SALT LAKE CITY, Utah, June 10, 2014 – Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics, Inc. (NASDAQ: MYGN), today announced that Vectra® DA data will be featured in eight posters at the 2014 European League Against Rheumatism (EULAR) Annual Meeting, June 11-14, 2014, in Paris, France. Vectra DA is a quantitative, objective multi-biomarker test to measure disease activity in patients with rheumatoid arthritis (RA). The Vectra DA test offers insight into the biological processes that drive disease activity to help rheumatologists manage RA and improve patient care.
At EULAR, data will be presented by researchers from the Swedish Farmacotherapy (SWEFOT) clinical trial that demonstrate the clinical utility of Vectra DA in assessing the risk of future joint damage at multiple points in time. Additionally, SWEFOT data indicate that changes in Vectra DA scores were associated with favorable response to both non-biologic and biologic therapies. Further, the data demonstrate that Vectra DA may have the potential to serve as an inclusion criterion for assessing patients who are candidates for clinical trials in rheumatoid arthritis.
"The breadth of data presented at EULAR is representative of the clinical utility of Vectra DA in the overall management of RA," said Oscar Segurado, chief medical officer at Crescendo Bioscience. "Vectra DA provides physicians with important, actionable insight to better assess risk of radiographic progression as well as manage therapy decisions in their patients with a precise and standardized tool. The EULAR data also point out the opportunity to identify more patients that may be eligible to participate in clinical trials."
The data to be presented at this EULAR meeting will build on a recently published study in the journal Annals of Rheumatic Diseases that demonstrated that Vectra DA scores at the start of the SWEFOT clinical study predicted radiographic progression of joint damage over the following year. The new data from the SWEFOT study being presented at EULAR demonstrate that Vectra DA scores at 3 months and 12 months also were predictive of subsequent radiographic progression over the following 2 years. Additionally, patients in the SWEFOT study who did not respond to 3 months of initial methotrexate therapy were randomized to receive either non-biological DMARD triple therapy or anti-TNF (infliximab) therapy. Patients with a high Vectra DA score at baseline that remained high following therapy were at a high risk for radiographic progression. By contrast, risk for progression was significantly lower among patients with a high Vectra DA score at baseline, but lower Vectra DA score following treatment. At all measured time points, low Vectra DA scores were associated with low risk for subsequent radiographic progression.
"These are clinically relevant findings for rheumatologists taking care of patients with RA," said Ronald F. van Vollenhoven, M.D., Ph.D, Department of Medicine, Karolinska Institute in Stockholm, Sweden. "These data show that Vectra DA may help identify those patients at higher and lower risks for radiographic progression while receiving antirheumatic therapy."
Poster Tour Presentations
Title: Using the multi-biomarker disease activity score as a complementary inclusion criterion for clinical trials in rheumatoid arthritis may enhance recruitment.Presenter: Ronald van VollenhovenDate: Presentation: June 13, 2014 12:00 PM, Room 251Poster: June 14, 2014; 10:15 AM, Poster Area D, Level 4Key Finding: In this analysis of the SWEFOT study, Vectra DA was found to be potentially useful as an inclusion criterion in clinical trials. Recruitment for clinical trials in patients with active RA may be enhanced by including patients with a Vectra DA score > 44 in addition to the conventional approach of only using patients with a CRP > 10 mg/L. This enhancement was achieved with a comparable response to treatment and subsequent radiographic progression. In this study the number of eligible DMARD naïve patients increased by 24 percent and the number of eligible MTX Non-responder patients increased by 47 percent.
Title: Multi-biomarker disease activity (Vectra DA algorithm) score is associated with power doppler ultrasound in patients with rheumatoid arthritis in low disease activity state: The Remira Cohort.Presenter: Margaret H. MaDate: Presentation: June 12, 2014; 12:00 PM; Level 2 Paris RoomPoster: June 14, 2014; 10:15 AM, Poster Area D, Level 4Key Finding: Vectra DA can detect joint inflammation despite the lack of clinicaldisease activity in RA patients. Among patients who had low clinical disease activity or were in remission, Vectra DA algorithm score correlated with the amount of joint inflammation (synovitis) detected by ultrasound imaging of joints.
Title: A multi-biomarker disease activity blood test in patients with juvenile idiopathic arthritis (JIA).Presenter: Kunihiro YamaokaDate: Presentation: June 12, 2014; 12:00 PM; Room 251Poster: June 13, 2014; 11:45 AM, Poster Area D, Level 4Key Finding: Researchers found a significant association between themulti-biomarker disease activity score and clinical disease activity in patientswith juvenile arthritis. Further assessment of the clinical value of amulti-biomarker disease activity test for JIA is warranted.
Poster Presentations
Title: In early RA, the multi-biomarker disease activity score at different time-points is predictive of subsequent radiographic progression.Presenter: Karen HambardzumyanDate: June 14, 2014; 10:15 AM; Poster Area D, Level 4Key Finding: This SWEFOT study found that Vectra DA scores at baseline and changes over time were predictive of radiographic progression for up to two years. These results, along with data recently published online in the Annals of Rheumatic Disease, further validate the finding that low/high scores of Vectra DA are associated with less/more joint damage over time.
Title: In early RA patients with non-response to methotrexate the change in multi-biomarker disease activity score is differentially associated with subsequent response to non-biological versus biological therapy.Presenter: Karen HambardzumyanDate: June 13, 2014; 11:45 AM; Poster Area D, Level 4Key Finding: This SWEFOT study suggests that changes in the Vectra DA score may help guide subsequent therapy. In DMARD-naïve patients who had inadequate responses to 3 months of methotrexate, the changes in Vectra DA score at month 3 were associated with the likelihood of having a subsequent response to either anti-TNF or triple (DMARD) therapy.
Title: Validation of a multi-biomarker disease activity score in rheumatoid arthritis in relation to imaging inflammation and damage.Presenter: Simon KrabbeDate: June 13, 2014; 11:45 AM, Poster Area D, Level 4Key Finding: Vectra DA correlated with imaging measures of joint inflammation and joint damage, providing further evidence that the test is associated with biological processes of disease in RA joints.
Title: Residual inflammatory activity assessed by a multi-biomarker disease activity blood test is linked to structural damage in RA patients in low disease activity/remission and normal C-reactivity protein level.Presenter: Georg SchettDate: June 12, 2014; 11:45 AM, Poster Area D, Level 4Key Finding: In RA patients who were in clinical remission or low clinical disease activity, Vectra DA was found to correlate with erosive damage in joints, as detected by imaging with high-resolution CT scanning, suggesting that the inflammatory mediators measured by Vectra DA are linked to structural bone damage in RA.
Title: Effects of tofacitinib treatment on leptin and other components of the multi-biomarker disease activity score in patients with rheumatoid arthritis.Presenter: Kunihiro YamaokaDate: June 13, 2014; 11:45 AM, Poster Area D, Level 4Key Finding: Using Vectra DA to evaluate treatment response in a clinical trial of the biologic agent tofacitinib, researchers found that the biomarker leptin increased with active treatment.
Source: Myriad Genetics, Inc.