Evidence map›Paper›PMID 28183276›Full record

Trial reportBMC neurology2017

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.

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

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC neurology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00906399 (A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00906399 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis

TypeinterventionalSponsorBiogenRan2009 to 2013Enrolled1,516ConditionsRelapsing Multiple SclerosisArmsBIIB017 (peginterferon beta-1a), Placebo
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 3 countries.

Douglas L ArnoldMontreal Neurological Institute, McGill University, Montreal, QC, Canada.
Peter A CalabresiDepartment of Neurology, Johns Hopkins University, Baltimore, MD, USA.
Bernd C KieseierDepartment of Neurology, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany.
Shifang LiuBiogen, 225 Binney St, Cambridge, MA, USA.
Xiaojun YouBiogen, 225 Binney St, Cambridge, MA, USA.
Damian FioreBiogen, 225 Binney St, Cambridge, MA, USA.
Serena HungBiogen, 225 Binney St, Cambridge, MA, USA. serena.hung@biogen.com.
Biogen (United States) · USJohns Hopkins University · USMcGill University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSubcutaneous 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.

methodsPatients 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.

resultsPeginterferon 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).

conclusionPeginterferon 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 registrationClinicalTrials.gov: NCT00906399 ; Registered on: May 20, 2009.

Indexed as

AdultBrainDisease ProgressionFemaleHumansImmunologic FactorsInterferon-betaMagnetic Resonance ImagingMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingPolyethylene GlycolsTreatment OutcomeImmunologic FactorsInterferon-betapeginterferon beta-1aPolyethylene GlycolsClinical trialInterferonMagnetic resonance imagingMultiple sclerosisNEDANo evidence of disease activityPeginterferon beta-1aPegylationPhase 3Relapse-remitting multiple sclerosis

Identifiers

PMID28183276
PMCPMC5301356
OpenAlexW2587369397

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.