Evidence map›Paper›PMID 28255449›Full record

ArticleRMD open2017

DAS28-CRP and DAS28-ESR cut-offs for high disease activity in rheumatoid arthritis are not interchangeable.

Roy M Fleischmann, Désirée van der Heijde, Philip V Gardiner, Annette Szumski, Lisa Marshall, Eustratios Bananis

2 registry-linked trialsAbstract read
In one paragraph

Article in RMD open, 2017. 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 59 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 5 pooled it
–field-weighted citation impact
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.

NCT00195494 phase4completednot on this map

A 24-Month,Randomized,Double-Blind,Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects With Early Rheumatoid Arthritis

TypeinterventionalSponsorWyeth is now a wholly owned subsidiary of PfizerRan2004 to 2008Enrolled542ConditionsRheumatoid ArthritisArmsEtanercept, Methotrexate, Placebo
NCT00913458 phase4completednot on this map

A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate

TypeinterventionalSponsorPfizerRan2009 to 2012Enrolled306ConditionsActive Rheumatoid Arthritis, Arthritis, Rheumatoid, Rheumatoid ArthritisArmsetanercept
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 5 syntheses or guidelines 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

6 authors.

Roy M FleischmannUniversity of Texas , Dallas, Texas , USA.
Désirée van der HeijdeLeiden University Medical Center , Leiden , The Netherlands.
Philip V GardinerWestern Health and Social Care Trust , Londonderry , UK.
Annette SzumskiinVentiv Health , Princeton, New Jersey , USA.
Lisa MarshallPfizer , Collegeville, Pennsylvania , USA.
Eustratios BananisPfizer , Collegeville, Pennsylvania , USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn most patients with rheumatoid arthritis (RA), Disease Activity Score 28-joint count C reactive protein (DAS28-CRP) is lower than DAS28 erythrocyte sedimentation rate (DAS28-ESR), suggesting that use of the DAS28-ESR cut-off to assess high disease activity (HDA) with DAS28-CRP may underestimate the number of patients with HDA. We determined the DAS28-CRP value corresponding to the validated DAS28-ESR cut-off for HDA.

methodsBaseline data were pooled from 2 clinical studies evaluating etanercept (ETN) plus methotrexate (MTX) or MTX in early RA; DAS28-CRP and DAS28-ESR were obtained, allowing the determination of the DAS28-CRP HDA value best corresponding to the DAS28-ESR cut-off of >5.1.

resultsAt baseline, as expected, fewer patients had HDA by DAS28-CRP than DAS28-ESR; DAS28-CRP>5.1 and DAS28-ESR>5.1 had only modest agreement (κ coefficients 0.45-0.54). Mean DAS28-CRP and DAS28-ESR were 5.7 and 6.2, respectively, in the ETN+MTX group (n=571), and 6.0 and 6.5 in the MTX group (n=262). A DAS28-CRP cut-off of 4.6 corresponded to a DAS28-ESR cut-off of 5.1.

conclusionsWe have shown that a DAS28-CRP of 4.6 corresponds to 5.1 for DAS28-ESR. Since this is substantially lower than the DAS28-ESR cut-off of 5.1, using 5.1 as the cut-off for DAS28-CRP underestimates disease activity in RA. TRIAL REGISTRATION NUMBER: NCT00195494; NCT00913458.

Indexed as

Anti-TNFDAS28Rheumatoid Arthritis

Identifiers

PMID28255449
PMCPMC5294021

What OpenQuestion holds

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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.