EXTENDED REPORT

Prediction of a major clinical response (BASDAI 50) to tumour necrosis factor blockers in ankylosing spondylitis

M Rudwaleit¹, J Listing², J Brandt¹, J Braun³, J Sieper¹

¹ Rheumatology, Department of Medicine, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany
² Epidemiology, Deutsches RheumaForschungszentrum, Berlin, Germany
³ Rheumazentrum Ruhrgebiet, Herne, Germany

Correspondence to:
Dr M Rudwaleit
Medizinische Klinik I, Charité–Universitäts-medizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, Germany; martin.rudwaleit{at}charite.de

Background: TNF blockers have been shown to be highly efficacious in patients with active ankylosing spondylitis (AS).

Objective: To identify parameters predicting the clinical response to TNF blockers in AS.

Methods: Patients with active AS participated in two placebo controlled, randomised trials conducted in Germany with infliximab (n = 69) and etanercept (n = 30), respectively. For inclusion in either trial patients had to have high disease activity (BASDAI 4) and a spinal pain score (numerical rating scale 0–10) 4 despite treatment with NSAIDs. A major clinical response was defined as a 50% improvement of the initial BASDAI (BASDAI 50) after 12 weeks’ treatment with active drug. Logistic regression likelihood ratio tests (univariate and multivariate), Student’s t test, and ² tests were performed.

Results: Univariate analysis showed the following to be predictors of a major response (BASDAI 50) to treatment: shorter disease duration (p = 0.003); lower BASFI (p = 0.007); younger age (p = 0.009); raised ESR (p = 0.033); raised CRP (p = 0.035). After adjustment for disease duration, BASFI, ESR, and CRP, but not age, remained significantly associated. After adjustment for disease duration and for BASFI, ESR, CRP, and in addition, a higher BASDAI were significantly associated with response. The best multivariate model built by stepwise regression contained the covariables disease duration, BASFI, BASDAI, and CRP.

Conclusion: A shorter disease duration, younger age, and a lower BASFI are predictors of a major clinical response to TNF blockers in active AS. Raised CRP and a higher BASDAI may also be valuable predictors. These data need to be confirmed in further studies.

Keywords: tumour necrosis factor blockers; ankylosing spondylitis; spondyloarthropathies; response; anti-tumour necrosis factor

Abbreviations: AS, ankylosing spondylitis; ASAS, Ankylosing Spondylitis Assessment Group; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; BASRI, Bath Ankylosing Spondylitis Radiology Index; CRP, C reactive protein; DMARD, disease modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; LRT, likelihood ratio test; MRI, magnetic resonance imaging; NSAID, non-steroidal anti-inflammatory drug; TNF, tumour necrosis factor

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