Scipher Medicine, a Waltham, Mass.-based precision immunology company matching patients with the most effective therapy, announced that in an independent validation study, PrismRA accurately predicted which patients with rheumatoid arthritis would not achieve EULAR good response criteria at six months of treatment using either adalimumab or etanercept.
A validation study with 68 RA patients who started either adalimumab or etanercept as their first biologic was recently presented at European League Against Rheumatism (EULAR) 2021, along with the Sint Maartenskliniek in the Netherlands. The study compared baseline PrismRA results with actual outcomes at six months using EULAR good response as the clinical outcome measure.
The study found a EULAR-based inadequate response in 37 out of the 68 patients, or 54.4%. The study demonstrated that patients with a molecular signature of non-response were four times more likely to achieve a EULAR inadequate response at six months than those lacking the molecular signature. Identifying those patients who will not respond to TNFi therapy in advance, before treatment begins, has the potential to reduce time spent on trial-and-error approaches and could result in improved outcomes and decreased patient burden.
“The successful validation of the novel test for EULAR inadequate response in this treat-to-target setting is promising,” says Johanna Withers, PhD, study co-author, and principal scientist at Scipher Medicine. “This could optimize care, reducing wasted time on ineffective therapies and potentially halting disease progression. Demonstrating PrismRA’s ability to accurately predict non-response in an independent cohort outside of the United States further demonstrates the test’s generalizability across diverse patient populations.”
In addition to this collaboration with the Sint Maartenskliniek, Scipher Medicine also published new data on the ability of PrismRA to predict inadequate response to TNF inhibitor therapies in seronegative RA patients as well as on efforts to define high-confidence treatment response outcomes using a Monte Carlo simulation approach to evaluate the true impact of therapeutic efficacy and response.
From a routine blood draw, the PrismRA test analyzes an individual’s molecular signature, helping identify who is unlikely to adequately respond to TNFi therapy, the world’s largest selling drug class, so non-responders can be prescribed alternative effective therapy.