Evidence map›Paper›PMID 18794178›Full record

Trial reportAnnals of the rheumatic diseases2009

Efficacy, safety and patient-reported outcomes of combination etanercept and sulfasalazine versus etanercept alone in patients with rheumatoid arthritis: a double-blind randomised 2-year study.

B Combe, C Codreanu, U Fiocco, M Gaubitz, P P Geusens, T K Kvien, K Pavelka, P N Sambrook, J S Smolen, R Khandker and 4 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 12 pooled it
1.9field-weighted citation impact, top 15% 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

31 citing papers in PubMed, 12 syntheses or guidelines pooled it, 67 citations in OpenAlex.

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  10. Etanercept for the treatment of rheumatoid arthritis.The Cochrane database of systematic reviews · 2013
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  12. Adverse effects of biologics: a network meta-analysis and Cochrane overview.The Cochrane database of systematic reviews · 2011
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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

14 authors at 7 institutions in 8 countries.

B CombeService d'Immuno-Rhumatologie, Hopital Lapeyronie, Montpellier, France.
C Codreanu
U Fiocco
M Gaubitz
P P Geusens
T K Kvien
K Pavelka
P N Sambrook
J S Smolen
R Khandker
A Singh
J Wajdula
S Fatenejad
Etanercept European Investigators Network
Diakonhjemmet Hospital · NOHôpital Lapeyronie · FRInstitute of Rheumatology · CZMaastricht University · NLMedical University of Vienna · ATPoliclinico Universitario di Catania · ITUniversity of Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine the efficacy and safety of etanercept and etanercept plus sulfasalazine versus sulfasalazine in patients with rheumatoid arthritis (RA) despite sulfasalazine therapy.

methodsPatients were randomly assigned to etanercept (25 mg twice weekly; sulfasalazine was discontinued at baseline), etanercept plus sulfasalazine (unchanged regimen of 2-3 g/day) or sulfasalazine in a double-blind, randomised, 2-year study in adult patients with active RA despite sulfasalazine therapy. Efficacy was assessed using the American College of Rheumatology criteria, disease activity scores (DAS) and patient-reported outcomes (PRO).

resultsDemographic variables and baseline disease characteristics were comparable among treatment groups; mean DAS 5.1, 5.2 and 5.1 for etanercept (n = 103), etanercept plus sulfasalazine (n = 101) and sulfasalazine (n = 50), respectively. Withdrawal due to lack of efficacy was highest with sulfasalazine (26 (52%) vs 6 (6%) for either etanercept group, p<0.001). Patients receiving etanercept or etanercept plus sulfasalazine had a more rapid initial response, which was sustained at 2 years, than those receiving sulfasalazine: mean DAS 2.8, 2.5 versus 4.5, respectively (p<0.05); ACR 20 response was achieved by 67%, 77% versus 34% of patients, respectively (p<0.01) Overall, PRO followed a similar pattern; a clinically significant improvement in health assessment questionnaire was achieved by 76%, 78% versus 40% of patients, respectively (p<0.01). Commonly reported adverse events occurring in the etanercept groups were injection site reactions and pharyngitis/laryngitis (p<0.01).

conclusionEtanercept and etanercept plus sulfasalazine are efficacious for the long-term management of patients with RA. The addition of etanercept or substitution with etanercept should be considered as treatment options for patients not adequately responding to sulfasalazine.

Indexed as

AdolescentAdultAgedAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodDrug Therapy, CombinationEtanerceptFemaleHumansImmunoglobulin GMaleMiddle AgedReceptors, Tumor Necrosis FactorSulfasalazineTreatment OutcomeAntirheumatic AgentsEtanerceptImmunoglobulin GReceptors, Tumor Necrosis FactorSulfasalazine

Identifiers

PMID18794178
PMCPMC2689524
OpenAlexW2115200931

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.