PrismRA Was Developed & Clinically Validated to Guide RA Therapy Selection
PrismRA® is a blood-based precision medicine test that was developed using the science of the human interactome to help guide the treatment of rheumatoid arthritis.
The human interactome is the network of all possible interactions between proteins in the human body. Based on the human genome project and consolidating data from over 20 different sources, the human interactome is foundational in identifying gene expressions relative to specific disease states and how each is affected by different medications.
In the case of RA, while up to 90% of patients are prescribed a TNFi as a first-line biologic1,2, only about 1/3 of those patients respond effectively and reach their treatment goals on a TNFi3-9.
Understanding that therapeutic response is affected by an individual’s disease biology, Scipher began to explore the network of gene expression features most closely associated with RA, as mapped by the human interactome. By using artificial intelligence and machine learning, the top 23 biological features most predictive of inadequate response to TNFi therapies in RA were identified10 and the PrismRA test became a viable option for helping to guide treatment selection.
The PrismRA test result will return 1 of 3 possible readouts for each patient: May respond to a TNFi, Unlikely to respond to a TNFi – 10% Chance of response, or Highly Unlikely to respond to a TNFi – 5% Chance of response. With this result in hand the physician is better equipped to make an informed decision about whether starting their patient on a TNFi is a good first step, or if they should try an alternative mechanism of action sooner, such as a T-cell or JAK.
Multiple clinical validation studies of PrismRA have been conducted with validated outcome measures in over 500 patients with RA.12-15 This tailored solution delivers proven, data-driven, precision medicine that can help patients with RA find the right medication and reach their treatment goals sooner.12
As shown in the clinical validation publications, when PrismRA predicts inadequate response to TNFi therapies11-13:
- Patients have a 90% chance of failing a TNFi (near 90% positive predictive value)
- Patients are up to 6 times less likely to reach CDAI low disease activity if they are prescribed a TNFi
- Patients are up to 27 times less likely to reach CDAI remission if they are prescribed a TNFi
When PrismRA results predict that a patient will be unlikely to respond to a TNFi therapy and an alternative medication is tried instead, the patient is more likely to reach treatment goals such as ACR50 within 6 months reducing their risks for surgeries, hospitalizations, and cardiovascular events.16
You can narrow down the treatment choices for your patients with RA by adding PrismRA to your therapeutic decision-making. With a routine blood draw, you can help your patients find the right medication sooner and improve their quality of life.16
Clinical Validation Publications:
- A Molecular Signature Response Classifier to Predict Inadequate Response to Tumor Necrosis Factor-a Inhibitors: The NETWORK-004 Prospective Observational Study, Cohen et al.
a. [https://link.springer.com/article/10.1007/s40744-021-00330-y]
- Analytical and clinical validation of an RNA sequencing-based assay for quantitative, accurate evaluation of a molecular signature response classifier in rheumatoid arthritis, Jones et al.
a. [https://www.tandfonline.com/doi/full/10.1080/14737159.2021.2000394]
