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. 2017 Jan 30;3(1):e000382.
doi: 10.1136/rmdopen-2016-000382. eCollection 2017.

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

Roy M Fleischmann  1 , Désirée van der Heijde  2 , Philip V Gardiner  3 , Annette Szumski  4 , Lisa Marshall  5 , Eustratios Bananis  5
Affiliations

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

Roy M Fleischmann et al. RMD Open. .

Abstract

Background: In 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.

Methods: Baseline 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.

Results: At 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.

Conclusions: We 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.

Keywords: Anti-TNF; DAS28; Rheumatoid Arthritis.

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Conflict of interest statement

Competing interests: RMF was a principal investigator for clinical trials used in this analysis and has received consulting fees unrelated to the development of this article. DvdH has received consulting fees from Pfizer unrelated to the development of this article. AS is an employee of inVentiv Health and was contracted by Pfizer to provide statistical support for the development of this article. LM and EB are employees of Pfizer.

Figures

Figure 1
Figure 1
DAS28-CRP cut-off values corresponding to the DAS28-ESR cut-off values for remission, LDA and HDA, average of three statistical approaches. Cut-offs for remission and LDA are from Fleischmann et al. DAS28-CRP, Disease Activity Score in 28 joints calculated with C reactive protein; DAS28-ESR, Disease Activity Score in 28 joints calculated with erythrocyte sedimentation rate; HDA, high disease activity; LDA, low disease activity.
See this image and copyright information in PMC

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