ASAS update: Preliminary draft definitions of flare for axial spondyloarthritis identified
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An Assessment of SpondyloArthritis international Society working group has made progress in creating a definition of flare in axial spondyloarthritis, but more work is needed before consensus is reached, according to an update presented at the European League Against Rheumatism Annual European Congress of Rheumatology.
The working group performed a systematic literature review to identify definitions of flare that were used in randomized, controlled trials of patients with axial spondyloarthritis (SpA) who received either NSAIDs or tumor-necrosis factor-alpha inhibitors. A single scenario model of a typical encounter with a patient with SpA was used to create 223 scenarios based on the change of either pain, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) with and without C-reactive protein (CRP), or the Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP between the first and second visit.
Laure Gossec
ASAS consultants voted on a random sample of 46 scenarios based on whether flare was perceived to be present from the perspective of the physician. Optimal cutoff values were derived using receiving operator characteristic curves. The change noted in each variable was analyzed and matched to the value of the variable seen during the flare when necessary. The results, combined with real patient data if available, were presented to the ASAS consultants during a workshop in January, and a consensus was reached on a preliminary set of definitions.
The preliminary cutoff for pain is two on a scale of zero to 10, four for BASDAI and six for ASDAS-CRP.
“Further steps will allow the assessment of these preliminary definitions on real patient data in order to select the most relevant definition(s),” the researchers wrote in their study abstract. “This work is important in the context of clinical trial design e.g., in tapering trials, to better define flares in future clinical studies.” - by Shirley Pulawski
Reference:
Gossec L, et al. Paper #AB1135. Presented at: European League Against Rheumatism Annual European Congress of Rheumatology. June 10-13, 2015; Rome.
Disclosure: The researchers report no relevant financial disclosures.