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Extended report
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
  1. Charles Peterfy1,
  2. Paul Emery2,
  3. Paul P Tak3*,
  4. Mikkel Østergaard4,
  5. Julie DiCarlo1,
  6. Kati Otsa5,
  7. Federico Navarro Sarabia6,
  8. Karel Pavelka7,
  9. Marie-Agnes Bagnard8,
  10. Lykke Hinsch Gylvin8,
  11. Corrado Bernasconi8,
  12. Annarita Gabriele8
  1. 1Spire Sciences, Inc., Boca Raton, Florida, USA
  2. 2Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds & NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK
  3. 3*Academic Medical Center/University of Amsterdam, Amsterdam, The Netherlands; *Current address also: University of Cambridge, Cambridge, UK and GlaxoSmithKline, Stevenage, UK
  4. 4Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Glostrup Hospital. University of Copenhagen, Copenhagen, Denmark
  5. 5Tallinn Central Hospital, Tallinn, Estonia
  6. 6Hospital Universitario, Seville, Spain
  7. 7Charles University, Prague, Czech Republic
  8. 8F Hoffmann-La Roche Ltd, Basel, Switzerland
  1. Correspondence to Professor Charles Peterfy, Spire Sciences, Inc., 5314 Boca Marina Circle North, Boca Raton, FL 33487, USA; charles.peterfy{at}spiresciences.com

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.

Trial registration number NCT00578305

  • Rheumatoid Arthritis
  • Magnetic Resonance Imaging
  • DMARDs (biologic)
  • Inflammation

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