Dupilumab Ups Histologic Response for Pediatric Eosinophilic Esophagitis

2024-06-27

临床结果

THURSDAY, June 27, 2024 -- For children with eosinophilic esophagitis, dupilumab results in a significantly higher percentage of histologic remission, according to a study published in the June 27 issue of the New England Journal of Medicine.

Mirna Chehade, M.D., M.P.H., from Icahn School of Medicine at Mount Sinai in New York City, and colleagues randomly assigned patients aged 1 to 11 years of age with active eosinophilic esophagitis who had had no response to proton-pump inhibitors proton-pump inhibitors to 16 weeks of a higher- or lower-exposure subcutaneous dupilumab regimen or placebo (two groups) in a 2:2:1:1 ratio (Part A). At the end of Part A, in each dupilumab group, eligible patients continued the same regimen, while those in the placebo groups were assigned to 36 weeks of higher- or lower-exposure dupilumab. Dupilumab was administered in one of four doses tiered according to baseline body weight at each level of exposure.

The researchers found that 68 percent of 37 patients in the higher-exposure group, 58 percent of the 31 patients in the lower-exposure group, and 3 percent of the 34 patients in the placebo group had histologic remission in Part A. Compared with placebo, significant improvements were seen in histologic, endoscopic, and transcriptomic measures in the higher-exposure dupilumab regimen. Between baseline and week 52, the improvements in histologic, endoscopic, and transcriptomic measures in all patients were generally similar to those between baseline and week 16 in the patients who received dupilumab in Part A.

"The higher-exposure regimen showed significant benefits as compared with placebo with respect to seven of the eight secondary end points," the authors write.