Dupilumab Enhances Histologic Response in Pediatric Eosinophilic Esophagitis

THURSDAY, June 27, 2024 -- A study featured in the New England Journal of Medicine reveals that dupilumab significantly enhances histologic remission in children with eosinophilic esophagitis. Dr. Mirna Chehade from the Icahn School of Medicine at Mount Sinai in New York City led the research, which involved patients aged 1 to 11 years who did not respond to proton-pump inhibitors.

The study, which was randomized, included children divided into groups receiving either high or low doses of subcutaneous dupilumab or a placebo. The allocation ratio was 2:2:1:1, with the trial divided into two parts (Part A and Part B). Part A lasted for 16 weeks, after which patients receiving dupilumab continued with the same regimen, while those initially on placebo were switched to either higher or lower doses of dupilumab for an additional 36 weeks in Part B.

Dupilumab doses were adjusted based on the child's baseline body weight. The study revealed striking differences in outcomes between the groups. In Part A, 68 percent of the 37 patients in the higher-exposure dupilumab group achieved histologic remission. Similarly, 58 percent of the 31 patients in the lower-exposure group also reached histologic remission. In stark contrast, only 3 percent of the 34 patients in the placebo group showed similar results.

The study also highlighted significant improvements in histologic, endoscopic, and transcriptomic measures in the higher-exposure dupilumab group when compared with the placebo group. These improvements were consistent from the baseline to the 16-week mark and were maintained between baseline and week 52 for all patients on dupilumab.

The authors noted that the higher-exposure dupilumab regimen demonstrated significant benefits across nearly all secondary endpoints when compared with placebo. This study underscores the potential of dupilumab in treating eosinophilic esophagitis in children, offering a promising alternative for those who do not respond to conventional proton-pump inhibitors.

The research received funding from Sanofi and Regeneron Pharmaceuticals, the manufacturers of dupilumab.