Evidence map›Paper›PMID 15345498›Full record

Trial reportAnnals of the rheumatic diseases2004

Outcomes of a multicentre randomised clinical trial of etanercept to treat ankylosing spondylitis.

A Calin, B A C Dijkmans, P Emery, M Hakala, J Kalden, M Leirisalo-Repo, E M Mola, C Salvarani, R Sanmartí, J Sany and 6 more

Open access · bronzeAbstract readClinical TrialMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 106 papers, 24 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
106citing papers in PubMed, 24 pooled it
15.4field-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.

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

106 citing papers in PubMed, 24 syntheses or guidelines pooled it, 317 citations in OpenAlex.

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  14. TNF-alpha inhibitors for ankylosing spondylitis.The Cochrane database of systematic reviews · 2015
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46 more citing papers are in PubMed but not listed here.

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

16 authors at 12 institutions in 8 countries.

A CalinRoyal National Hospital for Rheumatic Disease, Upper Borough Walls, Bath, UK. calinandrei@hotmail.com.
B A C Dijkmans
P Emery
M Hakala
J Kalden
M Leirisalo-Repo
E M Mola
C Salvarani
R Sanmartí
J Sany
J Sibilia
J Sieper
S van der Linden
E Veys
A M Appel
S Fatenejad
Women's Health Research Institute · CACharité - Universitätsmedizin Berlin · DEFriedrich-Alexander-Universität Erlangen-Nürnberg · DEGhent University Hospital · BEHôpital d'Hautepierre · FRHôpital Lapeyronie · FRLeeds General Infirmary · GBMaastricht University · NLUniversidad Autónoma de Madrid · ESUniversitat de Barcelona · ESUniversity of Helsinki · FIVrije Universiteit Amsterdam · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveA double blind, randomised, placebo controlled study to evaluate the safety and efficacy of etanercept to treat adult patients with ankylosing spondylitis (AS).

methodsAdult patients with AS at 14 European sites were randomly assigned to 25 mg injections of etanercept or placebo twice weekly for 12 weeks. The primary efficacy end point was an improvement of at least 20% in patient reported symptoms, based on the multicomponent Assessments in Ankylosing Spondylitis (ASAS) response criteria (ASAS 20). Secondary end points included ASAS 50 and ASAS 70 responses and improved scores on individual components of ASAS, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), acute phase reactants, and spinal mobility tests. Safety was evaluated during scheduled visits.

resultsOf 84 patients enrolled, 45 received etanercept and 39 received placebo. Significantly more etanercept patients than placebo patients responded at the ASAS 20 level as early as week 2, and sustained differences were evident up to week 12. Significantly more etanercept patients reported ASAS 50 responses at all times and ASAS 70 responses at weeks 2, 4, and 8; reported lower composite and fatigue BASDAI scores; had lower acute phase reactant levels; and had improved spinal flexion. Etanercept was well tolerated. Most adverse events were mild to moderate; the only between-group difference was injection site reactions, which occurred significantly more often in etanercept patients.

conclusionsEtanercept is a well tolerated and effective treatment for reducing clinical symptoms and signs of AS.

Indexed as

AdultAntirheumatic AgentsC-Reactive ProteinDouble-Blind MethodEtanerceptFemaleHumansImmunoglobulin GImmunologic FactorsMaleMiddle AgedReceptors, Tumor Necrosis FactorSeverity of Illness IndexSpineSpondylitis, AnkylosingTreatment OutcomeAntirheumatic AgentsC-Reactive ProteinEtanerceptImmunoglobulin GImmunologic FactorsReceptors, Tumor Necrosis Factor

Identifiers

PMID15345498
PMCPMC1754832
OpenAlexW2134280423

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.