Histologic Response Up With Benralizumab for Eosinophilic Esophagitis

2024-06-26

临床3期临床结果

WEDNESDAY, June 26, 2024 -- Benralizumab yields a greater histologic response than placebo for patients with eosinophilic esophagitis, but does not affect dysphagia symptoms, according to a study published in the June 27 issue of the New England Journal of Medicine.

Marc E. Rothenberg, M.D., Ph.D., from the Leiden University Medical Center in the Netherlands, and colleagues conducted a phase 3 randomized trial involving patients aged 12 to 65 years with symptomatic and histologically active eosinophilic esophagitis. Participants were randomly assigned to receive benralizumab (30 mg) or placebo every four weeks (104 and 107 patients, respectively).

The researchers found that more patients had a histologic response to benralizumab than placebo at 24 weeks (87.4 versus 6.5 percent). However, no significant between-group difference was seen for the change from baseline in the Dysphagia Symptom Questionnaire score. Furthermore, no substantial between-group difference was seen in the change from baseline in the Eosinophilic Esophagitis Endoscopic Reference Score. Overall, 64.1 and 61.7 percent of patients in the benralizumab and placebo groups, respectively, reported adverse events.

"Benralizumab resulted in a higher incidence of histologic response than placebo but did not result in a greater reduction in dysphagia symptoms," the authors write. "This trial calls into question the clinical relevance of monitoring eosinophilic esophagitis for treatment effect solely on the basis of the degree of eosinophilic inflammation."