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

AbstractBACKGROUND:
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.
AuthorsM Rudwaleit, J Listing, J Brandt, J Braun, J Sieper
JournalAnnals of the rheumatic diseases (Ann Rheum Dis) Vol. 63 Issue 6 Pg. 665-70 (Jun 2004) ISSN: 0003-4967 [Print] England
PMID15037444 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antibodies, Monoclonal
  • Antirheumatic Agents
  • HLA-B27 Antigen
  • Immunoglobulin G
  • Receptors, Tumor Necrosis Factor
  • Tumor Necrosis Factor-alpha
  • C-Reactive Protein
  • Infliximab
  • Etanercept
Topics
  • Adult
  • Age Factors
  • Antibodies, Monoclonal (therapeutic use)
  • Antirheumatic Agents (therapeutic use)
  • C-Reactive Protein (analysis)
  • Etanercept
  • Female
  • HLA-B27 Antigen (analysis)
  • Humans
  • Immunoglobulin G (therapeutic use)
  • Infliximab
  • Male
  • Receptors, Tumor Necrosis Factor (therapeutic use)
  • Severity of Illness Index
  • Spondylitis, Ankylosing (drug therapy, physiopathology)
  • Time Factors
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha (antagonists & inhibitors)

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