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Achieving good arthritis predictions
SALT LAKE CITY—Crescendo Bioscience, a wholly owned subsidiary of Myriad Genetics Inc., has presented new data that show Vectra DA is a better predictor of radiographic progression over two years than other tests used to assess the risk of joint damage in rheumatoid arthritis (RA), such as C-reactive protein (CRP). The oral presentation was featured at the 2014 American College of Rheumatology (ACR) Annual Meeting in Boston. Myriad acquired Crescendo in Feb. 2015 as part of its three-part growth strategy focused on oncology, a diversified product portfolio and expansion internationally, notes Ron Rogers, Myriad’s executive vice president of corporate communications.
The study included 143 patients with RA who had received a stable treatment and were enrolled in the Brigham and Women’s Rheumatoid Arthritis Sequential Study (BRASS) registry in the United States. Patients were evaluated at their initial visit in the BRASS registry for the Vectra DA score and conventional measures of disease activity, including CRP, DAS28-CRP, CDAI, SDAI and RAPID3, and provided X-rays of hands and wrists at approximately the initial visit and two years later. These data were used to assess the relationship between disease activity and the amount of subsequent new joint damage seen on X-rays (radiographic progression).
The results showed that Vectra DA was the best independent predictor of disease progression over two years when compared with standard measures based on the exam or patient-reported outcome. The odds ratio for predicting progression was highest for Vectra DA and lowest for RAPID3. Importantly, among patients with a low CRP at baseline, defined as <1 mg/dL, radiographic progression was observed in 34.8 percent of patients with a high Vectra DA score versus 8.1 percent of patients with a low/moderate Vectra DA score (p=0.003), providing further evidence that Vectra DA provides information for predicting joint damage that is not provided by CRP.
“In this study of U.S. patients, Vectra DA was a strong predictor of joint damage over two years, compared with other tests,” said Dr. Eric Sasso, vice president of medical and scientific affairs at Crescendo Bioscience. “These data build on prior studies demonstrating that Vectra DA can assess risk for joint damage and complement other measures of disease activity.” Sasso notes that a low score (less than 30) would indicate low, infrequent damage, where a moderate score of between 30 and 44 on the continuum and 44 or higher indicated a heightened risk profile.
Another study featured at ACR provided an analysis of radiographic progression in patients with early RA from the Swedish Farmacotherapy (SWEFOT) clinical trial. The Vectra DA test was used to evaluate 220 patients for progression from baseline to year one and from baseline to year two. In addition, progression from year one to year two was evaluated for 133 patients who had inadequate initial responses to methotrexate and were treated from month three with the addition of a TNF inhibitor or with triple therapy using methotrexate, sulfasalazine and hydroxychloroquine.
Among patients with a high Vectra DA score at baseline, 25 percent of those with a high Vectra DA score at month three showed rapid radiographic progression during the first year, and 35 percent of those with a high Vectra DA score at one year showed rapid radiographic progression between year one to year two. By contrast, for patients whose high baseline Vectra DA score declined to low after three months or one year of treatment, only 6 percent and 4 percent showed rapid radiographic progression between year one to year two. Moreover, for patients who had a moderate Vectra DA score at baseline and achieved a low Vectra DA score at three months, none showed rapid radiographic progression during the first year.
“In this study, a high Vectra DA score was associated with markedly increased risk for joint damage, and a low Vectra DA score was associated with low risk for subsequent joint damage,” said Sasso. “These findings suggest how Vectra DA may be used to objectively assess disease activity following initiation of therapy to help manage the patient’s disease.”
Vectra DA is reportedly the only multibiomarker blood test for RA disease activity that integrates the concentrations of 12 serum proteins associated with RA disease activity into a single objective score, on a scale of one to 100, to help physicians make more informed treatment decisions. Vectra DA testing is performed at the Crescendo Bioscience CLIA-certified facility, and test results are reported to the physician five to seven days from shipping of the specimen to Crescendo. Physicians can receive test results via standard mail, by fax or via the private web portal, VectraView.
Crescendo Bioscience, located in South San Francisco, Calif., is a molecular diagnostics company dedicated to developing and commercializing quantitative blood tests for RA and other autoimmune diseases. Crescendo Bioscience develops quantitative, objective, reproducible blood tests to provide rheumatologists with deeper clinical insight to help enable more effective management of patients with autoimmune and inflammatory diseases.
In other news, parent company Myriad Genetics recently announced that it has received approval from the U.S. Food and Drug Administration (FDA) for BRACAnalysis CDx to be used as the only companion diagnostic in conjunction with AstraZeneca’s drug Lynparza (olaparib). Lynparza is the first poly ADP-ribose polymerase (PARP) inhibitor for patients with germline mutations in BRCA1/2 advanced ovarian cancer who have had three or more lines of chemotherapy. BRACAnalysis CDx is Myriad’s first FDA-approved companion diagnostic for use with a novel PARP inhibitor.