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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. 1 Institute of Health and Biomedical Innovation, Queensland University of Technology, Translational Research Institute, Princess Alexandra Hospital, Brisbane, Australia
  2. 2 St George & Sutherland Clinical School, University of New South Wales, Sydney, Australia
  3. 3 School of Medicine, University of Queensland and Royal Brisbane and Women’s Hospital, Brisbane, Australia
  4. 4 School of Medicine, Swedish Medical Center and University of Washington, Seattle, Washington, USA
  5. 5 Department of Rheumatology, Ghent University Hospital, Ghent, Belgium
  6. 6 Speciality Care, Pfizer, West Ryde, New South Wales, Australia
  7. 7 Inflammation & Immunology, Pfizer, Collegeville, Pennsylvania, USA
  8. 8 Department of Biostatistics, inVentiv Health, Princeton, New Jersey, USA
  9. 9 Department of Rheumatology, University Pierre et Marie Curie Paris 6 HÃ’pital 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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Footnotes

  • Contributors All the authors made substantial contributions to conception and design, acquisition of data and analysis and interpretation of data; were involved in drafting the manuscript and revising the manuscript critically for important intellectual content and have given final approval of the version to be published.

  • Funding This study was funded by Pfizer. Pfizer was involved in the design of the study, in data collection, analysis and interpretation and in content approval. Editorial/medical writing support was provided by Iain McDonald of Engage Scientific Solutions and was funded by Pfizer. Publication of the article was not contingent upon approval by Pfizer.

  • Competing interests MAB has received research grants, consulting fees or other remuneration or participated in speakers’ bureau for AbbVie, Novartis, Pfizer, UCB, Wyeth, Leo Pharma, NIAMS, NHMRC, Arthritis Australia and the Queensland Government; PAB has participated in speakers’ bureau for Pfizer, AbbVie, Roche, Janssen and BMS; PCR has received research grants, consulting fees or other remuneration from AbbVie, UCB, Janssen and Roche; PJM has received research grants, consulting fees or other remuneration or participated in speakers’ bureau for AbbVie, Amgen, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB; FvdB has received consulting fees or other remuneration, or participated in speakers’ bureau for AbbVie, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer and UCB; CS and ZW are full-time employees of Pfizer Australia and hold stock or stock options; HJ and LM are full-time employees of Pfizer and hold stock or stock options; AS is an employee of InVentiv Health and was contracted by Pfizer to provide statistical support for the development of this manuscript; MD has received research grants, consulting fees or other remuneration from Pfizer, AbbVie, UCB, Merck, Novartis, Lilly and Sanofi.

  • Ethics approval The Institutional Review Boards of participating centres.

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

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