January 4, 2012
Results from a biomarker study using clinical specimens collected from the ITN RAVE study (comparing Rituximab with cyclophosphamide in ANCA-associated Vasculitis (AAV); results here) were recently published in Arthritis and Rheumatism. AAV is a chronic disease that can be controlled with immunosuppression, but long-term management is challenging, flares are common and unpredictable, and generic inflammatory markers (proteinase 3 ANCA titers, erythrocyte sedimentation rate, C reactive protein, etc.) are unreliable predictors of disease outcomes. In the article, titled “Circulating markers of vascular injury and angiogenesis in Antineutrophil Cytoplasmic Antibody-associated Vasculitis,” Monach et al. used RAVE clinical specimens to look for better biomarkers of active disease vs. remission for AAV.
Specifically, the investigators measured molecular markers of angiogenesis and vascular injury as potential disease indicators. These included: thrombomodulin, P-selectin, vascular endothelial growth factor (VEGF) and multiple matrix metalloproteinases (MMPs). They compared the serum levels of the selected markers at screening (all patients with active disease, n=146) with corresponding serum levels at 6 months (remission: n=123; active disease: n=23). They also compared serum levels between the remission and active disease cohorts to determine which markers could distinguish the groups.
Most of the selected markers showed significantly higher serum levels at screening compared to remission, however only one of the markers, MMP-3, was able to distinguish active disease from remission. This should be further explored as a potential laboratory test to assist in AAV evaluation and management.
The ITN is committed to maximizing the impact of clinical samples collected from its trials to advance science and medicine. RAVE samples were collected from a large cohort of patients at defined time points with associated clinical data for tolerance studies, which makes them also extremely valuable for biomarker research. Available samples from long-term follow-up of RAVE patients may provide the opportunity to further investigate the clinical utility of promising biomarkers to help physicians guide treatment for this challenging and unpredictable disease.
Those interested in searching currently available ITN samples for use in biomarker research can visit the ITN’s sample sharing site, TrialShare.
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