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Evaluation of the effect of baseline MRI sacroiliitis and C reactive protein status on etanercept treatment response in non-radiographic axial spondyloarthritis: a post hoc analysis of the EMBARK study
  1. Matthew A Brown1,
  2. Paul A Bird2,
  3. Philip C Robinson3,
  4. Philip J Mease4,
  5. Filip van den Bosch5,
  6. Christine Surian6,
  7. Heather Jones7,
  8. Annette Szumski8,
  9. Lisa Marshall7,
  10. Zirke Wiid6,
  11. Maxime Dougados9
  1. 1Institute of Health and Biomedical Innovation, Queensland University of Technology, Translational Research Institute, Princess Alexandra Hospital, Brisbane, Australia
  2. 2St George & Sutherland Clinical School, University of New South Wales, Sydney, Australia
  3. 3School of Medicine, University of Queensland and Royal Brisbane and Women’s Hospital, Brisbane, Australia
  4. 4School of Medicine, Swedish Medical Center and University of Washington, Seattle, Washington, USA
  5. 5Department of Rheumatology, Ghent University Hospital, Ghent, Belgium
  6. 6Speciality Care, Pfizer, West Ryde, New South Wales, Australia
  7. 7Inflammation & Immunology, Pfizer, Collegeville, Pennsylvania, USA
  8. 8Department of Biostatistics, inVentiv Health, Princeton, New Jersey, USA
  9. 9Department of Rheumatology, University Pierre et Marie Curie Paris 6 Hôpital Cochin, AP-HP, INSERM U1153 and PRES Sorbonne Paris City, Paris, France
  1. Correspondence to professor Matthew A Brown, Queensland University of Technology, Institute of Health and Biomedical Innovation, GPO Box 2434, Brisbane QLD 4001, Australia; matt.brown{at}qut.edu.au

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The efficacy of tumour necrosis factor alpha (TNFα) inhibitors for patients with non-radiographic axial spondyloarthritis (nr-axSpA) has now been firmly established1–3; however, identification of objective markers, predictive of treatment response, will be of considerable benefit in optimising patient outcomes and ensuring the most appropriate treatment prioritisation and resource allocation. We have investigated this further using the findings of EMBARK (effect of etanercept on symptoms and objective inflammation in nr-axSpA, a 104 week study) (ClinicalTrials.gov identifier: NCT01258738), a phase IIIb, 104-week randomised controlled trial in >200 patients with nr-axSpA,4–6 which showed a possible association between higher baseline C reactive protein (CRP) levels or magnetic resonance imaging (MRI) sacroiliac joint (SIJ) scores and a placebo (PBO)-adjusted treatment effect. The objective of this post hoc analysis was to determine whether MRI sacroiliitis (positive/negative (+/−)) and/or high-sensitivity CRP (hs-CRP) (elevated/normal (+/−)) at baseline are predictive of changes in measures of disease activity on etanercept (ETN) treatment in patients with nr-axSpA.

Eligible patients were randomised to 12 weeks’ double-blind treatment with 50 mg ETN once weekly or PBO. Both groups continued stable non-steroidal anti-inflammatory drug (NSAID) therapy. MRI scanning of the SIJ and spine was performed at screening and …

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