SOUTH SAN FRANCISCO, Calif., Oct. 28, 2013 (GLOBE NEWSWIRE) -- Crescendo Bioscience, a molecular diagnostics company dedicated to developing and commercializing quantitative blood tests for rheumatoid arthritis (RA) and other autoimmune diseases, announced today that Vectra DA data will be presented in three oral and five poster presentations at the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) annual meeting in San Diego, CA, October 25-30, the largest gathering of rheumatologists in the United States. Data presented will demonstrate that the Vectra DA test is able to measure disease activity, independent of fibromyalgia influence, in patients with RA who are on a variety of therapies and can help rheumatologists identify patients who are at greatest risk for developing progressive joint damage.
"For Crescendo, the record number of oral presentations at ACR/ARHP is a testament to the strength and breadth of the data that show how Vectra DA can assist rheumatologists in managing their patients with RA more effectively," said William A. Hagstrom, President and CEO of Crescendo Bioscience. "This has been a pivotal year for Crescendo, with Vectra DA now covered nationally by Medicare and available in all 50 states. Since commercial launch in late 2010, more than 100,000 Vectra DA tests have been completed, helping both physicians and patients gain deeper insight into the biology of this challenging autoimmune disease."
Vectra DA is a validated blood test that objectively assesses the level of inflammatory disease activity in patients with RA using a score of 1-100 to provide rheumatologists with actionable information to address clinical uncertainty over the course of the disease. Results from the Brigham and Women's Hospital and Harvard Medical Center study (BRASS) demonstrated that Vectra DA is able to detect RA disease activity independent of fibromyalgia, a painful, non-inflammatory condition that is estimated to co-exist with RA in about 20 percent of patients. The study also demonstrated that Vectra DA measured elevated levels of disease activity in patients with low levels of C-reactive protein (CRP), the most common test that rheumatologists use to assess RA disease activity. This information can be valuable in the management of the disease since studies have shown that up to 50 percent of patients with RA can have a low CRP level despite having elevated disease activity.
Two separate oral presentations will highlight the ability of the Vectra DA score to help identify which RA patients are likely or are not likely to have worsening joint damage over time. These studies identified patients with clinically relevant radiographic progression, despite treatment with conventional therapies or a TNF inhibitor. High rates of joint damage were observed when the Vectra DA score was high but not when it was low, even in patients with a low CRP.
"These results demonstrate the limitations of the CRP test and the need for Vectra DA, which reflects both disease activity and the likelihood of progressive joint damage," said Oscar Segurado, M.D. Ph.D., Chief Medical Officer, Crescendo Bioscience. "All of the data presented at ACR this week continue to build evidence of the test's clinical utility in helping rheumatologists better understand the underlying biology of their patient's RA and thus, make more informed disease management decisions."
Oral Presentations
Tuesday, October 29, 3:15 PM PT
Abstract #2683
In the oral presentation Application of a Multi-Biomarker Disease Activity (Vectra DA) Score for Assessing Rheumatoid Arthritis Patients with Fibromyalgia or Low C-Reactive Protein, Crescendo Bioscience and researchers from the Brigham and Women's Hospital and Harvard Medical School will show that in patients with RA, traditional methods of disease assessment, including tender joint count, DAS28-CRP, and Patient Global Assessment were markedly increased by the presence of fibromyalgia, a painful, non-inflammatory syndrome that can confound the assessment of patients with RA. In contrast, the Vectra DA test measured essentially the same level of disease activity in patients with RA independent of the presence of fibromyalgia or low CRP. This result highlights the objective nature of the Vectra DA test and its potential value for assessing patients with RA and fibromyalgia, especially when CRP is low.
Monday, October 28, 5:00 PM PT
Abstract #1788
In another oral presentation, The Multi-Biomarker Disease Activity Test (Vectra DA) Estimates Risk of Radiographic Progression for Patients with Rheumatoid Arthritis from the Leiden Early Arthritis Clinic, Crescendo Bioscience and researchers from the Leiden University Medical Center, Leiden, Netherlands, found a correlation between the Vectra DA algorithm score and risk of radiographic progression over a 12-month period, independent of CRP levels in DMARD-treated patients. Researchers concluded that the Vectra DA algorithm score may be helpful to rheumatologists for identifying patients at high risk for radiographic progression and potentially preventing future progression.
Monday, October 28, 5:15 PM PT
Abstract #1789
In this oral presentation, In Early Rheumatoid Arthritis, the 12 Individual Biomarkers that Comprise the Multiple Biomarker Disease Activity Score Relate Differentially to Clinical Response and Radiographic Progression: Results from a Randomized Trial, Crescendo Bioscience and researchers from the Karolinska Institutet, Stockholm, Sweden, will present data from the SWEFOT study, the Swedish Pharmacotherapy Trial. The study evaluated patients with early RA who were started on methotrexate therapy and re-assessed at three months. The objective of this study was to assess the ability of the Vectra DA score and its 12 biomarkers, measured at baseline, to predict clinical response at three months and radiographic progression at one year. Researchers found that the Vectra DA score significantly improved after three months in the patients who had responded to methotrexate treatment. In addition, Vectra DA at baseline was independently associated with radiographic progression and was significantly higher for patients who progressed.
