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  • Inflammatory and structural changes in vertebral bodies and posterior elements of the spine in axial spondyloarthritis: construct validity, responsiveness and discriminatory ability of the anatomy-based CANDEN scoring system in a randomised placebo-contr…

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Imaging
Original article
Inflammatory and structural changes in vertebral bodies and posterior elements of the spine in axial spondyloarthritis: construct validity, responsiveness and discriminatory ability of the anatomy-based CANDEN scoring system in a randomised placebo-controlled trial
  1. Simon Krabbe1,2,
  2. Inge J Sørensen1,2,
  3. Bente Jensen3,
  4. Jakob M Møller4,
  5. Lone Balding4,
  6. Ole R Madsen2,5,
  7. Robert G W Lambert6,
  8. Walter P Maksymowych7,
  9. Susanne J Pedersen1,2,5 and
  10. Mikkel Østergaard1,2
  1. 1 Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark
  2. 2 Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
  3. 3 Center for Rheumatology and Spine Diseases, Frederiksberg and Bispebjerg Hospitals, Copenhagen, Denmark
  4. 4 Department of Radiology, Herlev and Gentofte Hospitals, Herlev, Denmark
  5. 5 Center for Rheumatology and Spine Diseases, Herlev and Gentofte Hospitals, Herlev, Denmark
  6. 6 Department of Radiology and Diagnostic Imaging, University of Alberta, Edmonton, Alberta, Canada
  7. 7 Department of Medicine, University of Alberta, Edmonton, Alberta, Canada
  1. Correspondence to Dr Simon Krabbe; simonkrabbe{at}gmail.com

Abstract

Background The Canada-Denmark (CANDEN) definitions of spinal MRI lesions allow a detailed anatomy-based evaluation of inflammatory and structural lesions in vertebral bodies and posterior elements of the spine in patients with axial spondyloarthritis (axSpA). The objective was to examine the reliability, responsiveness and discrimination of scores for spinal inflammation, fat, bone erosion and new bone formation based on the CANDEN system and to describe patterns of inflammatory and structural lesions and their temporal development.

Methods 49 patients with axSpA from an investigator-initiated, randomised, placebo-controlled trial of adalimumab underwent spinal MRI at weeks 0/6/24/48. MR images were scored according to the CANDEN system and the Spondyloarthritis Research Consortium of Canada (SPARCC) method. Total scores, and various subscores, were created by summing individual lesion scores.

Results The CANDEN spine inflammation score had high responsiveness, similar to the SPARCC MRI spine index (Guyatt’s responsiveness index 1.88 and 1.67, respectively), and discriminated between adalimumab and placebo treatment already at 6 weeks’ follow-up (P=0.03). Anterior/posterior corner inflammation subscores showed similar responsiveness. Inter-reader reliability for the CANDEN spine inflammation and fat scores was good to very good for status and change scores (intraclass correlation coefficient (ICC)=0.71–0.92). Reliability for CANDEN new bone formation and erosion scores was good to very good for status scores (ICC=0.61–0.75) but, due to minimal progression, poor for change scores (ICC≤0.40).

Conclusions The CANDEN spine inflammation score showed good responsiveness, discrimination between active treatment and placebo and reliability. The CANDEN spine structural scores had good cross-sectional reliability, but longer studies are needed to investigate their sensitivity to change.

Trial registration number NCT01029847; Results.

  • magnetic resonance imaging
  • spondylarthritis
  • outcomes research
  • inflammation

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/rmdopen-2017-000624

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    Footnotes

    • SJP and MØ contributed equally.

    • Contributors MØ, SJP and IJS designed the trial. JMM obtained MR images. IJS, BJ, ORM and SJP collected clinical data. SJP and SK were the primary MRI readers that read all spinal MR images according to the CANDEN and the SPARCC method. WPM read all spinal MR images according to the SPARCC method. SK performed data management and statistical analyses and drafted the manuscript. All authors critically revised the manuscript.

    • Funding The study was based on data from an investigator-initiated study supported by AbbVie. AbbVie had no role in the study design or in the collection, analysis or interpretation of the data, the writing of the manuscript or the decision to submit the manuscript for publication, and publication of this article was not contingent on approval by AbbVie. SK has received a PhD fellowship grant from The Danish Rheumatism Association (A3866).

    • Competing interests None declared.

    • Patient consent All patients gave written informed consent.

    • Ethics approval The study was approved by the Danish Health Authority and the Regional Ethics Committees in the Capital Region of Denmark, ethics approval number: H1-2013-118.

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

    • Data sharing statement Data may be shared after agreement with MØ.