Ankylosing Spondylitis Assessment Study (ASAS) group response criteria in AS patients treated with biologics

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Arthritis Rheum. 2004 Jun 15;51(3):316-20.

Validation exercise of the Ankylosing Spondylitis Assessment Study

(ASAS) group response criteria in ankylosing spondylitis patients

treated with biologics.

Stone MA, Inman RD, JG, Maetzel A.

University of Toronto, Toronto Western Hospital, Ontario, Canada.

stonem@...

OBJECTIVES: To define what expert clinicians consider a dramatic

response in ankylosing spondylitis (AS) patients treated with biologic

therapies based on patient and physician assessments of global disease

activity. To compare this expert clinician-derived criteria to the

Ankylosing Spondylitis Assessment Study (ASAS) Group criteria for

improvement. METHODS: Forty consecutive AS patients were treated in a

1-year open-label protocol with infliximab. Response to treatment at

week 52 was defined using ASAS response criteria. For the purpose of

this exercise, improvement using ASAS criteria was defined by consensus

among experts as good with 50% improvement from baseline (ASAS(50)) and

dramatic with 70% improvement from baseline (ASAS(70)). Experts

established separate criteria for improvement in disease activity as

good or dramatic based on patient and physician global assessment of

disease activity. RESULTS: Twelve of 40 patients met the ASAS(70)

criteria, however, only 8 met the expert definition of a dramatic

improvement based on physician global scores and 5 met the expert

definition of a dramatic improvement based on patient global assessment

of disease activity. Agreement was poor between ASAS(50) or ASAS(70) and

expert definition of improvement based on physician global scores (kappa

< 0.3), but agreement was moderate to good between ASAS(50) or ASAS(70)

and expert definition of improvement based on patient global scores,

(kappa = 0.6-0.7).

CONCLUSIONS: Differential response experienced by AS patients treated

with infliximab was adequately captured by the ASAS composite

improvement criteria. Overall, this study demonstrates the validity of

the ASAS criteria for the detection of improvement in AS patients

treated with biologics. However, the patient global assessment of

disease activity may be sufficient to monitor changes in disease

activity in these patients.

PMID: 15188313

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