for authorised users
Footnotes
1
Relapses (confirmed by the independent neurologic evaluation committee) were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for ≥24 h, and accompanied by new objective neurologic findings, and separated from the onset of other confirmed relapses by at least 30 days.
 
2
Disability progression was defined as an increase in the EDSS score of ≥1.0 point in patients with a baseline score of ≥1.0, or an increase of ≥1.5 points in patients with a baseline score of 0, confirmed after 12 or 24 weeks.
 
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Metadata
Title
Peginterferon beta-1a improves MRI measures and increases the proportion of patients with no evidence of disease activity in relapsing-remitting multiple sclerosis: 2-year results from the ADVANCE randomized controlled trial
Authors
Douglas L. Arnold
Peter A. Calabresi
Bernd C. Kieseier
Shifang Liu
Xiaojun You
Damian Fiore
Serena Hung
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Neurology / Issue 1/2017
Electronic ISSN: 1471-2377
DOI
https://doi.org/10.1186/s12883-017-0799-0

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