Dr. Katie DeNiro, acting assistant professor, will lead the Harborview trials as part of a multi-site NIH grant studying the treatment of SJS/TEN (Stevens-Johnson syndrome and Toxic Epidermal Necrolysis), severe, blistering skin diseases that are potentially fatal.
Dr. DeNiro, along with Dr. Sam Mandell, a UW Medicine burn surgeon, will lead the randomized control trial at Harborview Medical Center, as part of the multi-site study titled The North American Therapeutics In Epidermal Necrolysis Syndrome (NATIENS) Study: A Phase III Randomized Double Blinded Study to Determine the Mechanisms and Optimal Management of Stevens-Johnson syndrome and Toxic Epidermal Necrolysis. The study is expected to be rolled out in 21 additional sites nationwide.
“Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), are severe, life-threatening adverse drug reactions that affect 60,000 patients per year globally at an incidence of 5 cases per 1,000,000 in the United States. This is the only trial of this kind and treatment options are limited.” From https://www.natiensstudy.org/
As part of the study, eligible patients with SJS/TEN are randomized to receive one of three potential therapeutics - etanercept, cyclosporine or supportive care (normal standard of care). The study then follows the patient’s disease progression over time to determine which approach(es) offers the most optimal outcomes.
Enrollment in the clinical trial is expected to begin 2021.