Data Presented on Crescendo RA Test Have Implications for Managed Care

Findings being presented in San Francisco show which patients may be able to stop anti-TNF therapy, and which ones will do well with conventional drugs as second-line treatment.

A test that predicts the progression of rheumatoid arthritis (RA) for individual patients could help physicians better manage treatment with anti-TNF therapies by showing who will respond best and who safely stop taking them, according to results being presented this week at the annual meeting of the American College of Rheumatology (ACR) in San Francisco, California. The meeting opened today and concludes Wednesday.

 

The results involve Vectra DA, a biomarker test from Crescendo Bioscience that combines measures of 12 separate serum proteins associated with RA into a single score. Used by rheumatologists to help predict the progression of RA, the Vectra DA test is also useful for health plans in deciding when the most expensive therapies are needed. (Crescendo Bioscience is a subsidiary of Myriad Genetics.)

 

Significantly, data presented at the ACR meeting included findings that show Vectra DA can help predict which patients may be able to withdraw from therapy. “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,” said Elena Hitraya, MD, PhD, who joined Crescendo Bioscience recently as chief medical officer.

 

The Vectra DA test produces a measure called a multi-biomarker disease activity or MBDA score, which has been shown in earlier studies to correlate with other indexes of RA disease activity. The lower the MBDA score, the less aggressive the disease. In addition, giving patients the Vectra DA test at regular intervals allows rheumatologists to track the progression of RA over time. While some parts of the diagnostic testing industry have struggled to gain coverage from CMS, Medicare fully covers this test.

 

Findings presented in San Francisco evaluated the following:

 

Which patients need anti-TNF therapy? Researchers examined records from 157 patients who took part in the Swedish Farmacotherapy (SWEFOT) trial and had incomplete responses to methotrexate, which is the standard first-line treatment in RA. The purpose was to see if the Vectra DA test could predict which patients would do better on conventional triple therapy or anti-TNF agents as second-line therapy. Patients with low MBDA scores were (<30) were much more likely to have better responses to triple therapy than anti-TNF agents (88% vs 18%). Conversely, patients with higher MBDA scores (>44) had poorer responses to triple therapy (35% vs 58%). Of note, an analysis of the data was able to pinpoint a score of 38 as a cut-off, below which triple therapy was optimal. Not only do the results have implications for creating more cost-effective therapeutic regimens now, the researchers wrote, but they suggest that it’s possible to further refine more individualized, cost-effective treatment plans.1

Which patients are likely to experience a relapse? For RA patients in remission who are decide to taper off disease-modifying anti-rheumatic drugs (DMARDs), the Vectra DA test can show which are most likely to experience a relapse. Researchers analyzed records from 100 patients who took part in a study called RETRO (Reduction of Therapy in patients with Rheumatoid arthritis in Ongoing remission). Moderate to high MBDA scores were seen in 35% of the patients, with scores in this range twice as likely (58%) among those who relapsed than those who remained in stable remission (25%). Baseline MBDA scores were also much higher among those who later relapsed. The study found that the MBDA score was an independent predictor of whether a patient would relapse, alongside the anti-citrullinated protein antibody (ACPA) status. Relapse rates were low (13%) in patients who had neither indicator, high (76.4%) who had both indicators, and moderate (31.8% to 33.3%) in patients who had one indicator but not the other.2

 

Who can stop therapy? Deciding which patients can stop anti-TNF drugs can be a tough call for patients and for health plans–no patient wants a relapse, but the cost therapy makes it desirable to figure out if it’s still needed. For this analysis, researchers looked at data from 439 patients who had been randomized to stop therapy in a Dutch trial. All had been on therapy for at least a year, and the trial protocol called for therapy to be restarted if their disease flared according to certain criteria. Researchers used the restart of therapy as an indicator of flare to evaluate whether there was any correlation with MBDA scores. They found that baseline scores were the best predictor: Flare was observed by 12 months in 59.5%, 68.4% and 81.3% of patients with low, moderate, or high MBDA score at baseline, respectively.3

 

References

 

1.      Hambardzumyan K, Bolce RJ, Saevarsdottir S, Forslind K, Karlsson JA, van Vollenhoven RF. The multi-biomarker disease activity score in methotrexate incomplete responders predicts clinical responses to non-biological versus biological therapy in early RA [abstract 618]. Arthritis Rheumatol. 2015; 67 (suppl 10).

2.      Rech J, Hueber AJ, Englbrecht M, et al. Prediction of disease relapses by multi-biomarker disease test activity in rheumatoid arthritis patients tapering DMARD treatment [abstract 2584]. Arthritis Rheumatol. 2015; 67 (suppl 10).

3.      Lamers-Karnebeek F, Ghiti Moghadam M, Vonkeman HE, et al. Multi-biomarker disease activity score as a predictor of flare in patients with rheumatoid arthritis who stop TNF-alpha-inhibitor therapy [abstract 2594]. Arthritis Rheumatol. 2015; 67 (suppl 10).