The 12-biomarker test is gaining acceptance among rheumatologists and was recently added to a clinical guideline.
Starting Sunday, Crescendo Bioscience will present a series of abstracts on its Vectra DA test at the 2016 annual meeting of the American College of Rheumatology (ACR) in Washington, DC. The company says the new round of abstracts will add to the growing body of evidence on the test’s clinical utility and ease of use.
Vectra DA, a 12-biomarker test, helps evaluate progression of rheumatoid arthritis (RA), a debilitating autoimmune disease with possible genetic and environmental causes that affects about 1.5 million Americans. RA is characterized by chronic inflammation, pain, and stiffness in the joints, which can progress to disability.
Bernard Tobin, president of Crescendo Bioscience, said the studies being presented at ACR build on earlier work, which has shown how clinicians and patients benefit from objective information about the course of the disease. Physicians use the test both at baseline, when a patient is diagnosed, and when patients report symptoms that can’t be explained by the physical exam.
In some cases, Tobin said, “The Vectra DA test will come back showing there’s smoldering disease that they’re not able to pick up clinically.”
In recent years, a new class of disease-modifying antirheumatic drugs (DMARDS), the so-called biologics, have proven been shown to target the action of the immune system, interrupting the inflammation and disease advancement. When these biologics work, they are game-changing, but they have side effects and do not work for everyone. Vectra DA helps rheumatologists evaluate which patients are experiencing disease progression that warrants use of biologics, and which patients might be able to take a break from these agents; this makes the test an important tool for rheumatologists, patients, and payers.
To that end, Crescendo, which is owned by Myriad Genetics, has embarked on a prospective outcomes study that will report results in 2018. The study will shed light on which RA patients will benefit from the enhanced DMARD therapy vs biologics, and Tobin said, “Managed care plans would very much like to know who those patients are.”
Abstracts being presented at the ACR meeting include:
Predicting radiographic progression.1 In this study, researchers evaluated 180 patients with early RA who took part in the OPERA trial (Optimized Treatment Algorithm for Patients with Early Rheumatoid Arthritis) to see how well the Vectra DA score, taken at baseline, predicted radiographic progression at the 12-month mark, and whether it made sense to add the test to the anti-cyclic citrullinated peptide (anti-CCP) test, an older antibody test that has been used to identify patients at higher risk of rapid disease progression.
Results found that patients with a high Vectra DA scores (>44 on a scale of 1 to 100) were more likely to see radiographic progression (31%), compared with just 3% of patients who had a score of 44 or less. While 34% of the patients who tested positive for anti-CCP and 12% who tested negative had radiographic progression at 12 months, none of the anti-CCP negative patients with a Vectra DA score of 44 or less showed progression, suggesting that the use of Vectra DA adds value to anti-CCP test in predicting future radiographic progression. By contrast, a commonly used functional assessment, DAS-CRP, turned out to have less predictive value in combination with anti-CCP.
Suspending use of Humira.2 This study evaluated how Vectra DA could be used to predict upcoming flares in patients who decided to stop taking the biologic Humira (adalimumab) after achieving remission. Researchers examined 42 patients who had been taking Humira and methotrexate who maintained remission (based on functional assessment) for at least 24 weeks and agreed to stop taking Humira. Clinical disease activity, functional status, and joint damage were recorded at the time the patients stopped taking the biologic, and the ability of Vectra DA to predict flares was measured at 6 months and 1 year. After a year, patients’ baseline Vectra DA score and corresponding flare rates were: remission, 13.6%; low, 50.0%; moderate, 33.3%, and high, 60.0%. The corresponding sustained remission rates were: remission, 63.6%; low, 33.3%; moderate, 33.3%, and high, 0%.
When to take the test. 3 Crescendo’s David Chernoff, MD, senior vice president for Medical Affairs, will present a study that compares the biological variability of Vectra DA scores over a 24-hours period for 28 patients. The study found that patients can take the test at any time during normal business hours without producing meaningfully different results; this is important for patients with RA, who may not prefer an early morning laboratory appointment.
Tobin said that this year’s ACR comes as Vectra DA is gaining acceptance among rheumatologists and making headway with commercial payers and guidelines committees. (Medicare already pays for 2 tests a year.) Myriad announced during its most recent investor’s call that United Rheumatology had included the test on its guidelines. Data provided by the company state that 68% of US rheumatologists use the test, and 280,000 of those with RA have received at least one test.
1. Brahe CH. Multi-biomarker disease activity (MBDA) score and the prediction of radiographic progression in a randomized study of patients with early RA treated with methotrexate alone or with adalimumab. Presented at the 2016 annual meeting of the American College of Rheumatology, November 15, 2016. Abstract 2520.
2. Hirata S, Tanaka Y. Predicting flare and sustained clinical remission after adalimumab withdrawal using the multi-biomarker disease activity (MBDA) score. Presented at the 2016 annual meeting of the American College of Rheumatology, November 15, 2016. Abstract 2639.
3. Chernoff D. Examination of diurnal and daily variation of the multi-biomarker disease activity (MBDA) score in RA to establish a minimally important difference. Presented at the 2016 annual meeting of the American College of Rheumatology, November 13, 2016. Abstract 535.