A drug approved for the treatment of moderate-to-severe atopic dermatitis (eczema) is showing promise as a treatment for eosinophilic esophagitis (EoE).
EoE is an inflammatory disease whereby the wall of the esophagus fills with eosinophils, a type of white blood cell that is normally not present in the esophagus. In young children, EoE often leads to difficulty feeding, dysphagia (difficulty swallowing) vomiting, abdominal pain, poor growth, malnutrition and weight loss.
At the World Congress of Gastroenterology held in Orlando, Florida, Regeneron and Sanofi presented positive results showing that patients who received dupilumab weekly reported a significant improvement in their ability to swallow versus placebo.
In the 12-week Phase II EoE study, 47 patients were randomized into two treatment groups. Patients received either Dupixent (the brand name for dupilumab) for 300 mg weekly following a 600-mg loading dose or placebo. At week 10, patients who received Dupixent 300 mg weekly showed a 45% improvement compared to a 19% improvement for patients randomized to placebo.
According to the companies, the mean change in the EoE Endoscopic Reference Score was significantly reduced: a 48% improvement in patients who received Dupixent weekly compared to 7% improvement for placebo patients at 12 weeks.
The companies also reported the mean percent change in overall peak intraepithelial eosinophil count at 12 weeks was reduced by 93% from baseline in patients who received Dupixent weekly, compared to a 14% increase among patients randomized to placebo.
“Dupilumab, a monoclonal antibody targeting interleukin IL-4 and IL-13, significantly improved patients’ ability to swallow, inflammation of the esophagus, and endoscopic signs of the disease. These positive Phase II results support further clinical development of dupilumab for patients with eosinophilic esophagitis,” Dr Ikuo Hirano, professor of medicine, Northwestern University Feinberg School of Medicine, said in a statement.