Biomarkers Consortium – Treatments Against RA and Effect on FDG PET-CT (TARGET Biomarker Study)
Accelerating treatments for rheumatoid arthritis and preventing people with the disease from also developing cardiovascular disease
Overview
The Biomarkers Consortium’s TARGET Biomarker Study seeks to identify a novel multi-marker of cardiovascular disease (CVD) risk in rheumatoid arthritis (RA) patients and assess its responsiveness to treatment with disease-modifying antirheumatic drug (DMARD) therapies. CVD is the leading cause of death in patients with RA, and researchers postulate that enhanced vascular inflammation leads to accelerated atherosclerosis and increased risk of CVD in RA patients.
The project leverages a multicenter, randomized clinical trial – treatments Against RA and Effect on FDG PET‐CT (The TARGET Trial) — funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS/NIH). The TARGET Trial uses 18-fluoro‐deoxyglucose positron emission tomography/computed tomography (FDG PET/CT) to detect baseline and DMARD‐associated changes in both joint and vascular inflammation in RA patients across two treatment arms: addition of a TNF inhibitor vs. addition of sulfasalazine plus hydroxychloroquine to background MTX (i.e., “triple therapy”) in methotrexate (MTX)-inadequate responders. The companion Biomarkers Consortium Project will analyze serum samples from the NIH TARGET Trial to correlate the changes in proteomic biomarkers with vascular FDG PET-CT scans across the two treatment regimens. The results from this study will also help to identify novel prognostic, predictive, pharmacodynamic and/or surrogate biomarkers for use in trials of CVD risk and RA, thus facilitating the development of new treatments in this disease area.
Partners
Public-Sector Partners
Private-Sector Partners
- Amgen, Inc.*
- Arthritis Foundation*
- Crescendo Bioscience*
- Merck Sharp & Dohme Corp.*
- Myriad RBM*
- Regeneron Pharmaceuticals, Inc.*
Academic Partners
*Provided financial or in-kind support for this program.
FNIH Contact
- Steve Hoffmann, Associate Vice President, Research Partnerships, shoffmann@fnih.org
Goals
- Identify a serum-based proteomic multi-marker of arterial inflammation and assess its responsiveness to different RA treatments.
- Evaluate the relationship between clinical measures of RA disease activity, vascular FDG PET/CT imaging and serum biomarkers of CVD risk.
- Generate comparative effectiveness data on RA therapies as relates to CV risk.