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SAT0486 Early MRI Measures Independently Predict 1- and 2- Year X-Ray Progression: Results from a Large Clinical Trial
- 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
- Subjects :
- medicine.medical_specialty
business.industry
Immunology
medicine.disease
Clinical disease
General Biochemistry, Genetics and Molecular Biology
Golimumab
Bone erosion
Surgery
law.invention
Clinical trial
Continuous variable
Rheumatology
Randomized controlled trial
law
Synovitis
Internal medicine
Joint damage
Immunology and Allergy
Medicine
business
medicine.drug
Subjects
Details
- ISSN :
- 14682060 and 00034967
- Volume :
- 72
- Database :
- OpenAIRE
- Journal :
- Annals of the Rheumatic Diseases
- Accession number :
- edsair.doi...........b508de4ec4d5ae8f4e04d5672817f1c4