Treatment with dupilumab demonstrated improvements in histological markers, symptoms, and endoscopic markers of eosinophilic esophagitis (EoE) regardless of previous history of esophageal dilation.
In patients with eosinophilic esophagitis (EoE), treatment with dupilumab (Dupixent) demonstrated improvements in histological markers, symptoms, and endoscopic markers of the condition regardless of previous history of esophageal dilation. The findings were presented in an abstract at Digestive Disease Week 2023, which took place from May 6-9 in Chicago.1
EoE is an immune condition characterized by a buildup of white blood cells called eosinophils, which leads to chronic inflammation and narrowing of the esophagus. Although esophageal dilation can provide relief from the symptoms of EoE, it does not mitigate the inflammation that causes these symptoms. When EoE is treated with esophageal dilation, this can cause dissociation between histology and symptoms, which may affect clinical trial data interpretation, the study authors noted.
Dupilumab, a monoclonal antibody blocking interleukin (IL)-4 and IL-13, was approved in 2022 by the FDA for EoE based on findings from the 3-part, phase 3 LIBERTY-EoE-TREET study.2 It was shown to improve histologic, symptomatic, and endoscopic aspects of EoE among patients in the trial.
The current study, a prespecified analysis of the LIBERTY-EoE-TREET trial, aimed to determine the efficacy of dupilumab in patients from part A and part B at 24 weeks regardless of prior history of esophageal dilation. Main end points were the percentage of patients who experienced histologic remission and symptom improvements from baseline determined by Dysphagia Symptom Questionnaire (DSQ) scores.
Additional end points included changes in peak esophageal intraepithelial eosinophil count and changes in EoE-Endoscopic Reference Scores and EoE-Histologic Scoring System grade and stage scores.
Patients who required dilation during the screening endoscopy were ineligible for the analysis. Additionally, concurrent treatment with dilation during the study was prohibited, but rescue dilation was allowed.
In part A of the trial, 42.9% of patients in the dupilumab cohort and 43.6% of those in the placebo cohort had a history of esophageal dilation. In part B, 32.5% and 41.8%, respectively, had a history of dilation.
The mean (SD) number of previous dilations in parts A and B were 1.9 (1.2) and 2.5 (3.1), respectively, in the dupilumab group. In parts A and B, the placebo group had mean of 2.0 (1.4) and 2.2 (2.8) previous esophageal dilations, respectively. Patients in the dupilumab group had a mean of 672.6 (767.2) and 818.8 (962.0) days since last dilation in parts A and B, respectively, and patients in the placebo group had a mean of 547.9 (729.9) and 1343.5 (2035.1) days since last dilation.
Patients given dupilumab showed improved outcomes compared with the placebo group in the primary and secondary end points regardless of dilation history. Dysphagia symptoms notably improved in the dupilumab cohort regardless of dilation history, DSQ scores showed. Further, treatment with dupilumab was well tolerated in the study.
Overall, the findings demonstrate the safety and efficacy of dupilumab for EoE, regardless of a patient’s history of esophageal dilation.
1. Bredenoord A, Dellon ES, Hirano I, et al. Dupilumab improves histologic, symptomatic, and endoscopic aspects of eosinophilic esophagitis, regardless of prior history of esophageal dilation. Presented at: Digestive Disease Week 2023; May 6-9, 2023; Chicago, IL. Accessed May 9, 2023. https://eppro01.ativ.me/web/page.php?page=IntHtml&project=DDW23&id=3862676
2. FDA approves first treatment for eosinophilic esophagitis, a chronic immune disorder. News release. FDA. May 20, 2022. Accessed May 9, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-eosinophilic-esophagitis-chronic-immune-disorder