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ISAEC Launches New Study in IBD; Completes Enrollment in Hypersensitivity, Liver Toxicity Trials

NEW YORK (GenomeWeb News) – The International Serious Adverse Events Consortium has finished enrolling two studies investigating genetic markers linked to drug-induced liver injury and hypersensitivity reactions, and it has launched a new study focused on finding markers of treatment-related inflammatory bowel disease.

Founded in 2007, the iSAEC brings together drug developers, regulatory organizations, and academic centers with the goal of conducting research to uncover the genomic underpinnings of drug-related serious adverse reactions. The consortium's research efforts around liver toxicity and hypersensitivity reactions have been ongoing for several years now.

The consortium has enrolled approximately 1,300 patients in the liver toxicity and hypersensitivity reactions studies. Tom Urban at Duke University and Paola Nicoletti at Columbia University will lead the genetic analysis for the liver toxicity study and researchers at Columbia will perform the data analysis for the hypersensitivity reactions study. Researchers are expecting results in the next six months.

Meanwhile, iSAEC will collaborate with researchers at the Royal Devon & Exeter Hospital in England to gauge genomic markers associated with treatment-related inflammatory bowel disease. The study, called PRED4, will be led by Tariq Ahmad, consultant gastroenterologist at the Royal Devon & Exeter Hospital, and aims to enroll 1,500 participants. To date, researchers have enrolled 900 patients.

The PRED4 study will specifically look for gene markers linked to nephrotoxicity, a type of kidney damage, caused by the anti-inflammatory drug 5ASA; inflammation of the pancreas and low white blood cell count due to the leukemia treatment thiopurine; a kidney disorder caused by proton pump inhibitors for treating stomach acid where the spaces between kidney tubules swell; and a nervous system disease that complicates anti-TNF therapy for rheumatoid arthritis, called demyelination.

In all these studies researchers will mostly apply genome-wide association techniques to identify markers linked to drug-related adverse reactions. Drug-related inflammatory bowel disease, liver toxicity, and hypersensitivity reactions are "quite rare" across drug groups, according to iSAEC CEO Arthur Holden. "In most cases, less than 2 percent of patients taking a given drug at proper dosing are at risk," he said.