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Study Validates Use of Vectra DA Test as an Objective Measure of RA Disease Activity

Published: Thursday, July 12, 2012
Last Updated: Wednesday, July 11, 2012
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Results published in Arthritis Care & Research support adoption of multi-biomarker blood test in combination with clinical assessment.

Crescendo Bioscience®, Inc. has announced the online publication of results validating the performance of Vectra™ DA to measure rheumatoid arthritis (RA) disease activity in Arthritis Care & Research, an official journal of the American College of Rheumatology (ACR).

Vectra DA is the only multi-biomarker blood test for RA disease activity that simultaneously integrates 12 key proteins consistently associated with RA disease activity into a single, objective and quantitative score to help physicians make more informed treatment decisions.

The study results demonstrate that Vectra DA has a statistically significant association with other validated clinical disease activity measures.

Moreover, changes in the Vectra DA algorithm score tracked over time significantly discriminated between clinical responders and non-responders to RA therapy such as TNF antagonists and methotrexate (MTX).

“Current RA treatment guidelines from the American College of Rheumatology recommend periodic quantitative disease assessment as an important component in any treatment plan for patients with RA,” said Jeffrey R. Curtis, MD, MS, MPH, lead author of the manuscript and director of the University of Alabama at Birmingham’s Arthritis Clinical Intervention Program.

Curtis continued, “This study shows that Vectra DA provides a valid and objective measure of disease activity. The results support the use of Vectra DA as a complement to existing clinical assessments to help clinicians assess disease activity over time and in response to RA treatments so as to impact care as well as potentially improve patient outcomes.”

Vectra DA was designed to be used in conjunction with existing clinical assessment measures, bringing the crucial understanding of individual disease biology into the mix of factors doctors traditionally consider before proposing or changing treatment plans.

The additional insight provided by Vectra DA has the potential to alert physicians to disease activity that is otherwise difficult to detect, given the limitations of clinical assessment methods developed over the last 30 years.

Study Results
The study found that Vectra DA’s multi-biomarker disease activity score had a statistically significant association (p<0.001) with DAS28-CRP, a composite algorithm score for the clinical assessment of RA disease activity that is commonly used in RA clinical trials.

The validity of the test was established in both seropositive patients (positive for either rheumatoid factor and/or anti-cyclic citrullinated peptide antibodies) and seronegative patients (negative for both).

Further, for patients initiating methotrexate or anti-TNF therapy, changes in the Vectra DA algorithm score were shown to be significantly associated with changes in clinically-assessed disease activity (p<0.001) and discriminated between clinical responders and non-responders to therapy. These findings confirm the validity of Vectra DA as an objective measure of RA disease activity to help inform patient management decisions.

“Based on the reported real-world experiences, and the study data reported to date, we believe Vectra DA represents a valuable new tool that has the potential to transform how rheumatologists manage RA patients,” said Oscar Segurado, MD, PhD, Chief Medical Officer at Crescendo Bioscience.

Segurado continued, “Importantly, it is the only quantitative metric available to these doctors that provides an objective value that can assess patients in different practice settings, or the same patients tracked over time, with an unprecedented level of precision and reproducibility. To date, Vectra DA has been ordered by over 400 US rheumatologists to inform the assessment of over 20,000 RA patients.”

Study Design
Serum samples from a total of 426 patients that were independent of prior research, both seropositive (230) and seronegative (196), were selected from three cohorts: the Index for Rheumatoid Arthritis Measurement [INFORM] (US), the Brigham and Women’s Hospital Rheumatoid Arthritis Sequential Study Registry [BRASS] (US), and the Leiden Early Arthritis Clinic cohort (Netherlands).

The study was designed to validate and evaluate the performance of Vectra DA compared to other clinical disease activity measures in both seropositive and seronegative patient groups.

The cross-sectional and longitudinal relationships between the Vectra DA score and clinical disease activity assessments were characterized separately in both seropositive and seronegative patient groups.

The changes associated with the Vectra DA algorithm score and clinical responses 6-12 weeks after initiation of anti-TNF or MTX treatment were evaluated in a separate cohort of 45 patients enrolled in BRASS.

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