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SAT0486 Early MRI Measures Independently Predict 1- and 2- Year X-Ray Progression: Results from a Large Clinical Trial

Authors :
Mikkel Østergaard
Elizabeth C. Hsia
Paul Emery
J. Lu
Joshua F. Baker
P.G. Conaghan
David Baker
Source :
Annals of the Rheumatic Diseases. 72:A746.1-A746
Publication Year :
2013
Publisher :
BMJ, 2013.

Abstract

Objectives Early predictors of progression in structural joint damage in RA are lacking. We evaluated if early MRI measures of inflammation & erosion at baseline (BL), 12 & 24wks could predict subsequent progression in structural damage as measured by standard x-ray at 1 & 2 yrs of follow-up among 256 pts from GO-BEFORE, a large randomized trial of golimumab+MTX vs MTX alone in RA pts who were MTX-naive. Methods Methods & results of the original trial have been published 1 . MRIs (contrast-enhanced; 1.5T) of the wrist & the 2 nd -5 th metacarpophalangeal joints of the dominant hand at BL & wks12, 24, 52, & 104 were obtained. MRIs were scored by 2 independent, blinded readers using the RA MRI Scoring (RAMRIS) system. X-rays (hands, wrists, forefeet at BL, wk 52, & 104) were scored by 2 other, blinded readers using the van der Heijde-Sharp (vdHS) system. X-ray progression was defined as a change in vdHS score > 0.5 as it was in the original trial. MRI synovitis & bone edema scores were evaluated as continuous variables (per unit difference or change). Change in RAMRIS bone erosion scores was highly skewed, & was therefore dichotomized at >0.5. Multivariable logistic regression was used to determine if BL & early measures of change in component RAMRIS scores predicted x-ray progression independent of clinical disease activity [DAS28(CRP)], change in DAS28(CRP), age, sex, BL vdHS score, & treatment group. Results Higher BL synovitis scores & less improvement in synovitis over the first 24 wks of follow-up were both significantly & independently associated with a greater risk of x-ray progression at 1- & 2 yrs (Table). Higher BL bone edema & less improvement in bone edema were independently associated with a greater risk of x-ray progression at 1yr, & tended to be associated with progression at 2yrs. An increase in RAMRIS bone erosion score >0.5 at wk 24 significantly predicted x-ray progression at 1- & 2 yrs. BL & wk12 changes in MRI scores all significantly predicted x-ray progression at wk52 (all p Conclusions Early MRI measures at 12 & 24 wks independently predict x-ray changes at 1 & 2 yrs of follow-up. These data support the use of MRI in clinical trials for early identification of pts with (OR who will develop) structural joint damage progression during follow-up. This has implications for clinical trial design. References Ostergaard M, Emery P, Conaghan PG, et al. Arthritis Rheum 2011; 63(12): 3712-3722. Disclosure of Interest J. Baker Grant/research support from: Janssen R&D, LLC, M. Ostergaard Grant/research support from: Janssen R&D, LLC, P. Emery Grant/research support from: Janssen R&D, LLC, E. Hsia Employee of: Janssen R&D, LLC, J. D. Lu Employee of: Janssen R&D, LLC, D. Baker Employee of: Janssen R&D, LLC, P. G. Conaghan Grant/research support from: Janssen R&D, LLC

Details

ISSN :
14682060 and 00034967
Volume :
72
Database :
OpenAIRE
Journal :
Annals of the Rheumatic Diseases
Accession number :
edsair.doi...........b508de4ec4d5ae8f4e04d5672817f1c4