title: Relationship of patient-reported outcomes with MRI measures in rheumatoid arthritis.
abstract: OBJECTIVE
  We assessed whether MRI measures of synovitis, osteitis and bone erosion were associated with patient-reported outcomes (PROs) in a longitudinal clinical trial setting among patients with rheumatoid arthritis (RA).
  
  
  METHODS
  This longitudinal cohort of 291 patients with RA was derived from the MRI substudy of the GO-BEFORE randomised controlled trial of golimumab among methotrexate-naïve patients. Correlations between RAMRIS scores (synovitis, osteitis, bone erosion) and physical function (Health Assessment Questionnaire (HAQ)), 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 generalised 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 HAQ 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 HAQ, 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 physical function, pain and patient global assessments. These observations support the validity of MRI biomarkers.
  
  
  BACKGROUND
  NCT00264537; Post-results.
authors.affiliation: Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania, USA.|School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.|Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Joshua F
authors.initials: JF
authors.lastname: Baker
authors.affiliation: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK.
authors.forename: Philip G
authors.initials: PG
authors.lastname: Conaghan
authors.affiliation: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Emery
authors.affiliation: Janssen Research & Development, LLC, Horsham, Pennsylvania, USA.
authors.forename: Daniel G
authors.initials: DG
authors.lastname: Baker
authors.affiliation: Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Glostrup, Denmark.|Faculty of Health and Medical Sciences, Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Mikkel
authors.initials: M
authors.lastname: Ostergaard
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000627:therapeutic use; D018771:Arthralgia / Q000209:etiology; D001172:Arthritis, Rheumatoid / Q000150:complications / Q000000981:diagnostic imaging* / Q000188:drug therapy*; D015415:Biomarkers; D005260:Female; D006304:Health Status; D006801:Humans; D008137:Longitudinal Studies; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D010000:Osteitis / Q000150:complications / Q000000981:diagnostic imaging*; D010147:Pain Measurement; D000071066:Patient Reported Outcome Measures; D011859:Radiography; D011795:Surveys and Questionnaires; D013585:Synovitis / Q000150:complications / Q000000981:diagnostic imaging*
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D015415:Biomarkers; C529000:golimumab
keywords: Disease Activity; Patient perspective; Rheumatoid Arthritis