Biomarkers Consortium - Treatments Against RA and Effect on FDG PET-CT (TARGET Biomarker Study)

The Biomarkers Consortium’s TARGET Biomarker Study seeks to utilize a panel of validated proteomic biomarkers of rheumatoid arthritis (RA) disease activity and inflammation to categorize baseline and disease-modifying antirheumatic drug (DMARD)-associated changes in vascular inflammation in RA patients. Cardiovascular disease is the leading cause of deaths in RA. Therapies that reduce joint inflammation might also reduce cardiovascular risk. Leveraging a NIH randomized controlled clinical trial, Treatments Against RA and Effect on FDG PET‐CT (The TARGET Trial), this companion biomarker project will compare and correlate the changes in these proteomic biomarkers with vascular and articular FDG PET-CT between two treatment regimens in methotrexate inadequate responders that represent a critical and common decision point for rheumatologists and patients: addition of a TNF inhibitor vs. addition of sulfasalazine plus hydroxychloroquine (triple therapy) to background MTX. Data from this study may also result in the identification of novel biomarkers for use as prognostic, predictive, pharmacodynamic, and/or surrogate biomarkers in trials of CV risk and RA, thus facilitating the development of new treatments in this disease area.

Goals

  • Identify a proteomic based serum multi-marker of arterial inflammation and assess its responsiveness to RA treatment.
  • Evaluate the relationship between clinical measures of RA disease activity, vascular FDG PET/CT imaging, and serum biomarkers of CVD risk.
  • Provide comparative effectiveness data for RA therapies on CV risk.

Media

FNIH Web Announcement (July 20, 2017): The FNIH Biomarkers Consortium Launches Study to Identify Cardiovascular Risk in Rheumatoid Arthritis Patients

NIH Research Portfolio Online Reporting Tools (RePORT), The TARGET Trial

Publications

Dose-Adjusted EPOCH-R Compared With R-CHOP as Frontline Therapy for Diffuse Large B-Cell Lymphoma: Clinical Outcomes of the Phase III Intergroup Trial Alliance/CALGB 50303. Bartlett NL, Wilson WH, Jung SH, Hsi ED, Maurer MJ, Pederson LD, Polley MC, Pitcher BN, Cheson BD, Kahl BS, Friedberg JW, Staudt LM, Wagner-Johnston ND, Blum KA, Abramson JS, Reddy NM, Winter JN, Chang JE, Gopal AK, Chadburn A, Mathew S, Fisher RI, Richards KL, Schöder H, Zelenetz AD, Leonard JP.J Clin Oncol. 2019 Jul 20;37(21):1790-1799. doi: 10.1200/JCO.18.01994. Epub 2019 Apr 2.

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