title: MRI assessment of suppression of structural damage in patients with rheumatoid arthritis receiving rituximab: results from the randomised, placebo-controlled, double-blind RA-SCORE study.
abstract: OBJECTIVE
  To evaluate changes in structural damage and joint inflammation assessed by MRI following rituximab treatment in a Phase 3 study of patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) who were naive to biological therapy.
  
  
  METHODS
  Patients were randomised to receive two infusions of placebo (n=63), rituximab 500 mg (n=62), or rituximab 1000 mg (n=60) intravenously on days 1 and 15. MRI scans and radiographs of the most inflamed hand and wrist were acquired at baseline, weeks 12 (MRI only), 24 and 52. The primary end point was the change in MRI erosion score from baseline at week 24.
  
  
  RESULTS
  Patients treated with rituximab demonstrated significantly less progression in the mean MRI erosion score compared with those treated with placebo at weeks 24 (0.47, 0.18 and 1.60, respectively, p=0.003 and p=0.001 for the two rituximab doses vs placebo) and 52 (-0.30, 0.11 and 3.02, respectively; p<0.001 and p<0.001). Cartilage loss at 52 weeks was significantly reduced in the rituximab group compared with the placebo group. Other secondary end points of synovitis and osteitis improved significantly with rituximab compared with placebo as early as 12 weeks and improved further at weeks 24 and 52.
  
  
  CONCLUSIONS
  This study demonstrated that rituximab significantly reduced erosion and cartilage loss at week 24 and week 52 in MTX-inadequate responder patients with active RA, suggesting that MRI is a valuable tool for assessing inflammatory and structural damage in patients with established RA receiving rituximab.
  
  
  BACKGROUND
  NCT00578305.
authors.affiliation: Spire Sciences, Inc., Boca Raton, Florida, USA.
authors.forename: Charles
authors.initials: C
authors.lastname: Peterfy
authors.affiliation: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds & NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Emery
authors.affiliation: *Academic Medical Center/University of Amsterdam, Amsterdam, The Netherlands; *Current address also: University of Cambridge, Cambridge, UK and GlaxoSmithKline, Stevenage, UK.
authors.forename: Paul P
authors.initials: PP
authors.lastname: Tak
authors.affiliation: Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Glostrup Hospital. University of Copenhagen, Copenhagen, Denmark.
authors.forename: Mikkel
authors.initials: M
authors.lastname: Østergaard
authors.affiliation: Spire Sciences, Inc., Boca Raton, Florida, USA.
authors.forename: Julie
authors.initials: J
authors.lastname: DiCarlo
authors.affiliation: Tallinn Central Hospital, Tallinn, Estonia.
authors.forename: Kati
authors.initials: K
authors.lastname: Otsa
authors.affiliation: Hospital Universitario, Seville, Spain.
authors.forename: Federico
authors.initials: F
authors.lastname: Navarro Sarabia
authors.affiliation: Charles University, Prague, Czech Republic.
authors.forename: Karel
authors.initials: K
authors.lastname: Pavelka
authors.affiliation: F Hoffmann-La Roche Ltd, Basel, Switzerland.
authors.forename: Marie-Agnes
authors.initials: MA
authors.lastname: Bagnard
authors.affiliation: F Hoffmann-La Roche Ltd, Basel, Switzerland.
authors.forename: Lykke Hinsch
authors.initials: LH
authors.lastname: Gylvin
authors.affiliation: F Hoffmann-La Roche Ltd, Basel, Switzerland.
authors.forename: Corrado
authors.initials: C
authors.lastname: Bernasconi
authors.affiliation: F Hoffmann-La Roche Ltd, Basel, Switzerland.
authors.forename: Annarita
authors.initials: A
authors.lastname: Gabriele
mesh_terms: D000328:Adult; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D002358:Cartilage, Articular / Q000473:pathology; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D008875:Middle Aged; D011859:Radiography; D000069283:Rituximab / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D000069283:Rituximab
keywords: DMARDs (biologic); Inflammation; Magnetic Resonance Imaging; Rheumatoid Arthritis