Eosinophil Depletion with Benralizumab for Eosinophilic Esophagitis.
Publication/Presentation Date
6-27-2024
Abstract
BACKGROUND: Benralizumab is an eosinophil-depleting anti-interleukin-5 receptor α monoclonal antibody. The efficacy and safety of benralizumab in patients with eosinophilic esophagitis are unclear.
METHODS: In a phase 3, multicenter, double-blind, randomized, placebo-controlled trial, we assigned patients 12 to 65 years of age with symptomatic and histologically active eosinophilic esophagitis in a 1:1 ratio to receive subcutaneous benralizumab (30 mg) or placebo every 4 weeks. The two primary efficacy end points were histologic response (≤6 eosinophils per high-power field) and the change from baseline in the score on the Dysphagia Symptom Questionnaire (DSQ; range, 0 to 84, with higher scores indicating more frequent or severe dysphagia) at week 24.
RESULTS: A total of 211 patients underwent randomization: 104 were assigned to receive benralizumab, and 107 were assigned to receive placebo. At week 24, more patients had a histologic response with benralizumab than with placebo (87.4% vs. 6.5%; difference, 80.8 percentage points; 95% confidence interval [CI], 72.9 to 88.8; P
CONCLUSIONS: In this trial involving patients 12 to 65 years of age with eosinophilic esophagitis, a histologic response (≤6 eosinophils per high-power field) occurred in significantly more patients in the benralizumab group than in the placebo group. However, treatment with benralizumab did not result in fewer or less severe dysphagia symptoms than placebo. (Funded by AstraZeneca; MESSINA ClinicalTrials.gov number, NCT04543409.).
Volume
390
Issue
24
First Page
2252
Last Page
2263
ISSN
1533-4406
Published In/Presented At
Rothenberg, M. E., Dellon, E. S., Collins, M. H., Bredenoord, A. J., Hirano, I., Peterson, K. A., Brooks, L., Caldwell, J. M., Fjällbrant, H., Grindebacke, H., Ho, C. N., Keith, M., McCrae, C., Sinibaldi, D., White, W. I., Datto, C. J., & MESSINA Trial Investigators (2024). Eosinophil Depletion with Benralizumab for Eosinophilic Esophagitis. The New England journal of medicine, 390(24), 2252–2263. https://doi.org/10.1056/NEJMoa2313318
Disciplines
Medicine and Health Sciences
PubMedID
38924732
Department(s)
Department of Medicine
Document Type
Article