So far, the promise of precision medicine has largely been in the field of oncology, i.e. recommending personalized treatments based on molecular diagnostic tests. But growing knowledge about whether specific individuals will or will not benefit from certain treatments is informing providers of a wider range of diseases.
on Monday, Scipher Medicine, a Waltham, Massachusetts-based precision immunology company announced clinical results from a study examining the treatment and outcomes of 212 rheumatoid arthritis (RA) patients whose healthcare providers Used its PrismRA blood test. Specifically, blood tests are used to predict non-response to the world’s largest drug class, tumor necrosis factor inhibitors (TNFi).
The Accelerated Molecular Signature Information Study (AIMS) found that RA patients whose PrismRA blood test indicated they would not respond to TNFi treatment but were still on treatment did not respond 90 percent of the time. Meanwhile, patients who received PrismRA-guided therapy had three times the clinical response compared to those who did not. Scipher’s findings were published in Molecular Diagnostics Expert Review.
Rheumatoid Arthritis is a type of arthritis that causes joint pain, swelling, stiffness and loss of function. While it can affect any joint, it is more common in the wrist and fingers. This is incurable.
In an email, Scipher Medicine’s chief medical officer, Sam Asgarian, explained that the gold standard for measuring clinical outcomes in rheumatoid arthritis is the ACR50 measurement. Created by the American College of Rheumatology, it is a composite score that measures at least a 50% improvement in the number of swollen joints and the number of tender joints. The same 50% or more improvement must also be demonstrated in three of the five measures, including surveys of physician and patient assessments and other clinical and laboratory results.
Scipher’s CMS-approved laboratory test is the only commercially available blood test that predicts a patient’s response to TNFi therapy, Asgarian said.
The AIMS study evaluated data from dozens of private and academic rheumatology practices and U.S. institutions, including Stanford University, Texas Health Presbyterian Hospital in Dallas, the University of Alabama at Birmingham, and the University of South Florida.
“This clinical study clearly shows that blood tests that can predict a patient’s response to commonly used rheumatoid arthritis therapies can fundamentally change treatment patterns,” said study co-author Vibeke Strand, PhD, adjunct clinical professor in the Division of Immunology. Rheumatology at Stanford University School of Medicine, in a press release. “Wide adoption of this important advance could significantly improve treatment outcomes.”
If Schipher’s PrismRA becomes part of routing care, it’s not just patient outcomes that it could significantly improve. That’s because of the financial burden of treatment failure, especially if the company’s claim that two-thirds of patients treated with TNFi are clinically unresponsive is accurate. In response to questions, Asgarian explained, retrospective Studies in RA patients It found that “patients who responded to targeted therapy had an average of $6,091 less in total annual medical costs (excluding the cost of targeted therapy) than patients who did not respond.”
That’s because they have fewer hospital and emergency room admissions, fewer outpatient visits, and lower spending on antidepressants and painkillers, among other factors.
“As a result, PrismRA can help payers and patients save on pharmacy and healthcare costs,” he said. “On the pharmacy side, the PrismRA test results may lead providers to prescribe an alternative, less expensive treatment option in the first place, unlike TNF inhibitors by default in patients requiring bio-prescribed treatment.”
According to Scipher Medicine, although there are five approved targeted therapies for RA, an estimated 90% of patients receive TNFi therapy. Some common TNFi treatments for RA include AbbVie Humira; Amgen/immune Embrel; and Jensen’s treat.
While the results of Scipher’s trial are promising, the success of PrsimRA will depend on obtaining insurance reimbursement. Currently, the company is awaiting a local coverage decision from Medicare, which would allow it to be reimbursed in federal health plans. It also partners with more than 20 companies (private health insurers and pharmacy benefit managers) to gain broad access and coverage.
RA isn’t the only disease the company is targeting. Asgarian said the company hopes to launch at least one test a year in the autoimmune disease area for the next five years. The company has ample funding to support these efforts. Scipher has raised $117 million in three funding rounds since its founding in 2015, Asgar said. Investors in the company include UnitedHealth Group, Optum, Alumni Ventures, aMoon, Northpond Ventures, ECHO and Khosla Ventures.
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