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  • Assessment by MRI of inflammation and damage in rheumatoid arthritis patients with methotrexate inadequate response receiving golimumab: results of the GO-FORWARD trial

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Clinical and epidemiological research
Extended report
Assessment by MRI of inflammation and damage in rheumatoid arthritis patients with methotrexate inadequate response receiving golimumab: results of the GO-FORWARD trial
  1. Philip G Conaghan1,2,
  2. Paul Emery1,2,
  3. Mikkel Østergaard3,
  4. Edward C Keystone4,
  5. Mark C Genovese5,
  6. Elizabeth C Hsia6,7,
  7. Weichun Xu6,
  8. Mahboob U Rahman7,8
  1. 1Section of Musculoskeletal Disease, Leeds Institute of Molecular Medicine, University of Leeds, Leeds, UK
  2. 2NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK
  3. 3Department of Rheumatology, Copenhagen University Hospital at Glostrup and Hvidovre, Copenhagen, Denmark
  4. 4Rebecca MacDonald Centre for Arthritis and Autoimmune Diseases, Mount Sinai Hospital, University of Toronto, Toronto, Canada
  5. 5Division of Immunology and Rheumatology,Stanford University, Palo Alto, California, USA
  6. 6Centocor Research and Development, Inc., Malvern, Pennsylvania, USA
  7. 7University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA
  8. 8Pfizer, Inc., Collegeville, Pennsylvania, USA
  1. Correspondence to Philip G Conaghan, Section of Musculoskeletal Disease, Leeds Institute of Molecular Medicine, University of Leeds, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK; p.conaghan{at}leeds.ac.uk

Abstract

Objective To evaluate golimumab's effect on MRI-detected inflammation and structural damage in patients with active rheumatoid arthritis (RA) despite methotrexate (MTX).

Methods Patients (n=444) were randomly assigned to placebo plus MTX, golimumab 100 mg plus placebo, golimumab 50 mg plus MTX, or golimumab 100 mg plus MTX (subcutaneous injections every 4 weeks). A subset of 240 patients participated in an MRI substudy. MRIs (1.5T+contrast enhancement) of the dominant wrist and metacarpophalangeal (MCP) joints were obtained at baseline and weeks 12 and 24. Images were scored by two independent, blinded readers for synovitis (0–9 wrist only (n=240), 0–21 wrist+MCP (n=223)), bone oedema (osteitis) (0–69) and bone erosions (0–230) using the OMERACT Rheumatoid Arthritis MRI Scoring system.

Results Significant improvements in synovitis and bone oedema (osteitis) were observed in the combined golimumab plus MTX groups versus placebo plus MTX at week 12 (−1.77 vs −0.15, p<0.001 wrist+MCP and −2.00 vs 0.19, p=0.003, respectively) and week 24 (−1.91 vs −0.38, p<0.001 wrist+MCP and −1.74 vs 0.71, p=0.004, respectively). Fewer than 10% of patients had a substantial degree of erosive progression (most showed no progression) across all treatment groups (including the control group), precluding adequate evaluation of golimumab's effect on bone erosions.

Conclusion Golimumab plus MTX significantly improved MRI-detected synovitis and osteitis (prognosticators of future structural damage) versus placebo plus MTX at weeks 12 and 24. The effect of golimumab on bone erosions could not be determined by semi-quantitative scoring in these RA patients with minimal progression of bone erosions.

This paper is freely available online under the BMJ Journals unlocked scheme, see http://ard.bmj.com/info/unlocked.dtl

https://doi.org/10.1136/ard.2010.146068

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    Footnotes

    • Funding This study was funded by Centocor Research and Development, Inc. and Schering Plough Research Institute, Inc.

    • Competing interests PGC has received consulting fees, speaking fees and/or research grants from Astra Zeneca, Bristol-Myers Squibb, Centocor, Merck, Sharpe and Dohme, Novartis, Roche and Pfizer. PE has received consulting fees, speaking fees and/or research grants from Abbott Laboratories, Bristol-Myers Squibb, Centocor, Roche, Pfizer, UCB and Merck, Sharpe and Dohme. MCG has received grant support from, and served as a consultant to, Johnson & Johnson, Inc., New Brunswick, NJ. ECK has received consulting fees, speaking fees and/or research grants from Abbott Laboratories, Amgen Inc., AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb, Centocor, F. Hoffmann-La Roche Ltd, Genentech Inc., Novartis Pharmaceuticals Corporation, Pfizer Pharmaceuticals, Schering-Plough Corporation, UCB and Wyeth Pharmaceuticals. MØ has received consulting fees, speaking fees and/or research grants from Abbott Laboratories, Amgen Inc., Bristol-Myers Squibb, Centocor, F. Hoffmann-La Roche Ltd, Genmab, GlaxoSmithKline, Novartis Pharmaceuticals Corporation, Pfizer Pharmaceuticals, Schering-Plough Corporation, UCB and Wyeth Pharmaceuticals. ECH and WX are employees of Centocor, a wholly owned subsidiary of Johnson & Johnson, Inc. (J&J) and own stock in J&J. MUR was formerly (during the conduct of this study) employed by Centocor R&D Inc. Currently he is employed by Pfizer, Inc. and owns J&J and Pfizer stocks.

    • Provenance and peer review Not commissioned; externally peer reviewed.