Evidence map›Paper›PMID 27060836›Full record

Trial reportBritish journal of clinical pharmacology2016

COMPARE: Pharmacokinetic profiles of subcutaneous peginterferon beta-1a and subcutaneous interferon beta-1a over 2 weeks in healthy subjects.

Xiao Hu, Shulian Shang, Ivan Nestorov, Jawad Hasan, Ali Seddighzadeh, Katherine Dawson, Bjørn Sperling, Brian Werneburg

Open access · hybridAbstract readClinical Trial, Phase IComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 7% 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.

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

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.

  1. Pooled it
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  4. Electrically regulated cell-based intervention for viral infections.Bioengineering & translational medicine · 2023
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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

8 authors at 1 institution in 1 country.

Xiao HuBiogen, Cambridge, MA, USA.
Shulian ShangBiogen, Cambridge, MA, USA.
Ivan NestorovBiogen, Cambridge, MA, USA.
Jawad HasanBiogen, Cambridge, MA, USA.
Ali SeddighzadehBiogen, Cambridge, MA, USA.
Katherine DawsonBiogen, Cambridge, MA, USA.
Bjørn SperlingBiogen, Cambridge, MA, USA.
Brian WerneburgBiogen, Cambridge, MA, USA.
Biogen (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimSubcutaneous (s.c.) peginterferon beta-1a injected once every 2 weeks and s.c. interferon beta-1a injected three times per week (Rebif®) have demonstrated efficacy in relapsing-remitting multiple sclerosis, but direct comparisons of pharmacological activity and tolerability between the two products are lacking. COMPARE was an open label, crossover, pharmacokinetic (PK) study evaluating drug exposure and the safety and tolerability of s.c. peginterferon beta-1a and s.c. interferon beta-1a, over 2 weeks in healthy subjects.

methodsThirty healthy subjects received one dose of peginterferon beta-1a (125 μg s.c.) or six doses of interferon beta-1a (44 μg s.c.) over 2 weeks, followed by the alternate treatment after a 2 week washout period. Drug concentrations were measured using an enzyme-linked immunosorbent assay (ELISA) and PK parameters including cumulative area under the concentration-time curve (AUC0-336h ) over 2 weeks and maximum observed serum concentrations (Cmax ) were estimated using a non-compartmental analysis.

resultsThe PK analysis population comprised 26 subjects for each treatment. Drug exposure (AUC0-336h ) was 60% higher with s.c. peginterferon than with s.c. interferon beta-1a (117.4 ng ml(-1) h, 95% confidence interval 95.6, 144.3 vs. 73.1 ng ml(-1) h, 95% confidence interval 61.2, 87.3, respectively; P < 0.0001). Injection-site reactions (ISRs) were the most common adverse events (AEs) observed with both treatments. Numerically lower frequencies and incidence rates of ISRs, headache, myalgia and chills were observed with s.c. peginterferon beta-1a.

conclusionsOne dose of s.c. peginterferon delivered significantly greater drug exposure than s.c. interferon beta-1a three times a week over 2 weeks, and a lower frequency of AEs.

Indexed as

Adjuvants, ImmunologicAdolescentAdultArea Under CurveCross-Over StudiesEnzyme-Linked Immunosorbent AssayFemaleHumansInjections, SubcutaneousInterferon-betaInterferon beta-1aMaleMiddle AgedPolyethylene GlycolsYoung AdultAdjuvants, ImmunologicInterferon-betaInterferon beta-1apeginterferon beta-1aPolyethylene GlycolsAUCexposureinjection-site reactionsmultiple sclerosispharmacokineticstolerability

Identifiers

PMID27060836
PMCPMC4972154
OpenAlexW2339126111

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.