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SAT0486 Early MRI Measures Independently Predict 1- and 2- Year X-Ray Progression: Results from a Large Clinical Trial
  1. J. Baker1,
  2. M. Østergaard2,
  3. P. Emery3,
  4. E. C. Hsia1,4,
  5. J. D. Lu4,
  6. D. Baker4,
  7. P. G. Conaghan3
  1. 1U of Penn Sch of Med, Phila, United States
  2. 2Copenhagen U Hosp of Glostrup, Glostrup, Denmark
  3. 3U of Leeds and NIHR Leeds MBRU, Leeds, United Kingdom
  4. 4Janssen R & D, LLC, Spring House, United States

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-naïve.

Methods Methods & results of the original trial have been published1. MRIs (contrast-enhanced; 1.5T) of the wrist & the 2nd-5th 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<0.05), & tended to be associated with x-ray progression at wk 104 (p= 0.004-0.2).

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

  1. Østergaard M, Emery P, Conaghan PG, et al. Arthritis Rheum2011; 63(12): 3712-3722.

References

Disclosure of Interest J. Baker Grant/research support from: Janssen R&D, LLC, M. Østergaard 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

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