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

The Problem
Rheumatoid arthritis (RA) is currently difficult to treat and people with RA are at increased risk for developing cardiovascular disease (CVD), yet researchers lack tools to effectively treat RA and to identify the warning signs for CVD.
The Solution
This project will develop tools to help researchers monitor disease progression in patients with rheumatoid arthritis and to determine their risk of developing cardiovascular disease or other serious health complications.

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

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Private-Sector Partners

  • Amgen, Inc.*
  • Arthritis Foundation*
  • Crescendo Bioscience*
  • Merck Sharp & Dohme Corp.*
  • Myriad RBM*
  • Regeneron Pharmaceuticals, Inc.*

Academic Partners

  • Brigham and Woman's Hospital
  • Columbia University  

*Provided financial or in-kind support for this program.

FNIH Contact

  • Stephanie Cush, Ph.D., Senior Project Manager, Inflammation and Immunity, scush@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.

Media

  • FNIH Web Announcement (July 20, 2017): The FNIH Biomarkers Consortium Launches Study to Identify Cardiovascular Risk in Rheumatoid Arthritis Patients Read more 
  • NIH Research Portfolio Online Reporting Tools (RePORT), The TARGET Trial Read more