Crescendo Bioscience to Present New Data on Vectra(R) DA Use to Assess Radiographic Progression Risk in Patients With Rheumatoid Arthritis Treated With Traditional and Biologic Therapies at the European League Against Rheumatism Annual Meeting (EULAR)

Vectra DA Used to Identify High Level of Disease Activity in RA Patients With Low CRP Independent of the Presence of Fibromyalgia

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| Source: Crescendo Bioscience

SOUTH SAN FRANCISCO, Calif., June 12, 2013 (GLOBE NEWSWIRE) -- Crescendo Bioscience, a molecular diagnostics company dedicated to developing and commercializing quantitative blood tests for rheumatoid arthritis (RA) and other auto-immune diseases, announced today that it will present data from ten different studies that further support the important role Vectra® DA can play in managing Rheumatoid Arthritis (RA) at the European League Against Rheumatism (EULAR) Annual Meeting held in Madrid, Spain, on June 12-15. EULAR is the largest gathering of rheumatology healthcare professionals in Europe. Vectra DA is an objective, validated blood test that provides rheumatologists with a score of 1-100, giving biological insight into the level of disease activity of rheumatoid arthritis. Data presented at EULAR will demonstrate Vectra DA's ability to assess risk of radiographic progression (joint damage over time) in patients with RA currently treated with traditional and biologic agents, including TNF inhibitors. In addition, data will show how Vectra DA can detect a high level of RA disease activity in patients with a low C-reactive protein (CRP) without being affected by fibromyalgia, a painful non-inflammatory condition that can co-exist with RA.

This week, researchers will present data from a study conducted by the University of Occupational and Environmental Health in Kitakyushu, Japan,  A Multi-biomarker Disease Activity (Vectra DA Algorithm) Score is Associated with Radiographic Outcomes in RA Patients Treated with TNF inhibitors (#SAT0012). This study found that patients who were being treated with adalimumab, etanercept or infliximab and had a low Vectra DA score (29 or less) in at least two of three visits over one year showed little or no radiographic progression.  In contrast, patients with high scores (greater than 44) for at least two of three visits had a much higher risk of clinically relevant radiographic progression. In addition, 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 is the first time risk of radiographic progression in patients treated with TNF inhibitors was assessed using Vectra DA over time.

"We know that anti-TNF drugs have been shown to help minimize the overall amount of radiographic progression," said Yoshiya Tanaka, MD, PhD, Professor and Chairman, University of Occupational and Environmental Health, Kitakyushu, Japan. "This study underscores the clinical utility of Vectra DA to objectively assess which patients remain at risk of radiographic progression despite anti-TNF therapy. This information could be important in helping rheumatologists confirm or potentially revise their treatment plan."

"This study demonstrates the additional value Vectra DA can bring to the overall RA patient management experience," said Oscar Segurado, MD, PhD, Chief Medical Officer at Crescendo Bioscience. "With a number of RA drugs available today, and more than 50 agents in development, a quantifiable disease activity measurement test like Vectra DA can be a true asset for physicians."

Researchers will also present new data regarding use of Vectra DA in patients with both RA and fibromyalgia. In Application of a Multi-Biomarker Disease Activity (Vectra DA) Score for Assessing Rheumatoid Arthritis Patients with Low CRP or Fibromyalgia (#SAT0099), researchers from the Brigham and Women's Hospital and Harvard Medical School showed 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, which highlights the value of the objective nature of the test.

"Vectra DA provides additional information about disease activity that is not provided by other assessment tools such as C-reactive protein (CRP)," said Segurado. "This study showed that in patients with low CRP, nearly half had Vectra DA scores in the moderate to high disease activity range, indicating that their RA was actually more active than originally found with CRP. This information will help physicians attain better insight to the underlying biology of the disease."

Additional Poster Highlights

A study selected by EULAR will be part of the Poster Tour (FRI0098) Friday, June 14 between 11:45 am and 1:30 pm, Biomarker-Based Estimates of Risk of Radiographic Progression in the Leiden Early Arthritis Cohort, and researchers from the Leiden University Medical Center, Leiden, the Netherlands will discuss the use of Vectra DA as a tool to estimate the risk of radiographic progression in RA. 

