Session Title: Vasculitis
Session Type: Abstract Submissions (ACR)
Background/Purpose: Assessment of disease activity in large vessel vasculitis (LVV) is challenging. The lack of specific, validated outcome measurements for both Takayasu’s (TAK) and giant cell arteritis (GCA) affects clinical care and research in these diseases.
Methods: The Delphi survey was sent out to >300 experts by e-mail. Experts were chosen from different specialties based on their interest in LVV and previous involvement in vasculitis clinical research. Experts from countries with high prevalence of either TAK or GCA were especially recruited. The first round included 99 items on a 5-point scale aiming to cover all potential disease manifestations. Items accepted or rejected by >70% of the voters are not advanced to subsequent rounds.
Results: 116 experts completed the survey and included physicians from 23 countries in Asia, Australia, Europe and North and South America. Most of the vascular/cardiovascular items (e.g. bruits, new loss of pulse, claudication) were accepted by >70% of experts for TAK; ocular findings (e.g. visual loss, blurred vision, retinal vasculitis) were considered high-priority outcomes for GCA. Vascular imaging (CT, MRI, PET, or ultrasound) was accepted for both TAK and GCA. SF36 and patient global assessment were widely accepted as tools for patient-reported outcomes in both diseases. Disease Extent Index-Tak (DEI.Tak) was the only composite index accepted by the majority for TAK. Only ESR and CRP were suggested as biomarkers in TAK, whereas hemoglobin level was also supported in GCA. Findings rejected by >70 % of the experts were erythema nodosum for TAK and pulmonary assessments for GCA. Many items were endorsed by a majority of experts but did not reach the 70% threshold for final acceptance; it is expected that additional items will reach the 70% threshold in subsequent Delphi rounds. Several new items were proposed by participants (e.g. IL-6 levels and novel patient reported outcome measures) that will be considered in subsequent rounds.
The majority of experts (63%) voted for aiming to have a common tool for both TAK and GCA but also develop additional tools specific for each disease. 25% felt the two diseases were unsuitable for common outcome measures.
Conclusion: This exercise points out the similarities and differences from experts’ perspective for assessing clinical activity in TAK and GCA. The completion of the Delphi will produce a consensus-driven set of outcomes to study prospectively with the long-term goal of developing a core set of validated outcomes for LVV. Based on these data it is anticipated that such a set of outcomes will include many data elements common to both diseases, supplemented by disease-specific items for TAK and GCA. Continued international collaborative work will be required to advance this research for these diseases.
S. Z. Aydin,
E. L. Matteson,
P. A. Merkel,
Actelion Pharmaceuticals US,
Genentech and Biogen IDEC Inc.,
Human Genome Sciences, Inc.,
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/assessment-of-disease-activity-in-large-vessel-vasculitis-initial-results-of-an-international-delphi-exercise/