WALTHAM, Mass.--(BUSINESS WIRE)--Scipher Medicine, a precision immunology company that helps match patients with their most effective therapy, today announced successful results from the PrismRA clinical validation study. The publication titled “Clinical validation of a blood-based predictive test for stratification of response to tumor necrosis factor inhibitor therapies in rheumatoid arthritis patients” was published in Network and Systems Medicine.
The study, co-authored by scientists from Scipher Medicine and experts in the field of clinical rheumatology, met the endpoint of determining a molecular signature that accurately predicts rheumatoid arthritis (RA) patients who will fail to respond adequately to tumor necrosis factor inhibitor (TNFi) therapies. Empowered with this information, healthcare providers can prescribe alternative therapy from day one without first having to cycle through and fail multiple TNFi drugs.
PrismRA uses whole blood gene expression data to identify if a patient’s molecular disease biology is suited to TNFi therapy. PrismRA is expected to be introduced to rheumatology practices later this summer and has the potential to improve treatment decisions and reduce trial-and-error attempts with treatments that are unlikely to be effective based on a patient’s unique biology.
“About 90% of patients with rheumatoid arthritis are prescribed TNFi therapy after failing disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate. However, a majority of patients fail to achieve a clinically meaningful change,” said Dr. Slava Akmaev, Chief Technology Officer of Scipher Medicine. “The need for precision medicine in RA and other complex diseases has never been more obvious, particularly now with provider access being severely limited due to heightened COVID-19 pandemic concerns. PrismRA has the ability to limit TNFi drug cycling and help patients manage their disease more effectively.”
“In this study, TNFi therapies failed to help nearly 70% of the unstratified patient population reach an adequate response. The PrismRA disease signature test could have prevented many of these individuals from taking a drug that did not adequately ameliorate the signs and symptoms of their disease,” said Jeffrey Curtis, M.D., M.S., MPH, Professor of Medicine in the Division of Clinical Immunology and Rheumatology at the University of Alabama at Birmingham. “RA is a complex disease with multiple biological factors implicated in disease progression and severity. A test such as PrismRA has the potential to be a powerful tool for treating patients with the right treatment at the right time.”
PrismRA was validated using the Comparative Effectiveness Registry to Study Therapies for Arthritis and Inflammatory Conditions (CERTAIN) data set of 175 biologic-naïve RA patients from the Consortium of Rheumatology Researchers of North America (CORRONA). PrismRA identified patients who were unlikely to have an adequate response to TNFi therapies with a positive predictive value (PPV) of 89.7% and specificity of 86.8%. Overall, a patient identified by PrismRA to be a non-responder is 6.6 times more likely to inadequately respond to a TNFi therapy compared to someone lacking that molecular signature.
PrismRA, a molecular signature test, is a revolutionary advancement bringing precision medicine to the treatment of rheumatoid arthritis, which affects 1.3 million patients in the United States alone. From a routine blood draw, PrismRA analyzes an individual's molecular signature, helping identify who is unlikely to adequately respond to TNFi therapy, the world’s largest selling drug class. Providers now have objective data to guide therapeutic decision-making and give patients the best chance of achieving treatment targets and improving clinical outcomes. For more information, please visit www.PrismRA.com.
About Scipher Medicine
Scipher Medicine, a precision immunology company, holds the fundamental belief that patients deserve simple answers to treatment options based on scientifically backed data. Leveraging our proprietary Network Medicine platform and artificial intelligence, we commercialize blood tests revealing a patient’s unique molecular disease signature and match such signature to most effective therapy, ensuring optimal treatment from day one. The unprecedented amount of patient molecular data generated from our tests further drives development of novel and more effective therapeutics. We partner with payers, providers and pharma along the health care value chain to bring precision medicine to autoimmune diseases.