Evidence map›Paper›PMID 28394418›Full record

Trial reportJournal of clinical pharmacology2017

Population-Based Pharmacokinetic and Exposure-Efficacy Analyses of Peginterferon Beta-1a in Patients With Relapsing Multiple Sclerosis.

Xiao Hu, Yaming Hang, Yue Cui, Jie Zhang, Shifang Liu, Ali Seddighzadeh, Aaron Deykin, Ivan Nestorov

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
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

8 authors.

Xiao HuBiogen, Cambridge, MA, USA.
Yaming HangBiogen, Cambridge, MA, USA.
Yue CuiBiogen, Cambridge, MA, USA.
Jie ZhangGilead Sciences Inc, Cambridge, MA, USA.
Shifang LiuBiogen, Cambridge, MA, USA.
Ali SeddighzadehBiogen, Cambridge, MA, USA.
Aaron DeykinBiogen, Cambridge, MA, USA.
Ivan NestorovBiogen, Cambridge, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Peginterferon beta-1a reduced annualized relapse rate as compared with placebo and was approved to treat multiple sclerosis patients. A population pharmacokinetic and an exposure-efficacy model were developed to establish the quantitative relationship between pharmacokinetics and annualized relapse rate. The pharmacokinetics was well described by a 1-compartment model with first-order absorption and linear elimination kinetics. Body mass index was the most significant covariate that impacted both clearance and volume of distribution, which in turn impacted area under the curve and maximum serum concentration. Cumulative monthly area under the curve and annualized relapse rate were best described by a Poisson-gamma (negative binomial) model, demonstrating that the improved efficacy of every-2-weeks dosing was driven by greater drug exposure. The results supported the superior efficacy of the every-2-week dosing regimen compared with the every-4-weeks dosing regimen.

Indexed as

Models, BiologicalAdultArea Under CurveDouble-Blind MethodFemaleHumansInterferon-betaMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingPolyethylene GlycolsTreatment OutcomeInterferon-betapeginterferon beta-1aPolyethylene Glycolsannualized relapse ratecount datainterferon beta-1apegylationpharmacometric analysis

Identifiers

PMID28394418
PMCPMC5516189

What OpenQuestion holds

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Registered trials

None linked

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.