Histologic Response Up With Benralizumab for Eosinophilic Esophagitis
26 Jun 2024
Phase 3Clinical Result
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."
Several authors disclosed ties to AstraZeneca, which manufactures benralizumab and funded the study.
Abstract/Full Text (subscription or payment may be required)
Editorial (subscription or payment may be required)
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Targets
-Drugs
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.