12:00 AM
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Dec 05, 2011
 |  BioCentury  |  Product Development

Change-up for BATTER-UP

BATTER-UP aims to predict response to TNF therapies in rheumatoid arthritis

A year after starting a biomarker study in rheumatoid arthritis, a broad-based consortium has been forced to retool its recruitment strategy. The Biomarkers of Anti-TNF Treatment Efficacy in Rheumatoid Arthritis -Unresponsive Populations Consortium had hoped to start getting data early next year that could help determine who will benefit from TNF therapy. It now hopes to report results in 2013.

The BATTER-UP Consortium had to go back to the drawing board this summer because, despite participation from large companies with extensive experience running RA trials, the group hadn't anticipated how difficult it would be for a consortium-led study to enroll patients at small community practices using payer prescription records.

The consortium is looking to validate an eight-gene biomarker panel to predict differential response to treatment with TNF alpha inhibitors.

The original members represented academia, biotech, pharma, a diagnostic company and a pharmacy benefits manager. Among the members, only Johnson & Johnson has a TNF inhibitor of its own, and only Crescendo Bioscience Inc. has designs on marketing a predictive test. The remaining members had other reasons for participating.

Some, like Biogen Idec Inc., are hoping to identify patients who could benefit from non-TNF molecules in their pipelines. Others, like Genentech Inc., wanted access to samples they can use for their own biomarker research.

The original plan was to identify patients based on prescription records from Medco Health Solutions Inc. But after enrollment flagged, the consortium shifted to traditional recruitment tactics and BATTER-UP has resumed recruitment without the PBM's assistance.

The remaining members expect the change will speed enrollment.

Getting started

RA patients are typically treated with TNF alpha inhibitors as second-line therapy when methotrexate fails to control their symptoms. The anti-TNFs work well, but only in one-third to one-half of patients.

Still, those whose symptoms are not adequately controlled are cycled through other TNF inhibitors, even though response rates decline with each cycle.

"There is probably no point commercially or medically going head-to-head against TNFs," said John Carulli, director of genetics and genomics at Biogen Idec, which has been pursuing alternatives.

The company and partner Genentech market Rituxan rituximab, a chimeric mAb against CD20, for RA and various cancers. In October, Biogen Idec in-licensed a spleen tyrosine kinase (SYK) inhibitor from Portola Pharmaceuticals Inc., which will enter Phase IIa testing for RA in 2H12 (see BioCentury, Nov. 7).

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