The Burrill Report


The non-profit International Serious Adverse Events Consortium launched the second stage of its landmark effort to research the genetic underpinnings of drug-induced serious adverse events. Building on earlier findings, it will further explore gene variants that may predict an individual's risk of developing immunologic-related adverse reactions to specific drugs or classes of drugs.

Drug-induced serious adverse events are an important cause of morbidity, resulting in hospitalizations, avoidable healthcare utilization and costs and, in some cases, death. Beyond the human costs, drug-induced serious adverse events observed during the development of new therapies can halt the study of what might have otherwise been a promising new treatment. If genetic factors are determined to contribute to these events, those at risk could be identified and exposure to the adverse event avoided.

“Understanding the genetic underpinnings of major drug-related adverse events such as drug-induced liver injury remains one of our top priorities at FDA,” says Janet Woodcock, director for the U.S. Food and Drug Administration's Center for Drug Evaluation and Research.

The consortium recently completed the first stage of its research activities, focused on pilot genome-wide association studies of drug-induced liver injury and serious skin rash. Researchers identified important genetic markers for certain drug-induced serious adverse events. They also revealed that some genetic variants associated with risk of developing immune-system mediated adverse events--including skin rashes, acute hypersensitivity reactions and drug-induced liver injury—confer this risk for multiple drugs.

The researchers believe that a spectrum of drug-induced immunologic reactions may be influenced by common genetic factors. In the second stage of their study, they will explore this hypothesis through a focused expansion of current drug-induced liver injury and serious skin rash cohorts. The consortium also will initiate an international acute hypersensitivity reaction research network in order to achieve a more integrated biological understanding of the genetics associated with immunologic-based drug-induced serious adverse events.

“Our ideal outcome would be to generate a set of predictive markers for drug-induced serious adverse events, across a number of drugs-drug classes,” says Arthur Holden, chairman of the consortium. “The launch of our Stage II research represents an important step towards this goal.”



September 30, 2010
http://www.burrillreport.com/article-finding_biomarkers_for_drug_induced_serious_adverse_events.html