Advocate Aurora Research Institute pediatric researchers contributed to the recent approval of the medicine Dupixent® (Dupilumab) – the first treatment approved by the U.S. Food and Drug Administration (FDA) for eosinophilic esophagitis, or EoE, in adults and children aged 12 years and older, weighing at least 40 kg (88 lbs).
EoE is a disease that causes difficulty with swallowing and may lead to narrowing of the esophagus, commonly known as the food pipe. Food may become stuck in the esophagus, which requires emergent removal through a medical procedure under general anesthesia.
FDA approval was granted after findings from a clinical trial evaluating Dupixent’s safety and effectiveness demonstrated it significantly reduced EoE symptoms compared to placebo.
“EoE is caused by an overreaction of the body’s immune system, which causes swelling, pain and injury to the esophagus, the tube that transfers the food we eat from our throat to our stomach,” said pediatric gastroenterologist T. Gunasekaran, MD, (Dr. Guna) who led the Center for Child and Family Research team at Advocate Children’s Hospital in Park Ridge, Illinois. “As EoE progresses over time, damage to the esophagus increases to the point where a child’s quality of life is altered, and some may have narrowing of the food pipe or poor nutrition when symptoms are severe. Having an additional treatment option to offer adolescent patients with EoE is a gamechanger.”
Dupixent works by blocking proteins in the body believed to contribute to the immune system’s overreaction, called an allergic inflammatory response. Results from the clinical trial showed that Dupixent, given as an injection just below the skin, improved participants’ ability to swallow and decreased the amount of inflammation and swelling in the esophagus.
“Children and adults with EoE often have to follow strict diets to prevent food blockages, and their nutrition and eating behaviors may become negatively impacted as EoE symptoms worsen,” said Cheryl Lefaiver, PhD, RN, director of the Center for Child and Family Research. “We’re honored to have supported a clinical trial that has led to the first FDA-approved medical treatment for this disease.”
Regeneron Pharmaceuticals, manufacturer of Dupixent, sponsored the international clinical trial.
To learn more about Advocate Aurora’s research, visit aah.org/research.