1. Jin Y, Desai RJ, Liu J, et al. Factors associated with initial or subsequent choice of biologic disease-modifying antirheumatic drugs for treatment of rheumatoid arthritis. Arthritis Res Ther. 2017 Jul 5;19(1):159. Doi: 10.1186/s13075-017-1366-1. 2. Curtis JR, Zhang J, Xie F, et al. Use of oral and subcutaneous methotrexate in rheumatoid arthritis patients in the United States. Arthritis Care Res (Hoboken). 2014 Nov;66(11):1604-11. Doi: 10.1002/acr.22383. 3. Pappas DA, O’Brien J, Guo L, Shan Y, et al. Treatment patterns and clinical outcomes in patients with rheumatoid arthritis initiating etanercept, adalimumab, or Janus kinase inhibitor as first-line therapy: results from the real-world CorEvitas RA Registry. Arthritis Res Ther. 2023 Sep 9;25(1):166. doi: 10.1186/s13075-023-03120-9. 4. Nüßlein HG, Alten R, Galeazzi M, Lorenz HM, Boumpas D, Nurmohamed MT, Bensen WG, Burmester GR, Peter HH, Rainer F, Pavelka K, Chartier M, Poncet C, Rauch C, Bars ML. Real-world effectiveness of abatacept for rheumatoid arthritis treatment in European and Canadian populations: a 6-month interim analysis of the 2-year, observational, prospective ACTION study. BMC Musculoskelet Disord. 2014 Jan 11;15:14. doi: 10.1186/1471-2474-15-14. 5. Wells AF, Greenwald M, Bradley JD, et al. Baricitinib in Patients with Rheumatoid Arthritis and an Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs in United States and Rest of World: A Subset Analysis. Rheumatol Ther. 2018 Jun;5(1):43-55. doi: 10.1007/s40744-018-0110-x. Epub 2018 Apr 21. 6. Fleischmann RM, Genovese MC, Enejosa JV, et al. Safety and effectiveness of upadacitinib or adalimumab plus methotrexate in patients with rheumatoid arthritis over 48 weeks with switch to alternate therapy in patients with insufficient response. Ann Rheum Dis. 2019 Nov;78(11):1454-1462. doi: 10.1136/annrheumdis-2019-215764. Epub 2019 Jul 30. 7. Dougados M, van der Heijde D, Chen YC, et al. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study. Ann Rheum Dis. 2017 Jan;76(1):88-95. doi: 10.1136/ annrheumdis-2016-210094. Epub 2016 Sep 29. Erratum in: Ann Rheum Dis. 2017 Sep;76(9):1634. 8. Taylor PC, Keystone EC, van der Heijde D, et al. Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis. N Engl J Med. 2017 Feb 16;376(7):652-662. doi: 10.1056/NEJMoa1608345. 9. Burmester GR, Lin Y, Patel R, et al. Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallel-group phase III trial. Ann Rheum Dis. 2017 May;76(5):840-847. doi: 10.1136/annrheumdis-2016-210310. Epub 2016 Nov 17. 10. Cohen S, Wells AF, Curtis JR, et al. A Molecular Signature Response Classifier to Predict Inadequate Response to Tumor Necrosis Factor-α Inhibitors: The NETWORK-004 Prospective Observational Study. Rheumatol Ther. 2021 Sep;8(3):1159-1176. doi: 10.1007/s40744-021-00330-y. 11. Jones A, Rapisardo S, Zhang L, et al. Analytical and clinical validation of an RNA sequencing-based assay for quantitative, accurate evaluation of a molecular signature response classifier in rheumatoid arthritis. Expert Rev Mol Diagn. 2021 Nov;21(11):1235-1243. doi: 10.1080/14737159.2021.2000394. 12. Curtis JR, Strand V, Golombek S, et al. Patient outcomes improve when a molecular signature test guides treatment decision-making in rheumatoid arthritis. Expert Rev Mol Diagn. 2022 Nov;22(10):973-982. doi: 10.1080/14737159.2022.2140586. 13. Cohen S, Wells AF, Curtis JR, et al. A Molecular Signature Response Classifier to Predict Inadequate Response to Tumor Necrosis Factor-α Inhibitors: The NETWORK-004 Prospective Observational Study. Rheumatol Ther. 2021 Sep;8(3):1159-1176. doi: 10.1007/s40744-021-00330-y. 14. Jones A, Rapisardo S, Zhang L, et al. Analytical and clinical validation of an RNA sequencing-based assay for quantitative, accurate evaluation of a molecular signature response classifier in rheumatoid arthritis. Expert Rev Mol Diagn. 2021 Nov;21(11):1235-1243. doi: 10.1080/14737159.2021.2000394. 15. Strand V, Cohen SB, Curtis JR, et al. Clinical utility of therapy selection informed by predicted nonresponse to tumor necrosis factor-α inhibitors: an analysis from the Study to Accelerate Information of Molecular Signatures (AIMS) in rheumatoid arthritis. Expert Rev Mol Diagn. 2022 Jan;22(1):101-109. doi: 10.1080/14737159.2022.2020648. 16. Holdsworth EA, Donaghy B, Fox KM, et al. Biologic and Targeted Synthetic DMARD Utilization in the United States: Adelphi Real World Disease Specific Programme for Rheumatoid Arthritis. Rheumatol Ther. 2021 Dec;8(4):1637-1649. doi: 10.1007/s40744-021-00357-1.