Poster Highlights
In a poster session, Repeated High or Low Multi-Biomarker Disease Activity (Vectra® DA Algorithm) Scores Associated with Radiographic Outcomes in Patients with Rheumatoid Arthritis Treated with Tumor Necrosis Factor Inhibitors (Abstract #1453), Crescendo Bioscience and researchers from the University of Occupational and Environmental Health in Kitakyushu, Japan, will present a study of patients who started treatment with TNF inhibitors adalimumab, etanercept or infliximab. The investigators found that patients had little or no radiographic progression if they had a low Vectra DA score (29 or less) in at least two of three study visits over one year. In contrast, patients with high Vectra DA scores (greater than 44) for at least two of three visits had a high risk of clinically relevant radiographic progression. Additionally, researchers found that change in the Vectra DA score over the first six months of treatment correlated with radiographic outcomes in the first year. This study evaluated multiple Vectra DA measurements over time to assess risk of radiographic progression in patients treated with TNF inhibitors.
In another study, A Multi-Biomarker Disease Activity Score for Rheumatoid Arthritis Predicts Radiographic Damage in the BeSt Study (Abstract #1347), Crescendo Bioscience and researchers from the Leiden University Medical Center, Leiden, Netherlands, evaluated the ability of the Vectra DA algorithm score to predict radiographic progression in patients with RA. They found that the Vectra DA score measured at baseline predicted the degree of radiographic progression observed over the following year. In addition, the score at one year was able to predict radiographic progression at year two. Researchers considered that the Vectra DA algorithm score may have value for managing patients with RA.
Another poster, A Multi-Biomarker Disease Activity Blood Test Correlates with Radiographic Progression in Early Rheumatoid Arthritis: Results from a Randomized Trial (Abstract #1312) Crescendo Bioscience and researchers from the Karolinska Institutet, Stockholm, Sweden, focused on the use of Vectra DA in assessing risk of radiographic progression in early RA. In patients with early RA who started treatment with methotrexate, the study found that the Vectra DA score measured at baseline was significantly correlated with the amount of radiographic progression in the first year. A high Vectra DA score at baseline was associated with a higher risk of radiographic progression, even in patients who had moderate disease activity assessed by DAS28 or low CRP at baseline. In addition, 98 percent of patients who had rapid radiographic progression at one year had a high Vectra DA score at baseline, independent of CRP level.
Other Vectra DA Posters Presented at 2013 ACR/ARHP Annual Meeting includes Abstract #1436 and Abstract #2377.
About Rheumatoid Arthritis (RA)
RA is a debilitating, chronic disease affecting approximately 1.5 million Americans and more than two million people in Europe. The primary symptoms of RA are painful, swollen joints and fatigue. The disease often results in permanent joint damage and disability. RA is also a highly variable, systemic disease. RA can detrimentally affect other parts of the body, potentially resulting in infection, osteoporosis, or cardiovascular disease, and it causes an increased rate of mortality.
Clinicians assess RA based on three factors: clinical disease activity (clinical signs and symptoms), structural damage in joints, such as erosions, and functional status. Many of the current clinical assessment tools used by physicians are qualitative and subjective and they may not adequately identify key properties of the disease.
Early and accurate detection of RA, accompanied by effective therapy, with frequent monitoring of disease activity, is critical for optimizing clinical outcomes. The American College of Rheumatology has developed guidelines supporting the goals of "Treat to Target" and "Tight Control" to help clinicians achieve clinical and structural remission in their patients, and improve their long-term functional status.
About Vectra® DA
Vectra DA is the only multi-biomarker blood test for rheumatoid arthritis (RA) disease activity that integrates the concentrations of 12 serum proteins associated with RA disease activity into a single objective score of 1 to 100 to help physicians make more informed treatment decisions. Now available in all 50 states and covered nationally by Medicare, Vectra DA testing is performed at the Crescendo Bioscience state-of-the-art CLIA (Clinical Laboratory Improvement Amendments) facility in South San Francisco, CA. Test results are reported to the physician 5 to 7 calendar days following receipt of the blood sample. Physicians can receive test results via standard mail, by fax or via the private web portal, VectraView. For more information on Vectra DA, please visit, www.Vectra-DA.com.
About Crescendo Bioscience, Inc.
Crescendo Bioscience, Inc., is a molecular diagnostics company dedicated to developing and commercializing quantitative blood tests for rheumatoid arthritis (RA) and other autoimmune diseases, located in South San Francisco, CA. Crescendo Bioscience develops quantitative, objective, blood tests to provide rheumatologists with deeper clinical insight to help enable more effective management of patients with autoimmune and inflammatory diseases. For more information, please visit the company's website at http://www.CrescendoBio.com.