Evidence map›Paper›PMID 28970212›Full record

Trial reportAnnals of the rheumatic diseases2018

Modification of structural lesions on MRI of the sacroiliac joints by etanercept in the EMBARK trial: a 12-week randomised placebo-controlled trial in patients with non-radiographic axial spondyloarthritis.

Walter P Maksymowych, Stephanie Wichuk, Maxime Dougados, Heather E Jones, Ron Pedersen, Annette Szumski, Lisa Marshall, Jack F Bukowski, Robert G Lambert

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01258738 (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), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
4.2field-weighted citation impact, top 6% 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
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 49 citations in OpenAlex.

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  11. New Bone Formation in Axial Spondyloarthritis: A Review.RoFo : Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin · 2024
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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

9 authors at 4 institutions in 3 countries.

Walter P MaksymowychDepartment of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Stephanie WichukDepartment of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Maxime DougadosParis Descartes University, Rheumatology Department, Cochin Hospital, Assistance Publique-Hôpitaux de Paris, INSERM (U1153): Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, France.
Heather E JonesMedical Affairs, Pfizer, Collegeville, Pennsylvania, USA.
Ron PedersenDepartment of Biostatistics, Pfizer, Collegeville, Pennsylvania, USA.
Annette SzumskiBiostatistics, inVentiv Health, Princeton, New Jersey, USA.
Lisa MarshallMedical Affairs, Pfizer, Collegeville, Pennsylvania, USA.
Jack F BukowskiClinical Affairs, Pfizer, Collegeville, Pennsylvania, USA.
Robert G LambertDepartment of Radiology and Diagnostic Imaging, University of Alberta, Edmonton, Alberta, Canada.
Pfizer (United States) · USUniversity of Alberta · CAPrinceton University · USUniversité Paris Cité · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the impact on structural lesions observed on MRI in the sacroiliac joints (SIJ) at 12 weeks in patients with non-radiographic axial spondyloarthritis (nr-axSpA) receiving etanercept or placebo in EMBARK (Effect of Etanercept on Symptoms and Objective Inflammation in nr-axSpA, a 104 week study).

methodsPatients were randomised to double-blind etanercept 50 mg/week or placebo for 12 weeks. Structural lesions at baseline and 12 weeks were scored by two independent readers using the Spondyloarthritis Research Consortium of Canada (SPARCC) SIJ structural score (SSS) on T1-weighted MRI. Change in SPARCC SSS and correlation with improvement in clinical outcomes was evaluated.

resultsMRI scans from 185 patients (etanercept, n=88; placebo, n=97) were reviewed. At baseline, there were no significant differences in mean SPARCC SSS between etanercept and placebo. From baseline to 12 weeks, change in mean SPARCC SSS was significantly greater for etanercept than placebo for erosion (-0.57 vs -0.08, respectively, adjusted p value=0.017) and backfill (0.36 vs 0.06, adjusted p value=0.022). A treatment difference was also present for the subgroup of patients with SIJ inflammation on MRI (SPARCC bone marrow oedema ≥2): erosion: -0.81 versus -0.13 for etanercept versus placebo, respectively, p=0.007; backfill: 0.48 versus 0.08, respectively, p=0.032. Decrease in erosion and increase in backfill correlated with improvement in more clinical outcomes for etanercept than placebo.

conclusionTreatment with etanercept was associated with significantly greater reduction in erosions and increase in backfill at 12 weeks compared with placebo, consistent with a very early reparative response to antitumour necrosis factor therapy. The impact on disease progression in spondyloarthritis should be studied further. TRIAL REGISTRATION NUMBER: NCT01258738; Post-results.

Indexed as

Magnetic Resonance ImagingAdultAntirheumatic AgentsCanadaDisease ProgressionDouble-Blind MethodEtanerceptFemaleHumansMaleSacroiliac JointSpondylarthritisTreatment OutcomeAntirheumatic AgentsEtanerceptanti-TNFmagnetic resonance imagingspondyloarthritis

Identifiers

PMID28970212
PMCPMC5754741
OpenAlexW2758911649

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.