Evidence map›Paper›PMID 25432952›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2015

Peginterferon beta-1a in multiple sclerosis: 2-year results from ADVANCE.

Bernd C Kieseier, Douglas L Arnold, Laura J Balcer, Alexey A Boyko, Jean Pelletier, Shifang Liu, Ying Zhu, Ali Seddighzadeh, Serena Hung, Aaron Deykin and 2 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2015. 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 49 papers.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed
9.3field-weighted citation impact, top 1% 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

49 citing papers in PubMed, 112 citations in OpenAlex.

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  19. Pegylated interferon beta-1a (Plegridy) Italian real-world experience: a Delphi analysis of injection-site reaction and flu-like symptom management.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2021
    Article
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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

12 authors at 7 institutions in 5 countries.

Bernd C KieseierDepartment of Neurology, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany Bernd.Kieseier@uni-duesseldorf.de.
Douglas L ArnoldMontreal Neurological Institute, McGill University, Montreal, Quebec, Canada/NeuroRx Research, Montreal, Quebec, Canada.
Laura J BalcerDepartment of Neurology, New York University, School of Medicine, New York, USA.
Alexey A BoykoMoscow MS Center at 11 City Hospital and Department of Neurology & Neurosurgery of the RSMRU, Moscow, Russia.
Jean PelletierDepartments of Neurology and Research, Aix-Marseille Université, CHU Timone, Marseille, France.
Shifang LiuBiogen Idec Incorporated, Cambridge, USA.
Ying ZhuBiogen Idec Incorporated, Cambridge, USA.
Ali SeddighzadehBiogen Idec Incorporated, Cambridge, USA.
Serena HungBiogen Idec Incorporated, Cambridge, USA.
Aaron DeykinBiogen Idec Incorporated, Cambridge, USA.
Sarah I SheikhBiogen Idec Incorporated, Cambridge, USA.
Peter A CalabresiDepartment of Neurology, Johns Hopkins University, Baltimore, USA.
Biogen (United States) · USAix-Marseille Université · FRHeinrich Heine University Düsseldorf · DEJohns Hopkins University · USMoscow City Hospital No 29 · RUNeuroRx Research (Canada) · CANew York University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of subcutaneous peginterferon beta-1a over 2 years in patients with relapsing-remitting multiple sclerosis in the ADVANCE study.

methodsPatients were randomized to placebo or 125 µg peginterferon beta-1a every 2 or 4 weeks. For Year 2 (Y2), patients originally randomized to placebo were re-randomized to peginterferon beta-1a every 2 weeks or every 4 weeks. Patients randomized to peginterferon beta-1a in Year 1 (Y1) remained on the same dosing regimen in Y2.

resultsCompared with Y1, annualized relapse rate (ARR) was further reduced in Y2 with every 2 week dosing (Y1: 0.230 [95% CI 0.183-0.291], Y2: 0.178 [0.136-0.233]) and maintained with every 4 week dosing (Y1: 0.286 [0.231-0.355], Y2: 0.291 [0.231-0.368]). Patients starting peginterferon beta-1a from Y1 displayed improved efficacy versus patients initially assigned placebo, with reductions in ARR (every 2 weeks: 37%, p<0.0001; every 4 weeks: 17%, p=0.0906), risk of relapse (every 2 weeks: 39%, p<0.0001; every 4 weeks: 19%, p=0.0465), 12-week disability progression (every 2 weeks: 33%, p=0.0257; every 4 weeks: 25%, p=0.0960), and 24-week disability progression (every 2 weeks: 41%, p=0.0137; every 4 weeks: 9%, p=0.6243). Over 2 years, greater reductions were observed with every 2 week versus every 4 week dosing for all endpoints and peginterferon beta-1a was well tolerated.

conclusionsPeginterferon beta-1a efficacy is maintained beyond 1 year, with greater effects observed with every 2 week versus every 4 week dosing, and a similar safety profile to Y1.Clinicaltrials.gov REGISTRATION NUMBER: NCT00906399.

Indexed as

AdolescentAdultAgedDisability EvaluationDisease ProgressionDouble-Blind MethodFemaleHumansInjections, SubcutaneousInterferon-betaMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingPolyethylene GlycolsRecurrenceTreatment OutcomeInterferon-betapeginterferon beta-1aPolyethylene GlycolsInterferonMRImultiple sclerosispeginterferon beta-1apegylatedphase 3relapserelapse-remitting multiple sclerosis

Identifiers

PMID25432952
PMCPMC4512519
OpenAlexW2161512169

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.