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Role of genes in serious skin reactions examined

International Serious Adverse Event Consortium welcomes further research with open information sharing.

Researchers can now access data that examines an individual’s risk of developing serious skin reaction — like Stevens-Johnson syndrome and toxic epidermal necrolysis — based on their genetic makeup.

“We are pleased to be able to provide these invaluable data to the research community to both improve the productivity of drug development and to begin the critical process of developing validated biomarkers to forecast patients who may be at risk for drug-induced serious adverse events,” Arthur Holden, chairman of the International Serious Adverse Event Consortium, said in a press release.

After completing a data use agreement located on the consortium’s website, http://dataportal.saeconsortium.org, interested researchers can generate custom data inquiries.

“This consortium has taken a significant step forward by promoting open sharing of drug safety data,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and research, said in a press release. “This type of cooperation has the potential to lead to more personalized approaches to medicine that can reduce a patient’s risk for experiencing an adverse drug event.”

The database from the International Serious Adverse Event Consortium is the result of a collaborative nonprofit partnership between several pharmaceutical companies, the Wellcome Trust, and academic institutions interested in researching the genetic basis of drug-induced adverse reactions. GlaxoSmithKline plc, London, donated the genetic samples from serious skin rash cases and matched controls. The consortium hopes to publish initial results later this year.