SAT0486 Early MRI Measures Independently Predict 1- and 2- Year X-Ray Progression: Results from a Large Clinical Trial
Authors: J. Baker, M. Østergaard, P. Emery, E. C. Hsia, J. D. Lu, D. Baker, P. G. Conaghan
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Objectives</h3> Early predictors of progression in structural joint damage in RA are lacking. We evaluated if early MRI measures of inflammation &amp; erosion at baseline (BL), 12 &amp; 24wks could predict subsequent progression in structural damage as measured by standard x-ray at 1 &amp; 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-naïve. <h3>Methods</h3> Methods &amp; results of the original trial have been published<sup>1</sup>. MRIs (contrast-enhanced; 1.5T) of the wrist &amp; the 2<sup>nd</sup>-5<sup>th</sup> metacarpophalangeal joints of the dominant hand at BL &amp; wks12, 24, 52, &amp; 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, &amp; 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 &gt; 0.5 as it was in the original trial. MRI synovitis &amp; bone edema scores were evaluated as continuous variables (per unit difference or change). Change in RAMRIS bone erosion scores was highly skewed, &amp; was therefore dichotomized at &gt;0.5. Multivariable logistic regression was used to determine if BL &amp; 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, &amp; treatment group. <h3>Results</h3> Higher BL synovitis scores &amp; <i>less improvement</i> in synovitis over the first 24 wks of follow-up were both significantly &amp; independently associated with a greater risk of x-ray progression at 1- &amp; 2 yrs (Table). Higher BL bone edema &amp; <i>less improvement</i> in bone edema were independently associated with a greater risk of x-ray progression at 1yr, &amp; tended to be associated with progression at 2yrs. An increase in RAMRIS bone erosion score &gt;0.5 at wk 24 significantly predicted x-ray progression at 1- &amp; 2 yrs. BL &amp; wk12 changes in MRI scores all significantly predicted x-ray progression at wk52 (all p&lt;0.05), &amp; tended to be associated with x-ray progression at wk 104 (p= 0.004-0.2). <h3>Conclusions</h3> Early MRI measures at 12 &amp; 24 wks independently predict x-ray changes at 1 &amp; 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. <h3>References</h3> Østergaard M, Emery P, Conaghan PG, et al. <i>Arthritis Rheum</i>2011; 63(12): 3712-3722. <h3>Disclosure of Interest</h3> J. Baker Grant/research support from: Janssen R&amp;D, LLC, M. Østergaard Grant/research support from: Janssen R&amp;D, LLC, P. Emery Grant/research support from: Janssen R&amp;D, LLC, E. Hsia Employee of: Janssen R&amp;D, LLC, J. D. Lu Employee of: Janssen R&amp;D, LLC, D. Baker Employee of: Janssen R&amp;D, LLC, P. G. Conaghan Grant/research support from: Janssen R&amp;D, LLC