BATTER-UP Consortium steps in to hit RA out of the park

Study to investigate predictive biomarkers in patients with rheumatoid arthritis receiving TNF inhibitors

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MANHASSET, N.Y.—The Biomarkers of Anti-TNF Treatment Efficacy in Rheumatoid Arthritis-Unresponsive Populations (BATTER-UP) Consortium announced recently that 1,000 patients are being recruited for a prospective study to investigate predictive biomarkers in patients with rheumatoid arthritis (RA) receiving tumor necrosis factor (TNF) inhibitors.

The consortium 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.

Rheumatoid arthritis is characterized by persistent and progressive joint inflammation, causing pain, stiffness and functional disability. It is estimated that about 1 percent of the world's population is affected by RA, including more than 1 million people in the United States.

Despite tremendous progress in treatment of the affliction, current published studies cite the need for larger, prospective clinical trials to replicate and validate promising biomarkers.

At present, disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate are the most common treatment for RA. Anti-TNF drugs are the first line of biologic therapy for patients with insufficient response to DMARDs.

The BATTER-UP study will investigate molecular signatures of response prediction in RA patients receiving TNF inhibitors. Biomarkers of differential response to anti- =TNF treatment will help rationalize treatment of RA patients with anti-TNFs as well as alternative biologic treatments.

"For more than a decade, anti-TNFs have advanced rheumatologists' approach to treating chronic, debilitating inflammatory diseases and have become the biologic standard of care in the management of RA," explains Mark Curran, senior director of immunology biomarkers at Centocor Research and Development, a subsidiary of Johnson & Johnson Pharmaceuticals. "Millions of patients have benefited from these treatments and TNFs will remain a highly effective treatment option for rheumatologists and their patients.

"TNFs have demonstrated significant efficacy in signs and symptoms and a significant effect in inhibiting the progression of joint destruction in patients with moderately to severely active RA," he adds.

It is estimated that anti-TNF treatments are effective for roughly two-thirds of the patients who receive them.

The consortium has among its goals to better understand which patients with RA will derive the greatest benefit from TNF inhibitors. The consortium brings together participants from not only academia, but also a pharmacy benefit manager, a diagnostic company and drug developers. The partners will utilize data analysis and predictive response modeling from a variety of sources to find ways to indicate which patients will be best served.

"The availability of anti-tumor necrosis factor-alpha therapies has redefined how rheumatologists treat patients with moderate-to-severe rheumatoid arthritis," says Weinblatt in a prepared statement. "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."

Curran adds that both clinical and post-marketing surveillance data have helped to better define the risk and benefit profile of these agents and who may or may not be an appropriate candidate for such treatment.

"Moreover, as with any immunosuppressive drug, physicians and patients must remain vigilant throughout the course of therapy as this class of agents carries warnings about serious adverse events, including infections and malignancies," Curran adds.

The BATTER-UP study will enroll patients who have been diagnosed with moderate to severe RA and who have been recently prescribed or have been receiving TNF inhibitor therapy. 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.

"It is our hope that the data collected from the BATTER-UP study will help to better understand the heterogeneity of RA so that treatment plans may be more appropriately personalized for individuals in need of a biologic therapy in the future," concludes Curran.

Gregersen agrees. "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," he adds in a prepared statement. "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."

The BATTER-UP team anticipates first experimental results toward the end of 2011 with the full collection being completed in 2012.

The BATTER-UP consortium's academic investigators direct its 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 and Development, Crescendo Bioscience, Genentech, Medco Health Solutions, Regeneron Pharmaceuticals and sanofi-aventis.

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