MANHASSET, NY – The Biomarkers of Anti-TNF Treatment Efficacy in Rheumatoid Arthritis – Unresponsive Populations (BATTER-UP) Consortium announced today that a prospective study to investigate predictive biomarkers in patients with rheumatoid arthritis (RA) receiving tumor necrosis factor (TNF) inhibitors is now enrolling patients. The BATTER-UP study will investigate molecular signatures of response prediction in RA patients receiving TNF inhibitors.
Through data analyses and predictive response modeling, the consortium aims to better understand which patients with RA will derive the greatest benefit from TNF inhibitors. The consortium brings together a multi-stakeholder representation and consists of participants from academia, a pharmacy benefit manager, a diagnostic company and drug developers. One of the investigators is Peter K. Gregersen, MD, Director of the Center for Genomics and Human Genetics at the Feinstein Institute for Medical Research.
“The availability of anti-tumor necrosis factor-alpha therapies has redefined how rheumatologists treat patients with moderate-to-severe rheumatoid arthritis,” said Dr. Michael E. Weinblatt, John R. and Eileen K. Riedman Professor of Medicine, Brigham and Women’s Hospital, another co-investigator in the study. “However, because these therapies are not effective in all patients and because we know a proportion of patients stop responding to any given agent, our aim through this study is to more accurately predict response in an effort to develop more personalized treatment for patients in the future.”
The BATTER-UP study, a multi-center, cross-sectional investigation of response to anti-TNF agents in rheumatoid arthritis, will enroll a cohort of approximately 1,000 patients who have been diagnosed with moderate to severe RA and who have been recently prescribed or have been receiving TNF inhibitor therapy. Additional study protocol details can be found at www.clinicaltrials.gov (reference #NCT01211678). Biological samples and clinical outcome information from BATTER-UP will be used to confirm and extend the utility of previously published biomarkers that can predict response to anti-TNF agents. These data may also generate new hypotheses for further testing. The BATTER-UP samples and data will be established as a reference set for investigation of personalized medicine in RA.
“Rheumatoid arthritis is a painful, destructive and potentially debilitating disease of the joints for millions of people around the world,” said Dr. Gregersen. “Because of the heterogeneity of the disease, there is a clear need to discover new biomarkers to better define the underlying biology and predict outcome and response to therapy. This is becoming even more critical as new biologic therapies enter the market place and clinicians face an array of choices in the treatment of their patients.”
About the BATTER-UP Consortium
The BATTER-UP consortium is focused on improving care for people living with rheumatoid arthritis and is structured as an academia-industry collaboration. Leadership for this innovative approach to personalized medicine is provided by Dr. Peter K. Gregersen of the Feinstein Institute and Dr. Michael Weinblatt from Brigham and Women’s Hospital, Harvard University. The academic investigators direct consortium scientific activities through a Scientific Advisory Board and publication team to ensure rapid dissemination of research. Joining forces to provide funding and operational support for BATTER-UP are several companies including: Biogen Idec, Bristol-Myers Squibb, Centocor Research & Development, Crescendo Bioscience, Genentech, Medco Health Solutions, Regeneron Pharmaceuticals and Sanofi-Aventis.
About Rheumatoid Arthritis
Rheumatoid arthritis is characterized by persistent and progressive joint inflammation, causing pain, stiffness and functional disability. It is estimated that about one percent of the world’s population is affected by RA, including more than 1 million people in the United States. For more information about RA, visit the Arthritis Foundation.
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