Purpose: We assessed whether magnetic resonance imaging (MRI) measures of inflammation and damage were associated with patient-reported outcomes (PROs) in a longitudinal clinical trial setting.
Methods: This longitudinal cohort was derived from the MRI sub-study of the GO-BEFORE randomized clinical trial of golimumab among methotrexate-naïve patients. Correlations between RAMRIS scores (synovitis, osteitis, bone erosion) and disability (Health Assessment Questionnaire), pain, and global patient scores were determined at 0, 12, 24, and 52 weeks. Correlations between interval changes were also assessed. Multivariable regression models using robust generalized estimating equations evaluated associations over all time-points and their relationship to other clinical disease activity measures. Results:
Greater synovitis, osteitis, and bone erosion scores were positively associated with disability at all time-points (all p<0.05) and with pain and patient global scores at 24 and 52 weeks. Over all visits, synovitis was associated with disability, pain, and patient global scores (p<0.03) independent of clinical disease activity measures. Improvements in synovitis and bone erosion were also associated with improvements in PROs. Less improvement in synovitis and progression in MRI erosion at 52 weeks were both independently associated with worsening in all PROs at 52 weeks while progression on x-ray was not associated. Similar associations were observed across treatment groups. Conclusions: MRI measures of inflammation and structural damage correlate independently with disability, pain, and patient global assessments. These observations support the validity of MRI biomarkers.
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)