Evidence map›Paper›PMID 16540554›Full record

Trial reportAnnals of the rheumatic diseases2006

A long-term, open-label trial of the safety and efficacy of etanercept (Enbrel) in patients with rheumatoid arthritis not treated with other disease-modifying antirheumatic drugs.

L Klareskog, M Gaubitz, V Rodriguez-Valverde, M Malaise, M Dougados, J Wajdula, Etanercept Study 301 Investigators

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 3 pooled it
4.5field-weighted citation impact, top 5% 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

32 citing papers in PubMed, 3 syntheses or guidelines pooled it, 83 citations in OpenAlex.

  1. Pooled it
  2. Etanercept for the treatment of rheumatoid arthritis.The Cochrane database of systematic reviews · 2013
    Pooled it
  3. Adverse effects of biologics: a network meta-analysis and Cochrane overview.The Cochrane database of systematic reviews · 2011
    Pooled it
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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 4 institutions in 4 countries.

L KlareskogDepartment of Medicine, Karolinska Institutet at Karolinska University Hospital, Stockholm 17176, Sweden. Lars.Klareskog@medks.ki.se
M Gaubitz
V Rodriguez-Valverde
M Malaise
M Dougados
J Wajdula
Etanercept Study 301 Investigators
Centre Hospitalier Universitaire de Liège · BEHôpital Cochin · FRKarolinska University Hospital · SEMarqués de Valdecilla University Hospital · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the long-term safety and efficacy of etanercept in patients with rheumatoid arthritis.

methods549 patients entered this 5-year, open-label extension study and received etanercept 25 mg twice weekly. All patients showed inadequate responses to disease-modifying antirheumatic drugs before entry into the double-blind studies. Safety assessments were carried out at regular intervals. Primary efficacy end points were the numbers of painful and swollen joints; secondary variables included American College of Rheumatology (ACR) response rate, Disease Activity Score and acute-phase reactants. Efficacy was analysed using the last-observation-carried-forward approach.

resultsOf the 549 patients enrolled in the open-label trial, 467 (85%), 414 (75%) and 371 (68%) completed 1, 2 and 3 years, respectively; 363 (66%) remained in the study at the time of this analysis. A total exposure of 1498 patient-years, including the double-blind study, was accrued. In the open-label trial, withdrawals for efficacy-related and safety-related reasons were 11% and 13%, respectively. Frequent adverse events included upper respiratory infections, flu syndrome, rash and injection-site reactions. Rates of serious infections and malignancies remained unchanged over the course of the study; there were no reports of patients with central demyelinating disease or serious blood dyscrasias. After 3 years, ACR20, ACR50 and ACR70 response rates were 78%, 51% and 27%, respectively. The Disease Activity Score score was reduced to 3.0 at 3 months and 2.6 at 3 years from 5.1. A sustained improvement was found in Health Assessment Questionnaire scores throughout the 3-year time period.

conclusionAfter 3 years of treatment, etanercept showed sustained efficacy and a favourable safety profile.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidBlood SedimentationC-Reactive ProteinDouble-Blind MethodDrug Administration ScheduleEtanerceptFemaleFollow-Up StudiesHumansImmunoglobulin GMaleMiddle AgedNeoplasmsOpportunistic InfectionsReceptors, Tumor Necrosis FactorAntirheumatic AgentsC-Reactive ProteinEtanerceptImmunoglobulin GReceptors, Tumor Necrosis Factor

Identifiers

PMID16540554
PMCPMC1798461
OpenAlexW2121621997

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.