SOUTH SAN FRANCISCO, Calif.—Roughly 1.5 million people in the United States alone suffer from rheumatoid arthritis (RA), an autoimmune disease that affects the linings of joints, causing pain and swelling that can lead to bone erosion. Crescendo Bioscience, a molecular diagnostics company developing and commercializing quantitative blood tests for RA and other autoimmune diseases, is advancing Vectra DA, a multibiomarker blood test for rheumatoid arthritis, in hopes of leading to better treatment options for patients with RA. The company has conducted multiple studies of Vectra DA, and shared data in several presentations at the recent annual meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals in San Francisco.
Vectra DA offers insight into disease activity by integrating the concentrations of 12 serum proteins (biomarkers) associated with RA disease activity into a single score. Individuals who rank with a score from one to 29 are considered to present with low disease activity, while those in the range of 30 to 44 have moderate disease activity, and anyone with a score of 45 to 100 has high disease activity. Crescendo notes that its test offers “a more complete picture of RA disease activity than single biomarkers such as erythrocyte sedimentation rate and C-reactive protein,” as well as a better assessment of the risk of joint damage.
“For diagnosis of rheumatoid arthritis, there is no single available test. There are criteria that includes clinical assessment measures and includes one inflammatory marker measurement that is not actually specifically rheumatoid arthritis … the way diagnosis happens now, seven criteria are listed, and patients need to fulfill several of them to be diagnosed with rheumatoid arthritis. So it’s very nonspecific,” explains Dr. Elena Hitraya, chief medical officer at Crescendo. In addition, she notes, RA is a very heterogeneous disease, with a variety of growth factors and cytokines playing a role in disease development. The fact that Vectra DA combines a dozen biomarkers for a single score, “is an advantage in light of that, in terms of measuring that activity.”
“Much work has been done over the past decade to develop and validate Vectra DA and establish the test as an objective measure for assessing disease activity in patients with rheumatoid arthritis,” Hitraya noted in a press release. “This year, our collaborators are presenting data on the role of Vectra DA in predicting response to second-line therapy. In addition, data will be presented examining Vectra DA’s ability to predict which patients may be able to successfully taper or withdraw from treatment. These data are important and deserve further exploration because they have the potential to help physicians tailor treatment plans for their patients and improve the use of healthcare resources.”
One of the studies highlighted at the annual meeting sought to determine if a Vectra DA score could be used to predict an optimal choice of second-line treatment for 157 patients with RA that were MTX incomplete responders. The results showed that in patients with early RA and an incomplete response to MTX, the Vectra DA test could predict the relative efficacy of second-line treatment with triple therapy versus anti-TNF.
“Predicting response to drug therapy is an important goal for personalizing treatment for individuals with RA,” commented Dr. Ronald F. van Vollenhoven of the Department of Medicine at the Karolinska Institute in Stockholm, Sweden, and the study’s lead investigator. “In this study, patients with a low Vectra DA score were more likely to respond to conventional triple therapy than to anti-TNF therapy. These findings may help facilitate and improve the development of individualized and cost-effective treatment plans for patients with RA.”
In another study, this one evaluating Vectra DA’s ability to predict disease relapse in patients with RA in sustained remission following the tapering of treatment with disease-modifying anti-rheumatic drugs, the test improved the prediction of relapse and, when combined with anti-citrullinated protein antibody status, resulted in a correct case classification of relapse in roughly 80 percent of patients.
And more studies are planned for the future, according to Hitraya. Crescendo is advancing its work on Vectra DA with an outcome study in response to requests for data that can demonstrate the economic benefit of the test.
Bernard Tobin, president of Crescendo, says that the company is also working to take advantage of Vectra DA’s potential in terms of the Medicare opportunity. Crescendo has improved its availability through its work with Labcorp, he adds, noting that Vectra DA can now be ordered to Labcorp and its national service network, which comprises more than 1,700 patient service centers. The company is also taking the multitude of data on Vectra DA to private payers as well. In addition, Tobin says, Crescendo is collaborating with a dozen or so pharma companies.
“They find real utility in an objective measure like Vectra DA in looking at things like enrolling patients in their clinical trials,” Tobin explains. “And as you can imagine, when something like that becomes part of the upstream of clinical development for pharmaceutical companies, it certainly aids in what they look at downstream in trying to make decisions.”