Prediction of a major clinical response (BASDAI 50) to TNF-alpha blockers in ankylosing spondylitis

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Ann Rheum Dis. 2004 Jun;63(6):665-70. Epub 2004 Mar 22.

Prediction of a major clinical response (BASDAI 50) to tumour necrosis

factor alpha blockers in ankylosing spondylitis.

Rudwaleit M, Listing J, Brandt J, Braun J, Sieper J.

Rheumatology, Department of Medicine, Charite-Universitatsmedizin

Berlin, Campus lin, Berlin, Germany.

martin.rudwaleit@...

BACKGROUND: TNFalpha 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 >or=4) and a spinal

pain score (numerical rating scale 0-10) >or=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 chi(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.

PMID: 15037444

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