CLINICAL AND EPIDEMIOLOGICAL RESEARCH

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 Sieper^1,23

¹ Rheumatology, Med Klinik I, Charité, Campus Benjamin Franklin, Berlin, Germany
² Leiden University Medical Center, Leiden, The Netherlands
³ Maastricht University Medical Center, Maastricht, The Netherlands
⁴ Epidemiology Unit, German Rheumatology Research Centre, Berlin, Germany
⁵ Dokuz Eylul University Hospital, Izmir, Turkey
⁶ Rheumatology Private Practice, Berlin, Germany
⁷ Rheumazentrum Ruhrgebiet, Herne and Ruhr University, Bochum, Germany
⁸ Veterans General Hospital, Taipei, Taiwan
⁹ University of Córdoba, Córdoba, Spain
¹⁰ Hospital Cochin, Paris, France
¹¹ Chinese PLA General Hospital, Beijing, China
¹² Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
¹³ Case Western Reserve University, MetroHealth Medical Center, Cleveland, Ohio, USA
¹⁴ 12 University of Ege, Izmir, Turkey
¹⁵ University of Alberta, Edmonton, Canada
¹⁶ University Hospital, Ghent, Belgium
¹⁷ University Hospital, Copenhagen, Denmark
¹⁸ Firat University Hospital, Elazig,Turkey
¹⁹ King George Hospital, London, UK
²⁰ University Militar Hospital, Bogotá, Colombia
²¹ Balgrist University Hospital, Zurich, Switzerland
²² Chung Shan Medical University, Taichung, Taiwan
²³ German Rheumatology Research Center, Berlin, Germany

Dr M Rudwaleit, Charité, Universitätsmedizin Berlin, Campus Benjamin Franklin, Rheumatologie, Med Klinik I, Hindenburgdamm 30, 12203 Berlin, Germany; martin.rudwaleit{at}charite.de

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.

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