"Using the Vectra DA score, we were able to see a correlation between the score and risk of radiographic progression over 12 months," said Tom W.J. Huizinga, M.D., Head of the Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands and primary investigator. "This tells us that Vectra DA can be helpful in identifying patients at high risk for radiographic progression and, thus, give rheumatologists more information to help prevent future progression."

Another poster, A Multi-Biomarker Disease Activity Blood Test (Vectra DA) Correlates with Radiographic Progression in Early Rheumatoid Arthritis: Results from the SWEFOT Trial (#FRI0060), focused on use of Vectra DA in assessing risk of radiographic progression in early RA. The SWEFOT study is the Swedish Pharmacotherapy Trial out of the Karolinska Institutet in Stockholm.

In early RA patients starting methotrexate, the study found that Vectra DA's score, when assessed at baseline, significantly correlated with radiographic progression in the first year.  "A high MBDA score at baseline was associated with a higher risk of radiographic progression, even in patients who had moderate disease activity by DAS28 or low CRP at baseline," said Ronald F. van Vollenhoven,M.D., Ph.D., Professor and Chief, Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), Chief, Clinical Trials Unit, Department of Rheumatology, the Karolinska Institute and primary investigator of the study.

Other Vectra DA Posters Presented at 2013 EULAR Annual meeting

Additional study results (presented in six posters listed below) further demonstrate and confirm the ability of Vectra DA to objectively assess disease activity and/or potentially identify risk for radiographic progression in early- and later-stage RA patients.

Poster #FRI0061

Multi-Biomarker Disease Activity (MBDA) Score and the 12 Individual Biomarkers in Early Rheumatoid Arthritis Patients Relate Differently to Clinical Response and Radiographic Progression: Results from SWEFOT Trial; K. Hambardzumyan, Karolinska Institutet, ClinTRID, Stockholm, Sweden, and other collaborators.

Poster #FRI0062

Evaluation of a Multi-Biomarker Disease Activity (Vectra DA Algorithm) in Early Rheumatoid Arthritis and Unclassified Arthritis Patients; K. I. Maijer, Department of Clinical Immunology and Rheumatology, Academic Medical Center/University of Amsterdam, Amsterdam, the Netherlands and other collaborators.

Poster #FRI0066

Behavior of the Multi-Biomarker Disease Activity (Vectra DA Algorithm) Score and Components in Patients with Rheumatoid Arthritis Treated with Tocilizumab; K. Hanami, The First Department Of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, and other collaborators.

Poster # FRI0075

A Multi-Biomarker Disease Activity (Vectra DA Algorithm) Score and Components are Associated with Sustained Clinical Remission in Rheumatoid Arthritis: the REMIRA Study; M. H. Ma, Academic Department of Rheumatology, King's College London, London, United Kingdom and other collaborators.

Poster #FRI0079

Response to MTX Plus Prednisone in CAMERA II Using a Multi-Biomarker Disease Activity Test (Vectra DA) and DAS28-ESR; M. S. Jurgens, Rheumatology & Clinical Immunology, UMC UTRECHT, Utrecht, Netherlands and other collaborators.

Poster #SAT0033

Characterization of the Multi-Biomarker Disease Activity (Vectra DA Algorithm) Score in a Subgroup of Patients from the Epidemiological Investigation of Rheumatoid Arthritis (EIRA) Cohort Receiving Methotrexate; W. Li, Crescendo Bioscience, Inc., South San Francisco and other collaborators.

About Rheumatoid Arthritis (RA)

RA is a debilitating, highly variable, 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, with the disease often resulting in joint damage and disability. RA is a systemic disease that can significantly affect other parts of the body, resulting in infection, osteoporosis, cardiovascular disease, and 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 to help physicians make more informed treatment decisions. Vectra DA testing is performed at the Crescendo Bioscience state-of-the-art CLIA (Clinical Laboratory Improvement Amendments) facility. Test results are reported to the physician 7 to 10 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 is a molecular diagnostics company focused in rheumatology and located in South San Francisco, CA. Crescendo Bioscience develops quantitative, objective, blood tests to provide rheumatologists with deeper clinical insights to help enable more effective management of patients with autoimmune and inflammatory diseases. For more information, please visit the company's website at www.CrescendoBio.com.

Media Contact:
Terri Clevenger
Continuum Health Communications
203-856-4326