Evidence map›Paper›PMID 26269397›Full record

Trial reportAnnals of the rheumatic diseases2016

Clinical and MRI responses to etanercept in early non-radiographic axial spondyloarthritis: 48-week results from the EMBARK study.

Walter P Maksymowych, Maxime Dougados, Désirée van der Heijde, Joachim Sieper, Jürgen Braun, Gustavo Citera, Filip Van den Bosch, Isabelle Logeart, Joseph Wajdula, Heather Jones and 6 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 57 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 6 pooled it
8.8field-weighted citation impact, top 2% 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.

NCT01258738 phase3completednot on this map

A Multicentre, 12 Week Double Blind Placebo Controlled Randomized Study Of Etanercept On A Background Nsaid In The Treatment Of Adult Subjects With Non Radiographic Axial Spondyloarthritis With A 92 Week Open Label Extension

TypeinterventionalSponsorPfizerRan2011 to 2014Enrolled225ConditionsSpondylitis, AnkylosingArmsetanercept, Background NSAID, PLACEBO
NCT03561649 nacompletednot on this mapstarted 2018, after this paper: background citation

Prediction of Adalimumab Treatment Response at 6 Months by Combinatorial Analysis of Serum Biomarkers in Biotherapy Naive Spondyloarthritis: Pilot Study

TypeinterventionalSponsorUniversity Hospital, GrenobleRan2018 to 2020Enrolled50ConditionsSpondylitis, AnkylosingArmsAdalimumab
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 6 syntheses or guidelines pooled it, 100 citations in OpenAlex.

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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

16 authors at 8 institutions in 6 countries.

Walter P MaksymowychDepartment of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Maxime DougadosRheumatology Department, Paris Descartes University, Hôpital Cochin, Paris, France.
Désirée van der HeijdeDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.ORCID http://orcid.org/0000-0002-5781-158X
Joachim SieperDepartment of Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Jürgen BraunRheumazentrum Ruhrgebiet, Herne, Germany.
Gustavo CiteraDepartment of Rheumatology, Instituto de Rehabilitación Psicofísica de Buenos Aires, Buenos Aires, Argentina.
Filip Van den BoschDepartment of Rheumatology, University of Ghent, Ghent, Belgium.
Isabelle LogeartMedical Affairs, Pfizer International Operations, Paris, France.
Joseph WajdulaClinical Affairs, Pfizer, Collegeville, Pennsylvania, USA.
Heather JonesMedical Affairs, Pfizer, Collegeville, Pennsylvania, USA.
Lisa MarshallMedical Affairs, Pfizer, Collegeville, Pennsylvania, USA.
Randi BoninClinical Affairs, Pfizer, Collegeville, Pennsylvania, USA.
Ron PedersenDepartment of Biostatistics, Pfizer, Collegeville, Pennsylvania, USA.
Bonnie VlahosClinical Affairs, Pfizer, Collegeville, Pennsylvania, USA.
Sameer KotakGlobal Health and Value, Pfizer, New York, New York, USA.
Jack F BukowskiClinical Affairs, Pfizer, Collegeville, Pennsylvania, USA.
Pfizer (United States) · USCharité - Universitätsmedizin Berlin · DEInstituto Nacional de Rehabilitación Psicofísica · ARLeiden University Medical Center · NLPfizer (France) · FRRheumazentrum Ruhrgebiet · DEUniversité Paris Cité · FRUniversity of Alberta · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of etanercept (ETN) after 48 weeks in patients with early active non-radiographic axial spondyloarthritis (nr-axSpA).

methodsPatients meeting Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA, but not modified New York radiographic criteria, received double-blind ETN 50 mg/week or placebo (PBO) for 12 weeks, then open-label ETN (ETN/ETN or PBO/ETN). Clinical, health, productivity, MRI and safety outcomes were assessed and the 48-week data are presented here.

results208/225 patients (92%) entered the open-label phase at week 12 (ETN, n=102; PBO, n=106). The percentage of patients achieving ASAS40 increased from 33% to 52% between weeks 12 and 48 for ETN/ETN and from 15% to 53% for PBO/ETN (within-group p value <0.001 for both). For ETN/ETN and PBO/ETN, the EuroQol 5 Dimensions utility score improved by 0.14 and 0.08, respectively, between baseline and week 12 and by 0.23 and 0.22 between baseline and week 48. Between weeks 12 and 48, MRI Spondyloarthritis Research Consortium of Canada sacroiliac joint (SIJ) scores decreased by -1.1 for ETN/ETN and by -3.0 for PBO/ETN, p<0.001 for both. Decreases in MRI SIJ inflammation and C-reactive protein correlated with several clinical outcomes at weeks 12 and 48.

conclusionsPatients with early active nr-axSpA demonstrated improvement from week 12 in clinical, health, productivity and MRI outcomes that was sustained to 48 weeks. TRIAL REGISTRATION NUMBER: NCT01258738.

Indexed as

Magnetic Resonance ImagingAdultAntirheumatic AgentsAxis, Cervical VertebraDouble-Blind MethodEtanerceptFemaleHumansMaleSacroiliac JointSeverity of Illness IndexSpondylarthritisTime FactorsTreatment OutcomeAntirheumatic AgentsEtanerceptAnti-TNFMagnetic Resonance ImagingSpondyloarthritis

Identifiers

PMID26269397
PMCPMC4941178
OpenAlexW2276452272

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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.