The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection
- M Rudwaleit1,
- D van der Heijde2,
- R Landewé3,
- J Listing4,
- N Akkoc5,
- J Brandt6,
- J Braun7,
- C T Chou8,
- E Collantes-Estevez9,
- M Dougados10,
- F Huang11,
- J Gu12,
- M A Khan13,
- Y Kirazli14,
- W P Maksymowych15,
- H Mielants16,
- I J Sørensen17,
- S Ozgocmen18,
- E Roussou19,
- R Valle-Oñate20,
- U Weber21,
- J Wei22,
- J Sieper1,23
- 1Rheumatology, Med Klinik I, Charité, Campus Benjamin Franklin, Berlin, Germany
- 2Leiden University Medical Center, Leiden, The Netherlands
- 3Maastricht University Medical Center, Maastricht, The Netherlands
- 4Epidemiology Unit, German Rheumatology Research Centre, Berlin, Germany
- 5Dokuz Eylul University Hospital, Izmir, Turkey
- 6Rheumatology Private Practice, Berlin, Germany
- 7Rheumazentrum Ruhrgebiet, Herne and Ruhr University, Bochum, Germany
- 8Veterans General Hospital, Taipei, Taiwan
- 9University of Córdoba, Córdoba, Spain
- 10Hospital Cochin, Paris, France
- 11Chinese PLA General Hospital, Beijing, China
- 12Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
- 13Case Western Reserve University, MetroHealth Medical Center, Cleveland, Ohio, USA
- 1412 University of Ege, Izmir, Turkey
- 15University of Alberta, Edmonton, Canada
- 16University Hospital, Ghent, Belgium
- 17University Hospital, Copenhagen, Denmark
- 18Firat University Hospital, Elazig,Turkey
- 19King George Hospital, London, UK
- 20University Militar Hospital, Bogotá, Colombia
- 21Balgrist University Hospital, Zurich, Switzerland
- 22Chung Shan Medical University, Taichung, Taiwan
- 23German Rheumatology Research Center, Berlin, Germany
- Dr M Rudwaleit, Charité, Universitätsmedizin Berlin, Campus Benjamin Franklin, Rheumatologie, Med Klinik I, Hindenburgdamm 30, 12203 Berlin, Germany;
- Accepted 6 March 2009
- Published Online First 17 March 2009
Objective: To validate and refine two sets of candidate criteria for the classification/diagnosis of axial spondyloarthritis (SpA).
Methods: All Assessment of SpondyloArthritis international Society (ASAS) members were invited to include consecutively new patients with chronic (⩾3 months) back pain of unknown origin that began before 45 years of age. The candidate criteria were first tested in the entire cohort of 649 patients from 25 centres, and then refined in a random selection of 40% of cases and thereafter validated in the remaining 60%.
Results: Upon diagnostic work-up, axial SpA was diagnosed in 60.2% of the cohort. Of these, 70% did not fulfil modified New York criteria and, therefore, were classified as having “non-radiographic” axial SpA. Refinement of the candidate criteria resulted in new ASAS classification criteria that are defined as: the presence of sacroiliitis by radiography or by magnetic resonance imaging (MRI) plus at least one SpA feature (“imaging arm”) or the presence of HLA-B27 plus at least two SpA features (“clinical arm”). The sensitivity and specificity of the entire set of the new criteria were 82.9% and 84.4%, and for the imaging arm alone 66.2% and 97.3%, respectively. The specificity of the new criteria was much better than that of the European Spondylarthropathy Study Group criteria modified for MRI (sensitivity 85.1%, specificity 65.1%) and slightly better than that of the modified Amor criteria (sensitivity 82.9, specificity 77.5%).
Conclusion: The new ASAS classification criteria for axial SpA can reliably classify patients for clinical studies and may help rheumatologists in clinical practice in diagnosing axial SpA in those with chronic back pain.
Trial registration number: NCT00328068.
Competing interests: None.
Funding: This study was supported financially by the Assessment of SpondyloArthritis international Society (ASAS).
The following ASAS centres have included at least one patient: N Akkoc, Izmir, Turkey; J Brandt, Berlin, Germany; F Heldmann, J Braun, Herne, Germany; E Collantes-Estevez, Cordóba, Spain; C-T Chou, Taipei, Taiwan; J Darmawan, Semarang, Indonesia; C Hudry, M Dougados, Paris, France; T Duruöz, Manisa, Turkey; O Fitzgerald, Dublin, Ireland; J Gu, Guangzhou, China; F Huang, Beijing, China; Y Kirazli, Izmir, Turkey; R Landewé, D van der Heijde, Maastricht, The Netherlands; A Linnssen, Ijmuiden, The Netherlands; W Maksymowych, Edmonton, Canada; M Matucci-Cerinic, Firenze, Italy; F van den Bosch, H Mielants, Ghent, Belgium; M Ostergaard, Hvidovre, Denmark; S Ozgocmen, Elazig, Turkey; M Rudwaleit, J Sieper, Berlin, Germany; E Roussou, London, UK; C Naclerio, S Scarpato, Scafati, Italy; IJ Sørensen, Copenhagen, Denmark; R Valle-Oñate, Bogotá, Colombia; U Weber, Balgrist, Switzerland; J Wei, Taichung, Taiwan.
Ethics approval: Ethics approval for the conduct of the study was obtained from the local ethics committee in each centre.
Patient consent: Obtained.