Evidence map›Paper›PMID 28970213›Full record

Trial reportAnnals of the rheumatic diseases2018

Evaluation of the change in structural radiographic sacroiliac joint damage after 2 years of etanercept therapy (EMBARK trial) in comparison to a contemporary control cohort (DESIR cohort) in recent onset axial spondyloarthritis.

Maxime Dougados, Walter P Maksymowych, Robert B M Landewé, Anna Moltó, Pascal Claudepierre, Manouk de Hooge, Robert G Lambert, Randi Bonin, Jack F Bukowski, Heather E Jones and 5 more

2 registry-linked trialsOpen access · hybridAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
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 2 registered trials, which are not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
5.1field-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.

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
NCT01648907 completednot on this map

French Cohort on Outcome of Recent Undifferentiated Spondyloarthritis

TypeobservationalSponsorAssistance Publique - Hôpitaux de ParisRan2007 to 2022Enrolled708ConditionsEARLY UNDIFFERENTIATED SPONDYLARTHROPATHIESArmsImaging exams
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 50 citations in OpenAlex.

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  5. Observational
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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

15 authors at 7 institutions in 4 countries.

Maxime DougadosParis Descartes University, Rheumatology Department, Cochin Hospital, Assistance Publique-Hôpitaux de Paris, INSERM (U1153): Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, France.
Walter P MaksymowychDepartment of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Robert B M LandewéAmsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands.
Anna MoltóParis Descartes University, Rheumatology Department, Cochin Hospital, Assistance Publique-Hôpitaux de Paris, INSERM (U1153): Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, France.
Pascal ClaudepierreUniversite Paris Est Creteil, EA 7379 - EpidermE, AP-HP, Service de Rhumatologie, Hopital Henri Mondor, Creteil, France.
Manouk de HoogeLeiden University Medical Center, Leiden, Netherlands.
Robert G LambertDepartment of Radiology and Diagnostic Imaging, University of Alberta, Edmonton, Alberta, Canada.
Randi BoninClinical Affairs, Pfizer, Collegeville, Pennsylvania, USA.
Jack F BukowskiClinical Affairs, Pfizer, Collegeville, Pennsylvania, USA.
Heather E JonesMedical Affairs, Pfizer, Collegeville, Pennsylvania, USA.
Isabelle LogeartPfizer France, Paris, France.
Ron PedersenDepartment of Biostatistics, Pfizer, Collegeville, USA.
Annette SzumskiBiostatistics, inVentiv Health, Princeton, New Jersey, USA.
Bonnie VlahosClinical Affairs, Pfizer, Collegeville, Pennsylvania, USA.
Désirée van der HeijdeLeiden University Medical Center, Leiden, Netherlands.ORCID 0000-0002-5781-158X
Pfizer (United States) · USDélégation Paris 5 · FRLeiden University Medical Center · NLUniversity of Alberta · CAPfizer (France) · FRPrinceton University · USUniversité Paris-Est Créteil · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo compare 2 years of radiographic sacroiliac joint (SIJ) changes in patients with recent onset axial spondyloarthritis (axSpA) receiving etanercept in a clinical trial (EMBARK) to similar patients not receiving biologics in a cohort study (DESIR).

methodsEndpoints were changes at week 104 per the modified New York (mNY) grading system in total SIJ score (primary endpoint) and net percentage of patients with progression defined three ways. Treatment effect was analysed with and without adjustment for baseline covariates.

resultsAt 104 weeks, total SIJ score improved in the etanercept group (n=154, adjusted least-squares mean change: -0.14) and worsened in the control group (n=182, change: 0.08). The adjusted difference between groups (etanercept minus control) was -0.22 (95% CI -0.38 to -0.06), p=0.008. The net percentage of patients with progression was significantly lower in the etanercept versus the control group for two of three binary endpoints: -1.9% versus 1.6% (adjusted difference for etanercept minus control: -4.7%,95% CI -9.9 to 0.5, p=0.07) for change in mNY criteria; -1.9% versus 7.8% (adjusted difference: -18.2%,95% CI -30.9 to -5.6, p=0.005) for change ≥1 grade in ≥1 SIJ; and -0.6% versus 6.7% (adjusted difference: -16.4%,95% CI -27.9 to -5.0, p=0.005) for change ≥1 grade in ≥1 SIJ, with shift from 0 to 1 or 1 to 0 considered no change.

conclusionDespite the slow radiographic SIJ progression rate over 2 years in axSpA, this study suggests a lower rate of progression in the SIJ with etanercept than without anti-tumour necrosis factor therapy. TRIAL REGISTRATION NUMBERS: NCT01258738, NCT01648907; Post-results.

Indexed as

AdolescentAdultAntirheumatic AgentsCohort StudiesDisease ProgressionDouble-Blind MethodEtanerceptFemaleHumansMaleMiddle AgedSacroiliac JointSeverity of Illness IndexSpineSpondylarthritisYoung AdultAntirheumatic AgentsEtanerceptanti-tnfspondyloarthritistreatment

Identifiers

PMID28970213
PMCPMC5867411
OpenAlexW2758393126

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.